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FDA restricts J&J’s COVID-19 vaccine due to blood clot risk

WASHINGTON (AP) — U.S. regulators on Thursday strictly restricted who can obtain Johnson & Johnson’s COVID-19 vaccine due to the continued risk of uncommon however critical blood clots.

The Food and Drug Administration mentioned the shot ought to solely be given to adults who can not obtain a distinct vaccine or particularly request J&J’s vaccine. U.S. authorities for months have beneficial that Americans beginning their COVID-19 vaccinations use the Pfizer or Moderna pictures as a substitute.

FDA officers mentioned in a press release that they determined to limit J&J’s vaccine after taking one other have a look at information on the risk of life-threatening blood clots inside two weeks of vaccination.

J&J’s vaccine was initially thought of an vital instrument in combating 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.

COVID vaccine
The FDA mentioned Johnson & Johnson’s vaccine ought to solely be given to adults who can’t obtain different pictures.

In December, the Centers for Disease Control and Prevention beneficial prioritizing Moderna and Pfizer pictures over J&J’s due to its questions of safety. Previously, U.S. officers had handled all three vaccines equally as a result of they’d every been proven to provide robust safety.

But follow-up research have constantly proven decrease effectiveness for J&J’s vaccine. And whereas the blood clots seen with J&J’s shot are uncommon, officers say they’re nonetheless occurring.

Federal scientists recognized 60 instances, together with 9 that had been deadly, as of mid-March. That quantities to one blood clot case per 3.23 million J&J pictures administered, the FDA mentioned Thursday. The vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the facet impact.

Johnson and Johnson
The FDA discovered one blood clot case per 3.23 million J&J pictures administered.

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.”

Despite the restriction, FDA’s vaccine chief Dr. Peter Marks mentioned J&J’s vaccine “still has a role in the current pandemic response in the United States and across the global community.”

The FDA primarily based its determination on “our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.”

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 risk — so long as recipients had been warned.

COVID-19 causes lethal blood clots, too. But the vaccine-linked sort is completely different, believed to type due to a rogue immune response to the J&J and AstraZeneca vaccines due to how they’re made. It kinds in uncommon locations, corresponding to veins that drain blood from the brain, and in sufferers who additionally develop abnormally low ranges of the platelets that type clots. Symptoms of the bizarre clots embody extreme complications per week or two after the J&J vaccination — not immediately — in addition to stomach ache and nausea.

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

The rollout of the company’s vaccine was harm by a sequence of troubles, together with manufacturing issues at a Baltimore manufacturing unit that compelled J&J to import thousands and 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 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.

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