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 chance of creating the uncommon and critical blood clots that prompted the companies 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 chance 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.
“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 stated. The potential advantages to girls over 50 have been even higher: It may forestall 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 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 advocate the pause be lifted. The vote was 10-4 with one abstention.
The choice additionally contains directions for the warning directed at girls beneath 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 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 advisable the pause on April 13 after reviews 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, 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 totally to folks, notably girls, who’re coming to be vaccinated.”
As to girls within the threat group needing to have a alternative of vaccines, Schaffner stated that will probably be addressed in another way throughout the nation.
“Each supplier is not going to have various vaccines of their location so there will probably be many various 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 right this moment’s resolution 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 vital choice as a result of it was handy to present 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 data describing the chance of the uncommon clotting dysfunction to its truth 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.