Coronavirus Updates January 1, 2022

[missy]

JAMA

At the beginning of the COVID-19 pandemic, the response of the US federal government was seriously flawed. For example, the Centers for Disease Control and Prevention (CDC) erred when it came to policy development and messaging for testing, surveillance, masking, and ventilation, and CDC-developed test kits were also defective. Some policies from the Department of Health and Human Services restricted private sector progress, further delaying availability of tests. Early guidance on testing was mistargeted, getting tested was a logistical nightmare, and too few tests were performed. Once an acceptable, yet suboptimal, testing infrastructure was established, it was marginalized, thought to be superfluous because of the vaccines. Even now, testing results are not reliably linked with sociodemographic data, vaccination status, or clinical outcomes; the availability of reliable rapid tests remains limited; and prices are too high.1

Similarly, there has never been comprehensive, geographically and population representative genomic surveillance to effectively detect and track variants of SARS-CoV-2, leaving the US with limited and delayed information about the emergence of new variants until other countries identify them. In addition, from the beginning of the pandemic until May 2021, the importance of aerosol transmission of SARS-CoV-2 was not fully recognized and appreciated,2 leading to incorrect, delayed, and highly confusing recommendations on masking, wearing high-quality respirators, and improving ventilation.

It appears that SARS-CoV-2 will persist, and the COVID-19 pandemic will continue for some time. Consequently, to achieve a sustainable “new normal” with substantially lower virus transmission and mortality from COVID-19, testing, surveillance, masking, and ventilation all need significant improvement.


Testing
First, the CDC needs to collect and disseminate accurate real-time, population-based incidence data on COVID-19 and all viral respiratory illnesses. The US should not be reliant on extrapolating cases and outcomes from data collected from a few, underrepresentative sites. The country needs a comprehensive testing and reporting system for all viral respiratory illnesses. Data from all medical and testing facilities, all emergency department cases, and all hospitalizations, ICU admissions, and deaths need to be reported to the CDC and linked to anonymized sociodemographic, vaccination, and clinical outcomes data. The reporting system should accommodate the ability to incorporate data from at-home tests, ensuring a simple mechanism to self-report results, and should provide real-time reporting on a public website.

Every person in the US should have access to low-cost testing to determine if they are infected and infectious. The Biden administration’s plan to distribute 500 million at-home rapid tests and ramp up production using the Defense Production Act is an important step in the right direction but many more are needed.3 The federal and state governments need to ensure these tests are in plentiful supply, free to individuals with Medicaid coverage, and free or low cost to the rest of the population to help individuals who might be infectious avoid transmitting the virus to others in their homes, workplaces, schools, and other settings and to get prompt medical care if needed. Several states currently send their residents free, rapid COVID-19 test kits. All states and the federal government should also make tests readily available.

Importantly, when the CDC tracking system receives notification of a positive test result from a health care facility or at home, the system should automatically provide clear guidance on self-isolation and treatment options that may include anti–COVID-19 medications or an opportunity to participate in research studies to assess therapeutic interventions. Additional effort will be needed to ensure that testing and therapeutics are made affordable and equally accessible to members of underserved communities, including individuals with low income and those in rural or other hard-to-reach areas.

More knowledge about disease epidemiology could be obtained from each clinical specimen. Deploying multiplexed molecular and rapid antigen tests for respiratory viruses that detect multiple respiratory pathogens will distinguish SARS-CoV-2, influenza, respiratory syncytial virus, other viruses, and bacterial pathogens. In addition, the US should accelerate development of new technologies, including wearables and other platforms (such as graphene-based) that can rapidly test for multiple pathogens with a single test.

Surveillance
The recent emergence of the Omicron variant has highlighted the need for a comprehensive, nationwide environmental surveillance system that includes wastewater and air sampling to monitor for potential outbreaks of viral and bacterial illnesses. Traditional surveillance systems are highly reactive. By the time a health system or laboratory detects and reports a concerning pathogen or variant, it is too late to contain its spread. Great progress has been made toward establishing environmental surveillance programs for SARS-CoV-2, but there is a need to rapidly expand to other pathogens and reach rural and other communities that lack wastewater systems. A comprehensive national system is needed to reach the full potential of this surveillance approach, which should empower local jurisdictions with rapid, actionable data and transform pandemic prevention into a more equitable and proactive practice.

In addition, a comprehensive genomic surveillance system for variants is needed to provide early indications of immunity escape and emergence of new variants. This includes the critical need to sequence vaccine breakthrough cases, even from mild infections. The country needs a system organized by the CDC to sequence a far greater and more geographically representative proportion of positive COVID-19 tests than is currently being sequenced, with the results uploaded into global databases in real-time. Rapid sharing of this genomic data could facilitate a broader analysis of the emergence and spread of novel variants, enabling targeted distribution of resources to slow the spread of a new variant.

The US needs to establish a real-time, opt-out digital surveillance system to monitor all vaccinated individuals for the frequency and severity of adverse effects, postvaccination infections, and waning immunity. Two years into the pandemic, the US is still heavily reliant on data from Israel and the UK for assessing the effectiveness and durability of COVID-19 vaccines and rate of vaccine breakthrough infections. In addition, when the definition of “fully vaccinated” shifts to 3 doses (or perhaps more doses) of mRNA vaccine, the US lacks a reliable way of identifying who has received only the first 2 doses and who has received a third dose.

Mitigation Strategies
Like influenza, SARS-CoV-2 is spread by aerosols.4 Well-established public health mitigation strategies can reduce risks and complications from viral respiratory infections including SARS-CoV-2. Mitigation strategies should be implemented, including new enforceable Occupational Safety and Health Administration standards, especially requiring workplace masking, distancing, and ventilation.5

The most effective way to prevent transmission of respiratory diseases, including COVID-19, is to eliminate exposure to potentially infectious individuals, encouraging individuals who may have illness to stay home. This requires systematic access to testing and paid sick and family medical leave for all US workers, especially low-wage, temporary, freelance, contractor, and gig economy workers.

The next most effective mitigation approach focuses on upgrades to ventilation and air filtration systems, including increasing the intake of outside air, using efficient filters (rated at minimum efficiency reporting value of 13 or higher) and adding high-efficiency particulate air filtering devices. These systems will need to be implemented in offices, schools, public transportation, and other congregate workplace and social settings, such as restaurants and bars. Congress has allocated tens of billions to schools for such upgrades,6 and should provide additional funding or tax incentives for targeted high-impact upgrades. New infrastructure funds for public transit and airport improvements should also be linked to implementing these permanent improvements. Localities should be incentivized to modify their building codes to require that all new buildings integrate these upgrades.

The country needs to encourage use of high-quality filtering facepiece respirators (FFRs), such as N95s or KN95s, rather than cloth or surgical masks, to reduce transmission of respiratory viruses including SARS-CoV-2 in crowded indoor settings where community exposure risk is elevated.7 To meet demand and prevent reliance on imported products of questionable quality, there needs to be a national initiative to sustainably produce domestic FFRs and ensure they are readily available to all US residents for free or very low cost. The government could mail vouchers to US households to pick up FFRs at pharmacies, grocery stores, schools, and other locations.

In addition, there needs to be a system for clear recommendations from trusted public health authorities, advising local governments and the public about the appropriate use of facial coverings, depending on the setting; an individual’s vaccination, immune, and risk status; and the level of community transmission. An easily interpretable risk assessment map that encompasses these variables to provide immediate risk determination at the zip code level for individuals could be developed and updated daily. Such a system would help reduce confusion and guesswork that many individuals face today as they make daily decisions on how to protect themselves.

Conclusions
To reduce COVID-19 transmission, achieve and sustain a “new normal,” and preempt future emergencies, the nation needs to build and sustain a greatly improved public health infrastructure, including a comprehensive, permanently funded system for testing, surveillance, and mitigation measures that does not currently exist.

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Article Information
Corresponding Author: David Michaels, PhD, MPH, Milken Institute School of Public Health, Environmental and Occupational Health, George Washington University, 950 New Hampshire Ave NW, Washington, DC 20052 ([email protected]).

 

[missy]

JAMA
Viewpoint

The First 2 Years of COVID-19Lessons to Improve Preparedness for the Next Pandemic​

Jennifer B. Nuzzo, DrPH, SM1; Lawrence O. Gostin, JD2
Author Affiliations Article Information
JAMA. Published online January 6, 2022. doi:10.1001/jama.2021.24394
COVID-19 Resource Center
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On December 31, 2019, the World Health Organization (WHO) Country Office in China reported novel “viral pneumonias of unknown cause” in Wuhan, but China did not confirm case clusters until January 3, 2020. Two years later, more than 285 million cases and 5.4 million deaths have been reported. As of December 2021, more than 800 000 COVID-19 deaths have occurred in the US, surpassing the 675 446 total deaths that occurred during the great influenza pandemic of 1918. The COVID-19 pandemic reduced global economic growth by an estimated 3.2% in 2020, with trade declining by 5.3%; an estimated 75 million people entered extreme poverty, with 80 million more undernourished compared with prepandemic levels.1 Although the COVID-19 and 1918 influenza pandemics stand alone in morbidity and mortality, evidence suggests the frequency of infectious disease emergencies will increase. What lessons does COVID-19 teach to advance preparedness, detection, and response?

Health Systems Should Become the Bedrock of Pandemic Preparedness
Since the first reports of SARS-CoV-2, health systems were instrumental in responding to COVID-19. Clinicians recognized novel viral pneumonias in Wuhan. Clinical data offered insights on transmission and progression to severe disease. Yet COVID-19 has stressed health systems beyond their capacities. Amid surging cases, China built 2 hospitals in Wuhan to isolate and treat patients with COVID-19. A global pattern emerged of hospital admission surges, creating shortages of hospital resources, such as critical care unit beds, personal protective equipment (PPE), and ventilators. Well over 100 countries ordered “lockdowns” (closure of commercial and leisure activity) by April 2020 to preserve health system capacities. Overcrowding led to delayed diagnoses and treatments for many health conditions, contributing to excess deaths that exceeded an estimated 1.2 million in 2020.2
These challenges were unsurprising. The 2019 Global Health Security Index found that health systems were the lowest-performing area of overall pandemic preparedness. That fundamental weakness continued in the 2021 index.3 These data suggest that health system surge capacities should become the bedrock of pandemic preparedness—adequate personnel, medical supplies, and intensive care beds to meet acute demands, including provision of routine diagnosis and care.
Testing Capacity Is Vital to Detect, Characterize, and Manage Crises
The COVID-19 response was severely hampered by insufficient testing capacities. Constrained capabilities led many countries to use travel-based algorithms to determine qualifications for SARS-CoV-2 testing. Diagnostic testing kits issued by the Centers for Disease Control and Prevention (CDC) were initially flawed, and all laboratory results had to be analyzed at the agency. Initially, only hospitalized patients with a travel history to China could be tested. Highly targeted and limited testing missed infections from other regions, particularly Europe, which seeded a major outbreak in New York City in March 2020 while delaying recognition of widespread community transmission.
Inadequate testing capabilities persist to this day. Although more diagnostic tools now exist, the US and many other countries still report results with higher-than-expected test positivity, indicating failures to cast a sufficiently wide net to identify infections and limit forward transmission. Uneven access to testing may create surveillance biases and limit disease prevention and control. Incomplete diagnosis and surveillance also limit the ability to characterize the virus as it mutates, including changes in transmissibility, pathogenicity, and evasion of immunity. The current Omicron variant, for example, appears to be more transmissible than the Delta variant, and also may reduce immune protection from disease recovery or vaccination.
Building Public Trust and Fostering Risk-Mitigation Behaviors
Public distrust of health agencies and lack of population-level adherence to risk-mitigation measures proved major impediments in the COVID-19 response. A US survey of 1305 people in early 2021 found high levels of distrust: only 52% expressed high trust in CDC, 37% in the Food and Drug Administration, and 41% in state health departments.4 This distrust has led to social and political division over the utility of masks and vaccinations. Nonpharmaceutical interventions require high levels of population-level adherence. Even highly effective medical countermeasures such as vaccines require population-wide uptake to reduce disease transmission and progression to serious disease. Building public trust in scientific recommendations, especially through community leaders and social and religious institutions, is vital to future preparedness.
Redressing Social Vulnerabilities and Inequities
COVID-19 did not affect all members of society equally. The US experienced stark racial and ethnic disparities. Age-adjusted per capita hospitalizations among American Indian or Alaska Native, Non-Hispanic Black, and Hispanic or Latino people were, respectively, 3.2, 2.5, and 2.5 times higher than among Non-Hispanic White people.5Similar disparities in severe disease among ethnic minority populations were reported globally, including in the United Kingdom, Brazil, and South Africa. These differences are likely due to long-standing social determinants of health. Future preparedness plans must include concrete measures to reduce disparities.
Income inequality as a barrier to adherence to public health guidance is another important factor in pandemic preparedness. US counties with greater income inequality experienced higher levels of cases and deaths. Higher-income individuals were more likely to report protective behaviors, whereas those with lower incomes were more likely to report life circumstances that impede risk mitigation, including inability to telework. A study examining 22 Organisation for Economic Co-operation and Development countries found those with greater income inequality experienced higher COVID-19 mortality.6
Global Cooperation and Robust Institutions
The pandemic exposed inadequacies in global institutions and international cooperation to ensure all countries have access to essential medical supplies, including testing reagents, PPE, and vaccines. Before the pandemic, China manufactured half the world’s supply of PPE and was a major producer of other medical resources. However, the Wuhan outbreak caused local disruption in production and increased domestic demand to manage the crisis. These shortages had ripple effects. Many countries responded to supply shortages by imposing export controls for domestically produced medicines, syringes, vaccines, and other essential medical goods, which exacerbated global supply disruptions.
Today, vast global vaccine inequities are the most egregious example of shortages. Although more than half the world’s population is fully vaccinated, only 7% of people in low-income countries have received at least 1 vaccine dose.7 Even though countries pledged to donate billions of vaccine doses, only millions have been delivered so far.8 Many donated doses have been delivered with little advance notice and close to their expiration dates, making it operationally difficult for countries to use these vaccines.9
Gross inequalities in access to vaccines and other medical supplies during COVID-19 should be anticipated for future events. When nearly every country is affected at once, it creates pressures on global response systems and weak global supply chains. With this pandemic reality, reliance on charitable donations for essential medical supplies should be questioned. Diversified regional manufacturing of products is more likely to ensure countries can predictably fulfil their supply needs. That would require pharmaceutical companies to transfer technologies to regional manufacturers, such as the WHO-backed messenger RNA hub in South Africa.
Pandemic Threats Are the New Normal
Although the global tolls of COVID-19 are unprecedented in the modern era, novel diseases are likely to accelerate. Just in the last few decades, the world experienced multiple disease emergencies: West Nile virus (1999), SARS (2003), H5N1 avian influenza (2004), pandemic H1N1 influenza (2009), Middle East respiratory syndrome (2012), Ebola in West Africa (2014), and Zika (2015), and more disease outbreaks should be expected. Even accounting for improved surveillance, novel emerging diseases have steadily increased since 1940.10 There are strong biological and environmental reasons to expect epidemics as, or more, serious than COVID-19.
The likelihood of even more challenging future scenarios should create urgency to invest in and maintain resilient health systems, testing and surveillance, public trust, equity, and strong global institutions. Failure to address clearly observed weaknesses in the COVID-19 response will have preventable adverse health, social, and economic consequences when the next novel outbreak occurs.
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Article Information
Corresponding Author: Lawrence O. Gostin, JD, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, 500 First St NW, Office 810, Washington, DC 20001 ([email protected]).

 

[House Cat]

Cyprus reportedly discovers a Covid variant that combines omicron and delta

The strain is being called "deltacron."

www.cnbc.com

 

[missy]

Will a fourth dose be approved in the U.S?

"

Breakthrough Covid-19 infections are everywhere these days, even among the boosted, so it’s natural to question whether we might need another dose to ward off the hyper-contagious omicron variant.

Israel has begun offering a fourth dose, and early results seem promising: A second booster of the Pfizer vaccine appeared to be safe and increase antibodies fivefold. The New York Times reported this week that people with compromised immune systems are going rogue and getting fourth and even fifth shots against recommendations.

And on Friday, Moderna CEO Stephane Bancel said another round of vaccine boosters will probably be needed this fall, even if immunity to omicron becomes widespread,

There are a few things to keep in mind, though. The first is that the primary goal of the vaccines is to prevent people from becoming severely ill and hospitalized, not to prevent them from getting the virus at all (though prevention is of course ideal).

“While it is possible at some point that we may be recommended to get a fourth vaccine dose in the United States, it is a bit premature to say we will definitely need one,” says Katrine Wallace, an epidemiologist at University of Illinois. Scientists are still in the process of gathering data about how well a third dose works, and for how long.

”If the third dose continues to give significant protection, a fourth dose may not be needed. For now, we will continue to follow the data,” she says.

“The exception is for people who are immunocompromised or are taking medicine that causes them to mount a less robust immune response to the vaccine. This group is already authorized for a fourth shot,” Wallace says.

A health worker prepares a swab sample for a Covid-19 test in Tel Aviv. Israel has begun offering fourth doses of vaccines.

Photographer: Kobi Wolf/Bloomberg

But before we start worrying about our next doses, there are still plenty of Americans who haven’t gotten the shots they’re already allowed to get — a critical step toward slowing the spread of the virus and stopping new variants of concern from emerging.

In the U.S, only about 38% of eligible adults have gotten a booster, and about 34% of those 5 and older haven’t completed their primary vaccination series, according to the Centers for Disease Control and Prevention.

Also key is getting vaccines to places where they are still in short supply. Unvaccinated populations allow the virus to spread and potentially mutate.

”Only 9.5% of the population of Africa has been vaccinated with their primary series,” says Wallace. “Vaccine equity should be prioritized above a fourth dose of vaccine in order to prevent more viral variants from emerging.”


"

 

[House Cat]

My 16 year old son tested positive this morning. So far, my husband and I are negative. My son’s only symptoms are a stuffy nose

 

[mom2dolls]

Our company has six employees that are in the office full time with everyone else remote. Four are out positive with Covid. 15 phlebotomists are out at our local plasma donation center! My brother-in-law works at a car dealership in the service dept, 5 of 7 employees are out. Omicron is spreading so quickly.

 

[mellowyellowgirl]

My mum has tested positive as well. No symptoms and my dad is fine after testing positive on 31st December.

They are both still wreaking havoc and driving me crazy so Covid has not stopped them!!!

Anyone having supply chain/grocery issues??? Our supermarket shelves are bare!!!

 

[Karl_K]

2 icu beds available in my region as of this morning.
Of those in the hospital for covid 90% are not vaccinated and delta is still driving the hospital numbers.

omicron has not peaked yet in my area they also are saying.
There are a lot of suspected omicron cases but it is not yet having a large scale hospital impact compared to delta.

N. IL zone 1 for those interested.

 

[House Cat]

Newsom sounded the alarm after being asked by a reporter about new guidelines that say health care workers who test positive and are asymptomatic for COVID-19 are allowed to return to work. No quarantine or testing is required.

Newsom warns of ‘tremendous strain’ at hospitals, defends ‘pragmatic’ policy on asymptomatic workers

Gov. Newsom said that at this phase of the pandemic the state needed to “be flexible” to deal with the latest challenge.

www.google.com

 

[missy]

Infectious Disease>COVID-19

Don't Fear 'Deltacron'; Hospitals on the Brink; FDA's Anti-Throat Swabbing Tweet​

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

by Molly Walker, Deputy Managing Editor, MedPage Today January 10, 2022

A new variant dubbed "Deltacron," that combines Delta and Omicron, was detected in Cyprus, though it is not expected to overtake the highly contagious Omicron variant. (Bloomberg)

Almost a quarter of U.S. hospitals are reporting a "critical staffing shortage" due to the Omicron variant, with many now "on the brink." (CNN)

Novartis and Molecular Partners reported positive phase II data for their intravenous antiviral, ensovibep, which reduced hospitalization and COVID-related emergency department visits by 78% in a secondary outcome.



States are receiving shipments of monoclonal antibodies from the federal government that may not be effective against Omicron. (Washington Post)

New research suggests T cells from past colds may help protect against COVID-19infection. (Nature Communications)

As of Monday at 8 a.m. EST, the unofficial U.S. COVID toll was 60,090,637 cases and 837,664 deaths, up 1,602,697 cases and 3,675 deaths since Friday.

The FDA approved of daridorexant (Quviviq) at two different dosages for treating insomnia in adults, drugmaker Idorsia announced.

The agency also warned the public in a tweet not to swab their throats with nose swabs used for COVID rapid tests.

Meanwhile, Israel's health ministry is recommending exactly that for rapid antigen tests. (Reuters)

Starting this week, certain immunocompromised individuals who received a third dose of COVID vaccine last summer will be eligible for a fourth dose. (New York Times)

New York became the latest state to require boosters for healthcare workers, with only limited exemptions. (NBC New York)



A judge ruled that FDA now has about 8 months (versus 75 years) to produce thousands of documents related to the licensing of Pfizer's COVID vaccine under a freedom of information act request. (Fierce Pharma)

The White House is finalizing plans with the U.S. Postal Service to ship over 500 million COVID test kits to American households. (Washington Post)

Coincidentally, the Postal Service has also sought a 120-day delay in complying with the COVID vaccine mandate. (NPR)

Several federal agencies are prepared to suspend employees who have yet to comply with the government's vaccine mandate. (The Hill)

CDC Director Rochelle Walensky, MD, received media training last fall, as unnamed agency scientists vented their frustration about her leadership. (CNN)

Last month, a federal judge rejected Purdue Pharma's restructuring settlement because it exempted the Sackler family from liability. Now a judge says the company can appeal that decision. (Reuters)



Relatedly, Georgia joined a $26 billion settlement against an opioid manufacturer and distributors. (Reuters)

A fire that burned down a Planned Parenthood building in Knoxville, Tennessee, was ruled an arson. (NPR)

Merck announced positive results from a phase III trial testing pembrolizumab (Keytruda) as adjuvant therapy in operable lung cancer.

New Zealand barred Jonie Girouard, a doctor who issued fake vaccine exemption cards, from practicing medicine. (New Zealand Herald)

 

[missy]

CDC Director: 'As the Virus Changes, the Science Changes'​

— Agency's first solo briefing in a year clarifies CDC's position on shorter quarantine​

For the first time in a year, CDC Director Rochelle Walensky, MD, held a CDC-only media briefing on Friday to discuss quarantine guidance, the state of the pandemic for children, and the possibility of a second booster shot.

She said that while she did over 80 briefings last year, "we heard over the last week that there was interest in hearing from the CDC independently," and said that she anticipated this would be the first of many briefings.



"I am committed to continue to improve as we learn more about the science," Walensky said. "The virus is ... constantly throwing us curve-balls. As the virus changes, the science changes."

Top of mind for most reporters was CDC's controversial shortened quarantine guidance from 10 days to 5 days. Walensky reiterated that the guidance applies only to those who "do not have symptoms anymore" and that wearing a "well-fitting mask" from days 6-10 since infection was detected is essential.

"The guidance is very clear that you should not leave isolation if you're still symptomatic," she added. "The first indication is do your symptoms remain or not."

Even if a patient leaves isolation, Walensky still recommended that people "don't go to restaurants, avoid traveling" and avoid contact with immunocompromised people.

"Wear a mask and anticipate you might have residual contagion still within you," she said.

When asked why testing was not included as a prerequisite to discontinue isolation, Henry Walke, MD, of the CDC, said that rapid antigen tests are best used early in the course of illness, but "aren't authorized by the FDA to evaluate the duration of infectiousness."



"The significance of an antigen test late in the course of illness" is unclear, he said, and a negative test "doesn't necessarily mean the absence of virus."

The Kids Aren't Alright

Walensky also addressed how the current Omicron wave has affected children, noting that "pediatric hospitalizations are at the highest rate compared to any prior point in the pandemic."

Hospitalizations are also increasing among children ages 0-4 who are too young to get vaccinated, she added, and stressed the importance of surrounding these kids with people who are vaccinated to provide them protection.

"We are still learning about the Omicron variant in children and whether increases [in hospitalization] reflect a greater burden of disease in the community" or a lack of vaccination, she said.

Walensky lamented that only 16% of children ages 5-11 are fully vaccinated, and that children older than age 4 are more likely to be hospitalized if they are unvaccinated. In fact, she pointed out that unvaccinated adolescents ages 12-17 are 11 times more likely to be hospitalized than those who are fully vaccinated.



She said she endorsed a recommendation for a booster dose at least 5 months after the primary series for adolescents ages 12-17 "to ensure they are up-to-date with vaccines and protected against the Omicron variant."

Whither a Fourth Dose?

Along those lines, Walensky added that she endorsed FDA's amended emergency use authorization (EUA) for a booster dose of Moderna's COVID vaccine for adults at least 5 months after the primary series (it was previously 6 months).

Reporters also asked about Israel's recent recommendation for a fourth dose, and wondered if the U.S. would be following suit. Walensky noted that only 35% of the population eligible for booster doses, or 73 million people, have received them.

The priority "has to be to maximize protection for tens of millions of people who continue to be eligible for a third shot before thinking about what a fourth shot would look like," she said.

However, she added that she is in touch with colleagues in Israel, and will be keeping an eye on how boosters are working, and their potential waning effectiveness not just against infection, but severe disease.

 

[missy]

COVID-19 Vaccines: What Does the Future Hold?​

— Many vaccines are still currently in development​

"There remain more than 100 different vaccines in human trials and development for COVID-19, from protein subunits to inactivated coronavirus vaccines, as well as another 70-plus in animal trials.

So, is boosting with our existing authorized vaccines going to be our "new normal?" Or, are there new vaccines still in development that would allow us to truly be "one and done."

On this week's episode, Dial Hewlett Jr., MD, the medical director for Westchester County, New York, and deputy to the commissioner for the Westchester County Department of Health, joins us to explain what future vaccines are coming down the pike and where research will lead us.

The following is an abridged transcript of his interview with "Track the Vax" host, Serena Marshall:

Marshall: Despite vaccines, despite the strides we've made with them, we are still looking at a really bleak winter here. Is that because it's not that the vaccines aren't working, it's that the virus is sort of evolving?



Hewlett: That's fair to say. I think this new Omicron variant, unfortunately, seems to be much more transmissible than some of the earlier variants, including the Delta variant. And as a result of that, we have a larger number of people who are becoming infected. Certainly it has run rampant among those who are unvaccinated. But it has now led to a lot more of what we call breakthrough infections among people who are fully vaccinated.

Fortunately, those individuals who are fully vaccinated are experiencing only mild symptoms, similar to say, a common cold. So, I think that that's the good news, in that the vaccines are preventing serious illness and hospitalizations and deaths.

Marshall: But they're not bulletproof, and boosters are going to be what's necessary in order to really up that antibody protection?

Hewlett: That is correct. I think that we have understood now clearly the benefit of the boosters and we are encouraging everyone who is fully vaccinated, if they are eligible, to come into either their health departments or to their physicians' offices, or other places where they can get the boosters, because we believe the boosters are going to be very, very helpful in preventing further infections.



Marshall: But how often will boosting or this reboost be necessary when it comes down to it? Especially with these mRNA vaccines, which is what is being used in the U.S. the most, and what's being recommended now, even over the adenovirus vector vaccine.

Hewlett: I don't think that we can really answer that question accurately at this time. This is really a moving target. We don't know whether this virus ultimately is going to behave like the influenza virus, which requires a shot every year, because there are variants that occur -- not really variants, but there are changes in that particular virus that necessitate revaccination every single year.

So, we don't know if that may be the case with this virus at all, just like the others. I think we have to wait and see what's happening as far as that's concerned. We don't have to wait and see with regard to the effectiveness of these vaccines at preventing serious disease, because we've seen that that's definitely occurring.



Marshall: So, we don't know how often we'll have to get boosted with these mRNA vaccines, but we're hearing some good news about future vaccines -- like Novavax.

Hewlett: Yes, we are. And I think that one of the good things about that vaccine is that it does use a different type of platform. It uses what we call a protein subunit platform, so it's a protein-based vaccine, which is very similar to the platforms that are used for some of the other types of vaccines. I think the influenza vaccine is on a similar platform.

One of the good news pieces of this is that the availability of this new vaccine is going to increase the supply. And so it's going to allow for some of the underserved parts of the world to be supplied with vaccine, which, according to studies that were recently published over the summer in the New England Journal, this vaccine is close to 90% effective in preventing serious illness and hospitalization. So, that's very good news.



It may well be that if this vaccine is tested further, that it may be something that will be added to the armamentarium here in the United States. We don't have approval for this vaccine yet here in the U.S. and we don't have a COVID vaccine as of now that's in this class of vaccines that's available to us.

Marshall: So, you said it's a subunit protein vaccine. Explain for us how that's different from the mRNA vaccines.

Hewlett: Yes. If I can, not being a basic scientist. The mRNA vaccines actually couple the material from the virus, that is, they actually take pieces of the spike protein, and it's coupled with the messenger RNA. And that is actually the platform by which the vaccine operates.

With protein subunits, they are actually using what they call nanoproteins, which are just small amounts of protein, and what they call an adjuvant. They are using essentially the entire protein subunit, as I understand it, from the spike protein of the coronavirus. And so, in that way, it's a bit different. At the end of the day, all of the vaccines, whether it's an mRNA vaccine or a protein subunit vaccine as this one is, or a viral vector vaccine, which is what the J&J vaccine is, or the AstraZeneca -- all of these vaccines will generate what we call an antibody response. So, antibodies will be generated, which will neutralize the virus and hopefully prevent the person from getting sick.



But the other part that we don't talk about that much is that they will all also generate what we call a memory response through what we call the T cells or some of the white cells in our body. And this is probably very, very important -- not probably -- but is very important in terms of the duration of the protection that a person has.

Marshall: Do we know, though, if the subunit protein vaccines create longer protection memory?

Hewlett: We don't, we really don't. We really are going to have to wait and see what happens to the individuals who were involved in these initial trials. The trials that were reported in the New England Journal back in July involved about 15,000 participants. And so in order to know exactly how long protection is going to last, you have to follow these individuals longitudinally. And you have to look at their antibody responses over time and you expect the antibody levels to go down, but you also want to look at the percentage of individuals who may develop symptoms that would then be attributable to the coronavirus infection. And that's really the only way that we'll know how long the protection is going to last.



Marshall: I mean, it sounds like the Novavax vaccine is using more of traditional vaccination approaches than the mRNA, which is relatively, for all intent and purpose, brand new.

Hewlett: Well, yes. The mRNA vaccines have been used previously, but certainly the mRNA technology is much newer than the protein subunit technology. The advantage of the mRNA technology was that it allowed scientists to develop and produce the vaccine much more rapidly than the traditional protein subunit vaccine.

Marshall: But the protein subunit -- we have to just, to be clear here -- don't infect you either. There's no way you can get COVID from the vaccine?

Hewlett: That's correct. And that's true with all of them. So, you're not being injected with the virus. You are receiving protein parts of or either the entire spike protein, if you will, of the virus. And that is what generates the immune response.



Marshall: There's another vaccine, Dr. Hewlett, that's just out of phase I. So it's really early. And it's being called an umbrella vaccine, protecting not just against COVID, but all SARS infections. It is coming out of Walter Reed's medical center, U.S. Army. And that one they're saying is using a spike ferritin nanoparticle COVID-19 vaccine. Can you explain for us what that is?

Hewlett: Unfortunately, I don't know a lot about this. I do know that the principle is one that has also been applied to the influenza vaccines. That is, if you can develop a vaccine that is going to offer universal protection against a whole array of coronaviruses, that of course is going to be much better in the long run than the vaccines that we have now that seem to have maybe a narrower range of protection.

And I think what they're talking about here is this umbrella, if you will, would allow for coverage of a broader range. And they can do this, if they can recognize a portion of the virus that is consistent across the entire range of coronaviruses and direct a response against that one particular portion of the virus, which might be in addition to, of course, the spike protein, which has been the focus up until now.



Marshall: I mean, that sounds like a really cool option, but for the flu, are we getting one that targets 24 or 20, however many different units ...?

Hewlett: I think that they have been working on that for many years. The flu virus has two major targets, the hemagglutinin and the neuraminidase, and those are targets for the currently used flu vaccines. And there's a lot of interest in trying to develop flu vaccines, influenza vaccines, which will be directed at some of the other proteins, which are more consistent, which don't seem to change from year to year.

Marshall: Okay, so, the goal then here would really be to prevent any other variants from being able to infect with this singular vaccine. That sounds pretty great.

Hewlett: Yes. If that can be accomplished. And I have confidence in our colleagues who are working in the laboratories. The technology is improving every single day. They are able to come up with novel ways of developing new vaccine products. And so I'm confident that they will come up with something very soon.



Marshall: How long do you think we're going to have to wait, though, for that to really come out of phase II, phase III and be distributed for something like that?

Hewlett: That's a good question. I think that if we look at our previous experience with the mRNA vaccines, where they were able to come up with a viable vaccine within a period of about a year, of course, that was based upon some of the previous work that was done. Who knows, maybe within another year or so there might be something that will be available. It's really pure conjecture on my part. But it's certainly possible.

Marshall: But a little hope/light at the end of the tunnel.

Hewlett: Yes, for sure.

Marshall: Now there's another type of vaccine that are being worked on, and those are non-injectable vaccines. So, can you tell us how those work? Those are inhalers. We've heard about this inhaler use for things like the flu in the past. And is that a legitimate option here for COVID?



Hewlett: Well, yes, they are. Again, not being a basic scientist it's difficult for me to go through all of the details, but I think that whether you are injecting a vaccine or if you are inhaling the vaccine, if you can basically expose the body's immune system to a high enough volume of the antigens, as we call it, then the body is going to generate a response. And it will generate a response not only by producing what we call antibodies, but it will also generate a response through the memory cells or the T-lymphocytes as we like to call them. And I think that these types of vaccines are not totally new. There are other types of vaccines that have been administered via the inhaled route, so this certainly is exciting.

Marshall: So, explain for us, though, how that would work. So, a vaccine, it gets into your arm, it goes into your immune system via the bloodstream. But when you inhale it, it goes into your lungs. So how has that response different?



Hewlett: It does, but it also is going to be absorbed through the small blood vessels that are present. And the same is true when you receive an intramuscular injection. And it then is going to cause a response as far as your immune system is concerned, so it really doesn't matter the route by which the vaccine enters the body.

The thing that is important is whether there's enough stimulation of the immune system. So, there are vaccines which are administered orally, that you take by mouth, and, so, it certainly is plausible. And it makes sense since this particular infection, we primarily acquire it through the respiratory route, it is logical that you could use a vaccine that was administered via the same route.

Marshall: But one wouldn't be necessarily better than the other?

Hewlett: No, it wouldn't be. However, I think that as time goes on they will have to look at the profile in terms of how effective the vaccines are when they're administered via this route. And also, the safety and the tolerability, there are many people who do not tolerate taking things via inhalation. Individuals who have respiratory disorders might not tolerate this route as well.



Marshall: I mean, this all sounds really promising, a promising future for COVID as we deal with this continued outbreak. And, in principle, it seems like it would be fantastic, but access is still going to be an issue. I mean, initially it was with the vaccines, now it's with tests, and we're learning about new types of tests, molecular analyses that can be used at home as well. Is that a way to really then kind of get ahead of this, as we continue to ramp up those vaccine technologies?

Hewlett: Well, yes. And I think that we have to look back on some of the errors that were made in the past. Many years ago there was, I think, a withdrawal of support for our response to things like pandemics and natural disasters. And this was recognized by many of the experts in the field.



And even during recent years, the public health infrastructure has been pretty much dismantled and we've had dismantling of some of the areas like our National Institutes of Health. There were draconian cuts to the Centers for Disease Control. And, unfortunately, as these cuts were starting to take effect, we were faced with the pandemic.

And so we were ill-prepared to deal with this pandemic. And I think now there has been an awakening and I think that now the support to some of these infrastructure areas is being renewed. And hopefully as we move forward, we will be in a better position. But things like home tests are certainly going to be very, very helpful in terms of improving access, and, of course, the technology for the tests. So, I think that these are certainly steps in the right direction that the administration is taking in terms of dealing with this testing issue.



Marshall: Is the problem or is the solution, I guess, going to be these new kinds of vaccines and figuring out how to boost and have that protection last? Or is it going to be that with a variant like Omicron, everyone will slowly get infected? And then it turns into more of a flu-like illness and we use testing to return to normal?

Hewlett: Well, that's a difficult question. I think that all of us are hoping that maybe -- and we have to keep in mind that coronaviruses have been around for a long, long time. They've been known as pathogens in animals since the 1930s. And they were identified as pathogens in humans in the late 1960s. And we know that the coronaviruses are responsible for about 30% of the common colds in certain parts of the world -- and so it is hopeful that as a result of many of the measures that are being taken, that it may return to that status.



Before we had SARS 1 and then MERS, the coronaviruses were felt to be rather benign. And so what happened to us in 2020 was totally unexpected, but possibly with a lot of the measures that have been taken already, combined with testing, we will be able to achieve normalization or at least a level of control.

But it may well be that in the future, we may have to include vaccinations for coronaviruses along with vaccinations for influenza, that's certainly a possibility on the horizon.

Marshall: And that's another vaccine that's being worked on, combining the two?

Hewlett: Yes. If you could combine them, that would really be a very good thing for people, so that when they got their flu vaccines every year, they could also get protection against coronaviruses.

Marshall: In the short term, though, just two arms, right? Roll up both sleeves.

Hewlett: That's pretty much where we are right now. We have to emphasize to everyone that the COVID-19 vaccines and boosters do not protect you against influenza. And the influenza vaccine does not protect you against COVID-19.



Marshall: Okay, well, I guess it sounds like COVID is here to stay for at least the long term and vaccines do remain our best weapon against them. But is the idea now that we reframe the goal to COVID testing and care?

Hewlett: Well, I guess we're going to have to ... there's no one solution. I think we can't get rid of testing just because we have vaccines. And just because we have testing, we can't stop vaccinating and encouraging everyone to be vaccinated and to have boosters. I think we have to have a multifaceted approach.

And I think while we're in this outbreak of the Omicron variant, we also have to emphasize the other things that we know are helpful in preventing infection, like masking and distancing, and also, unfortunately, avoiding large indoor gatherings, until this is under better control.
"

 

[missy]

JAMA

"Association of a Third Dose of BNT162b2 Vaccine With Incidence of SARS-CoV-2 Infection Among Health Care Workers in Israel​

Avishay Spitzer, MD1,2,3; Yoel Angel, MD, MBA2,4,5; Or Marudi, MSc2; et alDavid Zeltser, MD, MHA2,6; Esther Saiag, MD, MHA2,7; Hanoch Goldshmidt, PhD, MBA2,8; Ilana Goldiner, PhD, MHA2,8; Moshe Stark, PhD2,8; Ora Halutz, MSc2,8; Ronni Gamzu, MD, PhD, MBA, LLB2,9; Marina Slobodkin, MD2,10; Nadav Amrami, MD2,10; Eugene Feigin, MD2,10; Meital Elbaz, MD2,11; Moran Furman, MD2,12; Yotam Bronstein, MD2,10; Amanda Chikly, MD2,11; Anna Eshkol, MD2,12; Victoria Furer, MD2,13; Talia Mayer, MD, MHA2,12; Suzy Meijer, MD2,11; Ariel Melloul, MD2,10; Michal Mizrahi, MD2,10; Michal Yakubovsky, MD2,11; Dana Rosenberg, MD2,13; Ari Safir, MD2,12; Liron Spitzer, MD2,12; Eyal Taleb, MD2,12; Ori Elkayam, MD2,13; Adi Silberman, MD2,13; Tali Eviatar, MD2,13; Ofir Elalouf, MD2,13; Tal Levinson, MD2,11; Katia Pozyuchenko, MSc14; Ayelet Itzhaki-Alfia, PhD2,14; Eli Sprecher, MD, PhD, MBA2,12,15; Ronen Ben-Ami, MD2,11; Oryan Henig, MD2,11
Author Affiliations Article Information
JAMA. Published online January 10, 2022. doi:10.1001/jama.2021.23641
https://jamanetwork.com/journals/jama/fullarticle/2788105
Key Points
Question What is the association between immunization with a third (booster) dose of BNT162b2 vaccine (Pfizer-BioNTech) and the incidence of SARS-CoV-2 infection among immunocompetent health care workers?
Findings In this cohort study of 1928 health care workers in Israel who were previously vaccinated with a 2-dose series of BNT162b2, administration of a booster dose compared with not receiving one was significantly associated with lower risk of SARS-CoV-2 infection during a median of 39 days of follow-up (adjusted hazard ratio, 0.07).
Meaning Among health care workers previously vaccinated with a 2-dose series of BNT162b2, administration of a booster dose compared with not receiving one was significantly associated with a lower rate of SARS-CoV-2 infection in short-term follow-up.
Abstract
Importance Administration of a BNT162b2 booster dose (Pfizer-BioNTech) to fully vaccinated individuals aged 60 years and older was significantly associated with lower risk of SARS-CoV-2 infection and severe illness. Data are lacking on the effectiveness of booster doses for younger individuals and health care workers.
Objective To estimate the association of a BNT162b2 booster dose with SARS-CoV-2 infections among health care workers who were previously vaccinated with a 2-dose series of BNT162b2.
Design, Setting, and Participants This was a prospective cohort study conducted at a tertiary medical center in Tel Aviv, Israel. The study cohort included 1928 immunocompetent health care workers who were previously vaccinated with a 2-dose series of BNT162b2, and had enrolled between August 8 and 19, 2021, with final follow-up reported through September 20, 2021. Screening for SARS-CoV-2 infection was performed every 14 days. Anti–spike protein receptor binding domain IgG titers were determined at baseline and 1 month after enrollment. Cox regression with time-dependent analysis was used to estimate hazard ratios of SARS-CoV-2 infection between booster-immunized status and 2-dose vaccinated (booster-nonimmunized) status.
Exposures Vaccination with a booster dose of BNT162b2 vaccine.
Main Outcomes and Measures The primary outcome was SARS-CoV-2 infection, as confirmed by reverse transcriptase–polymerase chain reaction.
Results Among 1928 participants, the median age was 44 years (IQR, 36-52 years) and 1381 were women (71.6%). Participants completed the 2-dose vaccination series a median of 210 days (IQR, 205-213 days) before study enrollment. A total of 1650 participants (85.6%) received the booster dose. During a median follow-up of 39 days (IQR, 35-41 days), SARS-CoV-2 infection occurred in 44 participants (incidence rate, 60.2 per 100 000 person-days); 31 (70.5%) were symptomatic. Five SARS-CoV-2 infections occurred in booster-immunized participants and 39 in booster-nonimmunized participants (incidence rate, 12.8 vs 116 per 100 000 person-days, respectively). In a time-dependent Cox regression analysis, the adjusted hazard ratio of SARS-CoV-2 infection for booster-immunized vs booster-nonimmunized participants was 0.07 (95% CI, 0.02-0.20).
Conclusions and Relevance Among health care workers at a single center in Israel who were previously vaccinated with a 2-dose series of BNT162b2, administration of a booster dose compared with not receiving one was associated with a significantly lower rate of SARS-CoV-2 infection over a median of 39 days of follow-up. Ongoing surveillance is required to assess durability of the findings.

Introduction
The Pfizer-BioNTech BNT162b2 messenger RNA COVID-19 vaccine was found to be highly effective in preventing asymptomatic, symptomatic, and severe SARS-CoV-2 infection.1-4Israel was among the first countries to achieve significant nationwide vaccination coverage, leading to rapid containment of SARS-CoV-2 transmission in the community.5,6 However, resurgence of COVID-19 cases predominated by the Delta variant was observed in June 20216,7 and raised concerns about waning immunity of the BNT162b2 vaccine. Declining protection of BNT162b2 against SARS-CoV-2 infection and hospitalization 4 months or more after full vaccination was demonstrated among individuals aged 60 years or older, in which those who completed a 2-dose series in March 2021 had a lower risk of SARS-CoV-2 infection compared with those vaccinated in January 2021.7 Similarly, analysis of US data of adults without immunocompromising conditions showed a significant decline in the effectiveness of the BNT162b2 vaccine against COVID-19 hospitalizations, from 91% to 72% more than 120 days after completion of vaccination.8 These findings are consistent with data showing time-dependent reduction in neutralizing antibody titers after vaccination.9,10
In response, on July 30, 2021, the Israeli ministry of health initiated BNT162b2 booster vaccination of persons older than 60 years11 and shortly thereafter expanded its recommendation to younger age groups. Analysis of nationwide data showed a lower risk of confirmed SARS-CoV-2 infection starting 12 days after booster vaccination among persons aged 60 years or older who received a booster dose12 compared with individuals vaccinated with 2 doses. Booster administration has also been shown to enhance immune response in immunosuppressed individuals.13 However, the effect of booster vaccination on younger adults and health care workers is unclear.
This study aimed to assess the association of booster vaccination with SARS-CoV-2 infection among health care workers at a large teaching hospital in Tel Aviv, Israel.
Methods
Study Design and Population
The COVI3 study was an investigator-initiated, prospective cohort study conducted at the Tel-Aviv Sourasky Medical Center, a tertiary medical center in Tel Aviv, Israel. Study population included health care workers (including employees, students, volunteers, and subcontractors) aged 18 years or older who received 2 doses of BNT162b2 vaccine at least 1 month before study enrollment. Participants who were immunocompromised, were taking biological or immunosuppressive drugs, were pregnant, or had documented past infection with SARS-CoV-2 were excluded.
Written informed consent was obtained from all participants at enrollment. Ethics approval and review according to the Declaration of Helsinki14 for this study were obtained from the hospital’s institutional review board. The study protocol is available in Supplement 1.
Study enrollment occurred between August 8 and 19, 2021. Results reported here include data collected up to September 20, 2021 (eFigure 1 in Supplement 2), with surveillance of participants planned to continue for 1 year after enrollment. The study was originally designed as an interventional study, offering a third dose of BNT162b2 to participants with anti–SARS-CoV-2 spike protein receptor binding domain (anti–S1-RBD) IgG levels below 5.5 index values, which was the median titer of the first 500 enrolled participants. However, shortly after study initiation the Israeli Ministry of Health recommended the administration of a booster dose to all health care workers, which mandated modifying the study design to a prospective cohort design. Therefore, timing of receipt of the booster dose was at the participants’ discretion and could have taken place at any point after enrollment in the study. This can be described most intuitively as a single cohort of health care workers in which exposure status could evolve over time, from unexposed to exposed, on booster immunization (Figure 1).
Data Collection
Data pertaining to demographics, employment sector and department, medical history including comorbid conditions, vaccination history, and medication use were obtained from the hospital’s information systems database and from a questionnaire completed by the participants at enrollment. Blood samples were obtained for anti–S1-RBD IgG levels at baseline and approximately 1 month after enrollment, which, for participants who opted to receive the booster dose, was at variable times after vaccination.
Participants were requested to undergo screening for SARS-CoV-2 infection with nasopharyngeal swab sampling and reverse transcriptase–polymerase chain reaction (RT-PCR) every 14 days regardless of symptom status. Reminders were sent by email and text messages to maximize screening compliance. Results of SARS-CoV-2 RT-PCR tests performed outside of study screening procedure (for example, because of symptoms or after exposure to a SARS-CoV-2–positive individual) were retrieved and analyzed.
Anti–S1-RBD IgG levels were determined with the ADVIA Centaur SARS-CoV-2 IgG assay (Siemens), which has an analytic measurement interval of 0.50 to 100.0 index values (eMethods in Supplement 2).
Participants who tested positive for SARS-CoV-2 during the study period underwent an interview to determine the presence of symptoms.
Definitions
On study enrollment, no participant had received a booster dose and thus all participants were initially considered booster nonimmunized. Participants were considered booster recipients on the day of booster dose administration, and then considered to have completed the booster immunization (ie, were booster immunized) once 7 days or more had elapsed since receipt of the third dose of BNT162b2, consistent with the Ministry of Health definition of fully vaccinated individuals after the second dose.
The risk of exposure to SARS-CoV-2 was classified according to work assignment at enrollment as high (persons working in emergency departments or dedicated COVID-19 wards), medium (persons working in internal medicine departments or who performed high-risk procedures), or low (other population subgroups).
Persons infected with SARS-CoV-2 were considered to be symptomatic if they reported new onset of any of the following: temperature greater than 37.6 °C, headache, sore throat, cough, dyspnea, rhinorrhea, diarrhea, myalgia, malaise, or loss of sense of taste or smell.
Study Outcomes
The primary outcome was RT-PCR–confirmed SARS-CoV-2 infection. Secondary outcomes included symptomatic and asymptomatic SARS-CoV-2 infection. Change in anti–S1-RBD IgG levels from baseline to follow-up was also analyzed among individuals who received a booster dose and those who did not, and follow-up P values were compared across groups.
Statistical Analysis
All continuous variables are displayed as mean (SD) for normally distributed variables or medians (IQR) for nonnormally distributed variables. Categorical variables are displayed as numbers (percentage) of participants within each group. Normally distributed continuous variables were compared with a t test, nonnormally distributed continuous variables with Wilcoxon rank sum test, and categorical variables with the χ2 test. Participants with missing data were excluded from all analyses.
Time-Dependent Cox Regression Analysis
To account for changing booster immunization status after enrollment in the study, a time-dependent Cox regression analysis was conducted, evaluating the hazard ratio associated with booster immunization status. Participants were defined as nonimmunized on enrollment in the study and as immunized at booster receipt date plus 7 days. To control for time from completion of the primary BNT162b2 series to booster receipt, a categorical variable was introduced, defining each participant as an “early” or “late” vaccine recipient (receipt of the second vaccine dose in January 2021 vs February to May 2021, respectively).
Participants were censored on event occurrence (ie, a confirmed SARS-CoV-2 infection) or at the end of the study period. To generate a model that was as parsimonious as possible, the effect associated with each covariate measured in the study was estimated in a preliminary Cox regression analysis by computing for each covariate a Cox model including only booster immunization status and the covariate in question as explanatory variables. Each of these models was tested against the basic model (that included only booster immunization status as an explanatory variable) with an analysis of variance test; only covariates that added a statistically significant contribution over the basic model were included in the final regression model, and all were tested with Schoenfeld tests to evaluate the assumption of hazard proportionality. A full list of covariates that were tested for significance is provided in eTable 1 in Supplement 2. When the association between booster immunization and the risk of symptomatic and asymptomatic SARS-CoV-2 infection was evaluated, the latter 2 were considered competing risks, censoring the asymptomatic cases at event occurrence and recomputing the Cox model for the symptomatic cases, and vice versa.
Cumulative incidence curves for the booster-immunized and booster-nonimmunized participants were estimated with the Kaplan-Meier method from the Cox regression model.
RT-PCR Test Density Over Time
RT-PCR test density (number of RT-PCR tests per 1000 participants) was computed separately for each day as follows: the number of RT-PCR tests performed among booster-immunized and booster-nonimmunized participants in a given day was divided by the number of participants in each group on that day.
Accounting for Baseline Anti–S1-RBD IgG Baseline Titers
A behavioral effect may have been introduced because participants were aware of their baseline anti–S1-RBD IgG titers and because the booster was initially offered only to those with “low” baseline anti–S1-RBD IgG titers (<5.5 index values) at the beginning of the study. To address this potential bias, a categorical covariate, stratifying the participants into low (<5.5 index values) or high baseline anti–S1-RBD IgG titer groups, was included in the Cox regression model.
Analysis of Anti–S1-RBD IgG Titers
Participants for whom follow-up serology measurement was available were categorized as booster recipients or nonrecipients. Statistical significance of between- and within-group differences in serology values were estimated with the Wilcoxon rank sum test.
Time From Booster Administration to Serologic Response
Discovery of the point at which a serologic response occurred after booster administration was conducted in a post hoc analysis by plotting the follow-up serology titers as a function of the time elapsed from booster dose administration. Serology results of participants tested before and after this point were evaluated with the Wilcoxon rank sum test for between- and within-group differences (baseline vs follow-up serology values).
Association Between Anti–S1-RBD IgG Titers and Incidence of Breakthrough Infections in Participants Vaccinated With 2 Doses
The cumulative fraction of SARS-CoV-2 infections in participants who did not receive the booster dose, across the range of baseline serology values in this group, was computed in a post hoc analysis by summing the number of SARS-CoV-2–positive participants in each baseline serology range (0 - i, where i is an integer in the range 0-100, by increments of 1) and dividing that by the total number of SARS-CoV-2–positive participants in this group. The same computation was conducted for the cumulative fraction of participants across the baseline serology range. Incidence rates within different ranges of baseline serology values were computed by dividing the number of SARS-CoV-2–positive cases by the cumulative follow-up time within the specified range. Statistical significance of the difference between incidence rates was estimated with the log-rank test.
All statistical analyses were performed with R version 4.0.3.15 All reported tests were 2 sided, and P < .05 was considered significant.
Because of the potential for type I error due to multiple comparisons, findings for analyses of secondary end points should be interpreted as exploratory.
Results
Study Population
A total of 2048 health care workers were screened for eligibility, and 1928 were included in the primary analysis. Participants were excluded because of incompatibility with inclusion criteria, withdrawal of consent, and missing data on demographics, employment data, medical history, or baseline serology results (Figure 1). The median age of the cohort was 44 years (IQR, 36-52 years) and 1381 were women (71.6%). The median time from receipt of the second vaccine dose to study enrollment was 210 days (IQR, 205-213 days). Other characteristics of the study cohort are shown in Table 1. Overall, 1650 participants (85.6%) opted to receive the booster dose throughout the study period and 278 (14.4%) did not (eFigure 2 in Supplement 2). The median follow-up for the entire cohort was 39 days (IQR, 35-41 days), and the median follow-up in the booster-immunized state (ie, ≥7 days after receipt of booster) was 26 days (IQR, 21-29 days).
Participants underwent 3552 SARS-CoV-2 RT-PCR tests during the study period, 1732 after booster immunization and 1820 before it. Overall, of the 1928 participants, 1583 (82.1%) underwent at least 1 RT-PCR test during the study period. There was no statistically significant difference between RT-PCR test densities in booster-immunized and booster-nonimmunized participants (median density, 22.3 vs 47.2 [IQR, 9.1-78.2 vs 11.1-74.5] per 1000 person-days, respectively; P = .30 for difference between groups, Wilcoxon rank sum test) (eFigure 3 in Supplement 2).
Primary Outcome
Association Between Booster Dose Administration and Incidence of SARS-CoV-2 Infection
A total of 44 SARS-CoV-2 infections occurred throughout the study period (incidence rate, 60.2 per 100 000 person-days) (eFigure 4 in Supplement 2). Of these, 31 infections (70.5%) were symptomatic and 13 (29.5%) were asymptomatic (eTable 2 in Supplement 2).
Five SARS-CoV-2 infections occurred in booster-immunized participants (incidence rate, 12.8 per 100 000 person-days) and 39 occurred in booster-nonimmunized participants (incidence rate, 116.1 per 100 000 person-days) (Figure 2).
Four covariates had a statistically significant effect in the preliminary covariate selection analysis and were included as explanatory variables in the final regression model (alongside booster immunization status): baseline serology result (≥5.5 or <5.5 index values), number of children, early or late receipt of the second vaccine dose, and number of RT-PCR tests in booster-immunized or booster-nonimmunized windows (a time-dependent covariate). None of the other covariates had a statistically significant effect on the results (eTable 1 in Supplement 2). All covariates, including those not included in the model, fulfilled the hazard proportionality assumption (eFigure 5 in Supplement 2). The hazard ratio of SARS-CoV-2 infection for booster-immunized vs booster-nonimmunized participants, as estimated by the time-dependent Cox regression analysis, was 0.07 (95% CI, 0.02-0.20) (Table 2).
Secondary Outcomes
Association Between Booster Dose Administration and Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infection
Symptomatic disease occurred in 3 of 5 cases (60%) among booster-immunized participants and 28 of 39 cases (71.7%) among booster-nonimmunized participants (incidence rates, 7.7 vs 83.4 per 100 000 person-days, respectively) (eFigure 6 in Supplement 2). Asymptomatic infection occurred in 2 of 5 cases (40%) among booster-immunized participants and 11 of 39 cases (28.3%) among booster-nonimmunized participants (incidence rate, 5.1 vs 32.7 per 100 000 person-days, respectively) (eFigure 7 in Supplement 2). The adjusted hazard ratio for symptomatic and asymptomatic infection was 0.07 (95% CI, 0.02-0.25) and 0.08 (95% CI, 0.01-0.4, respectively (Table 2; eFigures 6 and 7 in Supplement 2).
Association Between Booster Dose Administration and Anti–S1-RBD IgG Titer
Follow-up serology was measured a median of 31 days (IQR, 28-34 days) after baseline measurement and was available for 1136 of the 1928 participants (58.9%; 60.3% of booster recipients and 50.7% of booster nonrecipients). Booster recipients had a higher proportion of men, participants with baseline titers less than 5.5 index values, and “early-vaccinated” participants compared with booster nonrecipients (eTable 3 in Supplement 2).
Median baseline levels of anti–S1-RBD IgG were 5.4 index values (IQR, 3.0-9.6 index values) for booster recipients and 9.3 index values (IQR, 5.4-19.0 index values) for nonrecipients (P < .001, Wilcoxon rank sum test).
For titers measured in booster nonrecipients, there was no statistically significant difference between baseline (shown earlier) and follow-up (11.1 index values [IQR, 6.2-31.1]; P = .70, Wilcoxon rank sum test). Conversely, the maximal value measured by the assay, 100 index values, was reached by 953 of 1021 (93.3%) booster recipients (P < .001 for difference between baseline and follow-up titers in booster recipients and P < .001 for difference between follow-up titers in booster recipients and nonrecipients, Wilcoxon rank sum test).
Post Hoc Analyses
Time From Booster Administration to Serologic Response
Some variation existed in the time elapsed between booster dose administration and follow-up serology sampling, which allowed assessment of the dynamics of serologic response to booster receipt. Among booster recipients for whom follow-up serology was measured between 5 and 42 days after the booster dose, 952 of 966 (98.6%) had reached the maximal anti–S1-RBD IgG level measurable by the assay used (100 index values) compared with 0 of 29 participants for whom follow-up serology was measured less than 5 days after booster administration (P < .001, χ2 test) (Figure 3). Furthermore, there was no statistically significant difference between baseline and follow-up serology titers in booster recipients for whom follow-up serology was measured less than 5 days after booster administration (P = .59, Wilcoxon rank sum test).
Association Between Anti–S1-RBD IgG Titers and Incidence of Breakthrough Infections in Participants Vaccinated With 2 Doses
The association between baseline anti–S1-RBD IgG titers and incidence of SARS-CoV-2 infections was assessed in the group of participants who did not receive a booster dose (n = 27. Plotting the cumulative fraction of SARS-CoV-2–positive participants against the range of baseline serology values revealed 3 segments with distinct inclines (Figure 4). In the first segment (≤7 index values), the incidence rate was 722 per 100 000 person-days. In the second segment (7-14 index values), the incidence rate was 169 per 100 000 person-days. In the third segment (>14 index values), the incidence rate was 154 per 100 000 person-days. The difference in incidence rates between the segments was estimated by pairwise comparisons with the log-rank test and was found to be statistically significant for the comparison between segments 1 vs 2 (P = .003) and 1 vs 3 (P = .002) but not for the comparison of segments 2 vs 3 (P = .10). All P values were adjusted for multiple testing with the Holm method.
Discussion
In this prospective cohort study of immunocompetent health care workers who were previously vaccinated with 2 doses of BNT162b2 messenger RNA vaccine, a booster dose was significantly associated with lower rates of symptomatic and asymptomatic SARS-CoV-2 infection at a median follow-up of 39 days. The adjusted hazard ratio for SARS-CoV-2 infection was 0.07 (95% CI, 0.02-0.20) compared with the protection conferred by a 2-dose regimen.
These findings are in line with the reduction in SARS-CoV-2–related hospitalizations across multiple age groups after booster administration reported in a large observational study in Israel,16 as well as with the reduction in SARS-CoV-2 infections observed after booster administration in persons older than 60 years reported in another Israeli nationwide study.12
Approximately 70% of SARS-CoV-2 infections in this cohort were symptomatic, similar to the proportion observed in other studies of vaccine breakthrough infection.17,18
An increase in anti–S1-RBD IgG antibody levels starting 5 days after booster vaccination was observed among booster recipients, whereas no such increase was observed in participants who did not receive the booster dose. This increase corresponds with an increase in anti-S1 antibodies observed after a third dose of BNT162b2 in a study of adults aged 60 years or older19 and after a third dose of mRNA-1273 vaccine (Moderna) in a cohort of kidney transplant recipients who did not have a serologic response to the first 2-dose regimen.20
A post hoc exploratory analysis of participants who did not receive a booster dose in this cohort revealed a greater incidence of SARS-CoV-2 infection in participants with baseline anti–S1-RBD IgG levels below 7 index values (approximately 153 binding antibody units/mL).21 There is currently no validated immune correlate of protection from SARS-CoV-2 infection. However, neutralizing antibody levels correlated with protection against SARS-CoV-2 infection and severe infection9,22 and an association between anti–S1-RBD IgG and neutralizing antibody levels after immunization with BNT162b2 have been previously reported.9,22-24 Because neutralization titers are not generally available at most clinical laboratories, more information is needed on clinical correlates of commercial immunoassays. Results of this study suggest that anti–S1-RBD IgG levels have potential usefulness for assessing waning immunity after BNT162b2 vaccination and should be validated in additional cohorts.
The strengths of this study include a prospective, investigator-initiated design, high SARS-CoV-2 incidence during the study period, a relatively homogenous population with a detailed data set that allowed robust analysis with adjustment for multiple confounders and correlation with anti–S1-RBD IgG levels, and periodic screening by RT-PCR of participants, which reduced testing imbalance between booster-immunized and booster-nonimmunized cohorts and allowed detection of asymptomatic infections. Moreover, this study addressed immunocompetent health care workers, a population not included in recent studies on the effect of booster vaccination.12
Limitations
This study has several limitations. First, the sample size was not powered to capture the effect of a booster dose on severe illness and hospitalization, especially in this cohort of immunocompetent individuals. Second, the low incidence of asymptomatic infection did not allow robust estimation of the association between booster administration and asymptomatic infection. The 14-day interval between tests, and that approximately 20% of the cohort did not undergo any RT-PCR test during the study period, may have caused some asymptomatic infections to be missed. However, the relatively high test density in this study and the similar rates of asymptomatic infections as observed in other reports17,18 do not support the presence of a such a detection bias. Third, this was an unblinded nonrandomized observational study, with participants aware of their baseline anti–S1-RBD IgG levels, which may have affected both their decision about whether and when to receive the booster dose and their health behavior throughout the study period. Some variability in the timing of second dose administration, study enrollment, and third dose administration was also present. However, the primary analysis included timing of second and third vaccine doses, baseline anti–S1-RBD IgG titers, and number of past influenza vaccines (a marker of health behavior) as model covariates to account for these confounders. Nevertheless, the presence of unknown confounders cannot be excluded. Fourth, neutralizing antibody levels and cellular immunity were not measured in this study, which limited the estimation of the immune response elicited by booster administration. Fifth, the short duration of follow-up does not allow conclusions to be drawn about the long-term effect of the booster dose. Sixth, our observations were made before Omicron emerged as a dominant variant of SARS-CoV-2, and therefore our results may not apply to that variant.
Conclusions
Among health care workers at a single center in Israel who were previously vaccinated with a 2-dose series of BNT162b2, administration of a booster dose compared with not receiving one was associated with a significantly lower rate of SARS-CoV-2 infection during a median of 39 days of follow-up. Ongoing surveillance is required to assess durability of the findings.
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Article Information
Corresponding Author: Oryan Henig, MD, Department of Infectious Diseases and Infection Control, Tel Aviv Sourasky Medical Center, Weizmann 6, Tel Aviv, Israel 6423906 ([email protected]).

"

 

[House Cat]

After reading many articles with doctors sharing their options on swabbing the throat, we went ahead and swabbed my son’s throat and nose. They say the virus proliferates in the throat for days before it shows up in the nose.

I realize the FDA and the CDC do not recommend this. The language they use leads me to believe they might recommend it in the future. They say they don’t have the research to support swabbing the throat at this time.

Swabbing my son’s throat produced a positive result. Thank goodness it did. He had a runny nose and came home early from school. That would have been 4 more full classrooms of kids that would have been exposed to him. I don’t know what the nasal swab would have produced. I do know his symptoms were relatively new.

 

[missy]

From one of our doctors newsletters.



"

COVID VACCINE NEWS


Everyone ages 12 and up is approved to receive Covid booster shots.
A few things to know: Pfizer still has the only booster formulation approved for people under 18.
The timeline for receiving the booster has changed. Previously it was recommended that you wait at least 6 months since your last vaccine. Now a booster is recommended after 5 months.
Despite all the breakthrough infections, the Covid vaccines have been a remarkable success. Studies show that the vaccine provides more protection from future infection than does the immune response from being infected with Covid. Vaccinated people also have drastically lower rates of hospitalization.
Your best protection against Covid is vaccination. If someone who is due for the booster gets Covid, they just have to wait until their 10 days isolation period is over before getting the booster.



COVID NEWS


If you have Covid symptoms, presume that you have Covid. Do not let a negative test stop you from isolation and quarantine. The NYC Department of Health reports a 20% positive test rate for NYC currently, compared to 0.4% positive in the summer.
I continue to have patients with a sore throat and runny nose tell me they think it is just an ordinary cold, because their home testing results were negative — only to test positive with a PCR test, or on the 3rd or 4th day of rapid testing. If you have a sore throat or runny nose, assume you have Covid and isolate. Even if you are convinced you have a cold or allergies or flu, be smart and be safe. Omicron is everywhere right now. Do serial testing in isolation or come in for a PCR test. Do not leave your home for anything other than testing if you have any symptoms. If you live with others, do not leave your bedroom if you have any symptoms.
Don’t give up on health and safety! Please don’t give in to the fatalistic “well everybody is just going to end up getting it” attitude toward Omicron that stops people from properly isolating and quarantining. Each infection sets off a chain of transmission. The result could be just a sore throat and body aches for a few days, but it could also lead to significant and permanent lung damage or even death in the unvaccinated and those at risk of severe disease.
And before you go off about the unvaccinated getting what they deserve, remember that not vaccinating is not always a choice. No one under 5 has been cleared for getting a vaccination; people with immunocompromising illnesses might not have full vaccine protection even if they are vaccinated; and some people get severe disease despite vaccination. We have a duty to protect the vulnerable and to look out for each other, in addition to remaining vigilant in looking out for ourselves.
QUARANTINE AND ISOLATION PROTOCOLS
For reference: Covid isolation and quarantine recommendations per the CDC:
https://www.cdc.gov/coronavirus/2019-ncov/your-health/quarantine-isolation.html
See my last addendum for more specifics.
COVID TESTING
I know it is hard to keep track of which Covid test to do, when to do it, and how to interpret the results. Here is a primer:
Rapid Tests
Also known as: Antigen Test or Lateral Flow Test
Brands: BinaxNOW, FlowFlex, iHealth, Carestart, Quickvue, On/Go
Turn-around time: 15-20 minutes
Most of the at-home tests are rapid tests that detect the presence of antigens (molecules that trigger an immune response). They detect Covid viral antigen in mucus. Viral antigen levels have to be at a certain level before they turn positive. This is why you can get a false negative for a few days before turning positive on serial testing. Vaccinated people are more likely to get false negatives because the immune response from the vaccine is killing the virus, so it takes longer for there to be enough virus in the body to be detected. Rapid tests are great because of their wide availability and fast results, but they are not nearly as sensitive in picking up early infection as office-based testing.
There has been some chatter about adding a swab of the throat when doing Covid rapid tests to increase the likelihood of picking up antigen. Based on the current information, I think that the tests should be administered as they were intended at home, but a trained professional could consider adding a throat swab. Environmental factors can cause false positives when done using the throat method. Here is an article discussing this practice:
https://www.prevention.com/health/a38684680/home-covid-test-throat-swab/
Before doing any at-home Covid test, please read the directions a couple of times and watch an instructional video from the company that makes the test.
The stronger and more quickly the test turns positive is an indicator of how much virus is present, which in turn could be an indicator of how contagious a person is. This is why some have recommended testing negative on a rapid test before coming out of isolation.
Rapid-testing scenarios:

1. If you are asymptomatic and have had no exposure and you are testing before a visit or meeting, take one test in the hours before the event.
2. If you are asymptomatic and are testing because you were exposed to someone with Covid, test once after being informed of the exposure. Follow CDC exposure protocol of masking when you are around other people, and monitor symptoms for 14 days. If you continue to be asymptomatic, test again on day 5. If you test negative, continue to monitor for symptoms but there’s no need for further testing unless symptoms develop. If you test positive, isolate, quarantine, and do contact tracing per CDC protocol.
3. If you are having Covid symptoms, test. If positive, start CDC isolation and quarantine and contact-tracing protocols. If negative, isolate and seek PCR or rapid PCR equivalent testing to determine if this is a false negative. Alternatively, isolate and repeat rapid testing every 1-2 days until your symptoms resolve. If serial rapid tests are negative over 4 days, or if the PCR test or rapid equivalent is negative, then — and only then — can you entertain the idea that this is not Covid.

PCR testing
Available: at a doctor’s office
Turn around time: 2-5 days.
COVID-19 PCR tests use primers (DNA tags) that match a segment of the virus’s genetic material. This allows many copies of that material to be made, which can be used to detect whether or not the virus is present. PCR is much more sensitive at picking up Covid earlier than rapid tests and for longer than rapid tests. The biggest downsides to PCR are the turnaround time and the need for an office visit. The PCR test is the most sensitive test, and it can detect the virus earlier than antigen testing. It also can continue to detect the SARS-CoV-2 virus past the point of contagiousness, so it should not be used to test for the resolution of illness.
Rapid PCR-quality tests
Brands: Cue, Lucira
Turn around time: 30 minutes
These high-accuracy Covid tests are available for home use. They are more sensitive than antigen tests. The differences between the two brands are mainly technical. Cue uses NAAT that has an accuracy rate similar to PCR testing; Lucira uses RT-LAMP that also has an accuracy rate similar to PCR testing.
The limiting factor here is cost and availability. Cue requires testers to purchase a test reader in addition to testing cartridges. Lucira is available as a stand-alone product. Both cost around $100 per each test.
Here is a article about testing:
https://www.npr.org/sections/health...ind-of-test-to-use-what-to-do-with-the-result
Here is a graphic on how testing works:
https://cdn.substack.com/image/fetch/f_auto,q_auto:good,fl_progressive:steep/https://bucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com/public/images/41b26250-9fb4-46ef-879b-b387ebc60e30_975x626.jpeg

"

 

[missy]

After reading many articles with doctors sharing their options on swabbing the throat, we went ahead and swabbed my son’s throat and nose. They say the virus proliferates in the throat for days before it shows up in the nose.

I realize the FDA and the CDC do not recommend this. The language they use leads me to believe they might recommend it in the future. They say they don’t have the research to support swabbing the throat at this time.

Swabbing my son’s throat produced a positive result. Thank goodness it did. He had a runny nose and came home early from school. That would have been 4 more full classrooms of kids that would have been exposed to him. I don’t know what the nasal swab would have produced. I do know his symptoms were relatively new.

Sending him healing vibes and well wishes @House Cat. Wishing him a full and speedy recovery.

 

[missy]

Kids’ Covid hospitalizations on the rise​

The number of patients hospitalized with Covid-19 is hitting record highs in the U.S. as cases fueled by the omicron variant soar, with children seeing the largest jump. Covid-19 hospitalizations are up 165% to an average 830 daily admissions for those 17 or younger, compared with the week ending Dec. 26, according to the most recent data from the Centers for Disease Control and Prevention. Death rates for all youngsters, however, remain low compared with the older population. As case numbers continue to surge, Adrienne Randolph, a senior physician at Boston Children’s Hospital who’s leading a CDC-funded study on Covid-19 in hospitalized kids, says it’s likely that the high volume is fueling the rise in admissions. It’s a mix of children sick with Covid and those who are hospitalized for another illness and test positive once there, she says. But more data are needed, especially on the risk of conditions that usually take more time to develop, like a type of heart inflammation called myocarditis, or neurological effects, Randolph says. EMS medics check the breathing of a Covid-19-positive child in Houston. Photographer: John Moore/Getty Images The CDC released data last Friday showing that among those 4 or younger—the age group not yet eligible for vaccination—4.3 per 100,000 were hospitalized with Covid, up from about 1 per 100,000 for older kids. Randolph says children under 4 are often the ones doctors see during cold months with respiratory illnesses. “The strain does have a predilection for the upper respiratory system,” she says, producing infections such as the croup and bronchiolitis that often affect young children who contract winter viruses. Studies have shown omicron appears less likely to infect cells deep in the lungs but stays in the upper airway. Kids exposed to Covid can also develop a rare condition that can damage the heart, lungs and brain, known as multisystem inflammatory syndrome, or MIS-C, which shows up about a month after exposure, meaning the level of MIS-C associated with omicron is yet unknown. In good news, Covid vaccination offers a high level of protection against MIS-C, according to a study Randolph was a part of that examined patients age 12 to 18 that was published last week by the CDC. Vaccine uptake among children and adolescents has been pretty low. Most who are hospitalized with severe disease are unvaccinated, Randolph says, and it’s straining medical centers around the country. At Boston Children’s, supervisors have told many workers they should be prepared to be on call 24/7 given the large number of staff out with Covid at any given time. “It’s so busy,” says Randolph.—Anna Edney

​ ​ ​ ​ Track the virus​

New Thinking in Emerging Economies​ Developing nations brought to their knees by earlier waves of Covid-19 -- Brazil, India, Indonesia and others -- are only now contending with the highly-contagious omicron variant. With the advantage of having watched it play out elsewhere, some are rejiggering policies so as not to eliminate the virus but to live with it. Read the full story here.

 

[missy]

"​

Ranking Seven COVID-19 Antigen Tests by Ease of Use: Report​

Megan Brooks
January 11, 2022


Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.
ECRI evaluated seven rapid COVID-19 antigen tests available for purchase online and in retail stores since December.
None of the tests were rated as "excellent" in terms of usability and some had "noteworthy" usability concerns, the company said.
If a test is hard to use, "chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result," Marcus Schabacker, MD, PhD, president and CEO of ECRI, told Medscape Medical News.

To gauge usability, ECRI used the "industry-standard" system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.

More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.

Test	Rating	Score (0 to 100)
On/Go (Intrivo)	Very Good	82.9
CareStart (Access Bio)	Very Good	80.8
Flowflex (ACON Labs)	Very Good	79.5
QuickVue (Quidel)	Good	75.6
BinaxNOW (Abbott)	Good	73.3
InteliSwab (OraSure)	Good	73.3
BD Veritor (Becton Dickinson)	Okay (marginally acceptable)	51.8

ECRI analysts found that some tests require particularly fine motor skills or have instructions with extremely small font size that may make it hard for older adults or people with complex health conditions to use the tests correctly.
"If you have a tremor from Parkinson's, for example, or anything which won't allow you to handle small items, you will have difficulties to do that test by yourself. That is the number one concern we have," Schabacker said.
"The second concern is readability, as all of these tests have relatively small instructions. One of them actually has doesn't even have instructions — you have to download an app," he noted.
Given demand and supply issues, Schabacker acknowledged that consumers might not have a choice in which test to use and may have to rely on whatever is available.

These tests are a "hot commodity right now," he said.

"If you have a choice, people should use the ones which are easiest to use, which is the On/Go, the CareStart, or the Flowflex," he said.

"

 

[missy]

Italy's COVID Woes Mainly Caused by Unvaccinated, Draghi Says​

By Reuters Staff
January 11, 2022

"

ROME (Reuters) - The small number of Italians who refuse to be vaccinated against COVID-19 are largely responsible for the continued health crisis, Prime Minister Mario Draghi said on Monday.
The government last week made vaccinations mandatory for everyone aged over 50, one of very few European countries to take such a step, in an attempt to ease pressure on its hospitals as new cases surge.
"We must never lose sight of the fact that most of the problems we have today are because there are non-vaccinated people," Draghi told a news conference. "For the umpteenth time, I invite all those Italians who are not yet vaccinated to do so, and to get the third shot."
Health Minister Roberto Speranza said 89.4% of all those aged 12 and over had received at least one vaccine dose, yet the unvaccinated accounted for two-thirds of all the COVID patients in intensive care units.

Latest data released on Monday showed there were 1,606 people in intensive care with COVID, up 11 on the previous day, while the country reported 101,762 new cases and 227 additional deaths over the past 24 hours.

Piling further pressure on people to get inoculated, new restrictions came into force on Monday banning those not yet vaccinated from entering bars and restaurants or from using public transport.

Only those who have recently recovered from COVID-19 will be exempted from the new rule.

"

 

[missy]

"​

US Reports Record-Breaking 1.35 Million New COVID Cases in a Day​

Carolyn Crist
January 11, 2022



The U.S. reported 1.35 million new COVID-19 cases on Monday, logging the highest daily total for any country in the world during the pandemic.
The U.S. set the previous record of 1 million cases on Jan. 3. (A large number of cases are reported on Mondays, since many states don't provide updates over the weekend, according to Reuters.)
Still, the 7-day average for new cases has surpassed 700,000, tripling in 2 weeks as the contagious Omicron variant continues to spread across the country.

The daily record of new cases came a day after the U.S. crossed the grim milestone of 60 million COVID-19 cases during the pandemic, according to the latest data from Johns Hopkins University. More than 11 million new cases were reported in the past 28 days, with 5 million reported since Jan. 2.

Globally, more than 310 million cases have been reported, resulting in nearly 5.5 million COVID-19 deaths. Almost 40 million cases have been confirmed worldwide during the past month, with the U.S. accounting for 28% of those.
Texas became the second state to report more than 5 million cases since the pandemic began, behind California's total of 6 million cases. Florida has reported more than 4.6 million, while New York has reported more than 4.1 million.
The U.S. has also hit an all-time high for hospitalizations, with nearly 146,000 COVID-19 patients in hospitals across the country, according to the latest datafrom the U.S. Department of Health and Human Services. The previous record was 142,000 hospitalizations in January 2021.

Tuesday's hospitalizations are more than twice as many as 2 weeks ago, according to CNN. About 78% of inpatient beds are in use nationwide, and 21% are being used for COVID-19 patients.
Deaths are averaging about 1,700 per day, Reuters reported, which is up from 1,400 in recent days but not much higher than earlier this winter. The peak average was 3,400 daily deaths in mid-January 2021.
The surging numbers of cases and hospitalizations across the country are straining hospitals. On Monday, Virginia Gov. Ralph Northam declared a state of emergency after the number of intensive care unit hospitalizations more than doubled since Dec. 1, CNN reported. The order allows hospitals to expand bed capacity, use telehealth options, and be more flexible with staffing.
Texas is hiring at least 2,700 medical staff to help with the surge, CNN reported, and Kentucky has mobilized the National Guard to provide support.

"Omicron continues to burn through the commonwealth, growing at levels we have never seen before. Omicron is significantly more contagious than even the Delta variant," Kentucky Gov. Andy Beshear said during a news briefingMonday.

Kentucky reported its highest weekly total of cases last week and has its highest rate of positive tests, at 26%. Beshear said the state is down to 134 available adult ICU beds.

"If it spreads at the rate we are seeing, it is certainly going to fill up our hospitals," he said.

Sources​

Reuters: "U.S. reports 1.35 million COVID-19 cases in a day, shattering global record."

Johns Hopkins University: "COVID-19 Dashboard."

U.S. Department of Health and Human Services: "Inpatient Bed Utilization by State."

CNN: "Covid-19 hospitalizations reach record high, HHS data shows."

Kentucky Office of the Governor: "Gov. Beshear: State Reports Highest Week Ever for New COVID-19 Cases."

"

 

[missy]

"Doubling Pace of Boosters in US Could Save 41,000 Lives: Report​

Ken Terry
January 11, 2022

By accelerating the rate of booster vaccinations, the United States could significantly "flatten the curve" of hospitalizations and deaths from COVID-19, according to a new blog post written by researchers at the Commonwealth Fund.
Currently, they note, about 770,000 booster shots are being administered daily. If that rate is maintained, the authors forecast, during the next 4 months COVID will cause 210,000 additional deaths, nearly 1.7 million more hospitalizations, and almost 110 million additional infections.
Doubling the pace to 1.5 million boosters per day, they figure, could prevent 41,000 deaths, more than 400,000 hospitalizations, and over 14 million infections by the end of April. (The computer simulation used by the researchers spans the period from January 1 to April 30.)

Tripling the daily rate of booster shots to 2.3 million, they say, could prevent over 63,000 deaths, nearly 600,000 hospitalizations, and more than 21 million infections. That would represent a 30% reduction in the expected number of COVID-19 deaths and a 35% drop in the expected number of hospitalizations during the next 4 months.

According to the COVID Data Tracker of the Centers for Disease Control and Prevention (CDC), 207.7 million Americans, or 62.5% of the population, are "fully vaccinated." Of those people, 75.4 million, or 36.3%, have gotten booster shots.
Breaking this down by age group, 60.4% of people who are 65 or older have received a booster, as have 51.2% of those aged 50 or older, and 39.4% of those aged 18 or older.

Upping Rate, Capacity​

Accelerating the rate of booster vaccination is achievable, the Commonwealth Fund report notes. In early 2021, more than 2 million doses of COVID vaccine were administered daily for almost 3 months.

Since then, the government has increased vaccination capacity, including the addition of 10,000 vaccination sites for a total of 90,000 sites. Moreover, the Federal Emergency Management Administration (FEMA) has deployed mobile vaccination clinics, and community health centers have been hosting family vaccination days.
The US COVID-19 vaccination campaign has already prevented nearly 1.1 million deaths, the authors point out. "But new variants combined with waning immunity require sustained efforts," they observe. "A booster vaccination is effective at reversing an individual's waning immunity in a matter of days. As Omicron spreads, our findings highlight the urgent need to administer boosters as quickly as possible to everyone who is eligible."

"

 

[missy]

Preparing Hospitals’ Medical Oxygen Delivery Systems for a Respiratory “Twindemic”​

Melissa Suran, PhD, MSJ
Article Information
JAMA. Published online January 12, 2022. doi:10.1001/jama.2021.2339

• https://jamanetwork.com/journals/jama/fullarticle/2778234
  

Regardless of whether another respiratory virus is surging across the US along with SARS-CoV-2—be it the influenza virus or respiratory syncytial virus (RSV)—experts again fear that a twindemic or possibly a tridemic could be in the making. Mirroring last year, several hospitals are reaching their tipping points, which begs the question: can they maintain an adequate supply of medical oxygen for patients experiencing respiratory distress?

Initially, “pediatrics was spared some of the oxygen allocation issues because it was only COVID—it wasn't RSV, it wasn't flu,” Daniel Rauch, MD, chief of Pediatric Hospital Medicine at Tufts Children's Hospital, said in an interview. “Now, we're looking at all of them.”
A US surge in COVID-19 cases after the Omicron variant emerged in autumn included children, who made up about 17% of new cases in early January, according to the American Academy of Pediatrics (AAP). And RSV cases—which often exhibit seasonal hikes during colder months and are the leading cause of infant hospitalization and pneumonia in the US—spiked earlier than usual this year and continue to rise.
Rauch, who also chairs the AAP’s Committee on Hospital Care, is concerned that hospitals won’t be able to accommodate everyone in need. “On any given day, we're asking… ‘If we have a bed, who gets it? Are we going to accept a transfer, or someone from our emergency room? The adult side is bursting at the seams; are we going to take a young adult? How do we juggle the resource that we have the least of—which apparently, at this point, is capacity?’”
Winter is generally tough on hospitals, bringing with it an influx of influenza cases. Although influenza isn’t typically a death sentence, it can result in serious complications, including pneumonia. According to the US Centers for Disease Control and Prevention (CDC), it’s especially dangerous for young children.
Influenza cases in the US remained low last winter due to COVID-19–related social distancing protocols. However, the CDC warned of a resurgence this year, noting that “reduced population immunity due to lack of flu virus activity since March 2020 could result in an early and possibly severe flu season”—which has already commenced. Influenza vaccination among children is also lower now than in previous years, while national cases are increasing. A study by University of Pittsburgh researchers not yet peer reviewed also warns of the risk to young children who likely have little immunity.
“We've had to do a lot of planning and purchase equipment in advance to make sure that we're ready for the [influenza] surge—we do anticipate it coming,” Cheryl Adams, LRT, MS, manager of Respiratory Care Services at Children's Minnesota, said in an interview. “Usually, we get our RSV season and our flu season, then you throw in COVID, and it could really be the perfect storm.”
According to the World Health Organization, lower respiratory tract infections were cumulatively the fourth leading cause of death across the globe in 2019. And a JAMA article that analyzed CDC mortality data found that influenza and pneumonia have been among the 10 leading causes of death in the US since 2015. Then SARS-CoV-2 came onto the scene; the CDC ranked COVID-19 as the third most lethal condition in the country during 2020.
Adams said that children hospitalized with COVID-19, RSV, influenza, or pneumonia almost always require supplemental oxygen. But many hospitals find it extraordinarily difficult to handle the current number of patients requiring oxygen therapy—assuming the facilities even have the necessary equipment.

Demand Exceeds Supply
In August, the Florida Hospital Association (FHA) reported that 68 Florida hospitals had less than a 2-day supply of medical oxygen for all patients in need.
“It was alarming,” FHA President and CEO Mary Mayhew said in an interview. “You had a number of states at the exact same time dealing with an unprecedented spike in COVID hospitalizations…along with an extremely high volume of critically ill non-COVID patients who also needed a significant volume of oxygen.”
On top of that, distribution companies struggled to find qualified drivers. The US Department of Transportation considers medical oxygen a hazardous material, meaning that truck drivers delivering it require special training.
“When a hospital received their distribution, it was less than what they normally would have received, so they were burning through it faster and were more dependent on more frequent deliveries,” Mayhew said.
Rich Craig, MBA, vice president of Technical and Regulatory Affairs at the Compressed Gas Association (CGA), echoed Mayhew’s sentiments about the supply-chain conundrum. “There’s no oxygen shortage; there are plenty of oxygen molecules around,” he said in an interview. “I would call it a supply-chain tightness.”
Medical oxygen in US hospitals is often sourced from cryogenic plants, which distill air at approximately −300 °F. The result is 99% pure oxygen—at minimum—in liquid form. According to Craig, “plants are typically no more than 300 miles from their use points” so that the oxygen doesn’t vaporize before it’s delivered. However, “in Florida over the summer, they were delivering product from 500, 600, 700 miles away just to make sure that it was getting there in the quantities that were needed.”
But even if hospitals project a higher-than-usual demand for medical oxygen, there’s only so much they can store. “It's not like gloves and masks where you buy a lot and put it on a shelf,” Craig said.
Once liquid oxygen reaches a hospital, it’s transferred into storage tanks where it’s vaporized and distributed to patients throughout the facility via an internal piping system. But tanks can only hold so much oxygen. Thus, even with adequate oxygen availability from manufacturing plants, hospitals can’t stockpile a surplus.
Retrofit for the New Normal
Not all hospitals were designed to support the high-flow oxygen needed during peak COVID-19 surges, so some have retrofitted their delivery systems. Oxygen overload may result in the oxygen becoming too cold for pipesand breaking them, especially in older buildings. Then there’s the upgrade itself. Craig mentioned that installing a new tank and vaporizer system may be challenging, because the old system can’t be out of service and removed until the new one is operating.
So why didn’t hospitals originally install larger tanks? Craig said it’s because tank sizes were based on projected demands—and since the pandemic began, the demands have been far greater than anticipated.
“COVID is going to be around for a while,” he noted. “Systems may need to be redesigned or reconfigured to address what everyone calls the new normal.”
In January 2021, the US Army Corps of Engineers began work to update oxygen delivery systems in Los Angeles hospitals when the inability to accommodate COVID-19 oxygen needs with aging equipment became dire.
And patients with COVID-19 use a lot of medical oxygen. For those with hypoxemia, the US National Institutes of Health recommends high-flow nasal cannula (HFNC) oxygen therapy. Standard delivery of oxygen via the nasal cannula is typically prescribed at or below 5 L per minute. Whereas many patients requiring HFNC oxygen vary in flow rate, those with severe COVID-19 may use up to 60 L per minute routinely. To prevent intubation, some clinicians have reported using up to 200 L per minute, which accelerated rationing protocols in some hospitals.
When Less Is More
Back at Children’s Minnesota, Adams’ greatest concern isn’t a lack of oxygen but rather a scarcity of related apparatuses, such as ventilators. “Last year, we could rent equipment, it was readily available. This year, it’s a struggle.” Shipping delays and backorders have compounded the stress, she added, on top of an influx of patients with respiratory illnesses.
COVID-19 has overwhelmed Minnesota's hospitals to the point where health care providers from across the state—including Children’s Minnesota—published a newspaper ad in mid-December that beseeched the public to get vaccinated. Furthermore, Minnesota saw an uptick in RSV cases a few months ago that still lingers.
“Children are wonderful, they share a lot of things,” Courtney Herring, MD, MHA, a pediatric hospitalist at Children's Minnesota, said in an interview. “They're also good at sharing viruses and disease.” Especially of the respiratory variety.
To ensure that every patient who needs supplemental oxygen gets it, Herring has aided efforts to optimize inpatient respiratory care—and high-flow therapy is a major component. Because it’s most effective when not approached as a one-size-fits-all intervention, Herring and an interdisciplinary team of clinicians met in mid-2020 during the COVID-19 pandemic to reevaluate their oxygen delivery methods.
Prepandemic, HFNC oxygen rates were often based on a child's weight. However, research published in Hospital Pediatrics found a nationwide increase in HFNC oxygen use without significant improvement in hospital outcomes for bronchiolitis. Herring said her team believes there are better ways of determining not only flow rate, but also whether supplemental oxygen is even necessary. For example, Herring said, it’s important to assess physiological responses, such as whether a patient is experiencing respiratory distress or even hypoxemia, and to define those responses by standardized clinical measures.
Rauch agrees. “Just because a child’s oxygen saturation is a bit low doesn't mean they need supplemental oxygen,” he said. “It's hard to not do things, but we have to remember [the] negative of overtreating, and hopefully, if we give the right treatment for the right amount of time, we'll be able to deal with the surges that we're anticipating.”
Although the pandemic was the impetus for oxygen optimization at Children’s Minnesota, it also threw a wrench into finalizing the new guidelines this year. High patient volume and staffing shortages left little time for anything except round-the-clock care.
“Our pediatric [intensive care units] have been full,” Herring said, noting that Children’s Minnesota doesn’t turn away patients and often places them in units wherever there are unoccupied beds. “At the same time, we're adapting how we push the limits of what our current guidelines are in regard to flow rates from a nasal cannula standpoint, [and] it's been necessary to care for patients with escalated respiratory needs.”
Their efforts have paid off. Despite the high volume of patients at Children’s Minnesota, neighboring hospitals have been struggling even more, to the point where no beds were available. So, Children’s Minnesota began admitting adults—many of whom required supplemental oxygen.
“We were taking patients up to 30 years [old], trying to alleviate some of the overflow from our adult counterparts in the Twin Cities,” Herring said. “We had a lot of room to optimize how we look at physiologically supporting patients with respiratory disease, whether it be in our neonatal range or our adult patients.”
Reevaluating and Revising
Children’s Minnesota isn’t alone in reexamining guidance for oxygen delivery systems. The CGA has published guidance for increasing flow rates via existing systems while also ensuring such upgrades don’t fail or become hazardous. On finding that Florida hospitals needed more medical oxygen, the FHA also followed up with oxygen conservation strategies. But deciding how much oxygen each facility requires is less centralized.
Rauch said that US hospitals don’t have national guidelines outlining how much oxygen to retain—they often estimate needs based on annual patterns and attempt to predict whether winter will come with an especially high surge of certain respiratory cases.
“Our guesstimates are really guesses this year, and we have all the supply-chain issues, so if you're wrong and you've undercounted, it's hard to get stuff,” Rauch added. “I'd rather be prepared for lots of bad things coming and have them not happen than prepare for nothing coming and be inundated …[but] we're trying not to fall back into bad habits of overutilizing resources.”
Reassessment of medical oxygen delivery is gaining traction worldwide. The Bureau of Investigative Journalism reported that several countries—many across Asia and South America—experienced severe shortages of medical oxygen in 2021. PATH, a nonprofit dedicated to global health equality, was on the frontlines of getting oxygen supplies to patients with COVID-19 in India as cases flooded the country. To help low- and middle-income countries, PATH has developed a toolkit on how to determine their oxygen-supply needs. Lisa Smith, MPH, MSW, director of PATH’s COVID-19 Respiratory Care Response Coordination project, said that the nonprofit has seen other countries focus intensely on strengthening their delivery systems. For example, Malawi drafted a governing strategy during the pandemic that includes an oxygen roadmap; Ethiopia and Nigeria conceived similar plans before COVID-19 existed.
“The pandemic created its own unique challenges that these countries had to respond to, but their health systems were able to react in thoughtful ways,” said Smith, who manages a grant awarded to PATH from the Bill & Melinda Gates Foundation for COVID-19 respiratory care response coordination. “They understand how critical oxygen is, and they understand how challenging it is to provide it reliably, so they have responded quickly and comprehensively.”
Despite the stressful conditions, hospitals have made progress. “[F]rom all of this has emerged further refinement of best practices and appropriate management of oxygen use within the hospital,” Mayhew said.
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Conflict of Interest Disclosures: None reported.

 

[dk168]

It is a great shame to hear Jonathan Van-Tam, our Deputy Chief Medical Officer has abruptly resigned today.

He is a great scientist and communicator, and an even greater teacher, as seen in one of the Royal Institution's Christmas Lectures last year when he was a co-presenter.

It will be a great loss for our government in UK.

Perhaps it is indicative of rats jumping off a sinking ship!

DK

 

[MamaBee]

My 16 year old son tested positive this morning. So far, my husband and I are negative. My son’s only symptoms are a stuffy nose

I hope he gets better quickly!

 

[dk168]

Just read about isolation period to be cut from 7 days to 5 days in England if backed by a negative ? LFT test on Days 5 and 6.

Coincidence with JVT resigning? Or perhaps he did not agree with this move as it is too much of a risk scientifically?

DK

 

[House Cat]

I hope he gets better quickly!

Thank you. He’s already pretty much recovered. He just has a small lingering cough. He is vaccinated and boosted.

 

[MamaBee]

Thank you. He’s already pretty much recovered. He just has a small lingering cough. He is vaccinated and boosted.

That’s such good news!

 

[missy]

Mapping the Covid-19 Outbreak Globally

Here’s where the coronavirus outbreak stands around the world.

www.bloomberg.com

​

"​

Mapping the Coronavirus​

Outbreak Across the World​

Updated: January 14, 2022, 5:21 AM EST

Entering the third year of the coronavirus pandemic, more than 320 millionpeople have been infected and the virus has killed more than 5.5 millionglobally. Efforts many countries took to stamp out the pneumonia-like illness led to entire nations enforcing lockdowns, widespread halts of international travel, mass layoffs and battered financial markets. New variants of the virus have led to new waves of cases, though new drugs and improved care may help more people who get seriously ill survive.

320,581,997
Confirmed cases worldwide


5,522,703
Deaths worldwide

Where deaths have occurred	Deaths	Cases
U.S.	846,488	64,082,824
Brazil	620,830	22,822,177
India	485,350	36,582,129
Russia	313,458	10,565,484
Mexico	300,912	4,257,776
Peru	203,255	2,473,709
U.K.	151,833	15,064,792
Indonesia	144,163	4,269,740
Italy	140,188	8,155,645
Iran	132,002	6,214,781
Colombia	130,625	5,440,981
France	127,520	13,351,132
Argentina	117,808	6,793,119
Germany	115,342	7,866,786
Ukraine	104,521	3,919,151
Poland	101,841	4,281,482
South Africa	92,989	3,546,808
Spain	90,620	7,930,528
Turkey	84,278	10,273,170
Romania	59,150	1,875,887
Philippines	52,736	3,092,409
Hungary	40,237	1,327,014
Chile	39,331	1,849,465
Czech Republic	36,799	2,573,945
Vietnam	35,170	1,975,444
Ecuador	33,699	559,950
Bulgaria	31,922	806,977
Malaysia	31,750	2,798,917
Canada	31,259	2,695,122
Pakistan	28,999	1,315,834

With Covid-19 now widespread around the globe, waves of disease have come and gone through every continent. Europe, the Americas, Africa and Asia have all faced cycles of outbreaks, driven in part by new variants of the virus that have proven more transmissible.

Vaccines have protected recipients from the worst consequences of illness, but access to the shots remains inequitable around the globe, even as many wealthier nations begin giving booster doses to their citizens.

Early in the pandemic, countries took drastic measures to mitigate the spread of Covid-19 on their homefront—including travel bans, school closures and restrictions on public gatherings and business activity. As countries have loosened public health restrictions in an effort to reboot their economies, many have seen a resurgence of infections. Even places that successfully contained outbreaks, like China and South Korea, have seen cases bubble back up.

Public health experts no longer talk about the elimination of SARS-CoV-2. Instead, the disease is likely to become endemic—no longer a crisis, but still a seasonal threat. Vaccines provide broad protection to most, and new treatments can reduce risk for people who get infected. But the virus is expected to be around for the foreseeable future, and as long as it circulates there is always the possibility of new mutations and more surges of new infections.

"

 

[missy]

The U.S. Supreme Court’s Republican-appointed majority rejected the centerpiece of President Joe Biden’s push to speed vaccinations amid an unprecedented Covid-19 infection surge, throwing out his mandate for large companies. The ruling is a victory for 26 business groups and 27 Republican-led states that challenged the policy. Three Democratic-appointed justices dissented. Only 63% of the U.S. is fully vaccinated, and of that group just 37% have received a booster, now seen as the most effective protection against severe disease. The U.S. leads the world in infection and deaths, as it has for most of the pandemic. More than 800,000 Americans have died.

The coronavirus loses most of its ability to infect shortly after being exhaled and is less likely to be contagious at longer distances, a preliminary study showed, reinforcing the notion that the virus is mainly transmitted over short distances and providing fresh support for social distancing and mask-wearing as means to curb infections. Around the world, the omicron variant is still wreaking havoc: China detected the mutation in a second major port city, deepening concern about a wider outbreak on Beijing’s doorstep; In the U.S., Biden said he will double an order of rapid tests to be sent to Americans, distribute “high quality” masks and deploy military doctors and nurses to hard-hit hospitals in six states. The current surge has dwarfed anything that’s come before in terms of new cases: On Jan. 11, there were 1.8 million confirmed infections worldwide on that day alone, and more than 5,300 deaths. There have been 312 million confirmed infections and 5.5 million deaths over the course of the crisis. Here’s the latest on the pandemic.

Senator Kyrsten Sinema of Arizona on Thursday did to Biden’s effort to pass voter protection laws what West Virginia Senator Joe Manchin did to his plan to expand social safety nets and fight climate change: she effectively killed it.

 

[AprilBaby]

I have been avoiding the grandkids since I last saw them Christmas Eve. Mom is a teacher, dad travels, 2 kids in school. This week the whole family got covid. Kids not vaccinated. (7,4) Looks mild except for mom who was ill, better, then ill again today. If we do shots every 6 mo mine expires mid Feb.