US FDA restricts usage of Johnson & Johnson's COVID vaccine over blood clot concerns

After performing an updated review of reports of unusual blood clots caused by Johnson & Johnson's COVID vaccine, the United States Food and Drug Administration (FDA) stated on Thursday that it is now restricting the approved usage of the vaccine. According to an ANI report, the Johnson & Johnson vaccine, which has been given to over 18 million Americans, has the probability to cause "life-threatening blood clots," thus, necessitating to limit on the COVID vaccine's approved usage. 

FDA said in a statement, “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 the onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 vaccine, warrants limiting the authorised use of the vaccine," as per a press release.  

In February last year, the Johnson & Johnson vaccine was approved for emergency use to curb the spread of COVID-19 disease. 

Despite the fact that blood clots are still exceedingly rare, experts say the Johnson & Johnson vaccination should be avoided because there are alternative, safer choices available, such as vaccines from Pfizer and Moderna, ABC News reported. 

FDA actively monitoring the occurrence of TTS following vaccine administration

Further, the FDA stated in the press release that the Johnson & Johnson vaccine would now be restricted to people aged 18 and up for whom other authorised or accepted COVID-19 vaccines are not "accessible or clinically appropriate," as well as adults who choose to obtain the vaccine or would not otherwise get inoculated. 

In addition to this, Peter Marks, head of the FDA's Center for Biologics Evaluation and Research noted that their move reflects their latest study’s findings on the risk of TTS following the delivery of this vaccination and restricts the use of the vaccine to select individuals, Xinhua reported.  

The FDA has already been actively monitoring the Janssen COVID-19 vaccination and the occurrence of TTS following its delivery, according to Marks, and has revised the authorisation based on new information from its safety surveillance systems. 

As per the FDA, the Food and Drug Administration and the US Centers for Disease Control and Prevention (CDC) has recognised 60 confirmed TTS cases as of March 18, including nine fatal cases. Apart from this, according to a CNN report, the CDC's vaccine advisory committee updated its recommendation on Johnson & Johnson's vaccine in December last year, stating that it allows 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 and above in the United States." 

TTS symptoms usually appear one or two weeks following inoculation. It is pertinent to note that shortness of breath, chest discomfort, leg swelling, persistent abdomen pain, neurological symptoms such as headaches or confused vision, or red patches just beneath the skin called petechiae beyond the immunisation area are all possible symptoms. 

(Image: AP)