US FDA limits Johnson & Johnson Covid-19 vaccine use over risk of blood clotting

Washington: The US Food and Drug Administration (FDA) on Thursday (May 6, 2022) stated that the Johnson & Johnson vaccine that has been administered to greater than 18 million Americans can doubtlessly cause “life-threatening blood clots”, and thereby warranted “limiting the authorized use of the vaccine.”

“After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), 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 COVID-19 vaccine, warrants limiting the authorized use of the vaccine,” the FDA in a press release.

The Johnson and Johnson vaccine was authorised for emergency use in February last year.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” Peter Marks, director of the FDA`s Center for Biologics Evaluation and Research was quoted as saying by Xinhua News Agency.

Marks additional stated the FDA has been intently monitoring the Janssen COVID-19 vaccine and the prevalence of TTS following its administration and has used updated data from its safety surveillance systems to revise the authorization.

Through March 18 this year, the FDA and the US Centers for Disease Control and Prevention (CDC) have recognized 60 confirmed TTS circumstances, together with nine deadly circumstances, in line with the FDA.

In December last year, the CDC`s vaccine advisory committee issued an up to date suggestion on Johnson & Johnson`s vaccine, saying it makes a “preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged >=18 years in the United States,” CNN reported.

Cases of TTS sometimes begin one or two weeks after vaccination. Symptoms include shortness of breath, chest ache, leg swelling, persistent stomach ache, neurological signs like complications or blurred vision, or red spots just under the skin referred to as petechiae beyond the site of vaccination.

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