Coronavirus updates February 2022

[missy]

Opinion | The New Kid on the Covid-Vaccine Block

Novavax, up for FDA authorization, will be a good booster option.

www.wsj.com

The New Kid on the Covid-Vaccine Block​

Novavax, up for FDA authorization, will be a good booster option.​

"
I’m usually cautious about prescribing new vaccines and treatments for my patients. For a year after the Food and Drug Administration’s 2017 approval of Shingrix, GlaxoSmithKline’s vaccine for shingles, I was reluctant to administer it, choosing to wait for the thousands of people who took it in the clinical trial to turn into millions in the real world. But now that I’m confident it’s well-tolerated and effective, I offer it to any patient over 50.

With the Covid emergency I suspended my practice of waiting and began recommending the mRNA vaccines as soon as they were available. I’m very glad I did. But Covid fatigue, fear of novel technology, and a sense that the mRNA vaccines may not be up to the task against future variants have held many people back from taking the vaccine in the first place or getting a booster.
There will soon likely be an alternative. Novavax last month applied to the FDA for emergency-use authorization of its “protein adjuvant” Covid shot—the same technology on which Shingrix is based. The Novavax shot has already been approved in other countries, including the U.K.
Data released by the company in December shows immune protection against the Omicron variant. An Oxford study found it to be effective against Omicron when given as a booster following another Covid vaccine, including those from Pfizer and Moderna.

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The Novavax vaccine is based on tried and true technology. It involves growing the virus’s spike protein in moth cells and then combining it with an adjuvant, a chemical that amplifies the protein’s effect on the immune system. Whereas the mRNA vaccines signal human cells to make part of the protein, Novavax injects it directly as a “nanoparticle,” which induces a robust immune response (antibodies and T-cells). Side effects appear to be minimal: flulike symptoms, headache, temporary fatigue and pain at the injection site.
There are several reasons to think that Novavax may give a more powerful boost than a third or fourth mRNA shot. For one thing, the nanoparticle includes the whole spike protein, which could provoke a more complete immunity. So could the glycosylation of the spike—the addition of a sugar molecule in insect cells, which isn’t what the virus is expecting. Perhaps most important, the adjuvant (known as Matrix-M1), which comes from the inner bark of a Chilean soapbark tree, is very high in quality and has been used to make a malaria vaccine effective.
If you take Novavax as your original vaccine, would there be an advantage to an mRNA booster? Not likely, since the Novavax vaccine is already introducing the spike protein of the virus into the body—unless the mRNA shot was specifically designed to target an emerging variant.
The Omicron wave is receding fast, but other variants could emerge. The more vulnerable people who are vaccinated and boosted, the sooner the pandemic will be over. The FDA should act expeditiously to authorize an important tool we need in our armamentarium against Covid.
Dr. Siegel is a clinical professor of medicine at NYU Langone Health and a Fox News medical correspondent.
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[missy]

Extend the Interval Between COVID Vaccine Doses​

— The safety and effectiveness data should prompt CDC to update its policy​

by Michael Daignault, MD, and Monica Gandhi, MD, MPH February 14, 2022

"

On Friday, February 4, the Advisory Committee on Immunization Practices (ACIP) quietly acknowledged the rapidly accumulating body of evidencesupporting an extended interval between the first and second dose of a two-dose COVID-19 vaccine series. ACIP members weighed the benefits of extending the interval between doses of the two mRNA vaccines -- currently 3 weeks for Pfizer (Comirnaty) and 4 weeks for Moderna (Spikevax) -- to 8 weeks, based on both effectiveness and safety data. Updating the guidelines would represent a seismic policy shift in this country.



We welcome the long-overdue recognition of this evidence-based approach already endorsed by multiple other countries including Canada, India, the U.K., and other countries in Europe. Although the two-dose series of the Pfizer vaccine was studied at an interval of 3 weeks and the Moderna vaccine at an interval of 4 weeks, the companies were aware of the urgent global need for an effective COVID-19 vaccine while designing these interval strategies. Except for rabies, no other vaccine is given at a dosing interval of 3 weeks. In fact, a principle of vaccinology is that priming the immune system with the first dose generates good responses to second doses of most vaccines for at least 6 months or more.

There are three main lines of evidence for extending the COVID-19 vaccine dosing interval: 1) immunologic; 2) vaccine effectiveness studies; and 3) safety studies regarding the low risk of myocarditis with mRNA vaccines.

Immunologic Research



Many immunologic studies have shown higher SARS-CoV-2 antibody levelsfrom extending the time between doses. Beyond the many studies showing a higher antibody response, several have shown that increasing the interval between doses amplifies the cellular immune response, which is important for durability. One important immunologic study verified that extending the interval of the Pfizer vaccine from 3 to 6 weeks not only increased antibody levels, but also, enriched T cells against COVID-19. T cells amplify the body's response to a virus, help recruit cells to attack the pathogen, and generally protect us from severe disease. COVID-specific T cells protect us against variants, including omicron. Another study of healthcare workers verified the increased antibody response from extending the interval from 3-4 weeks to 6-8 weeks with Pfizer, and also showed a 7-fold increase in the magnitude of the B-cell response. B cells triggered by the vaccines are able to produce new antibodies if they ever see the virus, even if it has mutated.



Vaccine Effectiveness in the Real World

In terms of vaccine effectiveness in real-world settings, the bulk of research is from countries that, early on in their vaccine rollout, opted to accelerate population coverage with a single dose in the face of limited supply of both the Pfizer/BioNTech and Oxford/AstraZeneca vaccines and the rapidly spreading alpha (B.1.1.7) variant. The interval between the first and second doses was extended up to 12 weeks and 16 weeks, in the U.K. and Canada respectively, to accomplish that goal, and with the anticipation that doing so would extend the longevity of protection. Data from Quebec verified that extending the interval of the Pfizer vaccine from 3 to 8 weeks increased vaccine effectiveness from 82% to 92% in real-world settings. The National Advisory Committee on Immunization in Canada (counterpart to the U.S. ACIP) recognized the increased effectiveness of the extended interval dosing in its formal guidelines.



Safety

In the context of unanimously approving Moderna's vaccine, ACIP members discussed the rate of myocarditis/pericarditis in those who received both Pfizer and Moderna vaccines. The rates are extremely low (67.5 and 46.8 cases per million, respectively for Moderna and Pfizer) and the vast majority of cases are self-limiting with full recovery.

Notably, the risk of these side effects is highest after the second dose. A pre-print study of 19.7 million doses of Pfizer and Moderna vaccine given to participants in Canada demonstrated a significantly lower risk of myocarditis/pericarditis in those who were vaccinated on an extended 8-week dosing schedule. Although the quantified risk of myocarditis/pericarditis is much higher with actual infection from COVID-19 than from mRNA vaccines, fear of this rare side effect has stopped some adults from getting vaccinated and prevented many parents from vaccinating their children. Nationally, only 28% of children 5 to 11 years old had received at least one dose of COVID-19 vaccine as of mid-January.



Therefore, a growing consensus for an extended interval of 8 weeks represents a "sweet spot" to both reduce this risk and address the concerns of unvaccinated adults and/or their children.

We do recognize that an extended interval between doses may not be an option for everyone, particularly high-risk groups like the elderly, those with multiple comorbid conditions, or those with moderate to severe immunocompromised conditions. This approach might also be unfavorable when disease prevalence is high.

Many of us have already advised our own patients and family members to strongly consider an extended interval between the first and the second doses. An official policy change from the CDC would go a long way to restore the public's trust in the organization's guidance. It would also send a strong signal to the public that our vaccine guidance is a continually evolving, data-based scientific process to ensure the most robust benefit while minimizing harm. For the millions of Americans who remain unvaccinated and who are perhaps overwhelmed by the daunting task of needing three vaccine doses to be up-to-date, an extended interval schedule could be more appealing and assuage their hesitancy.



We strongly recommend that ACIP further discuss the benefits of an 8-week extended dosing interval for a two-dose vaccine series and formally adopt this policy at their next meeting.

Michael Daignault, MD, is an emergency physician at Providence Saint Joseph Medical Center in Burbank, California. Monica Gandhi, MD, MPH, is a professor of medicine in the school of medicine at University of California, San Francisco.

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[missy]

Higher Estrogen Levels May Protect Against COVID-19 Death​

— Postmenopausal women on hormone replacement therapy had lower risk of severe outcomes​

by Amanda D'Ambrosio, Enterprise & Investigative Writer, MedPage Today February 14, 2022

"

Women with increased estrogen levels had a lower risk of death from COVID-19, suggesting that female sex hormones may have protective effects against severe illness, according to a cohort study from Sweden.
Postmenopausal women who were taking hormone replacement therapy were more than 50% less likely to die from COVID-19 compared with those with natural estrogen levels, and the association remained significant after adjustment for confounders (adjusted OR 0.47, 95% CI 0.34-0.63), reported Anne-Marie Fors Connolly, MD, PhD, of Umeå University in Sweden, and colleagues.

On the other hand, postmenopausal women who had pharmaceutically decreased levels of estrogen due to adjuvant endocrine therapy for breast cancer were more than twice as likely to die of COVID-19 (OR 2.35, 95% CI 1.51-3.65), though this association was no longer significant after adjustment for confounders, they noted in BMJ Open.
"This study shows an association between estrogen levels and COVID-19 death," Fors Connolly and colleagues wrote. "Consequently, drugs increasing estrogen levels may have a role in therapeutic efforts to alleviate COVID-19 severity in postmenopausal women and could be studied in randomized control trials."
The authors also found that older age and comorbidity index were associated with increased risk of death from COVID-19. For every year increase in age, the adjusted odds ratio of COVID-19 death was 1.15 (95% CI 1.14-1.17). For every increase in the weighted comorbidity index, the risk of COVID-19 death was 13% higher (adjusted OR 1.13, 95% CI 1.10-1.16). Low income and education level were also associated with increased risk of death from COVID-19 among this population.

One possible mechanism for the decreased risk of COVID-19 death among women with high estrogen levels is the hormone's effect on the ACE2 receptor, a key entry point for SARS-CoV-2, Fors Connolly and colleagues said. A previous study found that cells exposed to testosterone and estrogen behaved differently -- while testosterone upregulates ACE2 expression in cells, estrogen downregulates it.
This nationwide registry study included 14,685 women ages 50 to 80 who tested positive for COVID-19, grouped into three categories based on their estrogen levels: 2,535 with increased estrogen due to hormone replacement therapy, 227 with decreased estrogen due to anti-estrogen treatment for breast cancer, and 11,923 with native estrogen (control group).
Fors Connolly and team compared COVID-19 deaths in each cohort, adjusting for confounders including age, annual income, education, and medical comorbidities.
Women who had lower levels of estrogen were older and had more comorbidities, and those with higher levels were more likely to have a high income and to have completed post-secondary education.

The absolute risk of death from COVID-19 was 2.1% among women with increased estrogen levels, 10.1% among those with decreased estrogen levels, and 4.6% among those in the control group.
Fors Connolly's group recognized that this research could not identify actual estrogen modulation levels, which may have limited the findings. Additionally, while there was a trend between decreased estrogen levels and a higher risk of death from COVID-19, the group of women who had decreased estrogen levels was too small to show significance. They also noted that they did not have data for potential confounding factors, such as BMI, nutrition, and smoking habits.

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[missy]

A possible new tool to fight omicron​

After omicron weakened some of the defenses that doctors have against Covid, an experimental treatment being developed by Novartis and a small Swiss biotech partner holds some promise as a new therapy. Last week, Novartis sought emergency approval from the U.S. Food and Drug Administration for an intravenous drug, called ensovibep, that’s similar in some ways to monoclonal antibody treatments. However, the way it works is significantly different, which might allow it to succeed where antibody therapies fail against omicron. The compound uses tiny proteins to attack the coronavirus’s spike protein in not just one, but multiple places. That appears to give it a leg up in fighting the virus even as it mutates. The building blocks of the treatment, developed by a company called Molecular Partners, are called DARPins. About one-tenth the size of traditional monoclonal antibodies, they can be hooked together into chains, providing a relatively fast way to design a biological drug that can launch a multi-pronged attack against disease. And unlike monoclonal antibodies, which are produced inside cells, the DARPins are made with bacteria, a much faster and cheaper way to manufacture large quantities. A health-care worker removes an IV infusion on a patient after receiving a monoclonal antibody treatment. Photographer: Emily Elconin/Bloomberg The Swiss drug giant exercised an option to license ensovibep this year after a 407-person trial showed that Covid patients who took the therapy had a 78% lower risk of needing an emergency health-care visit, being hospitalized or dying. Investors have noticed. Molecular Partners’s market value has increased by about a third this year to about 750 million francs ($811 million). However, significant hurdles remain. Bloomberg Intelligence pharma analyst Sam Fazeli has said there’s a lack of safety data, and it’s still unclear whether doctors would be able to use the medicine repeatedly — or how soon it would need to be given after symptoms appear. The therapy needs to be administered via an intravenous infusion, which makes it less convenient than antivirals from Merck and Pfizer that are taken as pills. The future of ensovibep will depend in part on how the pandemic unfolds. Public health authorities caution that it’s impossible to rule out more variants and a potential resurgence, in particular in places with lower vaccination rates. Also yet to be seen is how the experimental drug performs in the larger study Novartis aims to finish by the second half of this year. — Thomas Mulier and Naomi Kresge

 

[missy]

Perspective

Health Care Safety during the Pandemic and Beyond — Building a System That Ensures Resilience​

List of authors.

• Lee A. Fleisher, M.D.,
• Michelle Schreiber, M.D.,
• Denise Cardo, M.D.,
• and Arjun Srinivasan, M.D.

"
For about two decades, the U.S. health care system was making strides in improving patient safety, as demonstrated by the reduction of health care–associated infections and other complications of care.1 Though there was still room for improvement, the trends were certainly in the right direction. Since the Covid-19 pandemic began, however, many indicators make it clear that health care safety has declined. The public health emergency has put enormous stress on the health care system and disrupted many normal activities in hospitals and other facilities. Unfortunately, these stressors have caused safety problems for both patients and staff. Managing the competing priorities of providing care for large numbers of patients with Covid, as well as for the patients without Covid who need care every day, and of maintaining safety efforts such as robust infection-control practices is both difficult and essential.

The fact that the pandemic degraded patient safety so quickly and severely suggests that our health care system lacks a sufficiently resilient safety culture and infrastructure. We believe the pandemic and the breakdown it has caused present an opportunity and an obligation to reevaluate health care safety with an eye toward building a more resilient health care delivery system, capable not only of achieving safer routine care but also of maintaining high safety levels in times of crisis.
We have observed substantial deterioration on multiple patient-safety metrics since the beginning of the pandemic, despite decades of attention to complications of care.2-4 Central-line–associated bloodstream infections in U.S. hospitals had decreased by 31% in the 5 years preceding the pandemic; this promising trend was almost totally reversed by a 28% increase in the second quarter of 2020 (as compared with the second quarter of 2019).3 There were also increases in catheter-associated urinary tract infections, ventilator-associated events, and methicillin-resistant Staphylococcus aureus bacteremia. Safety has also worsened for patients receiving postacute care, according to data submitted to the Centers for Medicare and Medicaid Services (CMS) Quality Reporting Programs: during the second quarter of 2020, skilled nursing facilities saw rates of falls causing major injury increase by 17.4% and rates of pressure ulcers increase by 41.8%. The surges of the delta and omicron variants of SARS-CoV-2 in late 2021 and early 2022 do not bode well for a return to prepandemic levels for any of these indicators.
There are multiple potential explanations for these increases in adverse events. The health care system has been challenged by repeated influxes of vast numbers of very ill patients, which have stretched staff and supplies. Health care personnel have responded with extraordinary effort and dedication, adapting with unprecedented speed and developing and modifying treatment protocols on the basis of data that have evolved by the week. They have done all these things while battling workforce-safety problems such as exhaustion and a dearth of personal protective equipment, at great risk to themselves and their loved ones. We have seen an increasing number of media reports about the rising incidence of staff burnout, which is causing health care workers to leave practice, retire, or move into other industries.
The strains on the system have also affected routine safety practices. Overworked clinicians have often had no time for safety rounds, safety audits, or error reporting. Supply-chain disruptions reduced access to personal protective equipment, putting both patients and health care workers at risk. Standard safeguards, such as checklists, quickly became inadequate. Moreover, the pandemic starkly highlighted health disparities, including inequities in the safety of patients and health care personnel.5
As Mary Dixon-Woods and colleagues argued in a 2011 article entitled “Explaining Michigan,” contextual influences are important in solving safety problems. We therefore need to reevaluate whether the health care system has sufficiently invested in ensuring a deeply embedded safety culture and maintaining an unflagging commitment to safety. It is abundantly clear that the health care ecosystem cannot ask clinicians and staff to work harder, but must instead provide them with more tools and an environment built on a strong foundation of wellness and on instilling and rewarding a culture of safety. CMS must also use our oversight functions to ensure that emergency-preparedness and quality-improvement programs are more than plans on a shelf. Such a culture would ensure that patients and staff are protected from harm while rendering the system more resilient, especially during a crisis. So how do we bolster the health care ecosystem to avoid future threats to patient safety?
As we emerge from this public health emergency, we at CMS and the Centers for Disease Control and Prevention (CDC) are committed to a renewed focus on patient safety. We seek to join leaders from throughout the health care ecosystem in reviewing safety practices and seeking better and more deeply embedded solutions that also help to close health disparities, since there is no true health care quality and safety without equity. We are already working together to expand the collection and use of data on safety indicators in our programs, including data in such key areas as maternal health and mental health, and we will work with other government and nongovernmental organizations to further enhance patient safety. We are also developing safety metrics that draw on the rich clinical data captured digitally in electronic medical records, which incorporate information from all health care payers. Some electronic clinical quality measures are already being considered for inclusion in patient-safety monitoring in the CMS Quality Payment Program.
Over time, the U.S. health care sector has implemented various pieces of the safety-assessment-and-improvement puzzle, but it has not instituted a thorough system of safety that reaches from the boardroom to the front lines and that can be maintained during times of crisis. For example, it is important to have sufficient resources such as staff and personal protective equipment for times of stress. The United States deserves breakthrough thinking about systems built on foundational principles of safety, akin to those used in other industries in which safety is embedded in every step of a process, with clear metrics that are aggregated, assessed, and acted on. We also need renewed national goals of harm elimination throughout the health care system and a core safety strategy that includes promoting radical transparency, addressing workforce shortages, and continuing to strive for safety while being sensitive to such trade-offs as reporting burden and costs. This effort should extend across the continuum of care, beyond the traditional hospital-based safety indicators, and include attention to diagnostic errors and outpatient care.
The health care sector owes it to both patients and its own workforce to respond now to the pandemic-induced falloff in safety by redesigning our current processes and developing new approaches that will permit the delivery of safe and equitable care across the health care continuum during both normal and extraordinary times. We cannot afford to wait until the pandemic ends.
Disclosure forms provided by the authors are available at NEJM.org.
This article was published on February 12, 2022, at NEJM.org.

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[missy]

"
Coronavirus vaccines not only protect pregnant people from severe covid-19 — they appear to protect infants, too, according to a new study from the Centers for Disease Control and Prevention. Researchers found that infants whose mothers were fully vaccinated with mRNA shots during pregnancy were 61 percent less likely to be hospitalized with the disease in their first six months of life. The protection was even stronger if the mothers got the shots after week 20 of pregnancy. The findings are the first real-world evidence that mothers can pass on vaccine-induced antibodies that shield their babies from severe illness.

Pandemic-era excess deaths — that is, deaths above the expected norm — surpassed 1 million in the United States this month, according to federal health data. That's more than the documented U.S. death toll from the coronavirus, which itself recently topped 900,000. The vast majority of the excess deaths tallied by the CDC were from the virus, though deaths from heart disease, hypertension, dementia and other conditions over the past two years were also elevated.

As the pandemic has evolved, so has our toolkit for managing it. Vaccines are the first line of defense. But it's become clear that we'll need more than the shots if we're going to live with the coronavirus for the foreseeable future. Here's a look at the medicines, treatments and teststhat will help us tame the pandemic.

With the wave of cases driven by the omicron variant subsiding, the Biden administration is laying the groundwork to prepare for future surges. My colleagues Tony Romm and Tyler Pager report that officials have told lawmakers the administration may need about $30 billion in additional pandemic aid to restock key public health programs that they tapped to deal with omicron. Republicans on Capitol Hill have signaled that they may not approve new spending until they get a fuller accounting of the roughly $6 trillion authorized since the start of the pandemic.

Protests against public health measures are still simmering in Canada. The movement has attracted a growing number of anti-government activists and far-right figures since it began late last month. In response, many Canadian truck drivers are distancing themselves from protest supporters they view as radical and fringe. Ottawans, meanwhile, want the protesters out of their city.

Other important news​

The CDC lowered its travel warning for cruises from “very high” to “high.”Avoid the big boats if you're unvaccinated, officials said.

For two years, Hong Kong held off the pandemic. Then, everything fell apart.

An Air Force officer can avoid the vaccine mandate for new on religious grounds, a court ruled. She's the first in the military branch to receive such an excusal.

Virginia's governor today signed a law to make masks in schools optional by March 1.

Some in the airline industry want a “no-fly” list for disruptive passengers. Eight GOP senators say they oppose it because it would equate mask opponents to “terrorists.”""

 

[missy]

Infectious Disease>COVID-19 Vaccine

Long COVID Less Likely in the Vaccinated​

— Even getting vaccinated after infection appears to help, review concludes​

by Crystal Phend, Contributing Editor, MedPage Today February 16, 2022

"
Vaccinated people are less likely to get so-called long COVID, while those infected while unvaccinated may recover from persistent symptoms faster if they get the shot, a U.K. Health Security Agency review determined.

Fully vaccinated people who became infected with COVID-19 were roughly half as likely to have any symptoms lasting more than a month, 78% less likely to have symptoms lasting 12 to 20 weeks, and 13% less likely to have at least one symptom at 6 months, according to six of the eight studies summarized in a rapid evidence briefing document.



One preprint study of moderate quality suggested the opposite -- a more than twofold higher risk of symptoms at 4 weeks from the date of diagnosis versus unvaccinated participants -- but it wasn't clear why this study contradicted the rest, the document noted, calling for more analysis.

In studies that broke down symptoms individually, there was lower likelihood of developing olfactory dysfunction and significantly lower risk at 6 months for anosmia, fatigue, hair loss, interstitial lung disease, myalgia, and "other" pain.

These findings are likely an underestimate of the effectiveness of vaccination in preventing long COVID, since the studies included only vaccinated people who were infected, not those who had infection prevented entirely, the document pointed out.

The review also found that people who already had long COVID but then got vaccinated were more likely to have improvement in symptoms -- either immediately or in the weeks afterward -- compared with those who remained unvaccinated, although most had no change in symptoms and a small number had worsening after vaccination.



The one study that looked at timing of vaccination suggested that getting the shot sooner was much better than later in terms of likelihood of symptom improvement.

"These studies add to the potential benefits of receiving a full course of the COVID-19 vaccination," said Mary Ramsay, MBBS, head of immunization at the U.K. agency, in a statement. "Vaccination is the best way to protect yourself from serious symptoms when you get infected and may also help to reduce the longer-term impact."

An estimated 2% of the U.K. population reported COVID symptoms lasting more than 4 weeks after infection as of Dec. 6, 2021, well into the Omicron wave of the pandemic.

According to a prior review of mobile app data tracking cases in U.S., U.K., and Swedish populations, symptoms persisted in up to 13% of infected individuals at 1 to 2 months and in 2.6% for 3 months or longer. Potentially more reliable data from clinic-based assessments suggested that 33% to 98% of survivors have symptoms for at least a month after infection.



The U.K. Health Security Agency analysis included a total of 15 studies of long COVID: four from the U.S., four from the U.K., two from India, two online with participants in multiple countries, and one each from France, Indonesia, and Israel. Full vaccination was universally considered two doses of a two-dose vaccine series or one of a single-dose vaccine.

The document cautioned that all of the studies considered were observational. "As there are many differences between people who are and are not vaccinated, there is a risk in all these studies that factors other than vaccination status may have influenced the results (in any direction)," it pointed out.

Additionally, the studies varied widely in their definition of long COVID, and the rapid review precluded pooled or meta-analysis of the findings together.

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[missy]

COVID Infection Linked to Slew of Mental Health Conditions​

— Including higher risk for new disorders and medications​

by Kristen Monaco, Staff Writer, MedPage Today February 16, 2022

"
People who battled COVID-19 infection had a higher risk of multiple mental health conditions, a new study found.
Among those who survived the first 30 days of COVID-19 infection, there was a 60% (HR 1.60, 95% CI 1.55-1.66) increased risk for having any new mental health diagnosis or a new mental health-related drug prescription compared with those who were never infected, reported Ziyad Al-Aly, MD, of the VA Saint Louis Health Care System in Missouri, and colleagues.

This heightened risk was largely driven by an uptick in mental health-related drug prescriptions, which increased by 86% (HR 1.86, 95% CI 1.78-1.95), the group wrote in The BMJ.
Of note, this higher risk for new mental health disorders was evident even in those who weren't hospitalized for COVID-19, the researchers noted.
In terms of the specific new mental health diagnoses, COVID-19 survivors saw significantly higher risks for developing anxiety disorders (HR 1.35, 95% CI 1.30-1.39), which included a higher risk for generalized anxiety disorder, mixed anxiety disorder, and panic disorder.
Likewise, these individuals carried a higher risk for depressive disorders (HR 1.39, 95% CI 1.34-1.43), including both single episode and recurrent major depressive disorder, as well as suicidal ideation. There was also a 38% higher risk for developing stress and adjustment disorders, which included both acute stress and adjustment disorder and PTSD.
COVID-19 infection was also significantly related with new substance use disorders (HR 1.20, 95% CI 1.15-1.26). This increased risk encompassed a higher risk of new-onset illicit drug disorder, alcohol use disease, and opioid use disorder, as well as sedative or hypnotics use disorder.

During the post-acute phase following COVID-19 infection, people also saw an 80% higher risk for neurocognitive decline. These individuals also struggled with sleep troubles, classified as a higher risk for both sleep disorders and new sleep-related medications.
People who were infected with COVID-19 had significantly higher risks for several new prescriptions versus individuals free of COVID infection:

• Any antidepressants: HR 1.55 (95% CI 1.50-1.60)
• Selective serotonin reuptake inhibitors: HR 1.54 (95% CI 1.49-1.60)
• Serotonin and norepinephrine reuptake inhibitors: HR 1.22 (95% CI 1.17-1.2
• Benzodiazepines: HR 1.65 (95% CI 1.58-1.72)
• Any opioids: HR 1.76 (95% CI 1.71-1.81)
• Naloxone or naltrexone: HR 1.23 (95% CI 1.18-1.29)
• Methadone: HR 1.94 (95% CI 1.47-2.56)
• Buprenorphine: HR 1.34 (95% CI 1.12-1.62)

Al-Aly's group also found that COVID-19 survivors still carried significantly higher risks for new mental health disorders when compared with individuals with seasonal influenza. Also, those hospitalized for COVID-19 likewise were at a higher risk compared with patients hospitalized for any other cause.
"The findings suggest that people who survive the acute phase of Covid-19 are at increased risk of an array of incident mental health disorders. Tackling mental health disorders among survivors of Covid-19 should be a priority," Al-Aly and co-authors wrote.

An accompanying editorial noted that despite the significant -- and consistent -- relationships seen in the study between COVID-19 infection and increased risks for mental health conditions, the associations might eventually fade. Scott Weich, MBBS, MD, MSc, of the University of Sheffield in England, said that while the study showed persistent group differences for the first 12 months after infection, the absolute risk of experiencing a psychiatric disorder decreased sharply after the first month.
"Importantly, mental healthcare might have been more accessible to those known to have had Covid-19 than contemporaries without this condition or among historical cohorts, further biasing estimates away from the null," Weich wrote.
"The worst of the pandemic might be behind us in terms of mortality and social restrictions," he said, adding that "much of the research concerned with the mental health impacts of Covid-19 represents more hindsight than insight."
Weich suggested that the healthcare community focus less on "syndromal phenotypes" of mental health disorders and instead shift focus to effective interventions, including new clinical trials.

For the analysis, the researchers examined data from the U.S. Department of Veterans Affairs. This included 153,848 patients who survived at least 30 days after a positive COVID test between March 2020 and January 2021 -- 132,852 who were not admitted to the hospital and 20,996 who were.
New diagnoses were based on ICD-10 codes, and new medications were based on prescription records.

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[missy]

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Medical News & Perspectives

February 16, 2022

When Physicians Spread Unscientific Information About COVID-19​

Rita Rubin, MA
Article Information
JAMA. Published online February 16, 2022. doi:10.1001/jama.2022.1083

In a poll of 2200 US adults conducted in December 2021 for the de Beaumont Foundation, a philanthropy that focuses on policy and public health, 78% said physicians who intentionally spread COVID-19 misinformation should be disciplined.
Professional medical societies and specialty boards agree, yet few physicians have been disciplined for espousing COVID-19 claims for which evidence is lacking.
For example, in October 2021, Howard Goldman, MD, of Delray Beach, Florida, filed a complaint with the Florida Department of Health’s Medical Quality Assurance Program about a physician he alleged “spread doubt about the safety and effectiveness of COVID-19 vaccines, promoted the use of unproven and possibly dangerous medications to treat COVID-19, [and] questioned the value of face masks in preventing the spread of the pandemic.”
The subject of Goldman’s complaint was internist Joseph Ladapo, MD, PhD, Florida’s Surgeon General and head of the Florida Department of Health.
However, the investigation manager for the Medical Quality Assurance Program’s Bureau of Enforcement notified Goldman in November that no action could be taken “because the healthcare provider has not violated any laws or rules regulating this profession.” Yet on December 17, 2021, Ladapo continued to publicly contradict CDC recommendations on vaccines, masks, and testing.
The Florida Department of Health media office did not respond to JAMA’s request for comment from Ladapo.
Researchers at the Center for Health Security at the Johns Hopkins Bloomberg School of Public Health recently estimated that 2 million to 12 million people in the US were unvaccinated against COVID-19 because of misinformation or disinformation. And an Axios-Ipsos poll of 995 US adults conducted in March 2021 found an association between susceptibility to COVID-19 vaccine misinformation and the likelihood of being unvaccinated. The poll asked people whether 6 false statements about COVID-19 vaccines—including 1 about microchips in vaccines to track recipients—were true or false and whether they were vaccinated. Only 15% of respondents who thought all 6 false statements were true said they were already vaccinated or very likely to be vaccinated, compared with 85% of people who correctly said all 6 statements were false.
COVID-19 misinformation and disinformation flood the public discourse; physicians are not the only source. But their words and actions “may well be the most egregious of all because they undermine the trust at the center of the patient-physician relationship, and because they are directly responsible for people’s health,” Pawleys Island, South Carolina, family medicine physician Gerald E. Harmon, MD, president of the American Medical Association (AMA), (which publishes JAMA), wrote recently. In November, the AMA House of Delegates adopted a new policyto counteract disinformation by health care professionals.
Few physicians have been disciplined so far, even though the Federation of State Medical Boards (FSMB), representing the state and territorial boards that license and discipline physicians, and, in some cases, other health care professionals, and the American Board of Medical Specialties (ABMS), consisting of the boards that determine whether physicians can be board-certified, have issued statements cautioning against spreading false COVID-19 claims.
In July 2021, the FSMB warned that spreading COVID-19 misinformation could put a physician’s license at risk. The organization said it was responding “to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals.”
The ABMS released a statement in September 2021. “The spread of misinformation and the misapplication of medical science by physicians and other medical professionals is especially harmful as it threatens the health and well being of our communities and at the same time undermines public trust in the profession and established best practices in care,” the ABMS said.

“No License for Disinformation”
In an annual survey of its 70 member boards conducted in fall 2021, the FSMB asked about complaints and disciplinary actions related to COVID-19. Of the 58 boards that responded, 67% said they had seen an uptick in complaints about licensees spreading false or misleading COVID-19 misinformation, according to results released in December 2021. But only 12 (21%) of the 58 boards said they’d taken disciplinary action against a physician for that reason.
Only state medical boards, not any other professional organizations and not the specialty boards that certify physicians, can grant, suspend, or revoke medical licenses, “the most important piece of paper a physician ever gets,” FSMB President and Chief Executive Officer Humayun Chaudhry, DO, said in an interview. State medical boards typically do not make public ongoing investigations.
“Misinformation and disinformation was not created by this pandemic,” Chaudhry said. “It’s always been around.” However, before the advent of social media, physicians espousing false information usually did so without attracting much attention, Chaudhry said.
The power of social media amplifies the message of the relatively few physicians making false claims, Rachel Moran, PhD, a postdoctoral scholar at the University of Washington’s Center for an Informed Public who studies the spread of misinformation and disinformation, said in an interview. This amplification “makes it seem like there is more of a split within the medical community,” she said, noting that “misinformation thrives in this uncertainty.”
Physicians who make false claims about COVID-19 vaccines and mitigation measures often couch them in technical language that sounds convincing to nonscientists, Moran said. “All you’re hearing is a lot of medical jargon that you don’t have the skills to debunk.” Complicating matters, she said, is that “your health decisions have become so intertwined with your political identity, which we haven’t seen before.”
Traditionally, state medical boards, which predate the internet and social media by decades, have focused on disciplining physicians whose actions caused harm to patients under their care, not to people the physicians have never met who follow them on social media, Chaudhry noted. Boards do not have the resources to scour the internet to find physicians who make false COVID-19 claims and instead depend on members of the public to file complaints about them, he said.
“Some state boards have said to us, ‘we need a little more guidance,’” Chaudhry acknowledged, adding that the FSMB’s Ethics and Professionalism Committee is developing a more comprehensive guidance that will be voted on for adoption by the organization’s House of Delegates in April.
Each case is different, and each board handles complaints differently, depending on the size of their staff and state laws. “We recognize that there are gray areas in medicine,” but even so, whatever physicians claim must be grounded in science, Chaudhry said.
The FSMB has not yet compiled 2021 data, but state medical boards disciplined fewer physicians overall in 2020, the pandemic’s first year, than in 2019. In 2020, among the more than 1 million licensed physicians in the US, state medical boards took disciplinary action against 7112 physicians, compared with 8166 in 2019, according to data supplied by the FSMB. The organization did not provide the reasons physicians were disciplined, including whether any of these actions involved the spread of unscientific information.
Nick Sawyer, MD, MBA, a Sacramento, California, emergency medicine physician, became so frustrated with what he viewed as state medical boards’ inaction over physicians spreading COVID-19 falsehoods that in September he created a nonprofit organization, No License for Disinformation, to get the word out.
“The state medical boards need to come out and support us,” he said in an interview. “As long as there are no real consequences, these people are going to continue what they’re doing.”
Strongly worded statements against false COVID-19 claims, such as those issued by the FSMB, are not enough, Sawyer said, noting that a widely publicized January 23, 2022, march against COVID-19 vaccine mandates in Washington, DC, included physicians among its sponsors and speakers. A livestream of the event showed attendees shoulder to shoulder in front of the Lincoln Memorial, vanishingly few wearing masks.
The Front Line of False Information
Simone Gold, MD, JD, is the founder of America’s Frontline Doctors, and she and her group vigorously oppose vaccination and mask mandates and instead promote ivermectin and hydroxychloroquine for prevention and early treatment of COVID-19. (The group’s information about hydroxychloroquine comes with a disclaimer that it is not medical advice.) Her organization’s website offers $90 telemedicine appointments with physicians who will prescribe the drugs and a pharmacy that will dispense them.
In late October 2021, the US House Select Subcommittee on the Coronavirus Crisis announced that it had launched an investigation into Gold’s group as well as SpeakWithAnMD.com, founded by conservative author Jerome Corsi, PhD, whose doctorate is in political science, for pushing COVID-19 misinformation and selling unproven treatments. In a letter to Gold, Subcommittee Chair James Clyburn, a South Carolina Democrat, wrote that her group was “reportedly among the top purveyors of questionable treatments nationwide and a prominent source of misinformation related to the coronavirus.”
But as of late January 2022, Gold, a Beverly Hills emergency physician, had a California medical license in good standing. “Simone Gold sends out verifiably false information,” Ashish Jha, MD, PhD, dean of the Brown University School of Public Health, said in an interview. “It is absolutely essential that the state medical board steps in.” A spokesperson for America’s Frontline Doctors did not respond to JAMA’s request for a comment from Gold.
“The Board is aware of the…allegations against Dr. Gold and media reports concerning the spread of COVID-19 disinformation and is looking into it,” Medical Board of California spokesperson Carlos Villatoro said via email in early January. “In general terms, publicly spreading false COVID-19 information may be considered unprofessional conduct and could be grounds for disciplinary action.”
Villatoro said the board requires a “relatively high burden of proof” that a violation of the state’s Medical Practice Act has occurred. “To date,” he said in January 2022, “the Board has not sanctioned a licensee for the spread of COVID-19 misinformation.”
Mary Talley Bowden, MD, is a Houston physician accused of promoting antiscience views about COVID-19. Bowden, a board-certified otolaryngologist, was suspended in November 2021 by Houston Methodist Hospital for “spreading dangerous misinformation” about COVID-19, including touting ivermectin. Bowden, who had not admitted any patients to the hospital, resigned shortly after.
Bowden accused hospitals of hiding what percentage of their COVID-19 patients have been vaccinated, and on January 18, 2022, she sued Houston Methodist in Harris County District Court to obtain that information as well as financial data. “I have no agenda. I have been transparent from the beginning,” Bowden told JAMA.
On January 10, 2022, she had tweeted to her more than 50 000 followers (by late January Bowden had more than 70 000 followers) that she “could think of no medically valid reason for anyone to get the vaccine now.” Two weeks later, that tweet had been retweeted more than 1500 times.
Challenges to Medical Boards’ Authority
According to Chaudhry, “Something has happened in this pandemic that has prompted members of the public and others to question what the state medical boards are doing. That’s new.” In states such as Florida, legislators are trying to take away their medical board’s authority to discipline physicians for spreading false COVID-19 information. Florida Senate Bill 1184, “Free Speech of Health Care Practitioners,” would prohibit “certain regulatory boards and the Department of Health from reprimanding, sanctioning, or revoking or threatening to revoke a license, certificate, or registration of a health care practitioner for specified use of his or her right of free speech without specified proof.”
In Tennessee, where legislators have introduced a least 7 bills to eliminate the medical board’s authority to discipline physicians for such behavior, at least 1 legislator has suggested he would like to eliminate the medical board, period.
In Tennessee, under pressure from John Ragan, a Republican state representative from Oak Ridge, the state medical board already removed the FSMB statement warning physicians that spreading COVID-19 misinformation or disinformation could put their license at risk.
In a December 13, 2021, column for the Oak Ridger newspaper, Ragan called the statement “an unlawful ultimatum” and noted that the Tennessee General Assembly has the power “to dissolve boards and agencies that are…not fulfilling their purpose under their creation legislation.” Ragan called it “unwise to censor or punish any doctor for exercising their independent medical judgment in the best interests of their patients,” and wrote that the Tennessee Code Annotated specifically restricts boards from using statements, as opposed to creating rules, for disciplinary requirements.
In a letter to the editor a few weeks after Ragan’s column was published, an Oak Ridge resident, citing Ragan’s views on vaccines and masks, suggested that the town’s nickname, “Science City,” was in jeopardy.
Devaluing Board Certification?
Houston physician and ivermectin proponent Bowden is board certified in otolaryngology and sleep medicine, according to the American Board of Otolaryngology–Head and Neck Surgery website.
Ladapo is board certified by the American Board of Internal Medicine (ABIM) but isn’t participating in maintenance of certification, which is required for all diplomates certified after 1990, as Ladapo was, according to the ABIM website. In an email, ABIM spokesperson Aaron Cohen said the board declined to answer questions for this story.
Gold is no longer certified by the American Board of Emergency Medicine (ABEM), but that is because she let it lapse, not because she espouses COVID-19 disinformation, ABEM President Marianne Gausche-Hill, MD, said in an interview.
“ABEM recognizes that there are numerous medical issues on which physicians will have legitimate differences of opinions—and that ABEM-certified physicians have every right to express their opinions on those issues,” the board said in an August 2021 statement. “However, making public statements that are directly contrary to prevailing medical evidence can constitute unprofessional conduct and may be subject to review by ABEM.”
As of mid-January 2022, the ABEM was investigating 15 board-certified emergency medicine physicians about whom it had received complaints related to spreading inaccurate COVID-19 information, said Gausche-Hill, medical director for the Los Angeles County Emergency Medical Services Agency. The ABEM has certified approximately 41 000 US physicians, which represents more than 90% of those practicing emergency medicine, she said.
“One of our diplomates said to me very plainly: I want to ensure that my certification really means something,” Gausche-Hill said. “The spreading of false information or unethical behavior really degrades the value of certification.”
The ABEM has not yet disciplined any of the 15 physicians it is investigating, she said, adding that “if an action is taken on someone’s license…then they cannot be a board-certified physician.”
Like the other specialty boards, the ABEM communicates with state medical boards almost daily, Gausche-Hill said. “We hear very quickly if there’s an action” taken by a state board against one of their board-certified physicians.
Freedom of Speech?
As Moran pointed out, the general public might not be able to discern misinformation and disinformation from evidence-based medicine.
Even though physicians can, they’re often reticent to complain about colleagues, New York University Grossman School of Medicine bioethicist Arthur Caplan, PhD, said in an interview. “They’re not going to rat out somebody in town that they golf with,” said Caplan, adding that he served on New York State’s medical board 30 years ago. Physicians do not realize that boards don’t make public the names of people who file complaints, he said.
As for the common argument that physicians who spread unscientific COVID-19 information are exercising their constitutional right to free speech, Caplan said professional speech is not the same thing.
For example, he said, if a physician told him he did not have a brain tumor, but he did, that would be malpractice, not free speech.
Article Information
Conflict of Interest Disclosures: Dr Caplan has served as an expert witness for the Vermont Board of Medical Practice and for the State of Vermont.

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Global Health
February 15, 2022

COVID-19 Vaccines Safe, Effective in Rheumatic Diseases​

Bridget M. Kuehn, MSJ
JAMA. 2022;327(7):614. doi:10.1001/jama.2022.1114
COVID-19 Resource Center

Vaccination against SARS-CoV-2 provides people with inflammatory or noninflammatory rheumatic and musculoskeletal disease similar levels of protection with a similar adverse event profile as the general public, according to data from a registry of 5121 patients from 30 countries.
Patients with inflammatory rheumatic and musculoskeletal diseases (RMDs) were excluded from COVID-19 vaccine trials, leaving unanswered questions about safety and effectiveness in this population. To fill this gap, the European Alliance of Associations for Rheumatology Coronavirus Vaccine registry between February 2021 and July 2021 collected voluntary postvaccination reports from rheumatology clinicians.
Seventy percent of the patients included in the registry received the BNT162b2 (Pfizer-BioNTech) vaccine, 17% received the ChAdOx1 nCoV-19 (Oxford/AstraZeneca) vaccine, and 8% received the mRNA-1273 (Moderna) vaccine. About 1% experienced a breakthrough infection after full vaccination. Thirty-seven percent experienced possible or probable vaccine-associated adverse events, with injection-site pain, fatigue, muscle pain, and fever being the most common. Only 0.5% of the patients experienced a severe adverse event.
About 4% of patients with an inflammatory RMD experienced a disease flare, on average 6 days after their most recent vaccine dose. The most common flare symptoms were arthritis, multiple joint pain, and fatigue. Most flares were mild or moderate and only 1.5% of patients required a new medication or an increased medication dose to treat them.

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Original Investigation
January 25, 2022

Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021​

Matthew E. Oster, MD, MPH1,2,3; David K. Shay, MD, MPH1; John R. Su, MD, PhD, MPH1; et alJulianne Gee, MPH1; C. Buddy Creech, MD, MPH4; Karen R. Broder, MD1; Kathryn Edwards, MD4; Jonathan H. Soslow, MD, MSCI4; Jeffrey M. Dendy, MD4; Elizabeth Schlaudecker, MD, MPH5; Sean M. Lang, MD5; Elizabeth D. Barnett, MD6; Frederick L. Ruberg, MD6; Michael J. Smith, MD, MSCE7; M. Jay Campbell, MD, MHA7; Renato D. Lopes, MD, PhD, MHS7; Laurence S. Sperling, MD1,2; Jane A. Baumblatt, MD8; Deborah L. Thompson, MD, MSPH8; Paige L. Marquez, MSPH1; Penelope Strid, MPH1; Jared Woo, MPH1; River Pugsley, PhD, MPH1; Sarah Reagan-Steiner, MD, MPH1; Frank DeStefano, MD, MPH1; Tom T. Shimabukuro, MD, MPH, MBA1
Author Affiliations Article Information
JAMA. 2022;327(4):331-340. doi:10.1001/jama.2021.24110
https://jamanetwork.com/journals/jama/fullarticle/2782900
Key Points
Question What is the risk of myocarditis after mRNA-based COVID-19 vaccination in the US?
Findings In this descriptive study of 1626 cases of myocarditis in a national passive reporting system, the crude reporting rates within 7 days after vaccination exceeded the expected rates across multiple age and sex strata. The rates of myocarditis cases were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively).
Meaning Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men.
Abstract
Importance Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear.
Objective To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US.
Design, Setting, and Participants Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021.
Exposures Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna).
Main Outcomes and Measures Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes.
Results Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%).
Conclusions and Relevance Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.

Introduction
Myocarditis is an inflammatory condition of the heart muscle that has a bimodal peak incidence during infancy and adolescence or young adulthood.1-4 The clinical presentation and course of myocarditis is variable, with some patients not requiring treatment and others experiencing severe heart failure that requires subsequent heart transplantation or leads to death.5 Onset of myocarditis typically follows an inciting process, often a viral illness; however, no antecedent cause is identified in many cases.6 It has been hypothesized that vaccination can serve as a trigger for myocarditis; however, only the smallpox vaccine has previously been causally associated with myocarditis based on reports among US military personnel, with cases typically occurring 7 to 12 days after vaccination.7
With the implementation of a large-scale, national COVID-19 vaccination program starting in December 2020, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration began monitoring for a number of adverse events of special interest, including myocarditis and pericarditis, in the Vaccine Adverse Event Reporting System (VAERS), a long-standing national spontaneous reporting (passive surveillance) system.8 As the reports of myocarditis after COVID-19 vaccination were reported to VAERS, the Clinical Immunization Safety Assessment Project,9 a collaboration between the CDC and medical research centers, which includes physicians treating infectious diseases and other specialists (eg, cardiologists), consulted on several of the cases. In addition, reports from several countries raised concerns that mRNA-based COVID-19 vaccines may be associated with acute myocarditis.10-15
Given this concern, the aims were to describe reports and confirmed cases of myocarditis initially reported to VAERS after mRNA-based COVID-19 vaccination and to provide estimates of the risk of myocarditis after mRNA-based COVID-19 vaccination based on age, sex, and vaccine type.
Methods
Data Sources
VAERS is a US spontaneous reporting (passive surveillance) system that functions as an early warning system for potential vaccine adverse events.8 Co-administered by the CDC and the US Food and Drug Administration, VAERS accepts reports of all adverse events after vaccination from patients, parents, clinicians, vaccine manufacturers, and others regardless of whether the events could plausibly be associated with receipt of the vaccine. Reports to VAERS include information about the vaccinated person, the vaccine or vaccines administered, and the adverse events experienced by the vaccinated person. The reports to VAERS are then reviewed by third-party professional coders who have been trained in the assignment of Medical Dictionary for Regulatory Activities preferred terms.16 The coders then assign appropriate terms based on the information available in the reports.
This activity was reviewed by the CDC and was conducted to be consistent with applicable federal law and CDC policy. The activities herein were confirmed to be nonresearch under the Common Rule in accordance with institutional procedures and therefore were not subject to institutional review board requirements. Informed consent was not obtained for this secondary use of existing information; see 45 CFR part 46.102(l)(2), 21 CFR part 56, 42 USC §241(d), 5 USC §552a, and 44 USC §3501 et seq.
Exposure
The exposure of concern was vaccination with one of the mRNA-based COVID-19 vaccines: the BNT162b2 vaccine (Pfizer-BioNTech) or the mRNA-1273 vaccine (Moderna). During the analytic period, persons aged 12 years or older were eligible for the BNT162b2 vaccine and persons aged 18 years or older were eligible for the mRNA-1273 vaccine. The number of COVID-19 vaccine doses administered during the analytic period was obtained through the CDC’s COVID-19 Data Tracker.17
Outcomes
The primary outcome was the occurrence of myocarditis and the secondary outcome was pericarditis. Reports to VAERS with these outcomes were initially characterized using the Medical Dictionary for Regulatory Activities preferred terms of myocarditis or pericarditis (specific terms are listed in the eMethods in the Supplement). After initial review of reports of myocarditis to VAERS and review of the patient’s medical records (when available), the reports were further reviewed by CDC physicians and public health professionals to verify that they met the CDC’s case definition for probable or confirmed myocarditis (descriptions previously published and included in the eMethods in the Supplement).18 The CDC’s case definition of probable myocarditis requires the presence of new concerning symptoms, abnormal cardiac test results, and no other identifiable cause of the symptoms and findings. Confirmed cases of myocarditis further require histopathological confirmation of myocarditis or cardiac magnetic resonance imaging (MRI) findings consistent with myocarditis.
Deaths were included only if the individual had met the case definition for confirmed myocarditis and there was no other identifiable cause of death. Individual cases not involving death were included only if the person had met the case definition for probable myocarditis or confirmed myocarditis.
Statistical Analysis
We characterized reports of myocarditis or pericarditis after COVID-19 vaccination that met the CDC’s case definition and were received by VAERS between December 14, 2020 (when COVID-19 vaccines were first publicly available in the US), and August 31, 2021, by age, sex, race, ethnicity, and vaccine type; data were processed by VAERS as of September 30, 2021. Race and ethnicity were optional fixed categories available by self-identification at the time of vaccination or by the individual filing a VAERS report. Race and ethnicity were included to provide the most complete baseline description possible for individual reports; however, further analyses were not stratified by race and ethnicity due to the high percentage of missing data. Reports of pericarditis with evidence of potential myocardial involvement were included in the review of reports of myocarditis. The eFigure in the Supplement outlines the categorization of the reports of myocarditis and pericarditis reviewed.
Further analyses were conducted only for myocarditis because of the preponderance of those reports to VAERS, in Clinical Immunization Safety Assessment Project consultations, and in published articles.10-12,19-21 Crude reporting rates for myocarditis during a 7-day risk interval were calculated using the number of reports of myocarditis to VAERS per million doses of COVID-19 vaccine administered during the analytic period and stratified by age, sex, vaccination dose (first, second, or unknown), and vaccine type. Expected rates of myocarditis by age and sex were calculated using 2017-2019 data from the IBM MarketScan Commercial Research Database. This database contains individual-level, deidentified, inpatient and outpatient medical and prescription drug claims, and enrollment information submitted to IBM Watson Health by large employers and health plans. The data were accessed using version 4.0 of the IBM MarketScan Treatment Pathways analytic platform. Age- and sex-specific rates were calculated by determining the number of individuals with myocarditis (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision [ICD-10] codes B33.20, B33.22, B33.24, I40.0, I40.1, I40.8, I40.9, or I51.4)22 identified during an inpatient encounter in 2017-2019 relative to the number of individuals of similar age and sex who were continually enrolled during the year in which the myocarditis-related hospitalization occurred; individuals with any diagnosis of myocarditis prior to that year were excluded. Given the limitations of the IBM MarketScan Commercial Research Database to capture enrollees aged 65 years or older, an expected rate for myocarditis was not calculated for this population. A 95% CI was calculated using Poisson distribution in SAS version 9.4 (SAS Institute Inc) for each expected rate of myocarditis and for each observed rate in a strata with at least 1 case.
In cases of probable or confirmed myocarditis among those younger than 30 years of age, their clinical course was then summarized to the extent possible based on medical review and clinician interviews. This clinical course included presenting symptoms, diagnostic test results, treatment, and early outcomes (abstraction form appears in the eMethods in the Supplement).23
When applicable, missing data were delineated in the results or the numbers with complete data were listed. No assumptions or imputations were made regarding missing data. Any percentages that were calculated included only those cases of myocarditis with adequate data to calculate the percentages.
Results
Case Characteristics
Between December 14, 2020, and August 31, 2021, 192 405 448 individuals older than 12 years of age received a total of 354 100 845 mRNA-based COVID-19 vaccines. VAERS received 1991 reports of myocarditis (391 of which also included pericarditis) after receipt of at least 1 dose of mRNA-based COVID-19 vaccine (eTable 1 in the Supplement) and 684 reports of pericarditis without the presence of myocarditis (eTable 2 in the Supplement).
Of the 1991 reports of myocarditis, 1626 met the CDC’s case definition for probable or confirmed myocarditis (Table 1). There were 208 reports that did not meet the CDC’s case definition for myocarditis and 157 reports that required more information to perform adjudication (eTable 3 in the Supplement). Of the 1626 reports that met the CDC’s case definition for myocarditis, 1195 (73%) were younger than 30 years of age, 543 (33%) were younger than 18 years of age, and the median age was 21 years (IQR, 16-31 years) (Figure 1). Of the reports of myocarditis with dose information, 82% (1265/153 occurred after the second vaccination dose. Of those with a reported dose and time to symptom onset, the median time from vaccination to symptom onset was 3 days (IQR, 1-8 days) after the first vaccination dose and 74% (187/254) of myocarditis events occurred within 7 days. After the second vaccination dose, the median time to symptom onset was 2 days (IQR, 1-3 days) and 90% (1081/1199) of myocarditis events occurred within 7 days (Figure 2).
Males comprised 82% (1334/1625) of the cases of myocarditis for whom sex was reported. The largest proportions of cases of myocarditis were among White persons (non-Hispanic or ethnicity not reported; 69% [914/1330]) and Hispanic persons (of all races; 17% [228/1330]). Among persons younger than 30 years of age, there were no confirmed cases of myocarditis in those who died after mRNA-based COVID-19 vaccination without another identifiable cause and there was 1 probable case of myocarditis but there was insufficient information available for a thorough investigation. At the time of data review, there were 2 reports of death in persons younger than 30 years of age with potential myocarditis that remain under investigation and are not included in the case counts.
Reporting Rates of Myocarditis Within 7 Days After COVID-19 Vaccination
Symptom onset of myocarditis was within 7 days after vaccination for 947 reports of individuals who received the BNT162b2 vaccine and for 382 reports of individuals who received the mRNA-1273 vaccine. The rates of myocarditis varied by vaccine type, sex, age, and first or second vaccination dose (Table 2). The reporting rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.73 [95% CI, 61.68-81.11] per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.86 [95% CI, 91.65-122.27] per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.43 [95% CI, 45.56-60.33] per million doses of the BNT162b2 vaccine and 56.31 [95% CI, 47.08-67.34] per million doses of the mRNA-1273 vaccine). The lower estimate of the 95% CI for reporting rates of myocarditis in adolescent males and young men exceeded the upper bound of the expected rates after the first vaccination dose with the BNT162b2 vaccine in those aged 12 to 24 years, after the second vaccination dose with the BNT162b2 vaccine in those aged 12 to 49 years, after the first vaccination dose with the mRNA-1273 vaccine in those aged 18 to 39 years, and after the second vaccination dose with the mRNA-1273 vaccine in those aged 18 to 49 years.
The reporting rates of myocarditis in females were lower than those in males across all age strata younger than 50 years of age. The reporting rates of myocarditis were highest after the second vaccination dose in adolescent females aged 12 to 15 years (6.35 [95% CI, 4.05-9.96] per million doses of the BNT162b2 vaccine), in adolescent females aged 16 to 17 years (10.98 [95% CI, 7.16-16.84] per million doses of the BNT162b2 vaccine), in young women aged 18 to 24 years (6.87 [95% CI, 4.27-11.05] per million doses of the mRNA-1273 vaccine), and in women aged 25 to 29 years (8.22 [95% CI, 5.03-13.41] per million doses of the mRNA-1273 vaccine). The lower estimate of the 95% CI for reporting rates of myocarditis in females exceeded the upper bound of the expected rates after the second vaccination dose with the BNT162b2 vaccine in those aged 12 to 29 years and after the second vaccination dose with the mRNA-1273 vaccine in those aged 18 to 29 years.
Clinical Course of Myocarditis After COVID-19 Vaccination in Persons Younger Than 30 Years of Age
Among the 1372 reports of myocarditis in persons younger than 30 years of age, 1305 were able to be adjudicated, with 92% (1195/1305) meeting the CDC’s case definition. Of these, chart abstractions or medical interviews were completed for 69% (826/1195) (Table 3). The symptoms commonly reported in the verified cases of myocarditis in persons younger than 30 years of age included chest pain, pressure, or discomfort (727/817; 89%) and dyspnea or shortness of breath (242/817; 30%). Troponin levels were elevated in 98% (792/809) of the cases of myocarditis. The electrocardiogram result was abnormal in 72% (569/794) of cases of myocarditis. Of the patients who had received a cardiac MRI, 72% (223/312) had abnormal findings consistent with myocarditis. The echocardiogram results were available for 721 cases of myocarditis; of these, 84 (12%) demonstrated a notable decreased left ventricular ejection fraction (<50%). Among the 676 cases for whom treatment data were available, 589 (87%) received nonsteroidal anti-inflammatory drugs. Intravenous immunoglobulin and glucocorticoids were each used in 12% of the cases of myocarditis (78/676 and 81/676, respectively). Intensive therapies such as vasoactive medications (12 cases of myocarditis) and intubation or mechanical ventilation (2 cases) were rare. There were no verified cases of myocarditis requiring a heart transplant, extracorporeal membrane oxygenation, or a ventricular assist device. Of the 96% (784/813) of cases of myocarditis who were hospitalized, 98% (747/762) were discharged from the hospital at time of review. In 87% (577/661) of discharged cases of myocarditis, there was resolution of the presenting symptoms by hospital discharge.
Discussion
In this review of reports to VAERS between December 2020 and August 2021, myocarditis was identified as a rare but serious adverse event that can occur after mRNA-based COVID-19 vaccination, particularly in adolescent males and young men. However, this increased risk must be weighed against the benefits of COVID-19 vaccination.18
Compared with cases of non–vaccine-associated myocarditis, the reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination were similar in demographic characteristics but different in their acute clinical course. First, the greater frequency noted among vaccine recipients aged 12 to 29 years vs those aged 30 years or older was similar to the age distribution seen in typical cases of myocarditis.2,4 This pattern may explain why cases of myocarditis were not discovered until months after initial Emergency Use Authorization of the vaccines in the US (ie, until the vaccines were widely available to younger persons). Second, the sex distribution in cases of myocarditis after COVID-19 vaccination was similar to that seen in typical cases of myocarditis; there is a strong male predominance for both conditions.2,4
However, the onset of myocarditis symptoms after exposure to a potential immunological trigger was shorter for COVID-19 vaccine–associated cases of myocarditis than is typical for myocarditis cases diagnosed after a viral illness.24-26 Cases of myocarditis reported after COVID-19 vaccination were typically diagnosed within days of vaccination, whereas cases of typical viral myocarditis can often have indolent courses with symptoms sometimes present for weeks to months after a trigger if the cause is ever identified.1 The major presenting symptoms appeared to resolve faster in cases of myocarditis after COVID-19 vaccination than in typical viral cases of myocarditis. Even though almost all individuals with cases of myocarditis were hospitalized and clinically monitored, they typically experienced symptomatic recovery after receiving only pain management. In contrast, typical viral cases of myocarditis can have a more variable clinical course. For example, up to 6% of typical viral myocarditis cases in adolescents require a heart transplant or result in mortality.27
In the current study, the initial evaluation and treatment of COVID-19 vaccine–associated myocarditis cases was similar to that of typical myocarditis cases.28-31 Initial evaluation usually included measurement of troponin level, electrocardiography, and echocardiography.1Cardiac MRI was often used for diagnostic purposes and also for possible prognostic purposes.32,33 Supportive care was a mainstay of treatment, with specific cardiac or intensive care therapies as indicated by the patient’s clinical status.
Long-term outcome data are not yet available for COVID-19 vaccine–associated myocarditis cases. The CDC has started active follow-up surveillance in adolescents and young adults to assess the health and functional status and cardiac outcomes at 3 to 6 months in probable and confirmed cases of myocarditis reported to VAERS after COVID-19 vaccination.34 For patients with myocarditis, the American Heart Association and the American College of Cardiology guidelines advise that patients should be instructed to refrain from competitive sports for 3 to 6 months, and that documentation of a normal electrocardiogram result, ambulatory rhythm monitoring, and an exercise test should be obtained prior to resumption of sports.35 The use of cardiac MRI is unclear, but it may be useful in evaluating the progression or resolution of myocarditis in those with abnormalities on the baseline cardiac MRI.36 Further doses of mRNA-based COVID-19 vaccines should be deferred, but may be considered in select circumstances.37
Limitations
This study has several limitations. First, although clinicians are required to report serious adverse events after COVID-19 vaccination, including all events leading to hospitalization, VAERS is a passive reporting system. As such, the reports of myocarditis to VAERS may be incomplete, and the quality of the information reported is variable. Missing data for sex, vaccination dose number, and race and ethnicity were not uncommon in the reports received; history of prior SARS-CoV-2 infection also was not known. Furthermore, as a passive system, VAERS data are subject to reporting biases in that both underreporting and overreporting are possible.38 Given the high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination, underreporting is more likely. Therefore, the actual rates of myocarditis per million doses of vaccine are likely higher than estimated.
Second, efforts by CDC investigators to obtain medical records or interview physicians were not always successful despite the special allowance for sharing information with the CDC under the Health Insurance Portability and Accountability Act of 1996.39 This challenge limited the ability to perform case adjudication and complete investigations for some reports of myocarditis, although efforts are still ongoing when feasible.
Third, the data from vaccination administration were limited to what is reported to the CDC and thus may be incomplete, particularly with regard to demographics.
Fourth, calculation of expected rates from the IBM MarketScan Commercial Research Database relied on administrative data via the use of ICD-10 codes and there was no opportunity for clinical review. Furthermore, these data had limited information regarding the Medicare population; thus expected rates for those older than 65 years of age were not calculated. However, it is expected that the rates in those older than 65 years of age would not be higher than the rates in those aged 50 to 64 years.4
Conclusions
Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.
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Article Information
Corresponding Author: Matthew E. Oster, MD, MPH, US Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333 ([email protected]).
Accepted for Publication: December 16, 2021.
Author Contributions: Drs Oster and Su had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Oster, Shay, Su, Creech, Edwards, Dendy, Schlaudecker, Woo, Shimabukuro.
Acquisition, analysis, or interpretation of data: Oster, Shay, Su, Gee, Creech, Broder, Edwards, Soslow, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, Lopes, Sperling, Baumblatt, Thompson, Marquez, Strid, Woo, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro.
Drafting of the manuscript: Oster, Shay, Su, Gee, Creech, Marquez, Strid, Woo, Shimabukuro.
Critical revision of the manuscript for important intellectual content: Oster, Shay, Su, Creech, Broder, Edwards, Soslow, Dendy, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, Lopes, Sperling, Baumblatt, Thompson, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro.
Statistical analysis: Oster, Su, Marquez, Strid, Woo, Shimabukuro.
Obtained funding: Edwards, DeStefano.
Administrative, technical, or material support: Oster, Gee, Creech, Broder, Edwards, Soslow, Schlaudecker, Smith, Baumblatt, Thompson, Reagan-Steiner, DeStefano.
Supervision: Su, Edwards, Soslow, Dendy, Schlaudecker, Campbell, Sperling, DeStefano, Shimabukuro.
"

 

[missy]

American ex-pat has déjà vu in Hong Kong​

Hong Kong is going through its worst outbreak since the coronavirus emerged more than two years ago, but I feel like I’ve been here before. The similarities between what I’m seeing in the Asian financial hub now and what I lived through in the U.S. in early 2020 are unsettling. Both governments originally gave detailed descriptions of every infection, until the case loads became so high they no longer had the manpower. The availability of tests fell far short of the number needed to comprehensively uncover the pathogen, and it spread silently in the community until it hit an undeniable critical mass. The virus infiltrated homes for the elderly and prisons — both high-risk areas where it’s hard to isolate everyone. Officials implemented mitigation measures intended to “flatten the curve” and reduce the risk of transmission. Places that once gave me solace — church, the gym — were closed. The grocery store became one of the few places people could go without question, but chatting in the aisles was uncommon. Friends and family didn’t gather. I didn’t see my parents for months, while others went for more than a year and eventually canceled major life events like weddings and reunions. A pedestrian passes a shuttered store in Hong Kong. Photographer: Bertha Wang/Bloomberg There are differences, of course. We have vaccinations now, and while Hong Kong’s elderly population is still largely unprotected, some defense is better than none. The highly transmissible omicron variant may be less deadly than the original strain, and hospitals know much better now how to treat seriously ill people with steroids, ventilators and positioning. Antiviral pills are slowly becoming more available, while there was nothing in early 2020. Other things may work against Hong Kong. Restaurants are still open until 6 p.m., even though only two people can eat together, as are shopping malls. While people are asked to work from home, it’s not required by most companies. And some people who are infected are now being asked to stay home until hospital beds can be found. And yet Hong Kong’s stated goal is it try to halt all transmission, eventually returning to zero daily cases. Experts are now saying that’s unlikely without a full-scale lockdown, something that would be exceedingly hard to do with Hong Kong’s notorious density and tiny apartments. What I’m worried about is reliving what happened in the U.S. It’s hard knowing what might come. I vividly remember writing the stories about overwhelmed hospitals and patients dying alone on ventilators. People with other conditions often couldn’t get care, or had to delay procedures. Partners couldn’t be present for births or to help those with dementia. The social isolation weighed heavy on everyone. Mental health suffered. It’s been two years. I hope Hong Kong is ready. — Michelle Fay Cortez

 

[missy]

Will wealth disparity lead to a new variant?​

For the richest nations, the money needed to supply lower-income countries with the tools needed to end the pandemic would be little more than a budget “rounding error,” according to the head of the World Health Organization. Yet there are few signs the wealthy are willing to pay their fair share to help deliver Covid-19 vaccines, medical equipment and treatments to low-income countries. Just six nations — Canada, Germany, Kuwait, Norway, Saudi Arabia and Sweden — met or exceeded their fair-share commitments to the WHO’s 2020/21 ACT-Accelerator program budget, which includes the Covax vaccination effort that delivered more than 1 billion doses to low- and middle-income countries. The U.S. was, by far, the biggest donor to the program but still failed to provide all the funds it was asked for — giving 64%. China was asked for the second-most but gave just 3% of its ask. Russia gave nothing to the program. Tedros Adhanom Ghebreyesus, the WHO’s director general. Photographer: Stefan Wermuth/Bloomberg With rich countries in Europe and North America moving to loosen and even abandon Covid restrictions altogether, this year’s funding gap might be worse. Of the $16.8 billion needed from wealthy countries for the 2022 ACT-Accelerator budget, only about $800 million has been raised so far. That’s creating the conditions for yet another pandemic reset, health experts warn. Regions with low immunity levels because of a lack of vaccines and medical gear are the most likely breeding ground for a new variant that will, once again, put the fight against the pandemic back on its heels. That’s what happened with the alpha, then delta and then, most recently, the omicron strains. Each variant forced public health officials everywhere to shift strategy while delaying a return to normalcy. “If we don’t do a better job of raising immunity levels we will definitely get another variant,” says Edward Kelley, a Global Health Adviser to Apiject Systems, and former Director of Health Services at the WHO. The best way to raise immunity levels in low-income countries is through vaccinations and ensuring health-care systems have the means to slow the spread. That requires just a “rounding error” worth of funds from the rich to avoid the mistakes of the past, says Tedros Adhanom Ghebreyesus, the WHO’s director general. “Science gave us the tools to fight Covid-19,” he says. “If they are shared globally in solidarity, we can end Covid-19 as a global health emergency this year.” — Andy Hoffman

 

[Gloria27]

Pfizer drops India vaccine application after regulator seeks local trial

Pfizer Inc (PFE.N) said on Friday it had withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India, after failing to meet the drug regulator's demand for a local safety and immunogenicity study.

www.reuters.com

 

[missy]

Antibodies induced by mRNA shots improve for months; blood cells damaged by COVID cause blood vessel problems

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

www.reuters.com

"
Feb 18 (Reuters) - The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

Antibodies improve for months after mRNA vaccine

Antibodies induced by mRNA COVID-19 vaccines keep improving in quality for at least six months while the immune system continues to "train" its antibody-producing B cells, according to a new study.

After vaccination, some B cells become short-lived antibody-producing cells, while others join "germinal centers" in lymph nodes - essentially, a training camp where they mature and perfect their skills. "Cells that successfully graduate (from germinal centers) can become long-lived antibody-producing cells that live in our bone marrow or 'memory B cells' that are ready to engage if the person gets infected," explained Ali Ellebedy of Washington University in St. Louis. Animal studies have suggested that so-called germinal center reactions last only weeks. But analyses of blood, lymph node tissue and bone marrow from volunteers who received the Pfizer (PFE.N)/BioNTech vaccine showed germinal center reactions induced by the shots lasted at least six months, with antibodies becoming increasingly better at recognizing and attacking the spike protein of the original version of SARS-CoV-2, Ellebedy's team reported on Tuesday in Nature.

They did not test the mature antibodies' ability to neutralize variants, but in theory, Ellebedy said, the antibodies should be better able to recognize parts of the spike common to the variants and the original strain. More research is needed to know whether this robust germinal center response is unique to mRNA vaccines or if it is also induced by more traditional vaccines.

Red blood cells damaged by COVID cause blood-vessel problems

Dysfunctional red blood cells contribute to the blood vessel injuries common in severe COVID-19, according to laboratory studies that also may suggest a way to treat the problem.

Many patients hospitalized for COVID-19 are thought to have damage to the endothelial cells lining the blood vessels, which can lead to blood clots, organ impairment, and other complications. New findings from the blood of 17 moderately ill COVID-19 patients and 27 healthy volunteers confirm "profound and persistent endothelial dysfunction" as an effect of the coronavirus, researchers reported on Wednesday in the Journal of the American College of Cardiology. Compared to the red blood cells in healthy people, those from COVID-19 patients release fewer beneficial nitric oxide molecules and more detrimental inflammation-causing molecules, said Dr. Ali Mahdi of Karolinska University Hospital in Stockholm. In combination with elevated levels of a certain enzyme, the inflammatory molecules injure the blood-vessel lining, his team found. As a result, the vessel cannot relax properly.

The dysfunction is reversed by drugs that restore normal enzyme levels and limit production of the harmful molecules, Mahdi said. Whether test-tube findings can be replicated in people is not yet clear. The experiment was performed on the original coronavirus, so it is also unclear whether red blood cells are similarly affected in infections caused by variants of SARS-CoV-2.

"

 

[missy]

"

The latest​

The masks are coming off. Many Americans are embracing a new phase of the pandemic in which the coronavirus is treated more like a nuisance rather than a full-blown emergency. But tensions are still running high.As infectious-disease experts continue to urge caution, they’re contending with fresh backlash from some who are intent on putting public health measures in the rearview mirror. It's a precarious moment. These experts want people to remain vigilant, but the public is exhausted and their credibility is on the line. “This is basically a kill-the-messenger phenomenon,” one epidemiologist told my colleague Joel Achenbach.

As cases from the omicron variant drop and officials roll back mask requirements, some Americans are racing to lock in vacation plans. Travel agents, hotel operators and restaurateurs are reporting big spikes in bookings as more people seek to take advantage of the relative lull in infections. We saw the same pattern last summer, when newly vaccinated Americans splurged on flights, hotels and entertainment they'd avoided in the first year of the pandemic. Call it “revenge travel” for a weary nation.

In California, the shift away from crisis mode is now official state policy. Gavin Newsom, the Democratic governor, this week announced that California would start treating the coronavirus as a manageable, endemic risk. That means focusing on containing outbreaks, stockpiling protective equipment and combating misinformation, with less emphasis on public health mandates. It appears to be the first state to announce such a move.

Masks, vaccination, boosters, limiting interactions and air filtration appear to have helped stave off a major coronavirus outbreak at a packed anime conference in New York City last fall, just as the omicron variant was taking hold. Just 119 of the 4,560 attendees whose test results were available became infected, according to a new report from the Centers for Disease Control and Prevention. A separate report found that the virus infected 16 of 23 friends who attended the event together and mingled together outside the convention. All of the omicron infections at the event came from that one cluster.

As calls mount to ramp up global vaccinations, the Biden administration is quietly planning to send more than $250 million in vaccine assistance to 11 African countries, including several where omicron was first detected. My colleagues Dan Diamond and Emily Rauhala report that officials are prioritizing countries in sub-Saharan nations most in need, focusing on in-person staffing, technical assistance and more diplomatic engagement. It's part of the Global VAX initiative the White House unveiled in December.

"

 

[missy]

Is It Time for Yet Another COVID Booster?​

"

Is it time to get an additional COVID booster shot?
The first COVID booster shot is now in the rear-view mirror for millions of Americans —for the 28% who got it, at least — but new data finds its effectiveness waning after about 4 months. The Centers for Disease Control and Prevention (CDC) has already recommended boosters for immunocompromised people.
So, is the next logical step another booster for every other adult?
The consensus among public health officials seems to be: Not so fast.

At the White House COVID-19 briefing Wednesday, chief White House medical advisor Anthony Fauci, MD, focused on the question of the hour. Citing data, he said that "a single booster shot continues to provide high level protection against severe disease caused by Omicron" in people who are not immunocompromised.

According to CDC research, cited by Fauci, vaccine effectiveness after two doses of the mRNA vaccine drops to 58% after 4-5 months. After a booster dose, the vaccine is initially 91% effective at preventing hospitalizations, but that drops to 78% at months 4 to 5. "Nonetheless, the level of 78 [%] is still a good protective area," Fauci said.
"The future requirement for an additional boost or a fourth shot for mRNA or a third shot for J&J is being very carefully monitored in real time," he said, adding that recommendations will be updated as needed and if needed as the data evolves.

Wait on the Data​

Other public health officials and agencies echo Fauci's advice: Wait on the data.

"At this time, CDC does not have a recommendation for a fourth dose/second booster dose for most Americans," said Scott Pauley, a CDC spokesperson, referring only to people who are not immunocompromised.
In a statement issued January 11, the World Health Organization (WHO) said that "a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable." In discouraging the repeated booster strategy, the WHO cited factors such as the need for global equity in access to vaccines and the evolution of the virus, with the emergence of variants.
"There is no data to support the generalized use of a fourth dose of the vaccine beyond the immunocompromised," said Amesh Adalja, MD, an infectious disease expert and senior scholar at the Johns Hopkins Center for Health Security. "In fact, there is data to suggest diminishing returns with fourth doses."

In a preprint study posted this week, researchers from Sheba Medical Center in Israel followed 274 healthcare workers after a fourth dose of either the Moderna or the Pfizer vaccine. They found the booster restored antibody levels to the same peak levels following the third dose, but was not effective in preventing mild or asymptomatic Omicron infections.

Breakthrough infections were common. The researchers concluded that their results suggest the urgency of "next-generation vaccine development."

Considering the Pandemic Trajectory​

Decisions about second booster recommendations demand evaluating the big picture, said William Schaffner, MD, infectious disease specialist at Vanderbilt University Medical Center in Nashville. At the moment, he said, hospitalizations are down, and "even deaths, a lagging indicator," are declining, although not to the same degree in all parts of the country. Even so, he said, the trends are going in the right direction.

At the White House COVID-19 press briefing Wednesday, CDC director Rochelle Walensky, MD, said federal officials are "cautiously optimistic about the trajectory we are on," noting that the current 7-day daily average of cases is about 147,000, down about 40% from the previous week. Hospital admissions, at 9500 a day, have declined about 28%, and the 7-day average of daily deaths are about 2200, a decreased of about 9% from the prior week.

The hope, Schaffner said, is that this combination of the Omicron spread, with many having natural immunity from that infection, along with vaccination, will produce a sustained reduction of cases. "If that is the case, we don't need a booster anytime soon."

However, that scenario also assumes we don't see a new variant of concern, he said.

Then, "as we move from pandemic to endemic, we will be able to determine at what interval a booster will be necessary and what the composition [of it] will be," Schaffner said. For now, however, "I don't think a fourth dose — a second booster — is in the cards in the near-term future [for those not immunocompromised], if everything goes the way it has been going."
"What you can’t see is that all my fingers are crossed," he added.

Booster Goals​

It's difficult to give definitive answers about boosters for the general population without sufficient data yet, agreed Alejandro Balazs, PhD, a virologist and principal investigator at the Ragon Institute of Massachusetts General Hospital, MIT and Harvard.

The critical question: "Are we trying to stop transmission or just severe disease?"

Adalja agreed: "If the goal is protection against serious disease, hospitalization and death, targeting the boosting of high-risk populations [but not others] makes sense as the standard regimens are holding up in the general population."

Even as antibody levels decline after vaccinations, your memory T-cell and B-cell response may endure, making it possible to fight the virus, Balazs said. "The antibodies can prevent the infection from establishing itself."

However, if antibody levels decline, and you get infected, your immunological memory response is ready to go. "That is probably contributing to less disease even after antibody levels have faded," he said.

Booost Now, Data Later?​

Despite the lack of data, doctors say their patients are asking now about second boosters. "At this point in time, it is impossible to predict whether additional booster doses will be needed for healthy people,'' said Aaron Glatt, MD, chief of infectious diseases at Mount Sinai South Nassau in Oceanside, New York.

Could premature boosting by healthy people have a downside? "I don't see any immediate harm [to that]," Schaffner said. "However, I'm not so sure about the benefit."

"The one harm is hypothetical," Adalja said, "and it is that continuing to boost with first-generation vaccines directed against the ancestral strain of the virus may blunt the ability of the immune system to fully respond to new variants, a phenomenon called original antigenic sin."

Another solution: "There are studies underway to see if there could be a universal vaccine," Glatt said. "These are very exciting prospects but are not yet clinical realities."

Schaffner, Glatt, Balazs, and Adalja have disclosed no relevant financial relationships.

"

 

[missy]

COVID Rates Jump After Denmark Lifts All Restrictions​

Carolyn Crist
February 17, 2022
"

Since Denmark became the first major country to lift its remaining coronavirus restrictions at the beginning of February, it has recorded more COVID-19 cases per capita than most other places in the world.
COVID-19 hospitalizations and deaths have jumped by nearly a third, signaling a warning to the U.S. and other countries that are now easing mask mandates, vaccine requirements, and limits for crowded spaces such as bars and nightclubs, according to Yahoo News.
"Not looking good in Denmark. Deaths are now 67% of peak with a steep ascent," Eric Topol, MD, director of the Scripps Research Translational Institute, wrote in a Twitter post this week.

He shared charts that showed sharp increases in COVID-19 cases, hospital admissions, and deaths from early February to mid-February. In a response to comments, he linked to a news story from September, when Denmark previously lifted all restrictions before cases climbed again.

"The world is looking to Denmark as a guide to removing all restrictions," Topol said. "It seems that we've seen this movie before."
In late January, COVID-19 cases appeared to peak in Denmark. After the emergence of BA.2, the Omicron subvariant, cases began to rise again and reached a new all-time high on Feb. 13, surpassing the record from December 2020.
Hospitalizations also climbed in Denmark, surpassing the U.K. rate in early February and the U.S. rate this week. About 1½ times more Danes are now hospitalized with COVID-19 than ever before during the pandemic. If COVID-19 deaths continue to increase, Denmark could set a record in coming days, Yahoo News reported.

But Danish health officials have pointed out that hospital burden is still low in the country, compared to former surges. Denmark also tests far more people than in the U.K. and the U.S., the news outlet reported.
In addition, about 81% of Danes are fully vaccinated, including 95% of those over age 65, and 62% have received a booster dose, according to the latest data from the Danish Health Authority. Overall, Danes have remained protected against COVID-19 and have less severe illness.
"Overall mortality in Denmark in all age categories has now fallen into the normal spectrum as Omicron has become fully dominant," Søren Neermark, an official at the Danish Health Authority, wrote in a Twitter thread on Monday.

At the same time, he noted, Denmark shouldn't necessarily be used as a model for other countries.

"Denmark cannot be used as a (sole) argument for lifting restrictions or maintaining restrictions in other countries," he wrote. "The capacity of the healthcare system in each country will vary and the same [with] overall vaxrate, trust, test, prior immunity etc."

In reality, countries will need to decide based on their own factors, and restrictions will likely toggle on and off in response to changing conditions, Kristian Andersen, PhD, an immunologist at the Scripps Research Institute, said in a podcast this week. Andersen, a Danish expat, said he has been watching the situation in Denmark closely in recent weeks to understand the trends.

"We have to be realistic. If we say we're not going to have restrictions, it's up to you to get your boosters and wear a face mask if you can. … We should probably expect that for the next few years to come, most people will get infected a couple of times a year," he said. "And we should expect 200,000 to 250,000 deaths [a year] in this country alone."

To keep up with the coronavirus, countries will also need to prioritize innovation, namely with "better home testing, better masks, better vaccines, better antivirals," Andersen said.

"But it also requires that we realize [COVID] is going to be a problem we're going to continue to deal with during the next 5 to 10 years," he said. "If we say it's all over, my concern is that the innovation stops. Because then it's like, 'Well, what's the point?'"

Sources​

Yahoo News: "In a warning to U.S., COVID rates soar after Denmark lifts all restrictions."
Twitter: @EricTopol, Feb. 13, 2022; @sneermark, Feb. 14, 2022.

Danish Health Authority: "Covid-19 surveillance," updated Feb. 17.

"

 

[missy]

Weekend update Bloomberg

"

The latest wave of the coronavirus is receding across much of the world, but in some places infections and hospitalizations remain at crisis levels. Japan is set to end a ban on new entry by foreigners and Portugal is dropping its work-from-home guidance. But Hong Kong is experiencingits worst outbreak since the virus emerged in 2020. Officials there are planning a testing blitz of the entire city of 7.5 million. In the U.S., cases are falling fast in many places, but some say it’s too early to drop mask requirements.

As Canadian police on Friday arrested dozens of the vaccine mandate protesters who have gridlocked Ottawa for weeks, banks are acting on Prime Minister Justin Trudeau’s emergency edict and freezing accounts allegedly connected to some demonstrators. Civil liberties advocates however have criticized the measures as dangerously overbroad.

The young and super-wealthy in Singapore are snapping up ornate mansions or villas that can date to colonial times, driving a surge in real estate transactions and prices. Meanwhile in New York City, renting an apartment with extra space is as competitive as buying a home.

China said it took steps to reduce the carbon impact of the Winter Olympics, including using renewable power, older venues and electric vehicles. But the claim of carbon neutrality is mostly just marketing. TV ratings for the Games are shaping up to be the lowest in U.S. history thanks to Covid-19, human-rights issues and relayed boycotts. But in China, it’s a different story.

Fast-food chains have been locked in a fried chicken sandwich battle, but they aren’t the only devotees of the high-carb feast. DJ Khaled, the Emmy award-winning producer and record executive-turned-restaurateur, has introduced the “Best Chicken Sandwich Ever,” a Nashville hot chicken with pink coleslaw. Meanwhile Houston restaurant Lucille’s has its own international take.

"

 

[missy]

"

How can we speed up global vaccinations?​

In this week's edition of the Covid Q&A, we look at global vaccine inequity. In hopes of making this very confusing time just a little less so, each week Bloomberg Prognosis picks one reader question and puts it to experts in the field. This week’s question comes to us from Robert in Toronto. He asks: How can we speed up global vaccination against Covid? I understand that world vaccination is what must happen to stop new variants from occurring. In this newsletter, we’ve talked a lot about the troubling vaccination rates in the U.S. but less about the worldwide situation. Stopping the spread of the virus isn’t just a national issue; its a global one, as just over half of the world population has been fully vaccinated. “Vaccinations have not been equally distributed across the globe,” says Katrine Wallace, an epidemiologist at University of Illinois at Chicago. “For example, the continent of Africa only has 11.5% of its people fully vaccinated, which is far below the global average.” People in those areas are disproportionately at risk for getting seriously ill or even dying from Covid-19. They also are incubators for new variants of the virus. The more people get infected, the more chances the virus has to mutate. “We will continue to have viral variants emerging if we have large reservoirs of unvaccinated people,” Wallace says. “Vaccinating certain parts of the globe is akin to fighting a house fire only in the upstairs rooms while the fire continues to burn downstairs.” A health-care worker administers a Covax initiative vaccine in Asuncion, Paraguay. Photographer: Maria Magdalena Arrellaga/Bloomberg So what to do about it? Several international groups are currently working to provide greater global vaccine equity. For example, Covax — a partnership between Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations; and the World Health Organization — announced last month that they had delivered their billionth vaccine dose. Corbevax is patent-free vaccine that was developed at Texas Children’s Hospital and Baylor College of Medicine. It’s intended for distribution in low-income countries to increase vaccine access, and was designed to be easily stored and manufactured. Wallace says misinformation is another global obstacle to vaccine equity. “Throughout this pandemic misinformation has been a risk factor for more disease and death, and this is also a big problem in the developing world,” she says. “In a way these countries have a double whammy. People may choose not to get vaccinated, even when it is made available.” "

 

[missy]

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Don’t kill Covid data tracking​

These days in Europe, it seems as though the pandemic is behind us. An increasing number of countries are ditching the use of certificates to enter indoor venues like restaurants or gyms and abandoning quarantine rules. And more people are going bare-faced, which reflects a certain level of regained normalcy. The U.K. was one of the first nations to accelerate that return to normal. Now, concerns are mounting that it may be getting ready to go a step further and scrap the weekly Covid-19 survey by the Office for National Statistics. While the U.K. Health Security Agency opened a new laboratory last week that will test new Covid vaccines, gather research and assess variants, the ONS weekly survey helps the government keep on top of infection rates and antibody levels across the country. It is less prone to fluctuations because it studies the same households, and can detect Covid in people who might not get tested, or in those who don’t know they’re infected as well as asymptomatic cases. The U.K. has been lauded by the World Health Organization for its broad tracking and sequencing efforts that contributed to global surveillance systems. Only a few countries, including South Africa and Israel, did so as intensively. Rishi Sunak, the U.K. chancellor of the exchequer, would need to give his blessing for further funding from April to avoid it being scaled back or even scrapped altogether, the i newspaper has reported. Morning commuters cross London Bridge. Photographer: Luke MacGregor/Bloomberg The prospect of axing the program raises questions about how to handle virus data-tracking efforts even as restrictions that were put in place to stem transmission fade away. After all, Covid data collection has been such a defining feature of how countries have tried to fight the pandemic. Just because countries are behaving as though the pandemic is over doesn’t mean it is. WHO chief Tedros Adhanom Ghebreyesus has repeatedly called on governments to continue to use every tool available. And they aren’t limited to curbs. They include expanding at-home testing, improving ventilation in public buildings and increasing efforts to track mutations. But countries are trying to balance opening up economies and reducing the huge costs that Covid, and the tracking of it, have brought against the potential risk of a fresh resurgence in the virus. Large parts of the world's population are still undervaccinated, providing a breeding ground for new strains to emerge, which could put fresh pressure on already strained health systems, much like omicron did at the end of November. We also have no guarantees a new variant will be as mild as omicron. It would be “crazy” to get rid of the surveillance amid the threat of emerging strains, says Martin McKee, a professor at the London School of Tropical Medicine. There are many things the U.K. government spends huge sums of money on, like defense spending on armored vehicles that can't be used, he says. Spending 400 million pounds ($545 million) a year is not that much — it’s paying for something that does work, he says. The availability of vaccines and treatments, and less severe illness from omicron are good news. But if the pandemic isn’t over until it’s over everywhere, we’ll rely on continued Covid data tracking even more now that restrictions are being lifted. “This virus will continue to evolve, which is why we call on countries to continue testing, surveillance and sequencing, the WHO’s Tedros said earlier this month. “We can’t fight this virus if we don’t know what it’s doing.” — Corinne Gretler

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[missy]

"
Is the abrupt move away from mask mandates happening too soon, or is it long overdue? Ask residents in any of the blue states where officials recently dropped mask requirements and you'll find adamant voices on both sides. But more people appear to be welcoming the change as the nation seeks to close the books on the era of mandatory masking. “It’s a choice right now, which is probably what it should have been," one Delaware resident told The Washington Post.

Ask a public health expert, on the other hand, and you're much more likely to hear arguments for keeping the requirements, at least for a little longer. A large body of evidence shows masking slows coronavirus transmission, protecting the wearer and the people around them. For some, that's reason enough to keep covering up.

Mysterious heart problems are arising in some people who’ve had covid-19, even those with mild cases. The prevalence of such symptoms suggests a cardiac crisis may be on the horizon, my colleague Ariana Eunjung Cha reports. More data is needed, but experts worry about a coming wave of cardiovascular problems directly and indirectly related to the virus. Patient advocacy groups are calling on President Biden and other leaders to invest in research and treatment, and to prepare the health-care system for the potential long-term consequences of a rise in post-covid heart problems.

The pandemic has been unpredictable and unforgiving for the parents of young children, who've had to contend with school closures, pediatrician visits and other complications that can upend carefully choreographed family routines. Now, another curveball: The Food and Drug Administration's decision this month to wait on authorizing a vaccine for kids under 5. Here's a look at how several of these parents are managing these challenges as they wait for regulators to act.

Low-income parents have been hit especially hard by child-care problems brought on by the virus. Day-care closures and other disruptions shot up in December and January, as the omicron variant sent caseloads into the stratosphere. Child-care issues were most common in households that make less than $25,000, where parents are less likely to have back-up child-care options or flexible working arrangements. Strapped for cash and with no paid leave from their employers, some have struggled to buy basic goods.
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[dk168]

I won't lie in that I am nervous and apprehensive about England soon to declare Covid-19 is over by lifting all remaining restrictions.

Personally, I do not believe we are quite ready, however, that may have something to do with my day job being a HCP working in the pharmaceutical industry.

I am particularly worried that, by withdrawing free LFT tests except for those who are most at risk, the rest of the population will not spend money on buying LFT test kits to test themselves on a voluntary basis, when they have other priorities such as rising fuel and food bills!

Only time will tell if the right decisions have been made.

DK

 

[missy]

A plant-based weapon against Covid​

Canada is set to be the first country to give citizens the option for a vegetarian coronavirus shot. The world’s first plant-derived Covid vaccine, Covifenz, was cleared for use in Canada this week, widening the country’s toolbox to combat the pandemic. It will be available for adults ages 18 to 64. Covifenz is made from plant-grown proteins that, to the human immune system, look like the virus that causes Covid-19. The vaccine also uses GlaxoSmithKline’s pandemic adjuvant, a substance that boosts the body’s virus-fighting response. The vaccination regimen calls for two doses in a three-week interval. The shot was jointly developed by Medicago, a Quebec City-based biopharma company owned by Mitsubishi Chemical and Philip Morris International, and Glaxo, the British pharma giant. The approval gives people who might be hesitant to take currently available vaccines made by Pfizer, AstraZeneca, Moderna and others another option. Many countries are struggling to raise vaccination ratesand are requiring citizens to be immunized to get into restaurants, shopping malls, trains and planes. Workers at a Medicago facility. Photographer: Gabriel Rancourt/Medicago Covifenz demonstrated 71% efficacy against multiple variants of the SARS-CoV-2 virus in December. To make it, Medicago uses a close relative to tobacco plants, nicotiana benthamiana, that has a weakened immune system, allowing it to easily host genetic material and grow particles that mimic viruses. For cigarette-maker Philip Morris, the vaccine project is part of a wider push into health and wellness products. Medicago hopes Covifenz will generate about $1 billion a year eventually, says Mitsubishi Chemical Chief Executive Officer Jean-Marc Gilson. One big selling point: The vaccine is easier to transport and store than rival mRNA shots, such as those from Pfizer and Moderna, because it doesn’t need to be kept at ultra-low temperatures. Medicago has a contract with the Canadian government to supply up to 76 million doses of the vaccine and is in talks with other countries about potential agreements, CEO Takashi Nagao has said. The immunization was granted fast-track designation for potential approval by the U.S. Food and Drug Administration in February 2021. We’ve come a long way from scrambling for Covid shots. With the arrival of new vaccines — both those using more traditional technologies as well as novel ones like Covifenz — there’s a chance more people will get vaccinated and help bring a faster end to the pandemic. —Kanoko Matsuyama

 

[missy]

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Farewell to restrictions, but not caution​

In this week's edition of the Covid Q&A, we look at lifting pandemic restrictions. In hopes of making this very confusing time just a little less so, each week Bloomberg Prognosis picks one reader question and puts it to experts in the field. This week’s question comes to us from Marilyn in Beaverton, Oregon. She asks: I will soon be 80. I am tired of staying home. Just how careful do I need to be in stores? With my friends? In restaurants or in theaters? For two years, the pandemic has forced us to constantly recalculate our tolerance for risk. Now, as a fuller return to office work, shopping and socializing looks imminent, many people are asking themselves: Am I ready for that? States are rolling back mask mandates; bars and restaurants are once again full. But in some regions the virus is still circulating at higher levels than in previous stages of the pandemic. It can be hard to know which factors to weigh most heavily. “It is evident that new Covid cases and hospitalizations are trending downward across the country and people are eager to return to a new normal,” says Vanderbilt University epidemiologist William Schaffner. “Nevertheless, I urge people to be both cautious and careful because, although the rates of new illnesses are moving downward, they are still not low enough to be carefree.” A "Masks Required" sign outside a bookstore. Photographer: Eric Lee/Bloomberg Being vaccinated and boosted is the most important thing you can do to protect yourself, says Schaffner. Equally important is making sure that people you socialize with have received all the shots they’re eligible for. It’s also important, he says, to keep up mask-wearing in places like supermarkets, workplaces and houses of worship. The U.S. Centers for Disease Control and Prevention on Friday loosened its mask guidelines, rolling out a new three-tiered system for classifying local Covid risks. Rapid tests can help add another layer of safety. “If you would like to gather with a small group of friends to play a game of bridge, go to a restaurant and the like, first be sure all are vaccinated and then also get a rapid test on the day of the event,” says Schaffner. “Assuring that all have negative test results provides additional assurance that the occasion will be low-risk and that the small group of friends or family can remove their masks.” People with increased risk of becoming severely ill with Covid should also continue to be extra cautious, he says. That includes people over 65, those with underlying conditions and people who are immunocompromised. "

 

[missy]

COVID Vax Myocarditis/Pericarditis Rates From Active Surveillance in Italy​

Crystal Austin, PhD, for Medscape
February 25, 2022




The study covered in this summary was published in medRxiv.org as a preprint and has not yet been peer-reviewed.

Key Takeaways​

• People younger than 40 years and males were at elevated risk for myocarditis/pericarditis in the first 7 days after vaccination with mRNA-based COVID-19 vaccines. The risk was especially elevated after the second dose.
• Vaccine-associated risks should be assessed in light of their efficacy in preventing serious COVID-19 disease.

Why This Matters​

• This is the first population-based active-surveillance study from Italy to investigate the association between two mRNA-based COVID-19 vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA1273) and the risk for myocarditis/pericarditis.
• The findings suggest that mRNA-based vaccines are associated with an increased risk for myocarditis/pericarditis in people younger than 40 years. The increased risk was moderate after vaccination with the second dose of BNT162b2 and in the youngest age group; and it was higher in males after both the first and second doses of mRNA-1273.
• These data should be taken into consideration when weighing the overall safety and efficacy profiles of these vaccines.

Study Design​

• This population-based study involved 2,861,809 people 12 to 39 years of age who received a first dose of COVID-19 mRNA vaccine between December 27, 2020 and September 30, 2021 in four regions of Italy, representing 36% of the country's population 12 to 39 years of age.
• The authors used an adapted self-controlled case series design to estimate the relative incidence of myocarditis/pericarditis, which allowed for control of the participants' time-independent characteristics.
• The main outcome measure was the first diagnosis of myocarditis/pericarditis identified at emergency care or at hospital admission during the study period. The incidence of events in the exposure risk periods for the first and second doses were compared with the baseline period.

Key Results​

• Throughout the study period, 441 people had emergency care or hospital admission related to myocarditis/pericarditis. Of those cases, 78.5% occurred in people vaccinated with BNT162b2 and 21.5% in those vaccinated with mRNA-1273.
• During the 21-day risk interval, 114 people developed myocarditis/pericarditis, with 64.9% of the cases occurring in those vaccinated with BNT162b2 and 35.1% in those vaccinated with mRNA-1273, for relative incidences (RIs) of 1.27 (95% CI, 0.87 - 1.85) and 2.16 (95% CI, 1.50 - 3.10) after the first and second doses, respectively.
• Overall, the risk for myocarditis/pericarditis was elevated from days 0 to 7 after both the first (RI, 6.55; 95% CI, 2.73 - 15.72) and second (RI, 7.59; 95% CI, 3.26 - 17.65) doses of mRNA-1273, whereas an elevated risk was observed for BNT162b2 only after the second dose (RI, 3.39; 95% CI, 2.02 - 5.6.
• In males, an elevated risk for myocarditis/pericarditis was observed from days 0 to 7 after the first dose of mRNA-1273 (RI, 12.28; 95% CI, 4.09 - 36.83) and after the second doses of both mRNA-1273 (RI, 11.91; 95% CI, 3.88 - 36.53) and BNT162b2 (RI, 3.45, 95% CI, 1.78 - 6.6.
• Females showed an elevated risk from days 0 to 7 only after the second dose of BNT162b2 (RI, 3.38; 95% CI, 1.47 - 7.74); no such association was seen with mRNA-1273.
• Among individuals 12 to 17 years and 18 to 29 years of age, there was an elevated risk for myocarditis/pericarditis from days0 to 7 after the second dose of BNT162b2: RI, 5.74 (95% CI, 1.52 - 21.72) and RI, 4.02 (95% CI, 1.81 - 8.91), respectively.
• An elevated risk for myocarditis/pericarditis was observed in people 18 to 29 years of age from days 0 to 7 after the first (RI, 7.58; 95% CI, 2.62 - 21.94) and second (RI, 9.58; 95% CI, 3.32 - 27.58]) doses of mRNA-1273.
• Those 30 to 39 years of age showed an elevated risk after a first mRNA-1273 dose from days 0 to 7 (RI, 6.57; 95% CI, 1.32 - 32.63]) and days 7 to 14 (RI, 5.87; 95% CI, 1.34 - 25.74).

• Limitations​

  • Notoriety bias resulting from overdiagnosis of myocarditis/pericarditis and increased awareness of potential mRNA vaccination adverse events could have influenced some of the results.
  • Myocarditis/pericarditis diagnoses were based on hospital discharge and emergency care visit databases, which were not validated through the review of clinical records.
  • Additional data to differentiate between emergency care admission and hospital admission, as well as hospitalization length, were not collected but could possibly have allowed assessment of outcome severity.
  • The sample size was large but there was a small number of events; it was not always possible to provide robust model estimates in some subgroup analyses.

• Disclosures​

  • The study did not receive commercial funding but was supported by funding from the Italian Medicines Agency (AIFA) in the framework of the collaboration agreement Effectiveness and safety of COVID-19 vaccines: cohort and self-controlled case series studies.
  • None of the authors reported relevant financial relationships.
• This is a summary of a preprint research study Post-marketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12-39 years in Italy: a multi-database, self-controlled case series study, written by researchers at the Istituto Superiore di Sanita (National Institute of Health), the Agenzia Italiana del Farmaco (Italian Medicines Agency), the Lazio Regional Health Service, Data Science e Data Analysis, the Azienda Regionale di Coordinamento per la Salute, the Veneto Tumour Registry, the Epidemiology Observatory, the Institute of Pharmacology at the Catholic University of Sacred Heart, the University Hospital in Verona, Italy, and the Friuli Venezia Giulia Region, on medRxiv provided to you by Medscape. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.
  
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[missy]

"​

How the World Health Organization Might Face Future Pandemics​

By Emma Farge
February 25, 2022

GENEVA (Reuters) - Negotiations on new rules for dealing with pandemics will begin at the World Health Organization on Thursday, with a target date of May 2024 for a treaty to be adopted by the U.N. health agency's 194 member countries.
A new pact is among more than 200 recommendations for shoring up the world's defences against new pathogens made by various reviewers following the COVID-19 pandemic that has killed more than 6.2 million people in two years.
The WHO itself is facing calls for reform after an independent panel described it as "underpowered" when COVID-19 struck, with limited powers to investigate outbreaks and coordinate containment measures.
A Washington-led effort to build a global pandemic prevention fund hosted by the World Bank is among initiatives that could determine the future of the 74-year old body.

WHAT IS THE PANDEMIC TREATY?

The WHO already has binding rules known as the International Health Regulations (2005) which set out countries' obligations where public health events have the potential to cross borders. These include advising the WHO immediately of a health emergency and measures on trade and travel.
Adopted after the 2002/3 SARS outbreak, these regulations are still seen as functional for regional epidemics like Ebola but inadequate for a global pandemic.
Suggested proposals for the pact include the sharing of data and genome sequences of emerging viruses and rules on equitable vaccine distribution.

The European Union is pushing for a ban on wildlife markets and incentives for reporting of new viruses or variants, an EU official told Reuters.
Member states have an August deadline to decide on an initial version of the pact, which is backed by WHO director-general Tedros Adhanom Ghebreyesus. He is likely to be elected unopposed for a second term in May.
It would be only the second such health accord after the 2003 Framework Convention on Tobacco Control, a legally-binding treaty which aims to reduce smoking via taxation and rules on labelling and advertising.
HOW DO COUNTRIES VIEW THE PACT?

The EU proposed the treaty and is its biggest backer, with support from Britain, Indonesia, Kenya and others.

The United States will take part in the talks but has opposed a binding treaty. India and Brazil have also voiced reservations.


With so many member countries involved, securing agreement is likely to be tricky.

HOW WOULD IT WORK?

Because its legal nature remains to be defined, in WHO jargon the pact is an "instrument", of which there are three types -- recommendations, regulations and conventions. Of those, regulations are automatically legally binding for members unless they explicitly object.

It is not yet clear how the 2005 regulations and the new pandemic treaty might fit together.

One suggestion is that they should be complementary, so that existing rules apply to local outbreaks with the treaty response only kicking in if the WHO declares a pandemic -- something it does not currently have a mandate to do.

It remains to be determined whether negotiators will include compliance measures such as sanctions.

WHAT OTHER REFORMS ARE IN THE WORKS?
Separate talks on a U.S. initiative to overhaul the 2005 rules are taking place this week.

Washington's proposals aim to boost transparency and grant the WHO quicker access to outbreak sites. Several diplomats said they are likely to prove too ambitious, with opposition from China and others expected on national sovereignty grounds.

China did allow WHO-led expert teams to visit the COVID-19 epicentre in Wuhan, but the WHO says it is still withholding clinical data from early cases that may hold clues about the origins of the SARS-CoV-2 virus.

Reforms to the WHO funding structure to make it more sustainable and flexible in the event of a pandemic are being discussed by WHO member states in another working group.

So far the United States, which until the pandemic was the WHO's top donor, has opposed plans to increase member countries' annual contributions.

Reuters Health Information © 2022



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[missy]

Myocarditis Following COVID-19 BNT162b2 Vaccination Among Adolescents in Hong Kong

This cohort study assesses the association between the single-dose COVID-19 BNT162b2 vaccination regimen and myocarditis risk among vaccinated adolescents in Hong Kong before and after the single-dose policy.

jamanetwork.com

"February 25, 2022

Myocarditis Following COVID-19 BNT162b2 Vaccination Among Adolescents in Hong Kong​

Xue Li, PhD1; Francisco Tsz Tsun Lai, PhD2; Gilbert T. Chua, MBBS3; et alMike Yat Wah Kwan, MSc4; Yu Lung Lau, MD3; Patrick Ip, MPH, MBBS3; Ian Chi Kei Wong, PhD2
Author Affiliations Article Information
JAMA Pediatr. Published online February 25, 2022. doi:10.1001/jamapediatrics.2022.0101
COVID-19 Resource Center

Cases of myocarditis following the second dose of messenger RNA (mRNA) vaccine are accruing worldwide, especially in younger male adults and adolescents.1-4 In weighing the risk of myocarditis against the benefit of preventing severe COVID-19, Norway, the UK, and Taiwan have suspended the second dose of mRNA vaccine for adolescents. Similarly, adolescents (aged 12-17 years) in Hong Kong have been recommended to receive 1 dose of BNT162b2 instead of 2 doses 21 days apart since September 15, 2021 (Figure).

Methods
This cohort study was conducted before the arrival of the Omicron variant. We linked vaccination records with the Hong Kong territorywide electronic health record database through government-commissioned population-based COVID-19 vaccine safety surveillance.3Among adolescents who received at least 1 dose of BNT162b2 between March 10 and October 18, 2021, inpatient myocarditis cases were identified using the International Classification of Diseases, Ninth Revision, Clinical Modification (422.x and 429.0). Adolescents with a history of myocarditis were excluded. The study was approved by the institutional review board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster and the Department of Health Ethics Committee with a waiver of informed consent because anonymized data were used. The statistical tests are described in the eMethods in the Supplement. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.
Results
A total of 224 560 first doses and 162 518 second doses of BNT162b2 were administered to adolescents. Forty-three adolescents had myocarditis-related hospitalization following receipt of BNT162b2 vaccination, and 84% of the hospitalizations (36 of 43) occurred after the second dose. The incidence rate was 3.12 (95% CI, 1.25-6.42) and 22.15 (95% CI, 15.51-30.67) per 100 000 persons for the first and second dose, respectively (Table). The number needed to harm for the first and second dose were 32 051 and 4515, respectively. The crude risk ratio of the second dose vs first dose was 7.11 (95% CI, 3.16-15.97). The cumulative incidence of myocarditis decreased from 43 cases in 202 315 adolescents vaccinated (21.25, 95% CI, 15.38-28.63) per 100 000 persons to 0 cases in 22 245 adolescents vaccinated at implementation of the single-dose policy. The 40 167 prepolicy first dose recipients did not receive the second dose because of the single-dose policy. Based on the number needed to harm of the second dose, an estimated 8.90 (95% CI, 6.23-12.32) myocarditis cases were prevented.
Discussion
In this cohort study, the single-dose regimen was found to be associated with reduction in myocarditis risk among vaccinated adolescents. Limitations include sample size during the postpolicy period. Since May 2021, no local transmission of SARS-CoV-2 has occurred in Hong Kong, with stringent nonpharmaceutical interventions. Among the 343 700 adolescents in Hong Kong, no COVID-19-related death has been reported, and the only one admitted to the pediatric intensive care unit due to COVID-19 was an imported case,5 indicating that the risk of death or complications from COVID-19 is extremely low among adolescents in Hong Kong. Vaccination policy for adolescents should consider the trade-off between risks and benefits. In countries with large outbreaks and to prevalent local transmission, the risk-benefit assessment would favor a 2-dose regimen because the single-dose regimen provides suboptimal protection from severe outcomes associated with COVID-19. However, in settings with no evident local transmission and stringent infection control policies, single-dose mRNA vaccination might be a viable option for offering protection to adolescents from severe outcomes associated with COVID-19.
Nevertheless, questions remain about the mechanism of myocarditis following mRNA vaccine. Potential ways to reduce myocarditis risk in adolescents could be the use of single-dose only, a lower dosage for 2 doses as recommended for children aged 5 to 11 years,6 or a lengthened interval between doses. More laboratory, trial, and postmarketing data may become available to answer these questions. Our study expands the current understanding of dose-response relationship and suggests that COVID-19 vaccination recommendations in adolescents may need to be customized rather than standardized to fit all.
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Article Information

Published Online: February 25, 2022. doi:10.1001/jamapediatrics.2022.0101
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[missy]

Good morning. We look at the surprising number of recent classroom shutdowns in the U.S.​

Noelle Rodriguez working from home in Fresno, Calif.Tomas Ovalle for The New York Times​

One in four​ ​

The debate over Covid-19 school closures can sometimes seem to be settled. There is now a consensus that children learned much less than usual — and that their mental health suffered — when schools were shut for months in 2020 and 2021. This consensus helps explain why very few school districts fully closed during the Omicron surge.​

But Covid-related school shutdowns did not really end during Omicron. They instead became more subtle, often involving individual schools, classrooms or groups of students, rather than entire districts.​

My colleagues at The Upshot recently conducted a poll, in collaboration with the survey firm Dynata, of almost 150,000 parents around the country. The results reveal much more lost school time during the Omicron wave than many people understood.​

I was genuinely surprised by the numbers: In January, more than half of American children missed at least three days of school. About 25 percent missed more than a week, while 14 percent of students missed nine or more days. For tens of millions of American children last month, school wasn’t anywhere close to normal.​

Source: Dynata survey of 148,400 parents.​

The data, as my colleagues Claire Cain Miller and Margot Sanger-Katz write, “demonstrates the degree to which classroom closures have upended children’s education and parents’ routines, even two years into the pandemic. Five days of in-person school each week used to be virtually guaranteed. Some parents are now wondering if they’ll get that level of certainty again.”​

These quiet closures have large costs. Even brief school disruptions can cause students to fall behind, research has found, with the effects largest among boys and children from low-income families, Claire and Margot note. “Routine is really important for young children’s sense of stability,” said Anna Gassman-Pines, a Duke University professor who specializes in psychology and neuroscience.​

The disruptions also create problems for parents, especially working-class parents who cannot do their jobs remotely as easily as many white-collar professionals can. Noelle Rodriguez, a hair stylist in Fresno, Calif., moved her salon to her house, installing a sink and buying a hair dryer chair, because she assumed her children would not reliably be going to school. Her husband could not watch them, because he is a sheet metal foreman who cannot work from home.​

Rodriguez was right to assume school would be disrupted: Her third-grade daughter was home for two weeks at one point, and Rodriguez could not see customers. “I cannot collect unemployment, I don’t get any sick pay, I’m self-employed, so I had zero income during that time,” she said.​

Unavoidable trade-offs​ ​

The obvious question is whether these partial school shutdowns are doing more good or more harm.​

Unfortunately, there is no simple answer. The Omicron surge led to a sharp increase in Covid-19 hospitalizations and deaths. If schools had allowed children, teachers and other staff members to go to school while they had Covid — and were contagious — they could have made the toll even worse.​

But many districts went further than requiring only contagious people to stay home. Some also told people to stay home if they had been exposed to Covid even if they hadn’t tested positive — or told them to stay home for many days after a positive test, likely beyond the window of infectiousness. These policies sometimes left schools without enough staff to function.​

In justifying the policies, school administrations have frequently said that they are acting out of an abundance of caution. It’s not so simple, though. Being abundantly cautious about Covid has other downsides. It can sometimes require a lack of caution in other areas, like children’s educational progress and mental health, as well as their parents’ jobs.​

“It means a lot of anxiety, and it’s just not sustainable for the long haul,” said M. Cecilia Bocanegra, a psychotherapist in the Chicago area and mother of three who has been frustrated by the disruptions. (The Upshot’s story recreates the chaotic calendars of a few families.)​

A recent poll by the Pew Research Center indicates that Bocanegra’s attitude is becoming more common. Most parents told Pew that they wanted districts to give priority to students’ academic progress and emotional well-being when deciding whether to keep schools open. By contrast, in the summer of 2020 — before vaccines were available — most parents instead wanted schools to put a higher priority on minimizing Covid risks.​

As has often been the case during the pandemic, there are some partisan differences here. Democratic areas have been quicker on average to disrupt classrooms than Republican areas, the Dynata survey suggests:​

Source: Dynata survey of 148,400 parents.​

Burbio, a research firm that tracks school closures, has found a similar pattern. And the Pew poll found that Democratic parents wanted schools to give similar weight to Covid risks, academic progress and students’ emotional well-being; Republican parents wanted schools to put more weight on academics and mental health than on Covid exposure.​

What now?​ ​

Whatever your views are, I think it’s worth remembering that both approaches have public health benefits and costs.​

If schools make reducing Covid cases the top priority, they will probably be able to reduce cases — but will also cause more learning loss and family disruption. The strongest argument for this approach is that it protects unvaccinated, immunocompromised and elderly people while a deadly virus is still causing widespread harm.​

If schools make returning to normal the top priority, they will probably reduce learning loss and family disruptions — but will also create more Covid exposure. The strongest argument for this approach is that it protects children and less-affluent families at a time when most severe Covid illness is occurring among unvaccinated people who have voluntarily accepted that risk.​

With Omicron receding, this dilemma is becoming easier to resolve: School disruptions have declined in recent weeks. But the dilemma has not disappeared. Many schools are still not functioning normally, and future Covid surges — which would force a new round of hard choices — remain possible.​

“We may be moving into a new phase of the pandemic,” Bree Dusseault of the Center on Reinventing Education at Arizona State University, told Claire, “where schools are generally kept open but there are sporadic bursts of disruption to smaller groups of students.”​