FDA limits use of J&J COVID-19 vaccine due to blood clot risk

It will be limited to individuals 18 and older and medically ineligible for another approved vaccine.



The United States (US) Food and Drug Administration (FDA) on Thursday drastically limited the recommended use of the Johnson & Johnson COVID-19 vaccine, citing cumulative data indicating an increased risk of a form of a dangerous blood clot. With safer two-dose vaccines such as Pfizer and Moderna widely available, the one-dose J&J shot should be limited "to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate," the agency said in a statement. While the J&J vaccine appealed to some since it just required one dosage, data soon emerged revealing an increased risk in people who have thrombocytopenia syndrome (TTS), a rare type of blood clot.


TTS is "a syndrome of rare and possibly life-threatening blood clots in association with low blood platelet counts," according to the FDA. Some people often young males typically developed symptoms about a week or two after getting the J&J shot. The data accumulated on this risk now "warrants limiting the authorized use of the vaccine," the agency said. In late February 2021, the vaccine acquired its first emergency use authorization. However, after six cases of TTS were reported, the FDA put the J&J shot on hold while it gathered additional information. According to the regulatory body’s latest evaluation, "the FDA and CDC have found 60 verified cases, including nine fatal cases," of TTS in patients who got the J&J vaccination by March 18, 2022.