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 US for all adults, the FDA and CDC mentioned Friday, though well being care suppliers ought to warn sufferers of the danger of growing the uncommon and severe blood clots that triggered 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 folks. 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..
Ultimately, the potential advantages of the vaccine far outweighed its dangers.
“When it comes to 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 mentioned. The potential advantages to girls over 50 had been even larger: It may forestall 4700 hospitalizations and 650 deaths.
“Ultimately, this vaccine was proven to be secure 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 beneath 50 who’ve an elevated threat of a uncommon however severe 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 beneath 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, mentioned in an interview the panel made the suitable suggestion.
He applauded each the choice to restart the vaccine and the up to date warning info that “will clarify [TTS] extra totally to folks, significantly girls, who’re coming to be vaccinated.”
As to girls within the threat group needing to have a selection of vaccines, Schaffner mentioned that shall be addressed in a different way throughout the nation.
“Each supplier won’t have different vaccines of their location so there shall be many alternative methods to do that. You might have to get this info and choose which website you’re going to relying on which vaccine is obtainable if this matter is essential to you,” he famous.
ACIP made in the present day’s choice after a 6-hour emergency assembly to listen to proof on good thing about 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.
In consequence, regulators felt like their messages had gotten out to medical doctors who now knew learn how to take particular precautions when treating sufferers with the dysfunction.
She mentioned the Johnson & Johnson shot remained an essential possibility as a result of it was handy to present and simpler to retailer than the opposite vaccines presently licensed within the U.S.
Peter Marks, MD, the director of FDA’s Middle for Biologics Analysis and Analysis, mentioned the company had already added info describing the danger of the uncommon clotting dysfunction to its reality sheets for sufferers and medical doctors.
Janet Woodcock, performing commissioner of the FDA, mentioned vaccination facilities may resume giving the “one and accomplished” pictures as early as tomorrow morning.