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 danger of creating the uncommon and critical blood clots that precipitated the businesses 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 chance is even decrease in ladies over the age of fifty at .9 instances 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.
“By way of advantages, we discovered that for each 1 million doses of this vaccine, the J&J vaccine may stop over 650 hospitalizations and 12 deaths amongst ladies ages 18-49,” Walensky mentioned. The potential advantages to ladies over 50 had been even better: It may stop 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 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 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 danger 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 experiences 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 skilled at Vanderbilt College in Nashville, and a non-voting ACIP member, mentioned in an interview the panel made the correct 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 ladies, who’re coming to be vaccinated.”
As to ladies within the danger group needing to have a selection of vaccines, Schaffner mentioned 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 alternative methods to do that. You could have to get this data and choose which website you’re going to relying on which vaccine is accessible if this matter is necessary to you,” he famous.
ACIP made right now’s resolution after a 6-hour emergency assembly to listen to proof on good thing about Johnson & Johnson’s protecting advantages towards COVID-19 vs. danger 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 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 necessary choice as a result of it was handy to offer and simpler to retailer than the opposite vaccines at the moment approved 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 danger of the uncommon clotting dysfunction to its truth sheets for sufferers and medical doctors.
Janet Woodcock, appearing commissioner of the FDA, mentioned vaccination facilities may resume giving the “one and executed” photographs as early as tomorrow morning.