FDA restricts J&J’s COVID-19 vaccine because of blood clot threat | Health

WASHINGTON (AP) — U.S. regulators on Thursday strictly restricted who can obtain Johnson & Johnson’s COVID-19 vaccine as a result of ongoing threat of uncommon however severe blood clots.

The Food and Drug Administration mentioned the shot ought to solely be given to adults who can’t obtain a special vaccine or particularly request J&J’s vaccine. U.S. authorities for months have really helpful that Americans get Pfizer or Moderna pictures as an alternative of J&J’s vaccine.

FDA’s vaccine chief Dr. Peter Marks mentioned the company determined to limit the vaccine after taking one other have a look at the info on the dangers of life-threatening blood clots and concluding that they’re restricted to J&J’s vaccine.

“If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks said. “But we’ve been careful to say that– compared to no vaccine– this is still a better option.”

The problem occurs in the first two weeks after vaccination, he added: “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.”

The FDA approved J&J’s shot in February final 12 months for adults 18 and up.

The vaccine was initially thought of an necessary software in preventing the pandemic as a result of it required just one shot. But the single-dose possibility proved much less efficient than two doses of the Pfizer and Moderna vaccines.

In December, the Centers for Disease Control and Prevention really helpful Moderna and Pfizer pictures over J&J’s due to its questions of safety.

As of mid-March, federal scientists had recognized 60 instances of the facet impact, together with 9 that had been deadly. That quantities to three.23 blood clot instances per 1 million J&J pictures. The drawback is extra frequent in ladies underneath 50, the place the demise price was roughly 1 per million pictures, in keeping with Marks.

Marks mentioned the FDA spent additional time analyzing the issue to make certain it wasn’t related to a separate situation, resembling ladies taking contraception drugs that elevate their threat of clotting.

The J&J vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the facet impact.

Under the brand new FDA directions, J&J’s vaccine may nonetheless be given to individuals who had a extreme allergic response to one of many different vaccines and may’t obtain an extra dose. J&J’s shot may be an possibility for individuals who refuse to obtain the mRNA vaccines from Pfizer and Moderna, and subsequently would in any other case stay unvaccinated, the company mentioned.

A J&J spokesman mentioned in an emailed assertion: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”

The clotting issues first got here up final spring, with the J&J shot within the U.S. and with an identical vaccine made by AstraZeneca that’s utilized in different nations. At that point, U.S. regulators determined the advantages of J&J’s one-and-done vaccine outweighed what was thought of a really uncommon ri sk — so long as recipients had been warned.

COVID-19 causes lethal blood clots, too. But the vaccine-linked form is totally different, believed to kind due to a rogue immune response to the J&J and AstraZeneca vaccines due to how they’re made. Clots kind in uncommon locations, resembling veins that drain blood from the mind, and in sufferers who additionally develop abnormally low ranges of the platelets that kind clots. Symptoms of the weird clots embrace extreme complications every week or two after the J&J vaccination — not instantly — in addition to belly ache and nausea.

The New Brunswick, New Jersey-based firm introduced final month that it didn’t anticipate a revenue from the vaccine this 12 months and was suspending gross sales projections.

The rollout of the corporate’s vaccine was damage by a sequence of troubles, together with manufacturing issues at a Baltimore manufacturing unit that pressured J&J to import tens of millions of doses from abroad.

Additionally, regulators added warnings concerning the blood clots and a uncommon neurological response known as Guillain-Barré syndrome.

Pfizer and Moderna have offered the overwhelming majority of COVID-19 vaccines within the U.S. More than 200 million Americans have been absolutely vaccinated with the businesses’ two-dose pictures whereas lower than 17 million Americans acquired the J&J shot.

This model corrects the speed of blood clots reported with J&J’s vaccine. It is 3.23 instances per 1 million vaccinations.

The Associated Press Health and Science Department receives assist from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely liable for all content material.

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