January 14, 2022

COVID-19 Weekly Newsletter: Masks, Tests and the Supreme Court

The Biden administration signaled new plans to make tests and masks available for free, in the same week that the Supreme Court blocked the federal government from enforcing its “vaccine or test” mandate for private employers.

At-Home COVID Tests Required To Be Covered

This week, the Biden administration announced it will require insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests. Starting January 15, those with private health coverage can get these tests for free. The over-the-counter COVID-19 diagnostic test must be authorized, cleared or approved by the U.S. Food and Drug Administration (FDA) in order to be covered by users’ plans or insurance. Insurance companies and health plans are required to cover eight free over-the-counter at-home tests per covered individual per month.

SCOTUS Rules on Vaccine Mandates

The Supreme Court of the United States (SCOTUS) on Thursday blocked the Biden administration from enforcing its “vaccine or test” requirements for businesses with 100 or more employees. After the ruling, President Biden encouraged businesses to voluntarily institute vaccination requirements. SCOTUS did allow the vaccine mandate to stand for medical facilities that receive Medicare or Medicaid payments, keeping in place the mandate for health care workers. For a look at how affected employers should respond to these opinions and their potential implications for legal challenges to other COVID-19 mandates, read this alert from our Faegre Drinker labor and employment colleagues. 

New School Testing

The White House released a new school COVID-19 testing strategy with a goal to keep all schools safely open for full-time in-person learning by increasing access to COVID-19 testing in schools. Supply shortages and operational challenges are problems that continue to persist and inhibit the pandemic response efforts. To address this, the Biden administration is gearing up to distribute 5 million free, rapid tests to schools each month, along with making 5 million lab-based PCR tests available through the Department of Health and Human Services’ (HHS) Operation Expanded Testing (ET) program. Also, the Department of Education and Centers for Disease Control and Prevention (CDC) will work to connect local school districts with state testing providers.

Mask Distribution Plan

Cloth masks have been found to be less effective at protecting against the COVID-19 virus. Next week, the White House will announce its plan to provide high-quality N-95 masks to Americans for free. President Biden yesterday noted the U.S. has more than tripled the national stockpile of N-95 masks to make sure they are widely available to the general public. Also, just this week, Sen. Bernie Sanders (I-VT) introduced legislation aimed at providing three N-95 masks per person.

Hospitals Struggle as COVID-19 Numbers Surge

Hospitals across the United States are struggling with staffing issues and reaching capacity limits as COVID-19 hospitalizations rise. In response, hospitals are starting to cut back on non-urgent services and supplementing their medical personnel with National Guard members. President Biden announced that starting next week 1,000 military medical personnel will be deployed to New York, New Jersey, Ohio, Rhode Island, Michigan and New Mexico. This is in addition to over 800 military personnel already deployed since Thanksgiving and over 14,000 National Guard members who support testing, vaccination and clinical care efforts.

Long-Term Vaccine Efficacy Studies

Two recently published studies have examined the long-term efficacy of certain vaccines in adults in the U.K., and vaccine efficacy in adolescents in the U.S. The studies focused on the Alpha and Delta virus variants. The U.K. study was large and comprehensive, aided by that country’s unified data-gathering and linked systems. The study linked over 6 million positive SARS CoV 2 PCR test results with individual’s vaccine status, age and other demographics, as well as the type of viral variant, and looked at the efficacy of mRNA vaccines and an adenoviral vector vaccine after one and two doses. The findings support other studies, demonstrating that vaccines are highly effective against symptoms after a two-dose regimen, but that symptom efficacy wanes over about 5 months. Importantly the study strongly demonstrated that over the same period or more, the vaccines remain highly efficacious against hospitalization and death.

The U.S. study examined the vaccine efficacy in 12- to 18-year-olds. The study results clearly demonstrated that full vaccination is highly efficacious in preventing hospitalization, ICU admittance and need for life-support. The study included over 1,000 individuals across 23 states; of those hospitalized, the large majority (96%) were unvaccinated; seven deaths occurred, all of whom were unvaccinated. The findings provide further support for the personal and public health benefit of vaccinating children against COVID-19.   

Podcast on Two-Years of COVID-19

A related podcast provides context and perspectives on these studies as well as learnings and perspectives on the past two years of science, medicine and public health with respect to COVID-19. The discussion identifies many areas in need of further study, including transmission dynamics, Omicron and potential future variants, and the appropriate timing of and efficacy of boosters for different age groups. The panelists note the significant advances and gains in vaccine, therapy, and testing science and technology; but that the biggest challenges are in public health communications and delivery and implementation of these benefits to the public. 

Household Exposure and Regular Use of Public Transport Associated With SARS-CoV-2 Seropositivity

A study from Sweden looked at SARS-CoV-2 antibodies in the blood serum of young adults from October 2020 to June 2021 and found that more than one in four individuals had “seen” the virus in some form, which could have been from a symptomatic or asymptomatic infection, or (for a small number of participants) from vaccination. Interestingly, the main common features separating those who had been infected from the never-infected was their household exposure to COVID-19, regular use of public transportation and neglecting to use masks. Other potential risk factors — such as gender, respiratory conditions (asthma, rhinitis), smoking and body mass index — seemed to play no role. The study also elucidated the details of the B-cell and T-cell immune responses in this population, which is important for a better understanding of the biology of the SARS-CoV-2 infection and eventually for finding treatments or ways to strengthen our protective mechanisms. 

Using the Right Test at the Right Time for the Right Purpose 

Testing for SARS-CoV-2 has become a major element of many countries’ pandemic control strategy. In the absence of a universal vaccination mandate, these tests are also viewed as indispensable on the path to economic recovery. A recent comprehensive review of the numerous tests is therefore quite timely and informative. In this article, an international team of authors discussed and compared various bioanalytical platforms and conditions of applicability of SARS-CoV-2 tests and highlighted how this virus’s unique features create both challenges and opportunities for the tests’ design and deployment. The authors also explained that some tests and screening protocols are more useful for clinical decision-making at the level of an individual patient, while others are better suited for containing an outbreak in a given community. For more basic information about the principles of SARS-CoV-2 testing, there are several recently updated primers, including the Food and Drug Administration’s (FDA) Coronavirus Testing Basics reference and the CDC’s COVID-19 Testing: What You Need to Know resource page. 

More Clarity on Reasons for Loss of Smell Due to COVID-19 

One of the mystifying symptoms of COVID-19 has been the loss of the sense of smell. Thanks to the work of numerous laboratories, summarized in this review (first published in September 2020 and now as part of the December 2021 issue of Neuroscientist), several plausible mechanisms have been proposed. One of the key routes seems to involve the virus’s attack on the so-called sustentacular cells, which surround and support olfactory neurons. Fortunately, sustentacular cells are able to regenerate relatively quickly. In cases where the loss of smell persists for longer than a few days, other parts of the olfactory system might additionally be damaged. There are still many unanswered questions, though, so the research continues.

FDA Revised Guidance on COVID-19 Plasma 

FDA revised its guidance on “Investigational COVID-19 Convalescent Plasma.” One of the reasons for this revision is the updated emergency use authorization (EUA) for COVID-19 convalescent plasma, which could be used to treat immunosuppressed COVID-19 patients. 

Omicron Lessons From Seven Countries 

The Omicron variant spread rather quickly across the globe, making countries face the challenge at about the same time. The countries vary, however, in the organization of their health care systems, population make-up and historical experiences with SARS-CoV-2 to date. The results seen in one country, therefore, are not necessarily applicable in the context of another. Nevertheless, a careful comparison of available data while accounting for the countries’ differences, could yield valuable insights for all. Such a contrast-and-compare analysis is presented in a recent article which studied the impact of Omicron in South Africa, Israel, France, U.K., Canada, Australia and Japan. Each regional segment ends with a section “What it means for the United States.”  Some of the U.S.-specific challenges are unalterable (e.g., the higher average age of the population), while others could be solved with concerted efforts (e.g., improving vaccination rates) and through fundamental structural improvements (e.g., ensure adequate medical staffing, and helping health care facilities recover from working in a crisis mode for the third year in a row).

Additional Resources

Global COVID-19-Related Patent Office Status and Deadline Extension Updates

Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.

Government Actions: COVID-19

Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.
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