FDA restricts J&J’s COVID-19 vaccine due to risk of blood clots

Virus Outbreak J And J Vaccine
Posted at 5:36 PM, May 05, 2022

The U.S. Food and Drug Administration announced on Thursday that it was limiting the authorized use of the Johnson & Johnson COVID-19 vaccine for adults due to studies showing people developing rare and potentially life-threatening blood clots.

"After conducting an updated analysis, evaluation, and investigation of reported cases, the FDA has 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 onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine," the FDA said in a press release.

The FDA said they are limiting the vaccine to anyone over 18 who can't receive a different vaccine or elect to get J&J's vaccine.

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. "Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals."

This isn't the first time the J&J vaccine has been hit with restrictions due to safety issues, the Associated Press reported.

In December, the Centers for Disease Control reviewed the J&J vaccine after they received reports of 54 people in the U.S. developing thrombosis with thrombocytopenia syndrome, including the reported death of seven women and two men.