FDA restricts J&J’s Covid-19 vaccine because of blood clot danger

Washington, May 6 (AP) US regulators have strictly restricted who can obtain Johnson & Johnson’s COVID-19 vaccine because of the ongoing danger of uncommon however critical blood clots.

The Food and Drug Administration stated the shot ought to solely be given to adults who can not obtain a distinct vaccine or particularly request J&J’s vaccine. US authorities for months have beneficial that Americans get Pfizer or Moderna photographs as an alternative of J&J’s vaccine.

FDA’s vaccine chief Dr. Peter Marks stated the company determined to limit the vaccine after taking one other take 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 stated. “But we’ve been careful to say that — compared to no vaccine — this is still a better option.” The drawback happens within 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 authorised J&J’s shot in February final yr for adults 18 and up.

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

In December, the Centres for Disease Control and Prevention beneficial Moderna and Pfizer photographs over J&J’s due to its issues of safety.

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

Marks stated the FDA spent further time analysing the issue to make sure it wasn’t related to a separate challenge, akin to girls taking contraception medicines that increase their danger of clotting.

The J&J vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the aspect 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 might’t obtain an extra dose. J&J’s shot may be an choice for individuals who refuse to obtain the mRNA vaccines from Pfizer and Moderna, and subsequently would in any other case stay unvaccinated, the company stated.

A J&J spokesman stated in an emailed assertion: “Data continue to support a favourable 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 US and with the same vaccine made by AstraZeneca that’s utilized in different nations. At that point, US regulators determined the advantages of J&J’s one-and-done vaccine outweighed what was thought of a really uncommon danger — so long as recipients had been warned.

COVID-19 causes lethal blood clots, too. But the vaccine-linked form is totally different, believed to type due to a rogue immune response to the J&J and AstraZeneca vaccines due to how they’re made. Clots type 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 type clots. Symptoms of the bizarre clots embrace extreme complications per week or two after the J&J vaccination — not instantly — in addition to stomach ache and nausea.

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

The rollout of the corporate’s vaccine was harm by a collection of troubles, together with manufacturing issues at a Baltimore manufacturing facility that pressured J&J to import hundreds of thousands of doses from abroad.

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

Pfizer and Moderna have supplied the overwhelming majority of COVID-19 vaccines within the US. More than 200 million Americans have been totally vaccinated with the businesses’ two-dose photographs whereas lower than 17 million Americans acquired the J&J shot.