US FDA limits using the Johnson & Johnson Covid-19 vaccine over blood clot risk

US FDA limits using the Johnson & Johnson Covid-19 vaccine over blood clot risk. 

The US Food and Drug Administration (FDA) said on Thursday that the Johnson & Johnson vaccine, which has been given to more than 18 million Americans, has the potential to induce “life-threatening blood clots,” necessitating “reducing the vaccine’s approved use.”

“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 the onset of symptoms approximately one to two weeks after administration of the Janssen COVID-19 vaccine, warrants limiting the authorized use of the vaccine,” the FDA said in a statement.

In February of last year, the Johnson & Johnson vaccine was approved for emergency use.

Xinhua News Agency quoted Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, as saying, “Our move reflects our latest study of the risk of TTS following delivery of this vaccination and limits the use of the vaccine to select individuals.”

ACCORDING TO MARKS, the FDA has been closely monitoring the Janssen COVID-19 vaccination and TTS occurrence following its administration and has revised the authorization based on updated information from its safety surveillance systems.

According to the FDA, the FDA and the US Centers for Disease Control and Prevention (CDC) had identified 60 verified TTS instances as of March 18, including nine fatal cases.

According to CNN, the CDC’s vaccine advisory committee updated its recommendation on Johnson & Johnson’s vaccine in December of last year, stating that 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.”

TTS symptoms usually appear one or two weeks following vaccination. Shortness of breath, chest pain, leg swelling, persistent abdomen pain, neurological symptoms such as headaches or confused vision, or red spots just beneath the skin called petechiae beyond the immunization site.