CDC and FDA recommend US pause use of Johnson & Johnson’s Covid-19 vaccine over blood clot concerns



The six reported instances had been amongst greater than 6.8 million doses of the Johnson & Johnson vaccine administered within the United States.

All six instances occurred amongst ladies between the ages of 18 and 48, and signs occurred 6 to 13 days after vaccination, based on a joint assertion on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance,” the assertion mentioned. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

CNN has reached out to Johnson & Johnson for remark.

For individuals who have acquired the Johnson & Johnson shot, those that have developed extreme headache, stomach ache, leg ache or shortness of breath inside three weeks after vaccination ought to contact their well being care supplier, based on the assertion.

The assertion additionally famous that these hostile occasions “appear to be extremely rare.”

“It’s a very rare event. You’re talking about 1 per million, and when you give millions of doses of vaccines, you will see events like this that you couldn’t see in the clinical trial just because you didn’t have millions of people enrolled,” Dr. Carlos del Rio, govt affiliate dean of the Emory University School of Medicine at Grady Health System, told CNN’s John Berman and Poppy Harlow on Tuesday morning.

“But I want to congratulate the CDC and the FDA for very quickly jumping on it, halting the vaccinations until we know more, and really trying to understand what’s going on,” del Rio mentioned. “I think vaccine safety has always been a priority — and I think this is exactly the right move until we understand what’s going on and what’s the way forward.”

Del Rio added that the blood clotting could also be related to how the Johnson & Johnson vaccine is an adenovirus vector vaccine — the identical kind as AstraZeneca’s coronavirus vaccine.

The AstraZeneca vaccine is not in use within the United States, however has been approved in additional than 70 international locations. The European Medicines Agency lately concluded that uncommon blood clots with low blood platelets needs to be listed as “very rare side effects” of the AstraZeneca vaccine. While advising the general public to look out for the indicators of clots, the regulators mentioned the advantages of the shot had been nonetheless well worth the danger.

“The adenovirus vector vaccine may have something to do with it,” del Rio mentioned. The two different Covid-19 vaccines approved for emergency use within the United States — Pfizer’s and Moderna’s — are mRNA vaccines, that are a distinct kind.

He added that he nonetheless recommends folks to get vaccinated towards Covid-19.

Federal well being channels to cease utilizing J&J vaccine instantly

The new announcement from the FDA and CDC means all federal well being channels — mass vaccination websites, neighborhood well being facilities and the like — that had been beforehand administering the Johnson & Johnson vaccine will instantly cease in the meanwhile, based on a federal well being official.

The companies are recommending that states do the identical, however it will likely be as much as the person states to make that call as a result of they’re given a separate allocation of doses.

The pause occurred as a result of this kind of blood clot isn’t listed on the record of potential hostile unintended effects that had been half of the emergency use authorization for J&J. While officers are stressing it’s uncommon, they need well being care suppliers to have time to grasp what potential unintended effects are and easy methods to finest deal with them.

The CDC and FDA got here to a call late final night time, a federal well being official mentioned.





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