The FDA recently announced officially limiting Johnson & Johnson’s COVID-19 vaccine to only a select group of people. The agency has restricted the emergency use of the vaccine to people 18 years or older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically or those who could not otherwise receive a COVID-19 vaccine.
The Johnson & Johnson vaccine was initially authorized for emergency use in February 2021. However, two months after authorization, reports of thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots with the onset of symptoms approximately one to two weeks following administration of the vaccine, prompted the agency to pause their recommendations of the use of the vaccine.
Following an investigation, the agency confirmed cases of TTS in people who used the vaccine. The FDA and CDC have identified 60 confirmed cases, including nine fatal cases, in a TTS analysis following the administration of the Johnson Johnson vaccine. However, the FDA has also determined that the vaccine’s benefits for the prevention of COVID-19 outweigh the risks for individuals 18 years and older.
According to Peter Marks, M.D., Ph.D., 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 the 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.”
Source: FDA News Release