FDA Covid-19 Activity the Week of November 30, 2020

The second Covid-19 vaccine candidate has been submitted to the US Food and Drug Administration (FDA) to request emergency use authorization (EUA).  Moderna’s vaccine has thus far demonstrated over 94% efficacy.  On Monday, November 30, 2020, the FDA announced its committee will review the EUA request Thursday, December 17, 2020, and “intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting.”

As vaccines appear poised to come to market, the American Hospital Association, American Medical Association, and American Nurses Association have released a joint public letter to Americans to promise transparency in rolling out vaccines safely and effectively “to all who are eligible and choose to get vaccinated,” with a commitment to “share the benefits and risks of a vaccine so that you can make an informed decision for yourself and your loved ones.”

In an emergency meeting Tuesday, December 1, 2020, the Centers for Disease Control and Prevention (CDC) voted 13-1, and the CDC Director approved, Phase 1a of vaccinations being prioritized “to both 1) health care personnel and 2) residents of long-term care facilities.”

Also on Tuesday, December 1, 2020, the FDA published a number of other updates related to the Covid-19 pandemic:

• Revised the August 23, 2020, EUA for convalescent plasma treatment of hospitalized patients with Covid-19
• Issued a warning letter to Avazo-Healthcare, LLC, “for selling adulterated and misbranded Covid-19 test kits and unapproved drug products with fraudulent Covid-19 claims,” including “CBD products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure Covid-19.”
• Issued other warning letters to additional entities
• Updated its guidance to manufacturers on notifying the government of production shortages/interruptions/cessations
• Recapped that to date they have approved 295 tests, including 227 molecular, 61 antibody, and 7 antigen tests

IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.

This material should not be considered as a substitute for legal, tax and/or actuarial advice. Contact the appropriate professional counsel for such matters. These materials are not exhaustive and are subject to possible changes in applicable laws, rules, and regulations and their interpretations.