FDA restricts J&J’s COVID-19 vaccine attributable to blood clot threat ::

— 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 Meals and Drug Administration mentioned the shot ought to solely be given to adults who can not obtain a special vaccine or particularly request J&J’s vaccine. U.S. authorities for months have really useful that Individuals beginning their COVID-19 vaccinations use the Pfizer or Moderna photographs as a substitute.

FDA officers mentioned in an announcement that they determined to limit J&J’s vaccine after taking one other take a look at knowledge on the chance of life-threatening blood clots inside two weeks of vaccination.

J&J’s vaccine was initially thought-about an vital instrument in combating 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 really useful prioritizing Moderna and Pfizer photographs over J&J’s due to its issues of safety. Beforehand, U.S. officers had handled all three vaccines equally as a result of they’d every been proven to supply robust safety.

However 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 at least one blood clot case per 3.23 million J&J photographs administered, the FDA mentioned Thursday. The vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the aspect impact.

Underneath 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 is also 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 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.”

Regardless of 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 based mostly 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 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 threat — so long as recipients had been warned.

COVID-19 causes lethal blood clots, too. However the vaccine-linked type 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. It types in uncommon locations, reminiscent of 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 instantly — 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 12 months and was suspending gross sales projections.

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

Moreover, 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 U.S. Greater than 200 million Individuals have been absolutely vaccinated with the businesses’ two-dose photographs whereas lower than 17 million Individuals bought the J&J shot.


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 answerable for all content material.

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