US drug regulator limits use of J&J Covid vaccine TheJournal.ie

The US DRUG regulator has limited the use of the Johnson and Johnson vaccine for fear of clotting.

The Food and Drug Administration (FDA) said that only adults who “have personal concerns” about mRNA vaccines, access issues, or medical reasons for refusing them can now receive the Johnson & Johnson Covid vaccine, which has been linked to rare but serious clotting. condition.

The vaccine, which was licensed as a single injection, is less protective than those developed by Pfizer and Moderna, and in December the Centers for Disease Control and Prevention advised the public to stay away.

The FDA’s decision Thursday builds on that recommendation by limiting the emergency use authorization of the J&J vaccine.

“Today’s action demonstrates the strength of our safety surveillance systems and our commitment to ensuring science and data guide our decisions,” FDA scientist Peter Marks said in a statement.

Sixty cases of thrombosis with thrombocytopenia syndrome (TTS), which produces rare and life-threatening blood clots with low levels of platelets in the blood, had been reported by March 18, with nine deaths.

Symptoms begin about one to two weeks after administration, and the condition, which can cause lifelong effects even when not fatal, occurs most often in premenopausal women.

Concerns about the vaccine have already limited uptake: Only 18.7 million doses have been administered in the United States, or about 3.2 percent of the total 577 million.

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But the FDA stopped short of completely disavowing it, and Marks acknowledged the impact a ban could have on global use of the vaccine, as well as concerns some may have specifically against mRNA vaccines, rather than the vector platform. of adenovirus used by J&J.

There are certain health-based justifications for not taking an mRNA vaccine, such as rare cases of heart inflammation in adolescent males and young men, although these are generally transient in nature and the vast majority affected make a full recovery.

However, anti-vaccine groups have also raised more general objections against mRNA vaccines, which are linked to conspiracy theories.

Although those types of concerns are not evidence-based, the exemption to use the J&J shot is extended to “individuals who have personal concerns about receiving mRNA vaccines and who would not otherwise receive a COVID-19 vaccine.” the FDA statement said.

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