J&J COVID-19 Vaccine Access Limited by U.S. FDA

The U.S. Food and Drug Administration (FDA) today announced it had limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and to adults who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive an mRNA COVID-19 vaccine.

'After conducting an updated analysis, evaluation, and investigation of reported cases, the FDA determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with the onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine,' stated the FDA.

The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered.

And the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the U.S. and across the global community. Our action (today) reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release issued on May 5, 2022.

“The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”

The revised authorization for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson (J&J).

The J&J - Janssen COVID-19 Vaccine was initially authorized for emergency use by the FDA on Feb. 27, 2021. 

As of today, the World Health Organization and the European Medicines Agency have not issued similar authorization changes.

Note: The FDA announcement was edited for clarity and manually curated for mobile readership.