FDA places the brakes on J&J vaccine after ninth clotting dying reported

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Bins of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination web site in Florida. (credit score: Getty | Paul Hennessy)

The US Meals and Drug Administration restricted using the Johnson & Johnson (Janssen) COVID-19 vaccine late Thursday, citing the chance of a really uncommon however extreme clotting dysfunction known as thrombosis with thrombocytopenia syndrome (TTS).

Any longer, the J&J vaccine is barely for use in folks ages 18 and up who’re unable or unwilling to obtain an alternate COVID-19 vaccine. That features individuals who have had a life-threatening allergic response (anaphylaxis) to an mRNA COVID-19 vaccine, individuals who have private considerations about mRNA COVID-19 vaccines and would in any other case not get vaccinated, and individuals who do not have entry to mRNA COVID-19 vaccines.

The limitation comes because the FDA and the Facilities for Illness Management and Prevention have been intently monitoring individuals who acquired J&J COVID-19 vaccinations for TTS. Up to now, the businesses have recognized and confirmed 60 instances of TTS linked to the vaccine, together with 9 deaths. That represents a fee of three.23 TTS instances per million doses of J&J vaccine administered, and a fee of 0.48 TTS deaths per million doses of vaccine administered, the FDA stated Thursday.

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