U.S. FDA Limits Use of Johnson & Johnson COVID-19 Vaccine Due to Rare Blood Clot Risk

The United States Food and Drug Administration (FDA) has limited the authorized use of the Johnson & Johnson COVID-19 vaccine due to the rare but life-threatening risk of blood clots.

The FDA announced on May 5 that the Janssen COVID-19 vaccine is now limited to people aged 18 and above who are unable to receive other vaccines because they are not accessible or clinically appropriate, or because they refused to get a different vaccine.

The FDA made the decision after conducting an updated analysis into reported cases of the rare blood condition called thrombosis with thrombocytopenia syndrome or TTS.

“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,” FDA Center for Biologics Evaluation and Research Director Peter Marks said.

“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 further said.

In a statement, Johnson & Johnson said that it will continue to work with health authorities to ensure healthcare professionals and individuals “are warned and fully informed about reports of TTS.”

Around 18.7 million people in the United States have received the Janssen vaccine, according to data from the U.S. Centers for Disease Control and Prevention.

The FDA first authorized the Janssen vaccine for emergency use in February 2021.

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