FDA Limits J&J COVID Vaccine Resulting from Blood Clots

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FDA Limits J&J COVID Vaccine Due to Blood Clots

FRIDAY, Could 6, 2022

Citing the gathered knowledge on a raised threat for a kind of harmful blood clot, the U.S. Meals and Drug Administration on Thursday drastically restricted the advisable use of the Johnson & Johnson COVID-19 vaccine.

With safer two-dose vaccines equivalent to Pfizer and Moderna extensively obtainable, the one-dose J&J shot ought to be restricted “to people 18 years of age and older for whom different approved or authorised COVID-19 vaccines will not be accessible or clinically acceptable,” the company mentioned in a statement.

It could even be utilized by “people 18 years of age and older who elect to obtain the Janssen COVID-19 Vaccine as a result of they might in any other case not obtain a COVID-19 vaccine [at all],” the FDA suggested.

Whereas the J&J vaccine has appealed to some as a result of it solely requires one-dose, knowledge quickly emerged suggesting the next threat in customers of a uncommon type of blood clot often called thrombocytopenia syndrome (TTS).

In response to the FDA, TTS is “a syndrome of uncommon and doubtlessly life-threatening blood clots together with low ranges of blood platelets.”

Some individuals — typically younger males — usually developed signs a couple of week or two after getting the J&J shot. The info gathered on this threat now “warrants limiting the approved use of the vaccine,” the company mentioned.

Getting the J&J vaccine can nonetheless assist stop critical sickness with COVID-19, so the shot “nonetheless has a task within the present pandemic response in the USA and throughout the worldwide group,” Dr. Peter Marks, director of the FDA’s Heart for Biologics Analysis and Analysis, mentioned within the assertion.

However “our motion displays our up to date evaluation of the chance of TTS following administration of this vaccine,” he mentioned, “and limits the usage of the vaccine to sure people.”

Marks added that “the company will proceed to observe the security of the Janssen [J&J] COVID-19 Vaccine and all different vaccines, and as has been the case all through the pandemic, will completely consider new security data.”

The vaccine first obtained an emergency use authorization in late February of 2021. However after six instances of TTS have been reported, the FDA positioned a brief “pause” on use of the J&J shot because it gathered extra knowledge.

That pause was lifted on April 23, 2021, when a complete of 15 instances of TTS have been reported from the greater than 8 million vaccine doses doled out throughout throughout the USA.

On the time, “the identified and potential advantages of Janssen [J&J] COVID-19 Vaccine outweighed its identified and potential dangers in people 18 years of age and older,” the FDA mentioned.

Nonetheless, by December, the company suggested that mRNA COVID vaccines (these made by Pfizer or Moderna) have been now most well-liked over the J&J shot.

Within the newest evaluation, the FDA famous that by March 18, 2022, “the FDA and CDC have recognized 60 confirmed instances, together with 9 deadly instances,” of TTS in individuals who’d obtained the J&J vaccine.

The danger nonetheless stays extraordinarily uncommon: About three instances for each 1 million doses of vaccine administered. It is stays unclear if any particular components place a person at heightened threat for the blood clots after receiving the vaccine.

Whereas very uncommon, TTS can rapidly show harmful, nonetheless. Sufferers “could quickly deteriorate, regardless of immediate prognosis and therapy,” the FDA mentioned, and the clots “can result in long-term and debilitating well being penalties,” together with a excessive threat for dying.

So, the most recent advice is that the J&J vaccine be used solely by individuals who might need a critical allergic reaction to the Pfizer or Moderna vaccines, or those that (for no matter purpose) don’t want to obtain an mRNA vaccine and who would due to this fact in any other case stay unvaccinated.

Extra data

Discover out extra about COVID-19 vaccines on the U.S. Centers for Disease Control and Prevention.

SOURCE: U.S. Meals and Drug administration, information launch, Could 5, 2022

By Robin Foster and Ernie Mundell HealthDay Reporters

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