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 growing 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 charge of occasions was 1.9 instances per million folks. In ladies 18 to 29 years there was an approximate 7 instances per million. The danger is even decrease in ladies over the age of fifty at .9 instances per million,” CDC Director Rochelle Walensky, MD, stated 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 might forestall over 650 hospitalizations and 12 deaths amongst ladies ages 18-49,” Walensky stated. The potential advantages to ladies over 50 had been even larger: It might forestall 4700 hospitalizations and 650 deaths.
“Ultimately, 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 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 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 instances of TTS, all in ladies and 13 of them in ladies below 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 knowledgeable at Vanderbilt College in Nashville, and a non-voting ACIP member, stated in an interview the panel made the proper suggestion.
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 threat group needing to have a alternative of vaccines, Schaffner stated that will probably be addressed in a different way throughout the nation.
“Each supplier is not going to have various vaccines of their location so there will probably be many alternative methods to do that. You could have to get this data and choose which web site you’re going to relying on which vaccine is offered if this matter is vital to you,” he famous.
ACIP made at the moment’s resolution after a 6-hour emergency assembly to listen to proof on advantage of 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.
In consequence, regulators felt like their messages had gotten out to medical doctors who now knew easy methods to take particular precautions when treating sufferers with the dysfunction.
She stated the Johnson & Johnson shot remained an vital possibility 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 Middle for Biologics Analysis and Analysis, stated the company had already added data describing the danger of the uncommon clotting dysfunction to its reality sheets for sufferers and medical doctors.
Janet Woodcock, appearing commissioner of the FDA, stated vaccination facilities might resume giving the “one and finished” pictures as early as tomorrow morning.