May 2022 Coronavirus Updates

[missy]

Good morning and happy May.
New thread for a new month.



"

When will kids under 5 get shots?​

In this week's edition of the Covid Q&A, we look at vaccines for young children. 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 Jay. He asks: What is the current status of the review process for approving vaccines for children under 5? It’s understandable if parents of young kids feel ready to throw their hands up. As the world starts to look a bit more like its old self, most of us are able to go about our lives knowing that even if we do catch Covid, vaccines afford us good protection against severe disease. And yet, more than a year after vaccines started rolling out, parents of kids under 5 in much of the world are still waiting for the same opportunity. “Pediatricians and families are eager to have a safe and effective Covid-19 vaccine available for children under 5 — the past two years have been incredibly difficult for families of young children, and this added layer of protection would provide great peace of mind,” says Lee Beers, the medical director for Community Health and Advocacy at Children’s National Hospital in Washington. Pfizer’s pediatric vaccine is only authorized for kids age 5 to 11. Photographer: Hannah Beier/Bloomberg The holdup hasn’t been without reason. So far, in trials, a two-dose regimen of Pfizer’s mRNA vaccine didn’t prove very effective in kids under 5. The study was complicated by a winter wave of cases spurred by the highly transmissible omicron variant. Now, Pfizer is studying a three-dose regimen and expects to report results within weeks. The U.S. Food and Drug Administration has started a rolling review of data from Pfizer, whose application is not yet complete. Pfizer’s chief executive officer said on a podcast that he hopes children under 5 will be able to get vaccinated by June. Meanwhile, Moderna offered parents some hope when a trial of its shot in kids age 6 months to 5 years showed effectiveness without any serious safety concerns. In that trial, though, the shot was still only modestly effective — it didn’t pass the 50% efficacy threshold regulators have typically looked for in approving Covid vaccines. On Thursday, Moderna approached the FDA with an application for an emergency-use authorization of the two-dose regimen in the age group. Health and Human Services Secretary Xavier Becerra said the FDA will begin to process the information as soon as it has all the data on hand. That means a comprehensive review is imminent, with multiple layers of expert review. “This is a careful process, which will follow the same steps as in other age groups, and we expect will be approached with the same level of urgency,” says Beers. “For parents this means that, if the data shows that the vaccine is both safe and effective, it could be authorized and available for children under 5 sometime this spring.” Thanks to all of you for writing in this week! Next Sunday, we'll be answering the best question we receive again. So if you have any, we want to hear from you. Write to us at [email protected] — Riley Ray Griffin and Kristen V. Brown"

 

[missy]

Covid-19 Boosters — Where from Here?​

List of authors.

• Paul A. Offit, M.D.
• April 28, 2022

"
On December 10, 2020, Pfizer presented results from a 36,000-person, two-dose, prospective, placebo-controlled trial of its Covid-19 messenger RNA (mRNA) vaccine, BNT162b2, to the Food and Drug Administration (FDA).1 The vaccine was 95% effective at preventing severe illness in all age groups, independent of coexisting conditions or racial or ethnic background. A remarkable result. Six months later, studies showed that protection against severe disease was holding up.2 The results of these epidemiologic studies were consistent with those of immunologic studies showing long-lived, high frequencies of Covid-19–specific memory B and T cells, which mediate protection against severe disease.3
In September 2021, 10 months after the BNT162b2 vaccine had become available, Israeli researchers found that protection against severe illness in people 60 years of age or older was enhanced by a third dose.4 In response, the Centers for Disease Control and Prevention (CDC) recommended that people 65 years of age or older should receive three doses of an mRNA vaccine.

In a study now reported in the Journal,5 Israeli researchers found that in a study population with a median age of 72 years, protection against severe disease was further enhanced by a fourth dose of mRNA vaccine during the wave of infections caused by the B.1.1.529 (omicron) variant of SARS-CoV-2. These findings were considered by the FDA and CDC in their decision-making process regarding the use of an additional booster dose of mRNA vaccine for people 50 years of age or older.
What about booster dosing for persons who are younger? One year after the BNT162b2 vaccine became available, studies in the United States showed that a third dose of vaccine also enhanced protection against severe disease for people as young as 18 years of age.6,7 Unfortunately, these studies did not stratify patients according to whether they had coexisting conditions. Therefore, it was unclear who among these younger age groups most benefited from an additional dose. Nonetheless, the CDC later recommended that everyone 12 years of age or older should receive three doses of BNT162b2, regardless of whether risk factors were present. This universal booster recommendation led some summer camps, high schools, universities, hospitals, and businesses to require three doses of mRNA vaccine. In February 2022, in a study that did not support the booster recommendation for children, CDC researchers found that two doses of BNT162b2 induced long-lived protection against serious illness in children 12 to 18 years of age.8
In addition to protection against severe disease, the initial phase 3 trial of BNT162b2 — which was performed over a period of several months — also showed 95% protection against mild illness.1Unlike protection against severe illness, however, protection against mild illness, which is mediated by high titers of virus-specific neutralizing antibodies at the time of exposure, declined after 6 months, as would have been expected.2 In response, studies by Pfizer were published in which a booster dose was shown to restore protection against mild illness9; unfortunately, this protection did not persist for more than a few months.6 Short-lived protection against mild illness will limit the ability of booster dosing to lessen transmission.
People are now confused about what it means to be fully vaccinated. It is easy to understand how this could happen. Arguably, the most disappointing error surrounding the use of Covid-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as “breakthroughs.” As is true for all mucosal vaccines, the goal is to protect against serious illness — to keep people out of the hospital, intensive care unit, and morgue. The term “breakthrough,” which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus. If we are to move from pandemic to endemic, at some point we are going to have to accept that vaccination or natural infection or a combination of the two will not offer long-term protection against mild illness.
In addition, because boosters are not risk-free, we need to clarify which groups most benefit. For example, boys and men between 16 and 29 years of age are at increased risk for myocarditis caused by mRNA vaccines.10 And all age groups are at risk for the theoretical problem of an “original antigenic sin” — a decreased ability to respond to a new immunogen because the immune system has locked onto the original immunogen. An example of this phenomenon can be found in a study of nonhuman primates showing that boosting with an omicron-specific variant did not result in higher titers of omicron-specific neutralizing antibodies than did boosting with the ancestral strain.11 This potential problem could limit our ability to respond to a new variant.
It is now incumbent on the CDC to determine who most benefits from booster dosing and to educate the public about the limits of mucosal vaccines. Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what Covid-19 vaccines can and cannot do.
Disclosure forms provided by the author are available with the full text of this editorial at NEJM.org.
This editorial was published on April 13, 2022, at NEJM.org.
:

 

[missy]

"

BA.2.12.1 Subvariant: Concerning, but No Need to Panic Just Yet​

— A number of factors are contributing to the Omicron subvariant's rise​

by Jennifer Henderson, Enterprise & Investigative Writer, MedPage Today

A new Omicron subvariant is rapidly gaining steam in New York and other parts of the Northeast. Experts are urging caution in the face of BA.2.12.1, and say a number of factors are contributing to its rise. But they're also warning against panic.
As of April 20, BA.2.12.1 accounted for more than 75% of sequenced cases in Central New York -- a region that has seen a dramatic uptick in the subvariant's presence since it was first detected there in February -- according to the state Department of Health. And, across New York, it accounts for about 42% of cases.

But it's not just New York. Other states across the Northeast are seeing a similar climb in the subvariant's proportion of cases, and nationwide, BA.2.12.1 has increased from 3.5% of cases a little more than a month ago to nearly 30%of cases last week.
"What we're seeing right now is a version of the virus that is much more transmissible than previous versions of the virus, perhaps, but also less likely to cause severe disease," Perry Halkitis, PhD, MPH, dean of the Rutgers School of Public Health, told MedPage Today.
"None of this is odd," Halkitis said. "What is problematic is the speed with which it seems to be spreading. And the speed with which it seems to be spreading, to me, has something to do with the virus, but more to do with human behavior."
Individuals have been going about their business without mitigation measures, he explained. They haven't been masking in public places, they've been going to extremely large gatherings, and they haven't been getting boosted and have waning antibodies.

"All of this in combination puts us in the situation that we see right now," Halkitis said.
However, there hasn't been the same magnitude of hospitalizations and deaths as with previous iterations, he added.
On April 13, less than a month ago, the New York State Department of Health announced the emergenceof what it called "recently identified, highly contagious Omicron subvariants," including BA.2.12.1, in the state.
The department said in a statement at the time that its findings were the first reported instances of significant community spread due to the new subvariants in the U.S. However, it noted in a response to questions from MedPage Today that "this was not the first reported incidence of these subvariants in existence."
BA.2.12.1 has indeed been detected in a number of different countries.
However, due to its prevalence in Central New York in particular, the state Department of Health has continued to recommend that residents in all counties there mask up in public indoor settings, regardless of vaccination status. The department has also continued to recommend that all New Yorkers get fully vaccinated and boosted when eligible; consider wearing a mask in public indoor settings; test after exposure, symptoms or travel; stay home and consult with a provider about treatments if COVID-positive; and improve air ventilation or gather outdoors.

When asked about the transmissibility and severity of BA.2.12.1, the department pointed MedPage Todayto its prior statement that, while currently "there is no evidence of increased disease severity by these subvariants," it is "closely monitoring for any changes."
The department has also stated that, when comparing BA.2.12 against BA.2.12.1, the latter "has been noted to be of higher concern, given additional mutations."
Tomoko Udo, PhD, associate professor in the School of Public Health at the University of Albany, noted the importance of taking precautions.
"We do know that, when the transmission rate is high in the community setting, it is helpful to wear a mask to slow down the spread of virus," Udo told MedPage Today.
"It's important to remember that the virus is here to stay, and it's going to keep mutating," Udo said. "We need to pay attention to variants, for sure."

At the same time, there is no need to panic on the initial news of each one, she said.
What is important, Udo said, is to pay attention to current CDC and state guidance and to get vaccinated and boosted according to recommendations.
Steven Sheris, MD, executive vice president and chief physician executive for Atlantic Health System in New Jersey, concurred.
It's important for the public to "learn how to be agile to changing conditions," Sheris told MedPage Today.
Sheris, who is also president of Atlantic Medical Group physician network, noted that, while the virus has been circulating and there have been more cases in the community, the uptick hasn't translated to a significant impact on the healthcare system, or to hospitalizations and deaths. There has been an increase in individuals presenting to the emergency department and outpatient locations, he said.
Variants occur all the time, he noted. For example, there is a new influenza virus every flu season.

"This is not a new concept, and it doesn't necessarily make the virus more dangerous -- it may or may not, that's why you have to listen to the public health authorities," Sheris said.
Overall, Halkitis agreed that the detection and increasing prevalence of BA.2.12.1 is no surprise.
"The fact is that the virus continues to circulate in the population, and it was never going to disappear in the population until you reached a point where everyone in the world was immunized or had antibodies, and you had herd immunity," Halkitis said. "But we never got there in the United States, and we certainly never got there in the world."
BA.2.12.1 likely will pick up speed in other parts of the country, as it has in the Northeast, Halkitis said -- with one caveat.
"The advantage we have right now is that we're at a time of the year where respiratory disease tends to decline because of the weather, so maybe we're not going to see that surge," Halkitis said. "But beware, September and October are just around the corner."

It's also important to remember that there are a number of people who are testing at home and not getting the genetic sequencing of their virus, so the subvariant's true proportion of current cases is hard to know, he said.
In light of new variants, the reformulation of the COVID vaccine will be significant, Halkitis said. "That is the future, right there," he said.
And though he likened BA.2.12.1 to a gnat -- pesky and annoying -- he said he does not believe it will be tragic.
"If people want to stay safe, and they want to protect their health and protect the people around them, there are things they can do...no big crowds, wear your mask, stay on top of your boosters...these are just good public health strategies," Halkitis said. "But don't panic."

 

[missy]

Is Air Trapping a Long-Lasting Sequela of COVID-19?​

Authors: News Author: Walter Alexander; CME Author: Laurie Barclay, MD
https://www.medscape.org/viewarticle/972668

"

Note: The information on the coronavirus outbreak is continually evolving. The content within this activity serves as a historical reference to the information that was available at the time of this publication. We continue to add to the collection of activities on this subject as new information becomes available. It is the policy of Medscape Education to avoid the mention of brand names or specific manufacturers in accredited educational activities. However, manufacturer names related to COVID-19 vaccines may be provided in this activity to promote clarity. The use of manufacturer names should not be viewed as an endorsement by Medscape of any specific product or manufacturer.

Clinical Context​

Nearly 30% of patients with post-acute sequelae of COVID-19 (PASC), including persons who had mild infection not requiring hospitalization, have persistent respiratory symptoms. Small airways disease with air trapping appears to be a long-lasting sequela of SARS-CoV-2 infection, according to a prospective study that compared 100 COVID-19 survivors who had persistent symptoms and 106 healthy control participants.

"Something is going on in the distal airways related to either inflammation or fibrosis that is giving us a signal of air trapping," noted senior author Alejandro P. Comellas, MD, in a press release.[1] The study was stimulated by reports from University of Iowa clinicians noting that many patients with initial SARS-CoV-2 infection who were either hospitalized or were treated in the ambulatory setting later reported shortness of breath and other respiratory symptoms indicative of chronic lung disease.

Given the millions of COVID-19 infections worldwide, this finding may have a substantial potential impact on healthcare systems. While this initial study had limitations, emerging data continues to be a vital tool for earlier identification and initiation of appropriate treatment for active COVID-19 infections and PASC; thus, improving patient outcomes.

Study Results​

Investigators classified patients (mean age, 48 years; 66 women) with PASC according to whether they were ambulatory (67%), hospitalized (17%), or required treatment in the intensive care unit (ICU) (16%). They then compared computed tomography (CT) findings of patients who had COVID-19 and persistent symptoms with those of a healthy control group.

COVID-19 severity did not affect the percentage of cases of lung with air trapping among these patients. Air trapping occurred at rates of 25.4% among ambulatory patients, 34.6% in hospitalized patients, and in 27.3% of patients requiring intensive care (P = .1). The percentage of lung affected by air trapping in ambulatory participants was sharply and significantly higher than in healthy control participants (25.4% vs 7.2%; P < .001). Also, air trapping persisted; it was still present in 8 of 9 participants who underwent imaging more than 200 days postdiagnosis.

Qualitative analysis of chest CT images showed that the most common imaging abnormality was air trapping (58%); ground-glass opacities (GGOs) were found in 51% (46/91), noted Comellas and co-authors. This suggests ongoing lung inflammation, edema, or fibrosis. These symptoms are often observed during acute COVID-19, frequently in an organizing pneumonia pattern, and have been shown to persist for months after infection in survivors of severe disease. The mean percentage of total lung classified as having regional GGO on chest CT scans was 13.2% and 28.7%, respectively, in the hospitalized and ICU groups, both very much higher than in the ambulatory group, at 3.7% (P < .001 for both). Among healthy control participants, the GGO rate on chest CT was only 0.06% (P < .001).

In addition, air trapping correlated with the ratio of residual volume to total lung capacity (r = 0.6; P < .001) but not with spirometry results. In fact, the investigators did not observe airflow obstruction by spirometry in any group, suggesting that air trapping in these patients involves only small rather than large airways and that these small airways contribute little to total airway resistance. Only when a large percentage, perhaps 75% or more, of all small airways are obstructed will spirometry pick up small airways disease, the authors observed.

Continuing Disease​

The findings taken together suggest that functional small airways disease (fSAD) and air trapping are consequences of SARS-CoV-2 infection, according to Comellas.

"If a portion of patients continues to have small airways disease, then we need to think about the mechanisms behind it," he said. "It could be something related to inflammation that's reversible, or it may be something related to a scar that is irreversible, and then we need to look at ways to prevent further progression of the disease."

He added, "Studies aimed at determining the natural history of [fSAD] in patients with post-acute sequelae of COVID-19 and the biological mechanisms that underlie these findings are urgently needed to identify therapeutic and preventative interventions," Comellas, professor of internal medicine at Carver College of Medicine, University of Iowa, Iowa City, concluded.

The study limitations, the authors stated, include the fact that theirs was a single-center study that enrolled participants infected early during the COVID-19 pandemic and did not include patients with delta or omicron variants, thus limiting the generalizability of the findings.

The study was published in Radiology.[2]

The reported findings "indicate a long-term impact on bronchiolar obstruction," stated Brett M. Elicker, MD, professor of clinical radiology, University of California, San Francisco, in an accompanying editorial.[3]

Because collagen may be absorbed for months after an acute insult, it is not entirely clear whether the abnormalities seen in the current study will be permanent.

Elicker said further, "the presence of [GGO] and/or fibrosis on CT were most common in the patients admitted to the ICU and likely correspond to post-organizing pneumonia and/or post-diffuse alveolar damage fibrosis."

He also pointed out that organizing pneumonia is especially common among patients with COVID-19 and is usually highly steroid-responsive. The opacities improve or resolve with treatment, but sometimes residual fibrosis occurs.

"Longer-term studies assessing the clinical and imaging manifestations 1-2 years after the initial infection are needed to fully ascertain the permanent manifestations of post-COVID fibrosis," Elicker concluded.

The study was supported by grants from the National Institutes of Health. The authors and Elicker have disclosed no relevant financial relationships.

Study Highlights​

• In this single-center study at a university teaching hospital, 100 adults with confirmed COVID-19 with persistent symptoms > 30 days after diagnosis were prospectively enrolled between June and December 2020 and compared with 106 healthy control participants prospectively enrolled between March and August 2018.
• The median age of adults with PASC was 48 years; 66 were women; 67% were classified as ambulatory, 17% as hospitalized, and 16% as ICU patients during their acute illness.
• On chest CT, the mean percentage of total lung classified as GGO was 13.2% in hospitalized and 28.7% in ICU groups vs 3.7% in the ambulatory group (P < .001 for both) and 0.06% among healthy control participants (P < .001).
• The mean percentage of total lung affected by air trapping was 25.4% in the ambulatory group, 34.6% in the hospitalized group, and 27.3% in the ICU group, respectively (P = .1), vs 7.2% in healthy control participants (P < .001).
• Air trapping correlated with residual volume/total lung capacity (r = 0.6; P < .001) but not with spirometry results, which showed no airflow obstruction in any group.
• Air trapping was not associated with time from diagnosis to CT imaging (median, ~ 75 days).
• Among 9 participants who underwent imaging > 200 days after diagnosis, air trapping persisted in 8.
• The most common chest CT abnormality was air trapping (58%); GGO occurred in 51%.
• The investigators concluded that in survivors of COVID-19, small airways disease with air trapping is a long-lasting sequela occurring independently of initial infection severity, with unknown long-term consequences.
• Compared with healthy control participants, patients with ambulatory COVID-19 had similar spirometry and lung volumes but higher percentage of lung affected by GGO, suggesting ongoing lung inflammation, edema, or fibrosis.
• The lack of airflow obstruction on spirometry in any group suggests that air trapping results from involvement of small rather than large airways.
• Air trapping is often missed with spirometry but detected with inspiratory and expiratory CT imaging and plethysmography.
• Combined with findings of previous studies, this analysis suggests that SARS-CoV-2 infection itself leads to fSAD and air trapping whereas restrictive lung disease and impairment in gas exchange result from lung injury and acute respiratory distress syndrome.
• The angiotensin-converting enzyme 2 receptor, which facilitates SARS-CoV-2 infection, is expressed in small airways and throughout the airway tract.
• Even in individuals with PASC after mild acute infection, direct infection of small airways may cause fSAD, or immune response to SARS-CoV-2 could cause fSAD as a form of postinfectious constrictive bronchiolitis.
• Persistence of respiratory abnormalities over ~ 75 days and ≤ 200 days from diagnosis to chest CT imaging raises concern for permanent airway remodeling and fibrosis after SARS-CoV-2 infection.
• Study limitations include it being a single-center study enrolling participants infected early during the COVID-19 pandemic, limiting generalizability as acute treatment was highly variable, and none had delta or omicron infection.
• In addition, participants with PASC did not have baseline imaging, the sample was small, and the study could not determine the prevalence of pulmonary function testing and imaging abnormalities among asymptomatic COVID-19 survivors.
• To identify therapeutic and preventative interventions, future research should examine the natural history of fSAD in patients with PASC and biologic mechanisms underlying these findings.
• Longitudinal assessment is needed to determine whether fSAD in patients with PASC improves over time or causes persistent or progressive lung disease.
• Larger studies are needed to determine whether presence of fSAD correlates with respiratory symptoms.
• An accompanying editorial noted a long-term effect on bronchiolar obstruction that might not be permanent, as collagen may be absorbed for months after an acute insult.
• Organizing pneumonia is especially common in COVID-19 and usually highly steroid-responsive, but residual fibrosis may occur. The editorial concurs that longer-term studies are needed.

Clinical Implications​

• In COVID-19 survivors, small airways disease with air trapping is a long-lasting sequela occurring independently of initial infection severity.
• Persistence of respiratory abnormalities raises concern for permanent airway remodeling and fibrosis after SARS-CoV-2 infection.
• Implications for the Healthcare Team: While identifying therapeutic and preventative interventions, clinicians should recall that air trapping is often missed with spirometry but detected with inspiratory and expiratory CT imaging and plethysmography.

"

 

[missy]

"

Sliding to the bottom​

China and Hong Kong occupy two of the three bottom spots in April’s Bloomberg Covid Resilience Ranking as the gap between their Covid Zero ideology and the global norm of living with the virus continues to widen. The two places were among the best performers in the monthly Ranking for most of 2021, and their plunge this year to No. 51 and 53 respectively in April reflects how the elimination approach — now termed “dynamic zero” by China’s central government — has deteriorated in its ability to limit social and economic disruption after the virus mutated to become more infectious. For much of the pandemic, China’s playbook of border restrictions, mass testing and targeted lockdowns meant its residents lived mostly virus-free. But as omicron evades China’s controls, fiercer lockdowns are needed to slow the variant’s onslaught in mega-cities like Shanghai and Beijing, bringing down its score on Stringency, Flight Capacity and Community Mobility — the very metrics that once buoyed it above other places. Police officers in personal protective equipment guard at an intersection during a lockdown due to Covid-19 in Shanghai. Source: Bloomberg As China’s Covid crisis spirals, economic activity and global supply chains are being disrupted. In 2020, it was the only major economy to grow. This year, economists have slashed their growth forecasts well below the government’s official target of around 5.5%, further pulling down its Ranking. The Ranking, a monthly snapshot of where the virus is being handled the most effectively with the least social and economic upheaval, scores 53 places on 11 data points from virus containment and the death toll, to economic growth and progress toward reopening. Five of the Ranking’s indicators — Lockdown Severity, Flight Capacity, Vaccinated Travel Routes, Community Mobility and GDP Growth Forecast — measure how well economies are reopening and normalizing life for their people. China’s argument for Covid Zero is that the saving of lives, rather than social and economic disruption, is paramount. Indeed, the country’s 3-Month Case Fatality Rate and Total Deaths Per 1 Million, the Ranking’s two death metrics, remain the best among the 53 ranked places. Its 1-Month Cases Per 100,000 score is also still lower than elsewhere. Yet with fatalities in Shanghai mounting and widespread outrage over deaths that may have stemmed from lockdown conditions, like a lack of access to medical care and food, this saving grace of the Covid Zero approach is coming under unprecedented pressure. Meanwhile, the chasm that’s opened up between the Covid Zero holdouts and the rest of the world grows. — Linda Lew "

 

[missy]

State of Affairs: May 2​

https://substack.com/profile/27227002-katelyn-jetelina

Katelyn Jetelina

"
Once again, many eyes are on South Africa. After a massive BA.1 wave and no BA.2 wave, BA.4 and BA.5 are taking hold while they move into the winter season. In the past two weeks, cases have increased 173% and test positivity rate is high (20%).


Hospital admissions have also started increasing. Gauteng—the epicenter (once again)—has seen a 63% increase in hospitalizations in the past week, but thankfully started off at a very low baseline. While it’s still early to draw conclusions about the severity of the resurgence, positive signals are coming from hospitalization data: 23% of admissions are for severe disease with BA.4/5 infection (vs. 34% with BA.1 and 64% with Delta). Case fatality rates also remain low compared to previous waves.

Figure from Mia Milan Twitter Here
We recently received critical information from the Sigal lab in South Africa about BA.4 and BA.5 (preprint here). The team measured antibody protection against BA.4 and BA.5 among people infected with the original (BA.1) Omicron. Immune escape from BA.4/5 was substantial. It was even more pronounced among unvaccinated compared to vaccinated (not boosted) people (5-fold difference).

Escape of BA.4 and BA.5 from Omicron/BA.1 elicited immunity. Green=vaccinated; Purple=unvaccinated. Source Here
This combined with South Africa’s low vaccination coverage (36%) is driving the infection wave in South Africa. If “endemic” SARS-CoV-2 is 6-month infection waves, we are in for a wild ride. It’s important to note that this study measured antibodies (our first line of defense) and not B-cells or T-cells (our second lines of defense). Because we know T-cells work very well against the original Omicron, we expect continued protection against severe disease and death among vaccinated people.

United States​

Back in the U.S., cases continue to slowly rise with a 49% increase in the past two weeks. The uptick is due to a mixture of Omicron sublineages. BA.2.12.1, in particular, has mutations to further escape immunity, so it’s quickly gaining speed because it’s finding new pathways of infection. BA.4 and BA.5 have been detected in the U.S., but are still at very low levels of detection. We expect this to change in coming weeks.

(CDC)
While the Northeast region is still the case leader, the most noteworthy case accelerator is Puerto Rico with a 271% case increase in the past 14 days. Virologists confirmed that BA.2 is responsible for the uptick, as opposed to BA.4 or BA.5.

(Financial Times)
If the same viral lineage is circulating in the Northeast, why is Puerto Rico getting hit particularly hard? There could be several reasons, like behavior differences. Also, seroprevalence data shows striking differences: 35% of the Puerto Rico population has some infection-induced immunity compared to 62% of the New York population.

Unfortunately, hospitalizations in Puerto Rico are following cases and have increased 120% in the past 14 days (daily average of 212 hospitalizations). Deaths have so far increased 10%. While Puerto Rico has one of the highest vaccination rates in the U.S. (77%), it’s not 100%, and many people will continue to get swept up in the waves.


Looking towards the Northeast, wastewater is having a bumpy ride. Metrics in Boston, for example, increased very clearly due to BA.2, then started falling, then started increasing again. This may be due to the introduction of BA.2.12.1. Time will tell. Compared to the original BA.1 wave, this increase is relatively minor thus far.


(Massachusetts Water Resources Authority)
Hospitalizations continue to lag cases in the U.S., but are increasing at a much slower rate (15% increase in the past 14 days) than cases. In New York, hospitalizations trended upwards but the absolute number remains low (6 per 100,000), and close to 100% of hospitalizations are among unvaccinated people.

(NYC Health)
Deaths in the U.S. continue to nosedive. Today we’re reporting 321 deaths per day, and we expect to reach the milestone of 1,000,000 total deaths soon. The Kasier Family Foundation updated their preventable deaths analysis last week. Since vaccines were readily available (June 2021), we’ve lost 234,000 Americans to SARS-CoV-2 that could have been prevented. In March alone, we lost 14,800 Americans to a vaccine-preventable disease.

(Kaiser Family Foundation: Source Here)
Thanks to base rate bias (see my previous post here), the more people vaccinated the more deaths we will see among vaccinated. This also shows that vaccines aren’t perfect, and transmission is, in fact, still important to track.

Bottom line​

We are getting mixed signals across the world and across the U.S. as different Omicron mutations take hold. We are confident, though, that vaccines continue to protect against severe disease and death. But keeping transmission low is still important so vulnerable populations don’t get swept up in the waves.

Love, YLE

Personal update​

In full transparency, my professional affiliation has changed. Today is the first day I am not a full-time University professor. I made the incredibly difficult decision to move from academia to health policy. As Director of Population Health Analytics, I will strive to elevate research for more data-driven policy to improve the health of Americans. I am joining a non-profit, non-partisan policy think tank (more here). This move also enables my little family to move back to my home—Southern California! I’ll continue this newsletter on the side, and I will continue as an adjunct Assistant Professor at UTHealth so I can continue to teach and work with students (my two favorite things). I still have no conflicts of interest to report.
"

 

[Asscherhalo_lover]

I still have managed to evade this. I have had 3 full doses of Moderna but my last one was August 2021. I'm going to get a booster next weekend.

 

[missy]

I still have managed to evade this. I have had 3 full doses of Moderna but my last one was August 2021. I'm going to get a booster next weekend.

Good luck!
I am waiting for my antibody results and then deciding.

 

[TooPatient]

Got my first booster today. DH got his second booster.

My aunt is staying home with my grandmother right now. The cousin who tested positive is still isolating. Not sure how completely as someone is bringing him food. Hoping they are being smart about it. The cousin who tested negative stayed home from school today with a bit of a fever. All of the negative test people have been very careless this whole pandemic. The positive cousin had to have gotten it from one of them so I expect at least one has a false negative. Just hoping my grandmother stays healthy!

 

[missy]

@TooPatient sending well wishes to your grandmother.


"

Long-COVID Symptoms a Serious Challenge for Older Patients, Physicians​

Bridget M. Kuehn





Even mundane tasks like making a meal can be exhausting for Louise Salant.
"I'm totally wiped out," said the 71-year-old former private music instructor with asthma who lives in New York City and has been coping with debilitating symptoms of fatigue, shortness of breath, and gastrointestinal symptoms since recovering from a severe bout of COVID-19 two years ago. "I just don't have the energy."
Salant is not alone. Many older people who contract COVID-19 experience prolonged symptoms of the disease. An analysis of Medicare Advantageclaims data published in the BMJ found that about one third of roughly 87,000 adults aged 65 in the database with a COVID-19 diagnosis sought care for persistent or new symptoms 21 or more days later.
That figure is about twice the rate of persistent COVID-19 related symptoms seen in a cohort of adults younger than age 65 with commercial insurance analyzed by the same group of researchers in a separate BMJ study. Compared with a 2020 comparator group of patients in this age cohort, these patients had a greater likelihood of respiratory failure, fatigue, hypertension, memory problems, kidney injury, mental health conditions, hypercoagulability, and cardiac rhythm disorders. When they compared post-COVID-19 symptoms to lasting symptoms of another serious viral disease — influenza — only respiratory failure, dementia, and post-viral fatigue were more common in the COVID-19 group.

"It became clear early in the pandemic that there is going to be a second pandemic related to all of the complications that we've seen related to COVID-19 infections," said Ken Cohen, MD, executive director of translational research and national senior medical director for Optum Labs in Minnetonka, Minnesota, who co-authored the BMJ studies.

The results are among a growing body of evidence suggesting that older adults are at high risk of persistent post-COVID-19 symptoms.
Researchers in Rome, for example, found that 83% of 165 patients aged 65 or older who had been hospitalized for COVID-19 reported at least one lasting symptom — problems like fatigue, shortness of breath, joint pain, and coughing — in the months after hospitalization. One third of those had two symptoms, and 46% had three or more.
A similar study in Norway found that two thirds of patients aged 60 or older reported reduced health-related quality of life during follow-up visits 6 months after hospitalization for COVID-19. The most-reported impairments among those patients were the inability to perform the tasks of daily life, reduced mobility, and increased pain and discomfort.

Cognitive Concerns​

Mounting evidence indicates that COVID-19 may contribute to chronic cognitive impairment in older adults. A multisite US study found that 28% of 817 adults presenting to emergency departments with COVID-19 had deliriumand poorer outcomes. A Chinese case-control study that enrolled 1438 individuals hospitalized in Wuhan for COVID-19, along with 438 of their uninfected spouses, found that 12% of COVID-19 survivors experienced cognitive impairment a year after discharge. Matteo Tosato, MD, PhD, head of the outpatient clinic for patients with long COVID symptoms at Gemelli Hospital in Rome, called those findings "very concerning."

• Jin Ho Han, MD, an associate professor of emergency medicine at Vanderbilt University, Nashville, Tennessee, said cognitive impairment is common after an acute illness, particularly in frail or vulnerable patients.
  
  "Hospitalization and the acute illness itself accelerate cognitive decline," said Han, and previous evidence links delirium with worsening cognition. He and his colleagues are studying the potential role of delirium in longer-term cognitive decline in older patients after COVID-19.
  
  Han emphasized the importance of preventing COVID-19-related delirium through vaccines and other strategies to reduce exposure of older patients to the virus. "Once you have cognitive decline, there are no interventions to reverse it," he said.
  
  

  Alarm Bells for Long-Term Care​

  Experts expressed concern that the situation might be even worse for people living in long-term care facilities. Many already need assistance with tasks of daily living and could be particularly vulnerable to lasting effects of COVID-19, said Karl Steinberg, MD, president of the Society for Post-Acute and Long-Term Care (AMDA). He estimated that roughly half of his patients who have had COVID-19, regardless of the severity of their symptoms, have endured some degree of functional decline.
  
  "It's common for long-term care facility residents to experience functional and cognitive decline, even after seemingly minor things, like a cold or a trip to the hospital," Steinberg, who has been a medical director of long-term care facilities in San Diego County for more than two decades, told Medscape Medical News. "It makes it a little harder to determine whether the declines we've been seeing post-COVID in these residents are attributable to post-COVID vs just an accelerated step in their overall expected decline."
  
  The pandemic may have contributed to worse outcomes for people in long-term care facilities in several ways: the disease itself, its effects on healthcare delivery, and necessary preventive measures to protect long-term care residents from exposure to the virus.
  
  "During the many months where family visits were prohibited, we saw people — whether they had COVID-19 or not — suffer major clinical, functional, cognitive declines or severe psychological symptoms," Steinberg said.
  
  Steinberg also emphasized the importance of preventive measures such as vaccines and boosters in patients in long-term care facilities. He said that benefit of preventing lasting symptoms is often a strong motivator for family caregivers of people with dementia to get them vaccinated or boosted.
  "It's clear that vaccination and booster reduce the incidence of post-COVID symptoms," he said. Almost all studies have been in younger cohorts, but he expects the benefits would also apply to older patients.
  
  

  Easing Symptoms and Offering Support​

  As with long COVID generally, many questions remain about the causes of lasting symptoms of COVID-19 in older patients, and how best to treat them. Tosato, who led the study of long-COVID patients in Rome, is focusing on inflammation as a critical factor in the condition. He and colleagues across Europe hope to answer some of them by launching a multicenter study of lasting COVID-19 symptoms.
  
  In the meantime, physicians like Steinberg and Tosato said they are doing their best to evaluate and treat patients empirically.
  
  "We pull from our armamentarium to treat system-specific symptoms," Steinberg said. "We want to improve the quality of life and help each day be the best it can."
  
  Physicians in long-term care facilities might use medications like antidepressants or nonpharmacologic approaches for patients experiencing depression symptoms. Families are also crucial in helping patients by bringing in home-cooked meals and encouraging loved ones who may be experiencing loss of taste or smell to eat, Steinberg said.
  
  "We've seen with the return of families and loved ones visiting to some extent has alleviated some people's symptoms, especially psychological ones," he said.
  
  Tosato said he and his colleagues start with an individualized, multidisciplinary assessment to determine what types of care may help. He noted that physicians might recommend medications or rehabilitative therapies depending on the patient's needs.
  
  
  "A personalized approach is key," Tosato said. His study also found that the proportion of older patients experiencing symptoms declined over time — a glimmer of hope that many will recover.
  
  Cohen emphasized the need for a multimodal rehabilitation, an evidence-based approach used to care for patients who survived hospitalization with severe COVID-19 — a group that has substantially higher rates of persistent symptoms. This approach includes cognitive rehabilitation, physical therapy, occupational therapy, and a graded exercise program.
  
  Han and colleagues are studying potential therapies like cognitive rehabilitation in adults who've experienced delirium. But until evidence-based treatments are available, they stress the role of support for patients with cognitive decline and their families.
  
  "A lot of the work we do is teach patients and their families to compensate for newly acquired cognitive deficits from any illness, including COVID-19," Han said.
  
  Salant said she has experienced some improvement in her energy since her pulmonologist recommended a new inhaler based on her symptoms. Her sense of smell and taste, lost to the infection, returned after she received her first dose of a vaccine against COVID-19. She takes comfort in participating in Survivor Corps, a group of more than 170,000 COVID-19 survivors and their families who advocate for more scientific research on the disease.
  
  She also expresses gratitude for the support she receives from her primary care physician, who she said has taken the time to learn more about the symptoms of long COVID, listens to her, and respects what she has to say.
  
  "I have hope that I will keep getting better by baby steps," Salant said.
  Tosato, Steinberg, and Han have disclosed no relevant financial relationships.
  
  Bridget M. Kuehn is a medical writer in Chicago.
  
  
  
  "
  
  
  
  
  

 

[missy]

Infectious Disease>COVID-19

NIH Probes Paxlovid Relapses; Pandemic of Unvaxxed No More? Musk Disses Wellbutrin​

— A daily roundup of news on COVID-19 and the rest of medicine​

by Molly Walker, Deputy Managing Editor, MedPage Today May 2, 2022

"
An NIH official said it is "urgent" to find out why some patients have experienced viral rebound after taking nirmatrelvir/ritonavir (Paxlovid) for COVID-19. (Bloomberg)

And speaking of the antiviral, Pfizer said nirmatrelvir/ritonavir failed to show a significant improvement over placebo when used as COVID-19 prevention for individuals with high-risk exposures.

Southern states should prepare for a summer COVID surge, while northern states should prepare for a winter surge, said Deborah Birx, MD, who led the Trump White House coronavirus task force. (CNN)



And that's bad news, because new Omicron subvariants prove there may be no end to coronavirus mutations. (Washington Post)

In somewhat related news, Moderna says it will have "large amounts" of an Omicron-specific booster available by the fall. (The Hill)

No longer a pandemic of the unvaccinated: data increasingly show that the share of COVID deaths is growing among the vaccinated -- particularly among older and immunocompromised individuals -- who made up 42% of deaths during the Omicron wave, according to a Washington Post analysis.

Mark your calendars: FDA is convening its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in June to discuss Pfizer's COVID vaccine for kids under 5 years and Moderna's for children under age 6; and for the Novastans out there, VRBPAC will also meet in June to discuss Novavax's COVID vaccine in adults.

Newly minted Twitter owner, Elon Musk, stirred up some controversy when he claimed antidepressant bupropion (Wellbutrin) should be taken off the market. (Forbes)



As of Monday at 8 a.m. EDT, the unofficial U.S. COVID toll was 81,399,020 cases and 994,793 deaths, increases of 403,997 cases and 2,214 deaths versus this time a week ago.

The Justice Department will challenge an Alabama law that criminalizes "medically necessary" care for transgender youth.

NIH's most recent changes to its COVID treatment guidelines include recommending against the use of ivermectin outside a clinical trial and recommending against the use of convalescent plasma collected prior to the Omicron variant.

The Lone Star tick, which makes people develop a red meat allergy, has been spotted in Washington D.C. (Washington Post)

FDA approved the Janus kinase inhibitor upadacitinib (Rinvoq) as an oral therapy for active ankylosing spondylitis in patients who fail on tumor necrosis factor inhibitors, AbbVie announced.

Meanwhile, the FDA rejected two drugs developed exclusively in China: surufatinib for advanced neuroendocrine tumors, said developer Hutchmed; and toripalimab for advanced or metastatic nasopharyngeal carcinoma, announced Coherus and Junshi Biosciences.



And FDA also took some time out of its schedule to reassure the public that there is a very low risk of contracting highly pathogenic avian influenza from grocery store eggs.

Thanks to the public's fascination with Elizabeth Holmes, Theranos merch continues to sell like (pricey) hotcakes on eBay. (The Guardian)

Purveyors of marijuana edibles have become increasingly brazen when it comes to targeting New York City children. (New York Post)

Take two hikes and call me in the morning: Canadian doctors will soon be able to prescribe national park passes to their patients with mental health issues. (CNN)

MedPage Today editor-in-chief Jeremy Faust, MD, on why he will be "quite comfortable" to have his 4-year old receive Moderna's COVID vaccine if authorized. (Boston.com)

"

 

[TooPatient]

Send all the dust and prayers and whatever positive you have towards my grandmother. She is okay so far, but now both of my cousins.have tested positive and my aunt is running a fever. My grandmother is heavily exposed. My aunt is in the house still caring for her fever and all. Don't know what else to do. My aunt and her kids have nowhere to go so can't just leave the house for any of us to go in and care for her instead. DH was hit hard last time so bringing it home would be very bad. My mom's husband has heart issues and a pacemaker so he really needs to not get it. My mom has already been exposed. What a mess!

I haven't been around any of them for 8 days at this point so we are probably safe. Just so worried about my grandmother.

 

[missy]

@TooPatient sending bucketloads of healing vibes to your grandmother and any other loved ones who need them. And gentle (((hugs))) to you. It's been a (very) challenging few years.

 

[missy]

"

US Likely to Find Out About Next COVID Booster by Summer: Fauci​

By Ahmed Aboulenein and Mrinalika Roy
May 02, 2022

WASHINGTON (Reuters) - Scientists and health officials by this summer should have a better sense of what type of COVID-19 booster will be needed to deal with the next phase of the pandemic and when it should be administered, top U.S. infectious disease expert Dr. Anthony Fauci said on Friday.
The National Institutes of Health, where Fauci serves as director of the National Institute of Allergy and Infectious Diseases, is conducting clinical studies to determine if the next COVID booster should be specific to a particular variant of the coronavirus or designed to address more than one variant, known as a bivalent vaccine, ahead of the fall season, he said.
"We likely will know over the summer when we'll be able to, and what we'll be able to, boost people with," Fauci said at a virtual event hosted by the National Press Club in Washington.
Fauci also said health experts are looking carefully into anecdotal reports that some people after taking a five-day course Pfizer Inc's oral antiviral treatment Paxlovid have tested positive for the coronavirus or experienced mild symptoms.

The government has been encouraging people at risk of severe disease who experience COVID symptoms to get a Paxlovid prescription as soon as possible.

While health officials look into whether a viral rebound after Paxlovid is a real phenomenon, Fauci said: "The drug is still clearly very effective in preventing you from progressing to requiring hospitalization, the 90% efficacy seems to be holding strong."
Fauci also said it will be very difficult for the U.S. population to reach "classical" herd immunity against this virus due to several factors. They include its ability to evolve and mutate into diverse variants, waning immunity from infections and vaccines, and an anti-vaccine movement that has kept millions of people from seeking protection.
It is unlikely the United States will ever eliminate COVID-19, he said, but the nation should strive to control the virus and get out of the acute pandemic phase.
"When I said we are no longer in that fulminant acute phase, that does not mean that the pandemic is over," he reiterated. "By no means is it over. We still are experiencing a global pandemic."
"

 

[missy]

"

When Paxlovid Isn’t Enough​

Pfizer has some advice for patients suffering a relapse in symptoms after taking a full course of their Covid treatment: Take more of the drug. “Paxlovid does what it has to do: it reduces the viral load,” Chief Executive Officer Albert Bourla said of its Covid pill in an interview on Tuesday. “Then your body is supposed to do the job.” Paxlovid has been a hit for Pfizer, dominating the market as the most popular antiviral for treating more severe cases of the virus and is expected to bring in at least $22 billion in global sales this year. And U.S. President Joe Biden has made Paxlovid a key feature of his pandemic strategy. But in recent weeks a puzzling trend has emerged to mar the drug’s reputation: Some patients have seen the virus rebound after completing a full course of Paxlovid. U.S. government researchers are now investigating why. Bourla said that for unknown reasons some patients aren’t able to clear the virus with the first course of the antiviral treatment. In cases where virus levels do rebound, Bourla said, “then you give a second course, like you do with antibiotics, and that’s it.” (Read the full story here.) Government researchers are investigating why one course of Paxlovid doesn’t always do the job. Photographer: Kobi Wolf/Bloomberg But there’s a problem: U.S. guidelines limit use to five consecutive days. That means patients might not be able to get another course of treatment. The FDA didn’t respond to requests for comment. Bourla and other top executives say they’re taking the matter seriously, though they believe the phenomenon is rare and unrelated to the drug. A clinical trial of high-risk patients showed that about 2% who received Paxlovid experienced viral-load rebound, according to the executives. The rate of rebound was about the same among patients who received a placebo, suggesting that the drug was likely not responsible for the resurgence, they said. “This is more about the virus and the disease in certain patients than a characteristic of Paxlovid,” Chief Scientific Officer Mikael Dolsten told me in our interview. The drugmaker is looking at relapse causes that might include the existence of reservoirs of virus in tissues or cells that aren’t reached by treatment, he says. The company is also investigating the possibility that patients may not be experiencing a relapse at all, but instead have become re-infected with the virus. Out in the real world, doctors treating Covid patients say they’re confused about how to proceed. David Wohl, an infectious disease expert at the University of North Carolina at Chapel Hill, has run into difficulty getting a second course of Paxlovid to a high-risk patient whose symptoms returned after treatment. The patient’s insurance initially denied a repeat course of the drug. “Pfizer’s statement fails to recognize the reality of use of the drug,” Wohl says. — Riley Griffin "

 

[Asscherhalo_lover]

With the newer vaccines being developed I'm more tempted to wait. I'd hate to get one and be ineligible for the newer ones.

 

[missy]

“
More than 15 million people—equal to the population of Manila, or Rio De Janeiro, or the entirety of Zimbabwe—have died as a result of the coronavirus pandemic that began more than two years ago in Wuhan, China, the World Health Organization said. That’s one out of every 500 people on Earth. They were mostly individuals killed by the virus, but also included those who died of other afflictions because health systems were overwhelmed by the infected. Though the U.S.—long the leader in confirmed infections and deaths—has now surpassed more than a million known fatalities, the new report says a larger number of deaths were in India. —David E. Rovella


“

 

[missy]

COMMENTARY

Our Biggest Mistakes During the COVID-19 Pandemic​

Arthur L. Caplan, PhD
DISCLOSURES
May 04, 2022

“
what were our 10 biggest mistakes? I think there are probably more than 10, but let's see what that list might look like just so we can not only begin to debate how to correct what I think were errors and mistakes, but also see whether we're ready for the next wave of whatever it is that might show up as a pandemic, such as future COVID-19 variants, flu variants, Ebola, Zika, or some other horrible thing that might put American society and the world at risk.

Language Matters​

The first thing I think we learned is that language matters. In this whole debate about COVID-19 and what to do, we heard terms like "warp speed" and "booster." Both of those terms, I think, were inaccurate. The suggestion that our vaccines were made at warp speed led some people to think they're not safe or they're cutting corners, or the evidence isn't good. Politicians, from Trump to Biden, wanted to take credit for getting vaccines out there very quickly in response to the appearance of COVID-19.


It's understandable, but you can't go around describing medicines or vaccines as "warp speed" or something that has never before been done at this rate. You scare people, and there's no reason to scare people. The evidence for COVID-19 vaccines was solid, impressive, and something that had been worked on in terms of basic science for many, many years. If there was a warp speed, it was because the manufacturers were given money to make the vaccines and have them ready to go as soon as approval came. The public often didn't understand that.

Similarly with boosters. They kept talking about the third shot as a booster. Many people hear the term booster and think, Well, that's not something I needor That's more voluntary. Look, the COVID-19 vaccine is a three-shot vaccine. It takes three shots to keep all the variants at bay, keep you out of the hospital, and keep you from dying. By talking about boosters all the time, the CDC and many other government agencies, I think, gave the impression that something really important was not.

There was even a hint that we were giving out boosters while the rest of the world didn't get any shots. That's inaccurate. It's a three-shot vaccine. The rest of the world needs three shots too. Everybody does. By misdescribing things and calling them boosters when they weren't, rather than saying you've got a vaccine that requires three shots to be complete, I think we undermined both Americans' willingness to get that third shot and set up a false scenario where the rest of the world was criticizing us, if you will, for indulging ourselves with boosters when they didn't have any vaccine. They certainly merit vaccine, but everybody merits the complete sequence of vaccination with the three shots. Every vaccinologist I've talked to says it's a three-shot vaccine, so this language of boosters really undercut what we could do.

The Ethics of Values vs Science​

Another lesson we learned is that the pandemic is as much about values as it is about science. It's really important to understand that some of our biggest failures in responding to COVID-19 had nothing to do with a lack of vaccines, an inability to prove that masks helped, that testing was valuable in terms of trying to quarantine and isolate infected people, or that ventilation was important. I mean, the science, I think, was done very well and held up well, but what we never messaged very well was the ethics and the values.

When people said things like, "I want to be free to go where I want and do what I want, even if it's a pandemic," that is not an acceptable interpretation of liberty. You don't get to go where you want, do what you want, and show up where you want if you're going to pose a danger to somebody else. It's very simple. Liberty gets restricted when the possibility is there that you could harm somebody else.


If you're going out infected or you don't know your COVID-19 status, which was true for many people throughout the COVID-19 epidemic, then you have a duty not to put them at risk. We never sold that message effectively about the obligations to let liberty be tamped down or temporarily restrained to protect us. That's a fundamental goal of society, and by the way, a principle we follow when we say you have to have rules governing how you drive your car and putting kids in child seats.


There are many parts of our lives where we restrict liberty so that we can have less mayhem and more, if you will, social activity permitted. More freedom by restricting things that people do. We don't say you go out and pick which side of the road you want to drive on tomorrow morning, that it's up to you, it's a liberty choice.

The Mess of Medical Messaging​

Another major failure I think we learned about is that we're not very good at communication within the medical and science communities to the public. I think there were many people who tried very valiantly to communicate messages to the public on mainstream media and social media, and they did their best. The battle about COVID-19 and getting messages across to fight misinformation about phony cures or the dangers of masks — that they're going to suffocate your children if they wear them — and many other powerful misinformation messages took place at the grassroots level.


The people who were peddling bunk showed up at the school board, the church, the synagogue, the high school, and at public meetings and public forums. It's great to have messaging top-down and to be on the national media, send out messaging there, get things into major print outlets and social media outlets, but the battle in public health communication is grassroots-up, too.


We need more people who are showing up at local forums and local activities to really get messages across to the local community, to answer questions, and also to serve as trusted sources. Throughout the whole COVID-19 pandemic, I think some of the most trusted people remain doctors and nurses — the personable people who had relationships with patients or that people knew.


That's where we've got to get more effective communication going and get those people out a little bit more locally. It isn't just top-down, as much as everybody wants to pay attention to what Biden says or what Tony Fauci says, or what pundits are saying on various TV networks. That's half of the messaging battle. When you don't fill in the other half, misinformation and bad information take off, and it really hurt during the COVID-19 pandemic.

Pandemic Exposed Problems With Vaccine Distribution​

I think there was another myth that grew, saying we were betraying the rest of the world when the richer countries vaccinated themselves. It would be useful to get vaccine out as fast as possible around the world. It's prudent because we know that new variants can occur in unvaccinated places, and it's obviously important for humanitarian reasons to help save lives in places that have dangerous outbreaks of COVID-19 or something else.


The world needs a better system to disseminate vaccines. It isn't enough just to send them on a boat to a dock. If the country where they arrived is corrupt and the leader is going to sell those vaccines to the highest bidder or some other country, if there are no refrigerators, if there are no roads, if there's no one trained to give the shots, if there's not even messaging that goes out to fight anti-vaccine misinformation in those countries, then vaccination isn't going to happen. It isn't as simple as just saying, "Give us the patents or give us the vaccine supply."


We've got an infrastructure challenge in much of the world that has to be overcome in order to vaccinate. Let me add that there are plenty of places in the world now where no one is getting in to vaccinate. Think about Ukraine, think about Ethiopia, think about Yemen, think about Somalia, North Korea. There's a big list of war-torn states and failed states where no one's going to be launching a vaccine campaign. We've got to come up with other tools in order to battle COVID-19 or any other outbreaks in those places.

Testing Took a Backseat, Supply Issues Caused Harm​

My last item on the top 10 list, although it's not really 10, is that we didn't use all our tools. It was a big push trying to vaccinate our way out of COVID-19. Vaccines helped, but they're not enough. We never really pushed hard for testing. We wound up doing things like shutting down cities, shutting down entire schools if they had one case. The right way to go is to get testing out there that is cheap, available, and regular, every day, so that you could keep your child home if they were infected rather than closing the whole school. Similarly with the workplace.


The idea of quarantining and isolation — they're valuable. They're all public health tools, but in modern economies and modern society, they're not practical. Even the Chinese trying to shut down Shanghai and other huge cities are learning the bitter truth — that it really is impractical to shut down 26 million people in a city. You've got to test your way through, and we didn't pursue that option, and we didn't pursue the option of antiviral medicines. They were the tools that we used to get past HIV, and we didn't use them effectively. We didn't develop them fast enough. We didn't have protective gear. It's inexcusable that we don't store it and maintain it. Ventilators as well.


The just-in-time system of supply might be useful for car manufacturers, but it isn't going to work in healthcare. We need a reservoir of backup so that if something breaks out, we can quickly disseminate the requisite protective gear — the requisite masks, gowns, and so on.


Last, this is an airborne disease. It took us a long time to admit it, but we need to make sure that not only are we paying attention to deep cleaning, which I think didn't do much of anything, but that we're really trying to get viruses out of the air by upgrading ventilation systems in schools and workplaces, in hospitals, in nursing homes. That's something that is a weakness in our system. We've got to fix it.


There were many lessons forthcoming from the COVID-19 experience that I think finger-pointing might be appropriate, but hopefully not only finger-pointing but also trying to learn, improve, and do better for the next pandemic. As the experts say, there will be a next pandemic, and hopefully what we did wrong or what we didn't do as well in this one, we can fix in time for the next one.


“

 

[missy]

“

FDA Severely Limits Use of J&J COVID Shot​

— Decision comes more than a year after "pause" over rare clotting events​

by Molly Walker, Deputy Managing Editor, MedPage Today May 5, 2022

Use of Johnson and Johnson's (J&J) COVID-19 vaccine should only be limited to certain adults, the FDA said on Thursday.
Due to an updated analysis of the rare cases of thrombosis with thrombocytopenia syndrome (TTS), which typically occur 1 to 2 weeks after vaccination, use of the J&J vaccine should be restricted to those for whom mRNA vaccines are "not accessible or clinically appropriate," or who would not get vaccinated if not for the J&J vaccine, the agency said.

"Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, in a statement.
FDA and CDC initially paused use of the vaccine in April 2021, following 15 cases of TTS. Through March 18 of this year, the agencies have confirmed 60 TTS cases and nine deaths.
"The reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered," the FDA said in its announcement. The greatest risk is among women ages 30 to 49 years (about 8 cases per million doses).
Additional reasons for this action included that the risk factors for TTS were "unknown," that an individual with TTS may deteriorate rapidly "despite prompt diagnosis and treatment," and that TTS may have "long-term and debilitating" health consequences.
The FDA added that they have included a warning statement at the beginning of the J&J vaccine fact sheet for healthcare providers "for prominence," summarizing the risks of TTS.
“

 

[missy]

FSMB Adopts Misinformation Policy​

— Provides guidance for state boards, licensees in order to reduce misinformation harms​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today May 5, 2022

“
The Federation of State Medical Boards (FSMB) approved a medical misinformation and disinformation policy at its annual meeting in New Orleans last weekend.

The guidance, written by FSMB's Ethics and Professionalism Committee, provides recommendations both for state medical boards when drafting their own policies, and for licensees regarding best practices.

"More than 2 years into this pandemic, the largest threat next to the spread of the virus itself is the spread of disinformation and misinformation," Humayun Chaudhry, DO, CEO and president of FSMB, said in an interview with MedPage Today.



Chaudhry noted that the first line of the document "sets the tone -- that truthful and accurate information is central to the provision of quality medical care."

"We acknowledge early on that [medical misinformation] isn't new," he said. "But it's important to keep in mind that when there is misinformed decision making, it can cause needless harm, including deaths."

The policy starts out by defining key terms, including misinformation and disinformation -- the distinction being that the latter involves intent -- and then by defining key principles including beneficence, non-maleficence, justice, autonomy, and professionalism.

It then jumps into recommendations for both boards and licensees. For boards, that includes adopting a policy, if they haven't already, that "clarifies board expectations regarding the dissemination of misinformation and disinformation by licensees."

Chaudhry said many boards believe they already have "adequate terminology and verbiage" within their statutes that enables them to take action against misinformation, as Oregon, Connecticut, and California have. But "not every state board has the necessary language," he added, and for those that don't, "a specific policy on misinformation is encouraged in light of the increased prevalence of and harm caused by physician misinformation in this ongoing pandemic."



Chaudhry noted that boards can consider the concept of informed consent in their policies. "Failure to adequately obtain informed consent by not providing adequate or truthful information to patients about proposed treatments could be a grounds for disciplinary action," he said.

But not all misinformation matters need to result in discipline, he continued. One recommendation specifically states that boards "consider whether there are options that do not involve disciplinary action."

Chaudhry said he's had conversations with state boards that have received complaints about physicians and misinformation, and when they reached out, the clinician wasn't aware of the misinformation.
“

 

[Gloria27]

De.Been discussing studies and new findings in regards to S1 protein which can form immune complexes. Immune complexes can result in type 3 hypersensitivity.

There are 4 types of hypersensitivities, type 1 is an immediat allergic reaction involving IgE (from the common allergy to the need of an epi pen), type 3 give autoimmune diseases like RA or lupus.

Links to the source articles/studies are in the video's description.

 

[missy]

"

CDC: COVID Boosters Blunted Omicron's Effect on Nursing Homes​

— Residents with a booster more protected than those with only a primary series​

by Molly Walker, Deputy Managing Editor, MedPage Today May 5, 2022

An additional booster dose of COVID vaccine helped substantially reduce the rate of infection in nursing home residents during the Omicron wave compared with a primary series alone, researchers found.
After adjustment, relative vaccine effectiveness (VE) of an additional dose of COVID vaccine was 46.9% (95% CI 44.8-48.9) in preventing cases among this population, reported Namrata Prasad, PhD, of the CDC, and colleagues, writing in the Morbidity and Mortality Weekly Report.

"Relative VE estimates in this study are slightly lower and might reflect declines in VE because of potential immune evasion of the Omicron variant, consistent with findings from other studies that indicated lower VE against Omicron variant infection compared with Delta variant infection among adults," they wrote.
They examined data from the CDC's National Healthcare Safety Network from Feb. 14 to March 27, 2022, during the Omicron surge. About 15,000 skilled nursing facilities provided both case count reports and resident count reports, with vaccination status based on reports from 2 weeks prior.
The weekly reports included about 1 million nursing home residents, two-thirds of whom received an additional or booster dose. Only 22% had received a primary series alone. Nearly all (over 90%) received mRNA vaccines.
Infection rates declined across the study period, but rates of infection were "consistently lower" among residents with an additional or booster dose versus residents with a primary series only. There were 7,510 cases among 1,509,674 resident-weeks with a primary series only and 11,334 cases among 4,416,401 resident-weeks with an additional or booster dose, the authors noted. This corresponded to crude infection rates of 5.0 versus 2.6 per 1,000 resident-weeks, respectively.

Prasad's group added, however, that time since vaccination could not be evaluated. National vaccine coverage data indicate more than half of nursing home residents received either an additional or booster dose by early December 2021.
Another limitation was the lack of control for unmeasured confounders, such as age, comorbidities, previous COVID infection or behaviors related to COVID infection risk.
Prasad and colleagues emphasized the importance of not only a booster dose for nursing home residents, but an additional primary dose plus a booster dose for immunocompromised residents.
"Efforts to keep nursing home residents up to date with vaccination should be implemented in conjunction with other COVID-19 prevention strategies, including testing and vaccination of nursing home staff members and visitors," they wrote.



"

 

[missy]

"

Infectious Disease>COVID-19 Vaccine

New COVID Vaccines From Canada, China Score in International Trials​

— But does the world even need any more, experts ask?​

by Molly Walker, Deputy Managing Editor, MedPage Today May 4, 2022

A plant-based vaccine developed in Canada and a protein subunit vaccine from China proved safe and effective against symptomatic COVID-19, a pair of phase III trials found.
The two-dose plant-based vaccine, a combination of coronavirus-like particles in plants plus an adjuvant, showed 69.5% efficacy (95% CI 56.7-78. against any symptomatic disease caused by five pre-Omicron variants, reported Brian Ward, MD, of developer Medicago in Quebec, and colleagues in the CoVLP Study Team.

A post-hoc analysis found that the vaccine (CoVLP+AS03) had 78.8% (95% CI 62.1-82.5) efficacy against moderate-to-severe disease, with no severe cases in the vaccine group, they wrote in the New England Journal of Medicine (NEJM).
A second NEJM study also showed positive results for a vaccine (ZF2001) out of China against symptomatic and severe-to-critical COVID-19 for at least 6 months after full vaccination.
But in an accompanying editorial, experts raised the question: "Does the world still need new COVID-19 vaccines?"
"Both of these COVID-19 vaccines are produced on new technology platforms," wrote Hanna Nohynek, MD, PhD, of the University of Bern in Switzerland, and Annelies Wilder-Smith, MD, PhD, of the World Health Organization (WHO), in the editorial. "Both vaccines have the advantage of not requiring extreme coldchain procedures for storage, which makes them user-friendly in primary health care settings as well as in low- and middle-income countries."

Nohynek and Wilder-Smith pointed out that both trials included "mostly working age adults," so no vaccine efficacy data was available for older adults, and both lacked efficacy data against Omicron, "as well data on durability of protection and safety in subpopulations such as older persons, pregnant women, and persons with immunosuppression."
Still, they heralded the use of new vaccine platforms as new weapons to be deployed in the fight against COVID.
"With more vaccine platforms available, we can possibly improve decision making regarding the selection of a vaccine, since different vaccine platforms may be more suitable for ... certain subpopulations," Nohynek and Wilder-Smith said, adding that the world is still in need of a vaccine that prevents infection.
"To slow down the circulation of the virus and to limit the speed at which further variants emerge, new vaccines that have a substantial effect on reducing mild infection and transmission are needed," they wrote.

CoVLP+AS03 is currently approved for use in Canada, while ZF2001 is approved for use in China and several other countries. As of press time, there was no word on whether the developers of ZF2001 plan to submit data to FDA for approval. Medicago's CEO recently said the company has started the filing process for FDA approval.
CoVLP+AS03
"In the cells of the plant leaves, the expression of the SARS-CoV-2 S protein leads to the formation of virus-like particles," Ward's group wrote, adding that they then harvest and purify these particles, which are stable for 6 months. The adjuvant system has been used in pandemic influenza vaccines and "initiates a transient innate response and increases the magnitude, quality, and durability of adaptive responses."
The phase III trial was conducted from March 15 to Sept. 2, 2021 in the U.S., Canada, Mexico, Brazil, Argentina, and the U.K. Participants were adults with no prior history of COVID vaccination or COVID infection. They were randomized to receive either two injections of CoVLP+AS03 vaccine or placebo, 21 days apart.

Overall, 24,141 participants were randomized and included in the intention-to-treat (ITT) population. Median age was 29, 51% were men, and about 15% were seropositive at baseline. Nearly all were younger than age 65 (90%) and white (89%), with 82% reporting Hispanic/Latinx ethnicity. Participants with pre-existing conditions were underenrolled, due to surges of Delta and Gamma variants that made participating in a clinical trial more risky, the authors noted.
The primary vaccine efficacy endpoint included 165 cases in the ITT population, with 40 in the vaccine group and 125 in the placebo group. Vaccine efficacy was 78.7% (95% CI 30.2-95.1) in the small group with pre-existing conditions.
There were three severe cases that led to two hospitalizations in the placebo group, the authors noted. A post-hoc analysis found vaccine efficacy was higher (86.0%, 95% CI 66.2-95.1) against moderate-to-severe disease among those who were seronegative at baseline. There were no deaths related to COVID-19.
The most common systemic adverse events (AEs) were headache, myalgia, fatigue, and "a feeling of general discomfort." Grade 2 and 3 AEs occurred more frequently after the second dose. Three participants reported grade 4 AEs, two in the vaccine group (headache, chills, and fever) and one in the placebo group (headache).

ZF2001
The phase III trial of a three-dose protein subunit vaccine, featuring a "dimeric form" of the SARS-CoV-2 receptor-binding domain (RBD) with an adjuvant. It showed vaccine efficacy of 75.7% (95% CI 71.0-79. against symptomatic COVID and 87.6% (95% CI 38.9-98.5) efficacy against severe disease.
"Although the receptor-binding domain (RBD) has been widely used as the COVID-19 vaccine target ... data regarding the efficacy of RBD-based vaccines are lacking," wrote George Gao, PhD, of the Chinese Academy of Sciences in Beijing, and colleagues in the ZF2011 Global Trial Group.
The study was conducted from Dec. 12, 2020 to Dec. 15, 2021 in Uzbekistan, Indonesia, Pakistan, and Ecuador. Adults received either three injections of vaccine or placebo, 30 days apart.
Overall, there were 25,193 participants in the updated analysis. Median age was 37, about 68% were men, and 78% were "Asian, but not Ethnic Chinese."
There were a total of 158 cases in the vaccine group and 580 in the placebo group. Six participants in the vaccine group and 43 in the placebo group had severe-to-critical COVID. There were two deaths in the vaccine group and 12 in the placebo group, for vaccine efficacy of 86.5% (95% CI 38.9-98.5) against death.
AEs were mostly mild or moderate, with the authors noting 98.5% were grade 1 or 2. Four participants had treatment-related serious AEs (hypersensitivity), which resolved after treatment "without sequelae." There were 48 deaths over 6 months of follow-up, but none were attributable to the vaccine, they added.

"

 

[missy]

"

1 Million COVID Deaths; Press Dinner Serves Up Infections; DEA Eyes Telehealth Firm​

— A daily roundup of news on COVID-19 and the rest of medicine​

by Mike Bassett, Staff Writer, MedPage Today May 5, 2022

Note that some links may require registration or subscription.
According to data compiled by NBC News, the U.S. surpassed 1 million COVID -19 deaths on Wednesday.
Journalists from multiple news outlets are testing positive for COVID after attending the annual White House Correspondents Dinner. (CNN)
The gene-edited pig heart transplanted into a dying patient earlier this year was infected with a pig virus. (MIT Technology Review)

The FDA provided an update on nirmatrelvir/ritonavir (Paxlovid), noting there is no evidence of any benefit from a longer course of treatment or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms.
Meanwhile, Pfizer CEO Albert Bourla said Paxlovid prescriptions have increased tenfold in the U.S. since February. (CNBC)
As of Thursday at 8 a.m. EDT, the unofficial U.S. COVID toll was 81,672,286 cases and 997,579 deaths, increases of 118,508 cases and 1,957 deaths versus this time yesterday.
Secretary of State Antony Blinken has tested positive for COVID-19 and is experiencing "mild symptoms." (USA Today)
Passengers on a Carnival Cruise ship that docked in Seattle Tuesday said more than 100 persons on the ship tested positive for COVID-19, leaving staff "overwhelmed." (AP)
Telehealth company Nurx reported a 300% spike in requests for emergency contraceptives following the leaked Supreme Court draft opinion which indicated the court may be ready to overturn Roe v. Wade. (Fox Business)

Beijing has closed 10% of its subway stations in an effort to stem the spread of COVID-19. (ABC News)
The telehealth company Cerebral will stop prescribing methylphenidate (Ritalin), amphetamine/dextroamphetamine (Adderall), and other controlled substances to new ADHD patients as reports surface that the DEA is investigating the company. (Fierce Healthcare)
The first test that can simultaneously detect four common sexually transmitted infections (STIs) -- the Alinity m STI assay -- won FDA clearance, device maker Abbott said.
Data firm SafeGraph is selling location data related to visits at clinics that provide abortions, including Planned Parenthood facilities. (VICE)
The Department of Justice announced that it has filed charges against 14 individuals, including 12 medical professionals, alleging involvement in crimes related to the illegal distribution of opioids.
A third case of Ebola has been confirmed in a city in northwest Democratic Republic of Congo. (Reuters)
More states are decriminalizing fentanyl testing strips in an effort to reduce overdoses. (CNN)


"

 

[missy]

"

The kids fighting long Covid​

When I noticed that children’s hospitals were opening their own long Covid clinics, I wondered what kinds of issues kids with the condition were experiencing. Symptoms of the condition in adults can be wildly varied. But what about kids? So in early March, I spent a day at University Hospitals Rainbow Babies & Children’s long Covid clinic in Cleveland. What I found was that the effects of long Covid can be particular tough for kids. At the clinic, I met 15-year-old Lincoln Brockmeyer, who was gearing up to be a star forward on his high school basketball team before he got sick. I sat in on Brockmeyer’s doctors appointment as he told the doctors about how he now can’t make it through most days without a nap. The pain in his legs is the worst. He also gets lightheaded when he runs and the veins in his arms and legs pop out deep purple when he stands up. He certainly can’t play basketball. Lincoln isn’t alone. In my latest for Businessweek, I write about the children and teens suffering from this still poorly understood illness. They seem to get long Covid less than adults, but Daniel Griffin, an infectious diseases expert at Columbia University who treats Covid patients and hosts a weekly podcast update on the disease, said that about 5% to 10% of kids who’ve had the virus come down with long-term symptoms. Even at the low end of the estimate, that translates to more than a half-million children of the 13 million so far infected. Hunter Reinard and Lincoln Brockmeyer, two of the thousands of kids and teens battling long Covid. Photographer: Daniel Lozada for Bloomberg Businessweek Those numbers are big enough that Rainbow Babies’ kids long Covid clinic is far from the only one in the U.S. At least 75 children’s hospitals across the country have now set up long Covid clinics. These doctors can’t offer their patients an easy cure — there is just still too much we don’t know about how and why long Covid occurs. But doctors can offer kids and teens like Brockmeyer support to take better care of themselves so their bodies can heal. Treatment from specialists such as cardiologists, gastroenterologists and physical therapists can help begin to treat the symptoms of the condition even as we learn more about it. For at least some patients, that seems to make a difference. In addition to the physical pain and fatigue, Brockmeyer told me his mental health had been suffering during his illness. That’s improving. “Now that I feel like we know it is long haul, it feels better to know what I actually have,” he said, “and that we’re able to do something about it.” — Anna Edney "

 

[missy]

What Do We Know About Paxlovid Rebound?​

— And how should clinicians handle relapses after a 5-day course?​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today May 6, 2022

It's not yet clear exactly how often it happens, but doctors are confident they're observing relapses after 5-day courses of nirmatrelvir/ritonavir (Paxlovid) for COVID-19.
Paul Sax, MD, clinical director of infectious diseases at Brigham and Women's Hospital in Boston, said most rebound cases he's seen have been mild, "but some, anecdotally, have been severe."
And even though COVID-19 has been associated with biphasic illness since the beginning of the pandemic, rebound with nirmatrelvir/ritonavir looks different, he said.

"I do think, though, that in these rebound cases, they have such a striking diminution in their symptoms, accompanied by clearance on home antigen tests, that at least part of the explanation for their biphasic illness must be nirmatrelvir acting as an antiviral," Sax told MedPage Today.
Despite widespread clinical observation, there have been less hard data on the phenomenon. Although it wasn't reported in the New England Journal of Medicine publication of nirmatrelvir/ritonavir data from the EPIC-HR trial, data submitted by Pfizer to the FDA (see pages 22-23) showed that "several subjects appeared to have a rebound in SARS-CoV-2 RNA levels around Day 10 or Day 14."
Pfizer also told NBC News that about 2% of participants in that trial experienced a rebound, compared with about 1.5% of those on placebo.
There's also a preprint case report from clinicians at the Boston VA involving a 71-year-old vaccinated and boosted patient who had a rapid and complete resolution of symptoms within two days of taking nirmatrelvir/ritonavir -- only to have a rebound a week later. Rebound symptoms were lesser, and resolved after two days, but the patient had clear peaks in viral load on day 1 and day 9, and no other respiratory pathogens were detected, Michael Charness, MD, and colleagues reported.

Fortunately, sequencing didn't reveal any treatment-emergent mutations, nor was there infection with a different subvariant, they reported. That's consistent with Pfizer data showing no evidence of resistance in rebound cases in preliminary analyses from EPIC-HR, according to the documents submitted to FDA.
But Sax warned that "we know in general with anti-infective treatments that are not completely effective at eradicating infection -- I'm thinking of our immunocompromised hosts -- there is potential to develop resistance, so that's something that will need to be carefully monitored."
There are many plausible explanations as to why rebound can occur. Antiviral treatment may blunt a helpful immune response, Sax said. It could also be that some people may be prone to prolonged viral replication and thus destined to rebound after 5 days, and those ideas aren't mutually exclusive, he said. It's also unknown if rebound has anything to do with not completing the full course of therapy.

Better monitoring is needed, and fast, Sax said. Prospective observational trials can be organized relatively quickly, and large health systems like Geisinger, Kaiser, or the VA can examine their existing data. There may also be a need for randomized controlled trials to figure out how best to treat patients who relapse, he said.
In an email to MedPage Today, a Pfizer spokesperson said the company "continue to monitor data from our ongoing clinical studies and post-authorization safety surveillance," but did not provide additional details on those assessments.
When asked about treatment duration, the Pfizer spokesperson said the 5-day course was "based on observations from the treatment of acute respiratory viral infections (e.g., [Xofluza] for influenza, remdesivir for hospitalized SARS-CoV-2, etc.) that showed a 5-day treatment duration to be adequate, with little evidence suggesting increased benefit of longer treatment durations."
"Based on these prior observations, the decision was made to evaluate a 5-day treatment course in EPIC-HR," the spokesperson stated, noting that results from the trial indicate the 5-day course was sufficient for the majority of patients. "There may be some patient populations who may benefit from longer durations of treatment, and we are considering additional studies to evaluate this in some populations."

In the meantime, clinicians are getting conflicting advice on how to proceed if a patient has a rebound. Pfizer CEO Albert Bourla told Bloomberg that patients who relapse can take another course of the antiviral.
The FDA, however, said earlier this week in a statement from John Farley, MD, MPH, director of the Office of Infectious Diseases at the Center for Drug Evaluation and Research, that there's no evidence of benefit for repeating a treatment course in people who relapse.
Sax said he would limit re-treatment with a second course to the most immunocompromised and vulnerable patients, because "without data, we don't know if we're doing good or if we're doing harm."
Patients who relapse and have symptoms and a positive antigen test need to behave as if they're contagious and can transmit the virus to others, he added.
Sax also said he's added a disclosure when he prescribes nirmatrelvir/ritonavir, telling patients they may experience a relapse after their treatment course.
"I prescribed Paxlovid this morning and part of my counseling now is that this can happen," he said. "I think it's important that clinicians remember to tell people this can happen."

 

[missy]

Case Series Hints at Possible Paxlovid Role in Long COVID​

— Two patients saw easing of symptoms following course of therapy, according to pre-print​

by Molly Walker, Deputy Managing Editor, MedPage Today May 6, 2022

Nirmatrelvir/ritonavir (Paxlovid) appeared to alleviate long COVID symptoms in two patients but was unable to prevent the development of long COVID in another, a small case series found.
Two of the individuals took nirmatrelvir/ritonavir weeks after testing positive -- one following COVID re-exposure -- but both patients' symptoms eased following treatment, reported Michael Peluso, MD, of the University of California San Francisco, and colleagues.

A third patient took nirmatrelvir/ritonavir within 24 hours of COVID symptom onset, yet experienced a rebound of symptoms and went on to develop long COVID, the authors wrote in a pre-print published on the Research Squareserver.
"It seems that Paxlovid may benefit patients with long COVID," said Peluso in a statement, "but there is no way to access the drug unless a doctor is willing to break the rules, which we are not advocating."
Peluso's group offered two hypotheses: one, that early antiviral therapy may prevent severe disease, but not long COVID in high-risk patients. The second is that nirmatrelvir/ritonavir helps to treat and even reverse persistent SARS-CoV-2 sequelae of "inflammation, local tissue damage, and end-organ disease."
Peluso's group examined data from three patients in the Long-Term Impact of Infection With Novel Coronavirus study who reported long COVID symptoms as well as nirmatrelvir/ritonavir use.

A 42-year-old man and a 43-year-old woman with no significant medical history were both vaccinated and boosted 2 to 4 months previously before testing positive for COVID-19. Neither patient initially received antiviral therapy. But 2 to 3 weeks after symptom resolution, both patients began to experience worsening myalgia and fatigue. Over the next 3 to 7 weeks, the patients experienced severe fatigue and myalgia, as well as malaise and trouble concentrating, or so-called brain fog.
After the man was re-exposed to the virus, he initiated a 5-day course of nirmatrelvir/ritonavir. The woman began her prescription 25 days following initial symptom onset.
Both patients' conditions improved dramatically, with both reporting gradual resolving of symptoms. The man reported "gradually approaching his baseline health" and the woman said she was able to re-engage in activities of daily living, though she still experiences shortness of breath and myalgias.
The third patient, however, had a different clinical course. He was a 48-year-old man with a prior medical history of presumed Behcet's disease. He was also vaccinated and boosted 5 months prior when he tested positive for COVID. The man was prescribed nirmatrelvir/ritonavir within 24 hours of symptoms. Within 4 days of completing his treatment, he experienced recurring fever, fatigue, rhinorrhea, cough, chest pain, rash, and brain fog.

Three weeks after testing positive, he had worsening fatigue, along with chest soreness, palpitations, and malaise lasting 30 days following symptom onset.
"The key aspect of this case is that longer courses of Paxlovid may be needed, and giving it too early might not be optimal," Peluso said. "Only by doing rigorous studies will we get answers."

 

[missy]

"

Assessing Long COVID; Exercise to Slow Kidney Function Decline​

— Also in TTHealthWatch: Failure of non-operative management of appendicitis in children​

by Rick Lange, MD, Texas Tech; Elizabeth Tracey, Johns Hopkins Medicine May 7, 2022


TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine in Baltimore, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week.
This week's topics include assessing long COVID, self-monitoring blood pressure in pregnancy, exercise to slow kidney function decline, and failure of non-operative management of appendicitis in children.

Program notes:
0:40 Long COVID symptom assessment
1:40 123 symptoms items
2:40 What can we do to minimize?
3:00 Nonoperative management of appendicitis in kids
4:00 Pain helped predict failure
5:00 Ultrasonography associated with failure
6:01 Self-monitoring blood pressure in pregnancy
7:02 Didn't diagnose earlier
8:03 If it's done routinely
8:30 Exercise and slowing down kidney function decline
9:30 Did slow the rate of decline
10:30 Pharmacologic interventions
11:42 End
Transcript:
Elizabeth Tracey: Factors associated with failure of non-operative management of appendicitis in kids.
Rick Lange, MD: Reporting long COVID symptoms.
Elizabeth: Can we stave off kidney failure in sedentary older adults?
Rick: And does home blood pressure monitoring have a role in pregnancy?
Elizabeth: That's what we're talking about this week on TTHealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I'm Elizabeth Tracey, a Baltimore-based medical journalist.
Rick: And I'm Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I'm also dean of the Paul L. Foster School of Medicine.

Elizabeth: Rick, let's turn right to the BMJ, this, I think, a laudatory attempt, the chronicle how can we assess long COVID.
Rick: This ends up being a substantial problem. Since COVID began, we have had more than 450 million infections and more than 6 million deaths. But for those individuals that aren't even hospitalized, we still have a significant number of them that have what are called long COVID symptoms.
What these investigators attempted to do was to describe the development and to validate a novel patient-reported outcome measure for symptom burden from long COVID and what the patients report, which is really most important.
This study was conducted in the United Kingdom. They took individuals that reported long COVID symptoms and they had 10 clinicians evaluate the content validity of their self-reported symptoms. Then they tested these symptoms in 274 adults with long COVID. In essence, what they were able to do is develop a pretty rigorous evaluation system with patients that had long COVID symptoms and then validate it in a larger cohort.

What they came up with was 123 different symptom items and what are called 8 interference items. These items revolved around breathing, pain, circulation, fatigue, memory, thinking, movement, ear, nose, and throat symptoms, stomach and digestion, muscle and joint, mental health wellbeing, vision -- a very robust way of assessing it. Now what this will allow us to do is to more rigorously assess how often these occur, but more importantly to try to assess whether interventions can help diminish these symptoms.
Elizabeth: How about promulgation of this checklist and then also, since it's patient assessments of their own condition, even getting them to do it?
Rick: I think in terms of promulgating it, it will be useful in individuals who are trying to assess whether a symptom or symptom complex can be either prevented or treated. I don't see it being applied to individuals just routinely across the United States, but I do see its usefulness in assessing how often these symptoms occur, whether an intervention early on in a disease process can prevent it, or more importantly, after it's developed, what can we do to minimize the symptoms?

Elizabeth: I'm just betting that we are absolutely going to see a lot about this with regard to its research utility. Let's go to JAMA Network Open. This is a look at something that we reported I don't even know how many years ago, the non-operative management of appendicitis, in this case it's in children.
This particular study investigates factors associated with the failure of non-operative management of appendicitis in children and then it compares patient-reported outcomes between patients whose treatment succeeded and those whose treatment failed.
This was a subgroup analysis conducted in 10 children's hospitals, 370 children aged 7 to 17 years with uncomplicated appendicitis. This was 1-year follow up comparing non-operative management with antibiotics versus surgery. Here is what they found.
Almost 34% of these kids ended up in treatment failure, which I thought was kind of a really pretty high number, especially when we compare it to adults. They also found that there were some symptoms that they could say suggested that there might be failure to have non-operative treatment be the right course.

One of those factors was pain. The higher pain, interestingly, that the child presented with seemed to be associated with a higher risk of initial failure, but that a longer duration of pain is associated with a lower risk. Then, finally they looked at satisfaction with treatment decisions at 1 year and it was higher among the patients with successful non-operative management.
Rick: There are complications associated with the operation. If you can avoid the operation by giving antibiotics, many kids and parents prefer to do that. The nice thing is they get to be a part of that decision-making process.,
What this study shows is that the vast majority of those kids do well and about 65% of them just do well with antibiotics. Of those that need an operation, half of them have it in the hospital. The other half have it over the next year. But all the parents overall had a very high satisfaction rate.

Elizabeth: The editorialist cites that fact. I thought the other thing that the editorialist brought up that was interesting is that patients who underwent ultrasonography alone with regard to the evaluation of their appendicitis were more than twice as likely to have in-hospital treatment failure as those who underwent CT. To me, that suggests -- we know that CT is widely available -- maybe we ought to be just routinely doing CT.
Rick: When it's available, the answer it would be that it's probably the preferred imaging technique for kids with appendicitis. The other thing interesting to me is when they looked at things associated with treatment failure that you and I would have predicted, they didn't account for any of it. For example, age, white blood cell count, sex, race, ethnicity, insurance status, symptoms of presentation, and imaging results, those did not predict who was likely to fail -- as you said, it was just symptom duration or symptom severity. For parents and kids that have uncomplicated appendicitis, non-operative therapy can be a viable alternative in many of those patients.

Elizabeth: Yeah. On to your next one, sir, what about monitoring -- self-monitoring largely -- blood pressure during pregnancy, high-risk and non-high risk patients?
Rick: All right, Elizabeth, we are going to talk about two different studies here. It goes back to the fact that if you just look at chronic hypertension, we have talked before about the fact that self-monitoring provides oftentimes more accurate assessments of blood pressure. It helps to direct treatment. It can have beneficial effects in terms of better control of blood pressure.
Does that same thing apply to women that are pregnant? Let's take two groups: those that are at high risk of hypertension, and secondly let's look at those that have chronic hypertension or high risk of preeclampsia, and say whether monitoring of blood pressure at home can be helpful.
Now, with the first group, what you'd like to be able to do is to be able to identify high blood pressure earlier so you can initiate therapy and help prevent some of the side effects or complications in the mother and in the child. That's what one study did.

In essence, when they looked at over 2,400 women and asked, "Can we diagnose it earlier?," the answer is they didn't. The diagnosis with self-monitoring was made at the same time as those that were just followed with the routine care.
Now, part of that is because mothers are routinely followed fairly regularly. In fact, this was conducted in the United Kingdom where they are seen about seven times during their pregnancy. So the self-monitoring of blood pressure didn't reveal hypertension any sooner.
The next study was in women that have chronic hypertension, does self-monitoring provide better control of blood pressure? There were 454 participants, again, in 15 hospital maternity units in England. The use of self-monitoring did not result in any better control than just routine care.
Now, on the one hand, you might call this disappointing. On the other hand, what I might say is, we're trying to again control blood pressure and routinely following these mothers during pregnancy does a pretty good job of it. Using self-monitoring blood pressure doesn't add anything, so we don't need to add that to something else that the mothers-to-be need to be concerned about.

Elizabeth: Yeah. Trying to get our arms around preeclampsia and trying to head that off at the pass, it would seem that self-monitoring would be helpful. Let me just mention that these studies are in JAMA.
Rick: It's not that monitoring blood pressure isn't helpful. It's just that if it's done routinely, as a part of the routine care during pregnancy, they can do a pretty good job.
Elizabeth: It's reassuring and I think that sounds good. For right now, I guess I'll stick with that. I would also say that there is something pretty persuasive for me anyway about empowering women to monitor their own blood pressure and just make sure that it's not creeping upward.
Finally, let's turn to JAMA Internal Medicine. This is a look at whether structured, moderate exercise can stave off kidney function decline in older adults who are sedentary. This is really a big issue. I see lots and lots and lots of kidney failure among older folks when they are hospitalized and it can be, of course, deadly. In this case, what they did was look at just shy of 1,200 community-dwelling sedentary adults aged between 70 and 89 years with mobility limitations and available blood specimens.

This was a structured, 2-year, partially supervised, moderate intensity physical activity intervention that included both strength and flexibility, things that they needed to do, compared with just a health education control intervention and they followed them up over 2 years. They looked at glomerular filtration rate using cystatin.
Basically what they found out was, compared with this health education group, physical activity and exercise slowed the rate of this kidney function decline, and I think that's just really such a great outcome.
Rick: This is a really difficult group. These are older individuals. They are sedentary because they had mobility limitations, so they picked the hardest group. What they attempted to do was to get them to walk 150 minutes per week, do 10 minutes of upper extremity strength training, 10 minutes of lower extremity strength training, and then some flexibility.
I would have predicted, "Gosh, this is a really hard group to do that in." They were somewhat successful, very few reached all of those goals, but they got better at it. More importantly, it decreased the decline in kidney function and there were fewer individuals that had rapid decline in their kidney function.

We have had trouble identifying things that can slow a decline in kidney function in these older individuals. We use a number of pharmacotherapies that haven't been beneficial and this is something doesn't require a medication. These individuals feel better because of the exercise regimen and more importantly it slows the decline of their kidney function. This is a pretty remarkable study.
Elizabeth: I think so. I think the fact that you mentioned about pharmacologic treatments largely targeting hypertension and diabetes in these folks certainly results in polypharmacy, and so that can even result in further compromise.
Rick: Right. Again, these are individuals aged 70 to 90, almost 1,200 of them, and they are usually on multiple medications as well. So using something as simple as exercise to slow kidney function decline is very important.
Elizabeth: Yeah. I wonder what it takes to overcome barriers to get folks who are sedentary previous to an intervention like this to start getting involved with daily exercise, or almost daily exercise.

Rick: These individuals attended exercise sessions at a field center twice a week and then they did the home-based activity three to four times weekly. It was a combination of group encouragement and then also following that up at home as well.
Elizabeth: Got to do more of that. That's a look at this week's medical headlines from Texas Tech. I'm Elizabeth Tracey.
Rick: And I'm Rick Lange, y'all listen up and make healthy choices.
"

 

[Ally T]

I have to say, covid has pretty much gone away where I live & life feels deliciously back to normal. We no longer have to self test twice a week, if we show covid symptoms we are advised (self isolation is no longer law) to stay at home until feeling better with no temp, which can be as quickly as 48 hours. There are no mask mandates in the UK now, it's all voluntary but I hardly see anybody wearing one. People are shaking hands again, which was weird for me the first time someone went to do it a few weeks ago (& I sneakily used hand gel immediately after!). I have my first stadium gig in 2 weeks (postponed from May 2020) & I cannot wait despite there being 90,000 people there. Most shops & supermarkets in my area have removed the glass screens at the counters or checkouts, as have my hairdressers. It is no longer on our daily news bulletins.

We spent Easter in the Caribbean & nobody caught it - we survived the airports, 2 long haul 9 hour flights & the holiday itself. That alone filled us with the confidence to book more trips abroad. Maybe we were lucky, or maybe the vaccines are doing their thing?

Vaccination uptake here was huge & quick & boosters are still recommended (my mother has her 2nd booster next week). The UK was FAR from perfect with how it handled the response to the pandemic & there were too many needless & tragic deaths, but I am thankful they were quick to order & roll out the vaccines.

I still gel my hands everytime I have contact with a child at school, which is A LOT given they are as young as 4 & will always sidle up to me & automatically slip their little hand in mine. But I still no longer crouch down when talking to them, instead just bending over & keeping my head away from theirs. And then I gel.

I think it will mentally take many years to dis-engage from covid hygiene habits, which has certainly seen me with less common colds.

In other news, today was the first day at school for an 8 year old Ukranian refugee. He is here with only his mother, as his father had to stay behind to fight. They are the first welcomed to our village, but hopefully not the last.

 

[missy]

"

COVID Increased 50% Among TSA Employees After Mask Mandate Lifted​

Carolyn Crist
May 05, 2022


COVID-19 infections have increased 50% among Transportation Security Administration employees in the 2 weeks since the federal mask mandate was lifted.
On Monday, 542 agency employees had active coronavirus infections, Forbes reported, citing a TSA spokesperson. That’s up from 359 infections on April 18, the day the federal mask mandate was struck down.
The increase in cases among TSA employees also appears to mirror the increase in COVID-19 cases nationwide, Forbes reported. After declining in March to some of the lowest numbers of the pandemic, COVID-19 cases began to increase again by the end of April.

The U.S. is now reporting more than 65,000 daily cases, according to the data tracker from The New York Times, marking a 54% increase during the past 2 weeks. Cases are increasing in all but four states, and in more than a dozen states, the daily case average is twice as high as 2 weeks ago.

Since the federal mask mandate was struck down, TSA employees haven’t enforced face covering rules in airports, and employees haven’t been required to wear masks on duty.
But the TSA said it will continue to enforce mask-wearing in airports located in "high transmission" areas, where the COVID-19 level is deemed high due to hospitalization rates, Forbes reported.
As of last week, the CDC classified 56 counties as having "high" community levels, primarily in the Northeast. That represents about 1.7% of counties in the country, with 8% in the medium category and 90.3% in the low category.

Counties with high community levels include several airports, such as Albany International, Buffalo Niagara International, and Syracuse Hancock International in New York; Burlington International in Vermont; and several smaller regional airports in the Northeast, according to Forbes.
Since the pandemic began, 23,468 TSA employees have been infected with COVID-19, and 22,891 have recovered, Forbes reported. In addition, 36 TSA employees and two contractors have died from COVID-19.
Sources:
Forbes: "TSA Covid Infections Have Jumped 50% Since The Mask Mandate Was Lifted."

The New York Times: "Coronavirus in the U.S.: Latest Map and Case Count, May 5, 2022."

CDC: "COVID Data Tracker: COVID-19 Integrated County View."
"