FDA narrows use of J&J vaccine due to blood clot risk

pharmafile | May 6, 2022 | News story | Medical Communications  

The FDA has limited the use of Johnson & Johnson’s coronavirus vaccine, to adults who cannot, or refuse to get, the Pfizer or Moderna jabs. The agency cited potentially life-threatening blood clotting side effects of the vaccine and investigation of reported cases of thrombosis with thrombocytopenia syndrome (TTS).

TTS is a blood-clotting disorder that can cause stroke or heart attack. It is rare, affecting around 1 person in 250,000 who receives the vaccine from J&J. TTS is more serious than the usually mild heart inflammation sometimes associated with both the Pfizer and Moderna vaccines.

The FDA have shared that the vaccine from Johnson & Johnson should not be used unless other vaccines are unavailable, or determined to be clinically inappropriate, the agency said.

“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. 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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. 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.”

In a press release, the agency shared: “The FDA and CDC have continuously monitored for and investigated all suspected cases of TTS reported to VAERS. In an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases.”

Ana Ovey

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