FDA restricts Covid vaccine over safety concerns – RT World News

By limiting the use of Johnson & Johnson’s Covid vaccine to certain adults only, the US health regulator cited potentially dangerous side effects

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

The agency announced the decision in a press release Thursday following a review of data, saying the J&J vaccine (also known as the Janssen vaccine) would no longer be licensed for minors due to “rare and life-threatening blood clots.”

“After conducting an updated analysis, evaluation, and investigation of the reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTTS)… warrants limiting the licensed use of the vaccine,” he said, referring to blood clotting disease. He noted that the symptoms usually appear “About one to two weeks” after administering the jab.

People under the age of 18 will no longer be allowed to receive the vaccine, the FDA continued. And even for adults, the J&J vaccine is now only recommended for those “for whom other authorized or approved Covid-19 vaccines are not accessible or clinically appropriate”, or who could not otherwise be vaccinated.

While the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, argued that the vaccine “still has a role in the current response to the pandemic” in the United States and around the world, he said “the risk of TTS” led the agency to restrict its use among Americans.

The regulator’s latest move isn’t the first setback for the J&J jab, whose deployment was put on a brief hiatus in April 2021 following multiple cases of blood clotting. While the FDA reapproved the vaccine after just over a week, an advisory body to the Center for Disease Control and Prevention (CDC) later recommended vaccines other than Johnson & Johnson’s for all American adults after a review of efficacy and safety data.

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