Feds Lift 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 about the businesses to pause the vaccine’s distribution earlier this month.
“What we’re seeing is the general fee 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, 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 may forestall over 650 hospitalizations and 12 deaths amongst girls ages 18-49,” Walensky stated. The potential advantages to girls over 50 have been even larger: It may forestall 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 night time.
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 contains directions for the warning directed at girls below 50 who’ve an elevated threat of a uncommon however critical blood clot dysfunction known 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 experiences 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 knowledgeable at Vanderbilt College in Nashville, and a non-voting ACIP member, stated in an interview the panel made the best suggestion.
He applauded each the choice to restart the vaccine and the up to date warning info that “will clarify [TTS] extra absolutely to individuals, significantly girls, who’re coming to be vaccinated.”
As to girls within the threat group needing to have a selection of vaccines, Schaffner stated that will likely be addressed otherwise throughout the nation.
“Each supplier won’t have various vaccines of their location so there will likely be many various methods to do that. You could have to get this info 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 right this moment’s determination after a 6-hour emergency assembly to listen to proof on advantage of Johnson & Johnson’s protecting advantages in opposition to 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 the usage of heparin, which isn’t suggested for treating TTS.
Consequently, regulators felt like their messages had gotten out to docs who now knew learn how to take particular precautions when treating sufferers with the dysfunction.
She stated the Johnson & Johnson shot remained an essential possibility as a result of it was handy to provide and simpler to retailer than the opposite vaccines at the moment approved within the U.S.
Peter Marks, MD, the director of FDA’s Middle for Biologics Analysis and Analysis, stated the company had already added info describing the danger of the uncommon clotting dysfunction to its reality sheets for sufferers and docs.
Janet Woodcock, appearing commissioner of the FDA, stated vaccination facilities may resume giving the “one and performed” photographs as early as tomorrow morning.