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November 20, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of November 16)

  • November 20, 2020

Companies developing vaccines for COVID-19 continued to report promising results this week, as Pfizer Inc. and German partner BioNTech announced they will submit an emergency use authorization (EUA) to the Food and Drug Administration (FDA) on November 20 for their vaccine candidate.

Earlier in the week, Pfizer reported a 95% efficacy rate for their messenger RNA (mRNA)-based vaccine, BNT162b2, without major safety issues following a final analysis of late-stage clinical trial data.

The companies said their vaccine could be available to high-risk populations in the United States by mid to late December.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement.

Meanwhile, Moderna Inc. said November 16 that preliminary data showed its mRNA vaccine candidate, mRNA-1273, also is 95% effective in preventing COVID-19.

According to Moderna, its phase 3 study of mRNA-1273 enrolled more than 30,000 participants in the United States. The interim analysis of available study data did not indicate any significant safety concerns, with the majority of adverse events from the vaccine mild or moderate in severity, the company said.

The company also said it will seek an EUA from the FDA shortly and plans to have roughly 20 million doses of its vaccine ready to ship in the United States by the end of the year. Moderna indicated the company is on track to manufacturer 500 million to 1 billion doses globally in 2021.

In addition, early results from a phase 2 trial published this week in the medical journal The Lancet indicated that the vaccine being developed by British-based pharmaceutical giant AstraZeneca and the University of Oxford produced a similar immune response in adults older than 56, including those over age 70, as in younger adults. Phase 3 trials on the vaccine’s efficacy are ongoing.

Agency Action

Department of Health and Human Services (HHS)

November 19—HHS launched a five-state pilot program to use COVID-19 molecular point-of-care (POC) test kits that generate results in about 20 minutes instead of being sent to a laboratory, which can take up to several days, the agency announced. HHS said the diagnostic technology, which was developed by Cue Health, Inc., was successfully used as the primary POC test to control the spread of COVID-19 within the National Basketball Association “bubble." HHS has distributed 27,000 test kits to Alaska, Florida, Louisiana, New Jersey, and Texas. The tests will be used internally at the Department of Defense as well, HHS said. Antigen tests also produce rapid results but can have false positives and, under certain circumstances, need to be confirmed with molecular tests. “With Cue’s COVID-19 Test, verifying the antigen test results can be done on the spot in many cases,” said HHS Assistant Secretary for Health ADM Brett Giroir, M.D. “The pilot program will help us determine how well the Cue test will be adapted in institutions and communities.” In October, HHS awarded a $481 million contract to Cue Health to expand its domestic production of COVID-19 test kits to 100,000 per day by March 2021.

Centers for Medicare & Medicaid Services (CMS)

November 17—About 12.5% of the nation’s one million nursing home staff have completed CMS training to help combat the spread of COVID-19, the agency announced. CMS made public a list of the 1,092 nursing homes where 50% or more of their staff completed the free training, which addresses infection control, screening and surveillance, personal protective equipment usage, disinfection, and cohorting and caring for individuals with dementia during a pandemic, among other topics. The CMS Targeted COVID-19 Training for Frontline Nursing Home Staff & Management is available online at

Food and Drug Administration

November 19—The FDA issued an EUA to Eli Lilly and Company for rheumatoid arthritis drug baricitinib, in combination with remdesivir, to treat suspected or confirmed COVID-19 in hospitalized patient over two years of age who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. According to the agency, in a clinical trial of hospitalized patients with COVID-19 the drug combination was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. The FDA said the safety and effectiveness of the therapy is still being evaluated and that Baricitinib, which blocks one or more enzymes that lead to inflammation, is not authorized or approved as a stand-alone treatment for COVID-19. Baricitinib is a prescription oral tablet medication that is sold under the brand name Olumiant.

November 17—The FDA issued an emergency use EUA for the first at-home diagnostic test for COVID-19 that provides results in 30 minutes or less. The Lucira COVID-19 All-In-One Test Kit is a molecular single use test authorized for home use with self-collected nasal swab samples in individuals 14 and older. The sample is placed in the test unit, which includes a light-up display to show whether a person is positive or negative for the virus. The test is available by prescription only. FDA previously authorized COVID-19 diagnostic tests for at-home collection, but the Lucira test is the first that can be fully self-administered and provide results at home, the agency said. The test also is authorized for use in POC settings for all ages, but only if the samples are collected by a health care provider in those younger than 14. “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.

Other Developments

November 17—Several groups representing the nation’s health care providers are calling on the Trump administration to share with the Biden transition team all critical data on COVID-19. In a letter to President Trump, the American Hospital Association, American Medical Association, and the American Nurses Association said “[a]ll information about the capacity of the Strategic National Stockpile, the assets from Operation Warp Speed, and plans for dissemination of therapeutics and vaccines needs to be shared as quickly as possible to ensure that there is continuity in strategic planning so that there is no lapse in our ability to care for patients.”