FOOD AND DRUG ADMINISTRATION restricts Covid vaccine more than safety issues

Whenever limiting the Johnson & Johnson’s Covid vaccine’s value to certain adults only, the united states health regulator cited possibly dangerous side effects.

The united states Food and Drug Administration (FDA) has limited its approval of Johnson & Johnson’s Covid vaccine to those over the age of 18, pointing to dangerous side effects observed in younger recipients.  

The agency announced the particular move in a  pr release   on Thurs following a review of data, stating the J& J photo (alternatively known as the Janssen vaccine) would no longer be authorized for minors due to  “ rare and possibly life-threatening blood clots. ”  

“ After conducting an updated analysis, assessment and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia symptoms (TTS)… warrants limiting the authorized use of the vaccine, ”   it stated, referring to the blood-clotting condition. It noted that symptoms typically appear  “ approximately one to two weeks”   after the jab is certainly administered.

People under 18 years old will not be permitted to receive the particular shot, the FDA continued. And even for adults, the J& J vaccine is now recommended only to those “ designed for whom other authorized or approved Covid-19 vaccines are not accessible or clinically appropriate, ” or who would not be able to receive an immunization otherwise.

While the director of the FDA’s Middle for Biologics Evaluation plus Research, Peter Marks, argued the vaccine “ still has a role in the current pandemic response” in the US and around the globe, he said “ the chance of TTS” drove the company to restrict its use among Americans.

The particular regulator’s latest decision is just not the first setback for the J& J jab, whose rollout was placed on a brief stop in April 2021 following several blood-clotting cases. While the FDA reapproved the shot after a little more than a week, an advisory body on the Center for Disease Control and Prevention (CDC) later on recommended other vaccines over Johnson & Johnson’s for everyone American adults after a review of effectiveness and safety data.

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