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Feds Raise Pause of J&J COVID Vaccine, Add New Warning


This story was up to date at 8:35  p.m. 

April 23, 2021 — Use of the Johnson & Johnson COVID-19 vaccine ought to resume in the USA for all adults, the FDA and CDC stated Friday, though well being care suppliers ought to warn sufferers of the danger of creating the uncommon and critical blood clots that brought on the companies to pause the vaccine’s distribution earlier this month.

“What we’re seeing is the general charge of occasions was 1.9 circumstances per million folks. In ladies 18 to 29 years there was an approximate 7 circumstances per million. The danger is even decrease in ladies over the age of fifty at .9 circumstances per million,” CDC Director Rochelle Walensky, MD, stated in a information briefing Friday night.. 

In the long run, the potential advantages of the vaccine far outweighed its dangers.

“By way of advantages, we discovered that for each 1 million doses of this vaccine, the J&J vaccine might stop over 650 hospitalizations and 12 deaths amongst ladies ages 18-49,” Walensky stated. The potential advantages to ladies over 50 have been even higher: It might stop 4700 hospitalizations and 650 deaths.

“In the long run, this vaccine was proven to be secure and efficient for the overwhelming majority of individuals,” Walensky stated at a press briefing on Friday evening.

The advice to proceed the vaccine’s rollout got here barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to suggest the pause be lifted. The vote was 10-4 with one abstention.

The choice additionally consists of directions for the warning directed at ladies underneath 50 who’ve an elevated danger of a uncommon however critical blood clot dysfunction referred to as thrombosis with thrombocytopenia syndrome (TTS). 

As of April 21, 15 circumstances of TTS, all in ladies and 13 of them in ladies underneath 50, have been confirmed amongst 7.98 million doses of the J&J vaccine administered within the U.S. Three ladies have died.

The FDA and CDC really helpful the pause on April 13 after stories that 6 ladies developed a blood clotting dysfunction 6 to 13 days after they obtained the J&J vaccine.

William Schaffner, MD, an infectious illness professional at Vanderbilt College in Nashville, and a non-voting ACIP member, stated in an interview the panel made the best advice.

He applauded each the choice to restart the vaccine and the up to date warning data that “will clarify [TTS] extra absolutely to folks, significantly ladies, who’re coming to be vaccinated.”

As to ladies within the danger group needing to have a selection of vaccines,  Schaffner stated that can be addressed in another way throughout the nation.

“Each supplier won’t have various vaccines of their location so there can be many alternative methods to do that. You might have to get this data and choose which web site you’re going to relying on which vaccine is out there if this matter is essential to you,” he famous.

ACIP made at the moment’s choice after a 6-hour emergency assembly to listen to proof on advantage of Johnson & Johnson’s protecting advantages in opposition to COVID-19 vs. danger of TTS.

Within the CDC-FDA press briefing, Walensky identified that over the previous few days, as regulators have reviewed the uncommon occasions, newly recognized sufferers had been handled appropriately, with out the usage of heparin, which isn’t suggested for treating TTS. 

Because of this, regulators felt like their messages had gotten out to medical doctors who now knew methods to take particular precautions when treating sufferers with the dysfunction.

She stated the Johnson & Johnson shot remained an essential choice as a result of it was handy to provide and simpler to retailer than the opposite vaccines presently approved within the U.S.

Peter Marks, MD, the director of FDA’s Heart for Biologics Analysis and Analysis, stated the company had already added data describing the danger of the uncommon clotting dysfunction to its truth sheets for sufferers and medical doctors.

Janet Woodcock, appearing commissioner of the FDA, stated vaccination facilities might resume giving the “one and executed” photographs as early as tomorrow morning.

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