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The U.S. Food and Drug Administration (FDA) on Thursday put strict limits on the use of the Johnson & Johnson (J&J) COVID-19 vaccine, citing the risk of a blood-clotting condition the agency described as “rare and potentially life-threatening.”
In a statement Thursday, the FDA said the risk of vaccine recipients developing thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine “warrants limiting the authorized use of the vaccine.”
The FDA said it has identified 60 cases of vaccine-induced thrombosis with thrombocytopenia syndrome, including nine deaths, out of about 18 million doses administered — although the condition is likely underreported.
Women 30 to 49 years old are at the highest risk of TTS from the J&J vaccine, with about eight cases per 1 million doses of vaccine administered, according to the FDA.
According to the latest data from the Vaccine Adverse Event Reporting System (VAERS), between Dec. 14, 2020, and April 29, 2022, there were 13,873 reports of blood-clotting disorders following COVID-19 vaccines in the U.S.
Of those, 6,227 reports were attributed to Pfizer, 4,943 reports to Moderna and 2,662 reports to J&J.
In the U.S., 575 million COVID-19 vaccine doses had been administered as of April 29, including 339 million doses of Pfizer, 217 million doses of Moderna and 19 million doses of J&J.
The agency said the “known and potential benefits” of the J&J vaccine for preventing COVID-19 outweigh the known and potential risks for individuals 18 and older “for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate,” or “who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.”
The agency described TTS as “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 [J&J] COVID-19 vaccine.”
