COVID-19 Weekly Newsletter: Booster Shots Continue To Gain Steam

Recent announcements on the prospect of booster shots for all vaccinated Americans, a vaccine mandate for staff at federally funded nursing homes and an encouraging uptick in vaccinations marked an eventful week in the COVID-19 response.

Booster Shots for All Vaccinated Americans

On Wednesday, August 18, the U.S. Department of Health and Human Services (HHS) released a statement noting booster shots will be available to all Americans who are fully vaccinated, as long as the Food and Drug Administration (FDA) authorizes the booster shots and the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) issues a recommendation to do so. CDC’s ACIP was scheduled to meet August 24 to discuss data on booster shots, but a day after HHS released its statement, it posted a notice on its site that the meeting will be rescheduled. However, based on recent data, HHS believes “the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout.” Booster vaccines will be offered starting the week of September 20 for those who received their second dose eight months ago. This would apply to those who were eligible in the initial vaccine roll-out phase — health care workers, seniors, nursing home residents, etc. — to get it. The HHS plans to offer booster shots only to those who received either of the mRNA COVID-19 vaccines. While the one-dose COVID-19 vaccine has been in circulation since March, further data is being gathered to determine if a booster shot for it is necessary.

Staff of Federally Funded Nursing Homes Must Be Vaccinated

The Centers for Medicare and Medicaid Services (CMS) will develop new emergency regulations that will require nursing homes to have all staff fully vaccinated as a condition of participating in the Medicare and Medicaid programs. CMS will follow the rule-making process over the next several weeks to issue the new rule in September. These new regulations would apply to nearly 15,000 nursing home facilities, which collectively employ approximately 1.6 million workers and serve approximately 1.3 million nursing home residents.

Transportation Security Administration (TSA) To Continue Mask Mandate

A federal mask mandate on public transportation and commercial flights set to expire in September has been extended to January 2022. First issued in January 2021, the mandate has already been extended once before in the spring. Some stakeholders have already reacted to the extension. The trade association of airlines has indicated they plan to enforce the mandate only on U.S. carriers. An association that represents flight attendants has been supportive, indicating it will continue to keep passengers and flight employees safe.

A Million Doses in One Day

For the first time in nearly two months, on Thursday, August 19, one million doses of the COVID-19 vaccines were administered on a single day. According to the White House, this marked a 31% week-over-week increase in the daily average of people receiving their second vaccine dose.

Effect of Public-Health Decisions Comes With a Time Lag

A study of the time progression of COVID-19 cases in all of the U.S. states showed that state-level measures related to the pandemic had about 10-14 day lag time before their effects were seen. When state legislatures introduced measures prioritizing public health protection, the slowing down of the COVID-19 spread was seen on average two weeks later. When decisions were made prioritizing economic reopening, the growth in cases was observed after about two weeks.

Crunching the Numbers to Reveal and Forecast COVID-19 Impacts

Forecasting the weather requires processing vast amounts of data about prevailing winds, temperature patterns and other factors, which serve as inputs into mathematical models built using knowledge about how the weather developed in the past. Similarly, predicting the trajectory and impact of COVID-19 — as well as the impact of potential countermeasures — will require both data and sophisticated modeling. A recently published close examination of data provided worldwide predictions for COVID-19 cases as well as country-by-country trends for GDP and unemployment, comparing the drops seen during to the pandemic to the changes over the previous years. Based on these data, the authors developed a mathematical model and dashboard, which they suggest could help decision-makers in planning the timing of various interventions while balancing the health and economic priorities.

Quick Reference Guide to SARS-CoV-2 Variants

The Journal of the American Medical Association (JAMA) published a brief reference guide on common SARS-CoV-2 variants (Alpha, Beta, Gamma, and Delta). The information is presented in a visual and easy-to-understand format, to facilitate use by the general public. The pamphlet stresses that vaccination is the best way to prevent infection, spread and further mutation of the virus.

Help for Communicators and Answer-Seekers

For those involved in communicating evidence-based information about COVID-19, as well as for those genuinely seeking truthful answers, a newly published comprehensive review of COVID-19 — and the many “false dichotomies” and ill-informed narratives that have made the virus so polarizing — will serve as a unique, trustworthy reference source. In its 47 pages, this document published in BMC Infectious Diseases presents easily digestible graphics and solid scientific explanations, all backed up by the unprecedented number of references (647) citing published studies. That wealth of information is brought to bear on the authors’ investigation of typical “either/or” lines of debate that have complicated the public discourse about COVID-19. The authors examine several such “all or nothing” dilemmas, including the following: health versus economy; unlimited lockdown versus unlimited (re)opening; droplets versus aerosol transmission; and universal masking versus no masking at all. The detailed and well-documented consideration of each such debate leads to the conclusion that these are false dichotomies, and that a more nuanced middle way — which may be more difficult to articulate or implement — is nevertheless the surest path out of the current crisis.

PCR Testing Less Sensitive With Saliva Samples Than With Nasopharyngeal Swabs

Researchers studied sensitivity of a PCR test using saliva samples as well as nasopharyngeal swabs from individuals exposed to a SARS-CoV-2 infection in their households, over the course of up to four weeks. They found that the PCR test sensitivity was lower for the saliva samples, that the test sensitivity peaked at about one week post-exposure and then faded, and that the sensitivity with samples from asymptomatic yet PCR-positive individuals was lower than for symptomatics across all time points.

Antigen Testing Could Match PCR Sensitivity if Used Regularly and Frequently

Antigen tests for SARS-CoV-2 have lower sensitivity compared to both nasal and saliva PCR. Nevertheless, antigen tests continue to be of interest because they are easier and cheaper to administer. It is noteworthy, therefore, that a recent study showed that regular (e.g., every three days) antigen testing could be as sensitive as PCR in detecting early infections and preventing them from spreading (e.g., in school populations).

FDA Explains COVID-19 Protections for Adolescents and Younger Children

Just in time for the start of a new school year, a COVID-19 vaccine has been authorized for adolescents in the U.S. The FDA, which granted the emergency use authorization (EUA), has provided answers to common questions about that vaccine for the general public on the FDA website. The agency also posted a 45-minute video where HHS and FDA leaders discuss COVID-19 protections for 12- to 17-year-olds as well as younger children.

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.

Tracking Fraud Related to the COVID-19 Pandemic
Tracking federal and state law enforcement and regulatory actions taken against bad actors who have exploited the COVID-19 emergency to defraud consumers and payers.

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