The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot.
The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.
All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement 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 statement said.
“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.”
According to Johnson & Johnson, the adverse events “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, executive associate 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 said. “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 may be connected to how the Johnson & Johnson vaccine is an adenovirus vector vaccine — the same type as AstraZeneca’s coronavirus vaccine.
The AstraZeneca vaccine isn’t in use in the United States, but has been authorized in more than 70 countries.
The European Medicines Agency recently concluded that unusual blood clots with low blood platelets should be listed as “very rare side effects” of the AstraZeneca vaccine.
Source: CNN
