The Food and Drug Administration has limited its authorization of the Johnson & Johnson COVID-19 vaccine due to the rare risk of blood clots.
The U.S. Food and Drug Administration on Thursday announced it's now limiting the authorized use of the Johnson & Johnson vaccine after conducting an updated investigation into reports of rare blood clots.
The decision was made after conducting an updated analysis into reports of the rare blood clot condition called thrombosis with thrombocytopenia syndrome, or TTS, the FDA said. "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," Marks said.
The Johnson & Johnson vaccine was first authorized for emergency use by the FDA in February 2021. Just two months later, the FDA and the CDC, announced a recommended pause in the administration of the vaccine to investigate a handful of cases of TTS that had been discovered in patients across the country.
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