Coronavirus (COVID-19) Update: May 11, 2021

FDA News Release

• For Immediate Release: May 11, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

• As part of the FDA’s effort to protect consumers, on May 6, 2021, the agency issued a warning letter to Covalon Technologies Inc. for selling unapproved products with fraudulent COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider. 
• The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts.
• On May 10, the FDA issued a press release about FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 through 15 years of age. The following documents have been updated to reflect the authorization of the vaccine in the adolescent population:
  • Pfizer-BioNTech COVID-19 Vaccine EUA Letter of Authorization
  • Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers Administering the Vaccine (Vaccination Providers)
  • Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers
• In addition, the FDA added a question, “What data did the FDA evaluate to support Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in individuals 12 through 15 years of age?”, to the Pfizer-BioNTech COVID-19 Frequently Asked Questions webpage. The FDA is currently working on translating the updated Fact Sheet for Recipients and Caregivers in multiple languages.
• Testing updates:
  • As of today, 370 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 270 molecular tests and sample collection devices, 76 antibody and other immune response tests, and 24 antigen tests. There are 49 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four antigen over-the-counter (OTC) at-home tests, and two molecular OTC at-home tests.
  • The FDA has authorized 9 antigen tests and 3 molecular tests for serial screening programs.
  • The FDA has also authorized 488 revisions to EUA authorizations.

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.