FDA announces Janssen COVID-19 vaccine use revisions

Dec. 15, 2021

The FDA has announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers warning of contraindication in the administration of the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia.

The change applies following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine, and to update the information about the risk of thrombosis with thrombocytopenia syndrome (TTS) following vaccination.

Cases of TTS following administration of the Janssen COVID-19 Vaccine have been reported in males and females 18 years of age and older, with the highest reporting rate of approximately 1 (one) case per 100,000 doses administered in females 30-49 years of age; overall, approximately 1 out of 7 cases has been fatal. The FDA and CDC continue to investigate the level of potential excess risk.

The FDA continues to find that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. Individuals should speak to their health care provider to determine which COVID-19 vaccine is most appropriate for their own situation.

Testing updates:

As of today, 421 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 89 antibody and other immune response tests and 41 antigen tests. There are 67 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.

The FDA has authorized 22 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 707 revisions to EUA authorizations.

FDA release

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