The US Food and Drug Administration (FDA) on Thursday said that the Johnson & Johnson vaccine that has been administered to more than 18 million Americans can potentially 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 statement.
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 further said the FDA has been closely monitoring the Janssen COVID-19 vaccine and the occurrence of TTS following its administration and has used updated information 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 identified 60 confirmed TTS cases, including nine fatal cases, according to the FDA.
In December last year, the CDC's vaccine advisory committee issued an updated recommendation 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 typically begin one or two weeks after vaccination. Symptoms include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms like headaches or blurred vision, or red spots just under the skin called petechiae beyond the site of vaccination.
( With inputs from ANI )
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