Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Yesterday, 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 the first request for emergency use authorization (EUA) for a vaccine for COVID-19 Coronavirus prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH.
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.
The FDA issued an EUA to LabCorp for its Pixel COVID-19 Test Home Collection Kit for use with LabCorp’s COVID-19 RT-PCR Test. The Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer (non-prescription) test system, allowing a person to self-collect a nasal sample in their home and then send the sample to LabCorp for testing. It can be used by anyone aged 18 or over, and purchased online or in a store without a prescription.
A health care provider delivers positive or invalid test results to the user by phone call. Users may access negative test results by an online portal or by email.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Paradigm RE, LLC for selling unapproved and misbranded products with fraudulent COVID-19 Coronavirus claims. The company sells “Thymosin Alpha 1” with misleading claims that the product can mitigate, prevent, treat, diagnose or cure COVID-19 in people.
The FDA requested that Paradigm immediately stop selling this unapproved and unauthorized product. Consumers concerned about COVID-19 should consult with their health care provider.
Testing updates:
As of December 9th, 298 tests and sample collection devices are authorized by FDA under EUAs; these include 229 molecular tests and sample collection devices, 61 antibody tests, and 8 antigen tests.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.
