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December 18, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of December 14)

  • December 18, 2020

An independent advisory panel recommended December 17 that the Food and Drug Administration (FDA) issue an emergency authorization for the COVID-19 vaccine candidate developed by Moderna Inc.

The Vaccines and Related Biological Products Advisory Committee voted 20-0, with one abstention, that the benefits of Moderna’s messenger RNA (mRNA-1273) vaccine outweigh its risks.

The FDA is expected to issue an EUA to Moderna shortly, which would make mRNA-1273 the second COVID-19 vaccine to receive the green light from the agency. On December 11, the FDA issued an EUA for Pfizer Inc. and German partner BioNTech’s vaccine, BNT162b2. Distribution of the vaccine already is being rolled out across the country to frontline health care workers.

The FDA issued an analysis in advance of the panel meeting this week confirming that Moderna’s vaccine was 94.1% effective based on data from its late-stage clinical trial.

“We have been working with the U.S. Centers for Disease Control and Prevention and Operation Warp Speed to prepare for the distribution of mRNA-1273, if the FDA chooses to grant an Emergency Use Authorization. We look forward to getting our vaccine to people in the U.S. to help address this ongoing public health emergency,” said Moderna CEO Stéphane Bancel in a statement.

Earlier in the week, the Department of Health and Human Services (HHS) announced that the federal government had secured an additional 100 million doses of Moderna’s vaccine, doubling the total purchased to 200 million doses.

“This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021,” said HHS Secretary Alex Azar.

Department of Health and Human Services

December 16—HHS is beginning Phase 3 distributions of $24.5 billion in Provider Relief Funds to more than 70,000 health care providers, up from the $20 billion originally planned. HHS said it increased the distribution by $4.5 billion after realizing the submissions for lost revenues and net changes in expenses would exceed the $20 billion budgeted for Phase 3. Payment distributions start January 21.

December 15—States and territories will receive $227 million for COVID-19 vaccine preparedness and tracking and tracing activities, HHS announced. The Centers for Disease Control and Prevention will award $140 million for COVID-19 vaccine preparedness and almost $87 million for tracking and testing, HHS said. The additional funding comes as states are beginning the first round of COVID-19 vaccinations.

Food and Drug Administration (FDA)

December 16—The FDA issued a new EUA for Abbott Diagnostics Scarborough, Inc.’s rapid test to detect COVID-19 at home with a prescription. The BinaxNOW COVID-19 AG Card uses a nasal collection swab with results available in about 20 minutes. Abbott partnered with telehealth service provider eMed to determine eligibility for the test, guide users through the self-collection process, help users obtain and understand the results, and meet state-mandated reporting requirements, the company said in a statement. In August, the FDA issued an EUA for the rapid test, but only if administered by a health care provider in point-of-care settings. Abbott said it expects to deliver and administer 30 million BinaxNow at-home tests in the first quarter of 2021, with 90 million more tests to follow.

December 15—The FDA issued an EUA for the Ellume COVID-19 Home Test, the first over-the-counter at home diagnostic test for COVID-19, which can be used in individuals two years of age and older “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. According to the FDA, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms, and 91% of positive samples and 96% of negative samples in individuals without symptoms. Results are delivered in about 20 minutes through a smartphone app.

Equal Employment Opportunity Commission (EEOC)

December 16—The EEOC offered guidance to employers on the application of federal anti-discrimination laws related to requiring employees to be vaccinated for COVID-19. The Americans with Disabilities Act (ADA) allows an employer to impose a safety-based qualification standard—in this case, to require COVID-19 vaccination—but if the requirement screens out an individual with a disability, the employer “must show that an unvaccinated employee would pose a direct threat due to a ‘significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.’” The EEOC goes on to note “If there is a direct threat that cannot be reduced to an acceptable level, the employer can exclude the employee from physically entering the workplace, but this does not mean the employer may automatically terminate the worker.” For example, while the employer may not be able to accommodate a request to be exempt from a vaccination requirement, another accommodation like working remotely may be available. The guidance also addresses an employer’s options under Title VII of the Civil Rights Act for employees who indicate they are unable to receive a COVID-19 vaccination because of sincerely held religious beliefs.

Office for Civil Rights (OCR)

December 16—OCR reached a resolution of a religious discrimination complaint against Mt. Sinai Health System in New York, the agency announced. In August, a Jewish community advocacy organization filed a complaint with OCR alleging that several hospitals in New York, including Mt. Sinai in Manhattan, were denying Jewish patients access to clergy in both COVID and non-COVID units. OCR's Conscience and Religious Freedom Division provided Mt. Sinai technical assistance and the health system clarified and updated its policy to explicitly state that one of the two visitors permitted to visit a patient each day could be a clergy member. The updated visitation policy also makes clear that clergy who travel from out-of-state are exempt from quarantine requirements for end-of-life visitations.