The U.S. Food and Drug Administration announced on Thursday that it has limited the use of Johnson & Johnson's COVID-19 vaccine, known as Janssen, due to the risk of rare blood clots.
The FDA said in their news release that adults should only receive the J&J vaccine if other authorized or approves vaccines aren't accessible, or the individual has requested to receive the J&J vaccine.
"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 statement said.
J&J's single-dose vaccine has been proven to be less effective than the two-dose Pfizer and Moderna vaccines, and the Centers for Disease Control and Prevention recommended in December 2021 that people prioritize the two-dose vaccines over the J&J, according to the Associated Press.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the news release that despite the limitations, the J&J vaccine "still has a role" amid the ongoing pandemic.
"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," Marks said in the statement. "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."
"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 FDA provided an updated fact sheet on the vaccine, and said that "approximately 15% of TTS cases have been fatal."
It was also noted that the highest rate of TTS has been in women ages 30-49, and there have been only 8 cases out of every one million doses of the vaccine administered.
"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," Marks said.
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