- 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:
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to an operator of one website, www.pharmacygeoff.md for marketing unapproved drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
- On April 23, the FDA and Centers for Disease Control and Prevention (CDC) issued a press release lifting the recommended pause on the use of Janssen (Johnson & Johnson) COVID-19 Vaccine following a thorough safety review. The FDA added and updated some questions about resuming the use of this vaccine to the Janssen COVID-19 Frequently Asked Questions webpage; they include:
- Why did the FDA and CDC make the decision to resume the use of the Janssen COVID-19 Vaccine?
- Since April 13, 2021, have additional cases of blood clots with low platelets been reported to VAERS?
- Why did the FDA and CDC recommend a pause in the use of the Janssen COVID-19 Vaccine?
- Am I at risk for these serious adverse events if I receive the Janssen COVID-19 Vaccine?
- What should health care providers look for in evaluating Janssen COVID-19 Vaccine recipients for these serious adverse events?
- In addition to reported allergic reactions, is information available about other less common adverse events, including serious adverse events?
- As part of the FDA’s effort to protect animals, the agency issued a warning letter to Group Cyrenne Inc. dba HomeoAnimal. The company sells a “Virus Defense Kit” containing “Immunopet,” “Silverpet,” and “Cordyceps,” and misleadingly represents that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in pets. The company also markets unapproved drugs for conditions such as cancer, epilepsy, heartworm, parvovirus, and anemia. The FDA requested the company take action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Pet owners concerned about COVID-19 should consult with their veterinarians.
- Testing updates:
- As of today, 369 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 23 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 over-the-counter (OTC) at-home antigen tests, and two OTC molecular tests.
- The FDA has authorized 8 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 466 revisions to EUA authorizations.
- Lauren-Jei McCarthy