FDA restricts Johnson & Johnson COVID vaccine due to blood clot risk
The Food and Drug Administration on Thursday limited who can receive the Johnson & Johnson COVID-19 vaccine, citing concerns over a rare and serious blood clotting condition.
The vaccine is under an emergency use authorization, for adults 18 and older, and the FDA said in a statement that it should now only be given to people who can't or won't get any other vaccine. The agency said it came to this determination after conducting "an updated analysis, evaluation, and investigation" of cases of thrombosis with thrombocytopenia syndrome (TTS) reported after receiving the vaccine. TTS can cause dangerous blood clots.
The FDA said the benefits of the Johnson & Johnson vaccine still outweigh the risks for those who have had a severe allergic reaction to mRNA COVID-19 vaccines, those with limited access to mRNA vaccines, and those who are concerned about mRNA vaccines and will only get a Johnson & Johnson vaccine.
More than 18.7 million doses of the Johnson & Johnson vaccine have been administered in the United States, the Centers for Disease Control and Prevention said Thursday. TTS cases usually begin one or two weeks after vaccination, CNN reports, with symptoms including shortness of breath, leg swelling, and chest pain. About three cases have been reported for every 1 million vaccine doses administered, with women between 30 and 49 years of age having the highest rate of cases. Read more at CNN.
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