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 mentioned Friday, though well being care suppliers ought to warn sufferers of the chance of growing the uncommon and critical blood clots that triggered the companies to pause the vaccine’s distribution earlier this month.

“What we’re seeing is the general price of occasions was 1.9 circumstances per million individuals. In girls 18 to 29 years there was an approximate 7 circumstances per million. The danger is even decrease in girls over the age of fifty at .9 circumstances per million,” CDC Director Rochelle Walensky, MD, mentioned 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 girls ages 18-49,” Walensky mentioned. The potential advantages to girls over 50 have been even higher: It might stop 4700 hospitalizations and 650 deaths.

“In the long run, this vaccine was proven to be protected and efficient for the overwhelming majority of individuals,” Walensky mentioned 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 advocate the pause be lifted. The vote was 10-4 with one abstention.

The choice additionally consists of directions for the warning directed at girls below 50 who’ve an elevated threat 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 girls and 13 of them in girls below 50, have been confirmed amongst 7.98 million doses of the J&J vaccine administered within the U.S. Three girls have died.

The FDA and CDC really useful the pause on April 13 after stories that 6 girls 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, mentioned in an interview the panel made the best suggestion.

He applauded each the choice to restart the vaccine and the up to date warning data that “will clarify [TTS] extra totally to individuals, notably girls, who’re coming to be vaccinated.”

As to girls within the threat group needing to have a selection of vaccines,  Schaffner mentioned that will probably be addressed in a different way throughout the nation.

“Each supplier is not going to have different vaccines of their location so there will probably be many alternative methods to do that. You will have to get this data and choose which web site you’re going to relying on which vaccine is obtainable if this matter is vital to you,” he famous.

ACIP made at the moment’s determination after a 6-hour emergency assembly to listen to proof on good thing about Johnson & Johnson’s protecting advantages towards COVID-19 vs. threat 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 using heparin, which isn’t suggested for treating TTS. 

Consequently, regulators felt like their messages had gotten out to docs who now knew find out how to take particular precautions when treating sufferers with the dysfunction.

She mentioned the Johnson & Johnson shot remained an vital choice as a result of it was handy to provide and simpler to retailer than the opposite vaccines at the moment licensed within the U.S.

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

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

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