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 jointly with the Federal Trade Commission to Trinity Natural Health & Pain Management, Inc. for selling an unapproved product with fraudulent COVID-19 claims. The company sells  “COVID-19 Formula” and misleadingly represents that it can mitigate, prevent, treat, diagnose or cure COVID-19 in people. The FDA requested that Trinity Natural Health & Pain Management, Inc. take immediate action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
• On Tuesday, the FDA and Centers for Disease Control and Prevention (CDC) issued a Statement regarding the Janssen (Johnson & Johnson) COVID-19 Vaccine. Out of an abundance of caution, the FDA and CDC recommended a pause in the use of this vaccine while we review the data from six reported cases in the U.S. of a rare and severe type of blood clot in people who received the vaccine. This pause was recommended, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot. The FDA added three questions about the recommended pause in the use of this vaccine to the Janssen COVID-19 Frequently Asked Questions webpage; they include:
  • Why are the FDA and CDC recommending a pause in the use of the Janssen COVID-19 Vaccine?
  • If I received the Janssen COVID-19 Vaccine am I at risk for these adverse events?
  • What should health care providers look for in evaluating Janssen COVID-19 Vaccine recipients for these rare events?
• The FDA updated one question, How many doses can be obtained from the multi-dose vials of Moderna COVID-19 Vaccine, to the Moderna COVID-19 Frequently Asked Questions webpage to address the number of doses in vials. This information is also reflected in the Letter Granting Moderna EUA Amendment and the Fact Sheet for Healthcare Providers Administering Vaccine: EUA of the Moderna COVID-19 Vaccine to Prevent COVID-19.
• Testing updates:
  • As of today, 363 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 266 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 22 antigen tests. There are 46 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 7 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 457 revisions to EUA authorizations.

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