- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, met to discuss a request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by ModernaTX, Inc. This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review. Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.
- Also today, the agency posted a new webpage: Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions, such as how does a vaccine go from emergency use authorization to licensure.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to Phoenix Biotechnology Inc. and Avila Herbals LLC for selling an unapproved drug product with fraudulent claims. These companies offer for sale “Oleander 4X” with false and misleading claims that it can mitigate, prevent, treat, diagnose or cure serious and/or life-threatening conditions such as COVID-19. FDA requested that Phoenix Biotechnology Inc. and Avila Herbals LLC immediately stop selling this unapproved product. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of Dec. 17, 304 tests and sample collection devices are authorized by FDA under EUAs; these include 232 molecular tests and sample collection devices, 62 antibody tests, and 10 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jane Hubbard