The US Food and Drug Administration on Thursday drastically limited Johnson & Johnson’s (J&J) COVID-19 vaccine’s authorized use due to the risk, as they say, of a rare but potentially life-threatening side effect after receiving the jab, which warrants limiting its use.
The use of the J&J vaccine is now only authorized for individuals over the age of 18 who can’t access or are unwilling to get the Pfizer-BioNTech or Moderna mRNA shots – the other approved vaccines – or for whom other vaccines aren’t clinically appropriate, the statement from the agency notes.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that the latest decision is a result of the FDA’s updated risk analysis of developing thrombosis with thrombocytopenia syndrome (TTS) a rare and possibly fatal combination of blood clots and low platelet counts one to two weeks after receiving the jab.
FDA decided that given the severity and urgency of the syndrome, the benefits of the J&J vaccine’s Covid-19 protection outweigh the risk of TTS only for people who cannot or will not receive other vaccines.
Marks pointed out that FDA will continue to monitor the safety of the Janssen vaccine and all other vaccines while the statement from J&J underscores that the company will continue to work with regulators worldwide to warn and fully inform the consumers about reports of TTS.
To increase awareness about the risk of TTS the company has, in the meantime, updated its US COVID-19 vaccine fact sheet.
Centers for Disease Control and Prevention (CDC) and FDA have identified 60 confirmed cases of TTS as of March 18, nine of which were fatal.
According to Thursday’s statement, the FDA has a registered reporting rate of TTS of 3.23 per million doses of administered vaccine, and the reporting rate of TTS deaths is 0.48 per million doses of administered vaccine.
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