August 13, 2022

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FDA restricts J&J’s COVID-19 vaccine as a result of blood clot threat

By MATTHEW PERRONE and LAURAN NEERGAARD

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

The Meals and Drug Administration mentioned the shot ought to solely be given to adults who can’t obtain a distinct vaccine or particularly request J&J’s vaccine. U.S. authorities for months have advisable that Individuals 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 another that seems to be equally efficient in stopping extreme outcomes from COVID-19, we’d quite see folks choosing that,” Marks mentioned. “However we’ve been cautious to say that– in comparison with no vaccine– that is nonetheless a greater choice.”

The issue happens within the first two weeks after vaccination, he added: “So if you happen to had the vaccine six months in the past you possibly can sleep soundly tonight understanding this isn’t a difficulty.”

The FDA licensed J&J’s shot in February final yr for adults 18 and up.

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

In December, the Facilities for Illness Management and Prevention advisable Moderna and Pfizer pictures over J&J’s due to its issues of safety.

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As of mid-March, federal scientists had recognized 60 instances of the facet impact, together with 9 that have been deadly. That quantities to three.23 blood clot instances per 1 million J&J pictures. The issue is extra frequent in girls beneath 50, the place the dying fee was roughly 1 per million pictures, in response to Marks.

Marks mentioned the FDA spent further time analyzing the issue to make certain it wasn’t linked to a separate concern, akin to girls taking contraception medicines that elevate their threat of clotting.

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

Underneath the brand new FDA directions, J&J’s vaccine might nonetheless be given to individuals who had a extreme allergic response to one of many different vaccines and might’t obtain a further dose. J&J’s shot is also an choice for individuals who refuse to obtain the mRNA vaccines from Pfizer and Moderna, and due to this fact would in any other case stay unvaccinated, the company mentioned.

A J&J spokesman mentioned in an emailed assertion: “Information proceed to assist a good benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, compared with no vaccine.”

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

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COVID-19 causes lethal blood clots, too. However the vaccine-linked form is completely 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, akin to veins that drain blood from the mind, and in sufferers who additionally develop abnormally low ranges of the platelets that kind clots. Signs of the weird clots embrace extreme complications per week or two after the J&J vaccination — not straight away — in addition to stomach ache and nausea.

The New Brunswick, New Jersey-based firm introduced final month that it didn’t anticipate a revenue from the vaccine this yr 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 hundreds of thousands of doses from abroad.

Moreover, regulators added warnings in regards to the blood clots and a uncommon neurological response referred to as Guillain-Barré syndrome.

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

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

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The Related Press Well being and Science Division receives assist from the Howard Hughes Medical Institute’s Division of Science Training. The AP is solely liable for all content material.

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