Feds Lift Pause of J&J COVID Vaccine, Add New Warning

&#13 &#13 This tale was up to date at 8:35  p.m. &#13 &#13 April 23, 2021…

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This tale was up to date at 8:35  p.m. &#13

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April 23, 2021 — Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all grown ups, the Food and drug administration and CDC explained Friday, even though wellbeing treatment vendors need to warn patients of the chance of acquiring the unusual and major blood clots that caused the companies to pause the vaccine’s distribution previously this month.

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“What we are observing is the overall price of occasions was 1.9 circumstances for every million folks. In women 18 to 29 decades there was an approximate 7 circumstances per million. The threat is even reduce in gals about the age of 50 at .9 situations for every million,” CDC Director Rochelle Walensky, MD, mentioned in a information briefing Friday evening.. 

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In the end, the possible added benefits of the vaccine significantly outweighed its hazards.

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“In terms of gains, we uncovered that for each 1 million doses of this vaccine, the J&J vaccine could avoid in excess of 650 hospitalizations and 12 deaths between ladies ages 18-49,” Walensky mentioned. The potential advantages to gals in excess of 50 had been even higher: It could avoid 4700 hospitalizations and 650 deaths.

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“In the conclusion, this vaccine was revealed to be harmless and successful for the large bulk of people,” Walensky said at a push briefing on Friday night.

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The recommendation to continue on the vaccine’s rollout came scarcely 2 hours soon after a CDC Advisory Committee on Immunization Methods voted to recommend the pause be lifted. The vote was 10-4 with one abstention.

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The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS). 

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As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the U.S. Three women have died.

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The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.

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William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.

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He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”

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As to women in the risk group needing to have a choice of vaccines,  Schaffner said that will be addressed differently across the country.

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“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.

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ACIP made today’s decision after a 6-hour emergency meeting to hear evidence on benefit of Johnson & Johnson’s protective benefits against COVID-19 vs. risk of TTS.

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In the CDC-FDA press briefing, Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS. 

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As a result, regulators felt like their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.

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She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the U.S.

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Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.

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Janet Woodcock, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as tomorrow morning.

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