On Friday, the Occupational Safety and Health Administration (OSHA) announced the suspension of the COVID-19 vaccine mandate for large companies. This suspension comes after U.S. Court of Appeals for the Fifth Circuit decided to uphold a stay on the mandate. Originally, OSHA gave employers with more than 100 employees a January 4th deadline to comply with the COVID-19 Vaccination and Testing Emergency Temporary Standard or face significant fines. After being met with swift opposition, including a suit filed by a group of Republican attorneys general and the eventual court decision the Department of Justice said “OSHA is not enforcing or implementing the regulation, so they are not engaging or offering compliance assistance.” (See the Administration section below for an update on the posture of the case).
Today, President Biden announced the purchase of the 10 million treatment courses of the Pfizer antiviral COVID-19 pill with delivery starting at the end of this year and through 2022. The Food and Drug Administration (FDA) still needs a full review of the antiviral pill which the company believes will dramatically reduce the risk of hospitalization and death for people infected by COVID-19. Following last weeks’ vaccine rollout for children aged 5 – 11 years, the White House said yesterday that 10 percent of the age group has received their first does of the vaccination. Ninety-five percent of Americans are now eligible to be vaccinated. The FDA plans to decide on authorization of Pfizer-BioNTech boosters for all adults as soon as today. FDA’s director of the Center for Biologics Evaluation and Research called the request the center’s “highest priority.” Yesterday, Moderna filed for Emergency Use Authorization for its COVID-19 booster dose for all adults to the FDA.
Yesterday, the Internal Revenue Service (IRS) provided answers regarding taxability and report of payments from Coronavirus State and Local Fiscal Recovery Funds (SLFR Funds) established under the American Rescue Plan Act (ARPA). The comments from the IRS state that some SLFR funds recipients may have to report certain payments as income and may owe taxes depending on the purpose of the payment.
Capitol Hill
On November 11, Sen. Dianne Feinstein (D-CA) and 35 House Democrats, led by Reps. Don Beyer (D-VA) and Ritchie Torres (D-NY), sent a letter to President Joe Biden urging him to “put in place requirements for airline passengers to provide proof of full vaccination against COVID-19 or a negative test to board a domestic flight. We also ask that safety protocols in place for trains and other popular modes of public transportation continue to be updated to reflect the best available data to prevent the spread of COVID-19.”
On November 12, House Oversight Select Subcommittee on the Coronavirus Crisis Chair James Clyburn (D-SC) sent a letter to former CDC Director Robert Redfield calling on him to appear for a transcribed interview “regarding the prior Administration’s failed response to the coronavirus crisis.” Chair Clyburn also sent a letter to HHS Secretary Xavier Becerra and CDC Director Rochelle Walensky requesting transcribed interviews with three CDC officials who possess relevant information regarding key events under investigation.
On November 17, the House Oversight Select Subcommittee on the Coronavirus Crisis held a hearing on “Combating Coronavirus Cons and the Monetization of Misinformation”. The hearing examined the challenges presented by the spread of coronavirus misinformation online, including how misinformation is used to market and sell hazardous treatments and fraudulent products.
Administration
At least 34 lawsuits challenging the Biden administration’s “vaccination or test” mandate for large companies were assigned to a Cincinnati appeals court; the court was randomly selected in a procedure used to consolidate cases that raise the same issue. The assignment removes the case from a New Orleans federal appeals court which placed a stay on OSHA’s mandate. The New Orleans court’s ruling held the mandate is fatally flawed and bars OSHA from enforcing the mandate. The mandate is supposed to take effect January 4, 2022.
President Biden announced FEMA funding to support all eligible COVID-19 work will continue at a 100% federal cost share through April 1, 2022. This funding remains available to local, state, tribal or territorial governments, and certain non-profit organizations for eligible costs associated with ongoing COVID-19 recovery efforts and vaccine initiatives.
The Hill reports a group of 12 states is suing the Biden administration to block its vaccine mandate for health care workers. The attorneys general of Alabama, Arizona, Georgia, Idaho, Indiana, Louisiana, Mississippi, Montana, Oklahoma, South Carolina, Utah, and West Virginia are all listed as plaintiffs in the lawsuit. Earlier, a coalition of 10 states, led by Missouri, filed a lawsuit against the mandate, which they said was "unconstitutional and unlawful." Missouri is joined in the suit by Nebraska, Arkansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, Kansas, and New Hampshire.
A large, long-term study of the impacts of COVID-19 on children enrolled its first participant at the NIH Clinical Center in Bethesda. The study will track up to 1,000 children and young adults who previously tested positive for COVID-19 and evaluate the impact of COVID-19 on their physical and mental health over three years.
NIH’s Alison Cernich writes that safe, in-person school during the COVID-19 pandemic requires research that involves community engagement in underserved or vulnerable areas. Earlier studies on safety measures in schools (e.g., masking, physical distancing, and symptom monitoring) were often conducted in affluent and ethnically homogeneous neighborhoods.
The FCC plans to commit over $421 million in the latest round of Emergency Connectivity Fund, bringing total program commitments to over $3.05 billion. The program supports off-campus learning such as nightly homework and virtual learning.
The FCC approved an additional 75 applications totaling over $42 million for Round 2 of its COVID-19 Telehealth Program, bringing the total to over $165 million awarded to health care providers. The program provides reimbursement for telecommunications services, information services, and connected devices necessary to enable telehealth during the COVID-19 pandemic.
HUD announced more than $73.9 million in Indian Community Block Grant-American Rescue Plan grants to 68 Tribal communities. The funding will expand access to safe housing, a suitable living environment, and economic opportunities. HUD also announced it is awarding $13.6 million to 51 HUD Fair Housing Initiatives Program agencies to conduct a range of fair housing enforcement and education and outreach activities related to the COVID-19 pandemic. Among the activities that will be conducted by the organizations is addressing discriminatory practices in underserved communities.
The FDA announced actions aimed at further increasing access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in doctor’s offices, hospitals, urgent care centers, and emergency rooms without having to be sent to a central lab for testing. There are currently 422 tests and sample collection devices authorized by the FDA under emergency use authorizations (EUAs). Also, HHS will invest $650 million to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests. “As at-home testing increases, the need for follow-up testing in health care settings will likely grow. For example, if someone buys an over-the-counter rapid antigen test at their local pharmacy to take at home and tests positive, they may seek out a health care provider who would conduct another test to confirm that result. This new investment will help ensure tests like these are readily available across the country and can provide results quickly.”
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People who work at large businesses will need to show their vaccination cards or routinely test negative for COVID-19 under new OSHA rules designed to curb the pandemic. Businesses with 100 workers or more will be required to verify all employees have been fully vaccinated or test negative for COVID-19 each week by January 4. As noted above, litigation on the OSHA mandate is pending.
A Texas government study found that unvaccinated people were 20 times more likely to die of COVID-19 than the fully vaccinated throughout most of September. The research, published by the Texas Department of State Health Services, determined that 81.3 percent of COVID-19-related deaths between September 4 and October 1 occurred among unvaccinated people. In comparison, 5 percent of these fatalities occurred among the partially vaccinated, and 13.7 percent involved fully vaccinated patients.
The TSA is expecting thanksgiving air travel to be back to pre-pandemic levels following a significant decrease in 2020 due to the coronavirus.
The Los Angeles Board of Education announced they will spend about $5 million on prizes, including gift cards to Amazon and Target as well as tickets to the play “Hamilton,” as incentives to encourage student vaccinations. The board hopes the incentive program will boost the county’s roughly 72 percent vaccine compliance rate for students.
DHS announced on November 8 that foreign nationals who have been fully vaccinated for COVID-19 and have appropriate documentation will be permitted to enter the U.S. via land ports of entry and ferry terminals for non-essential reasons such as tourism.
Vaccine News
Pfizer requested emergency authorization for its antiviral oral COVID-19 treatment after a study found the pills dramatically reduced the risk of hospitalization. Pfizer is asking the FDA to grant authorization of Paxlovid to treat mild to moderate COVID-19 patients at a higher risk of hospitalization and death. Pfizer’s request makes Paxlovid the second oral COVID-19 treatment that the FDA is considering for an emergency use authorization. Merck and its partner Ridgeback Biotherapeutics submitted for authorization of molnupiravir last month.
AstraZeneca found its antibody cocktail to be more than 80 percent effective at preventing symptomatic COVID-19 in a company analysis released today, a strong result for a treatment that could help immunocompromised people avert severe COVID-19 illness. The company said its study showed its long-acting antibody combination called AZD7442 reduced the risk of symptomatic COVID-19 by 83 percent over six months, compared to those who received the placebo. The data has not yet been peer-reviewed but will be submitted for publication.
HHS announced a $143.5 million investment to expand community-based efforts to conduct tailored local outreach about vaccines, build vaccine confidence and address barriers to vaccination in their communities.
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