The CDC and FDA are currently putting the Johnson & Johnson COVID-19 on ice. In a joint statement, the two entities recommended a “pause” citing an “abundance of caution.”
Six reported U.S. cases of a rare type of blood clot occurred in individuals after they received the vaccine. The six cases were out of a total of 6.8 million doses. Those affected were women between as young as the age of 18.
“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 FDA’s Dr. Peter Marks and the CDC’s Dr. Anne Schuchat said in their joint statement. “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.”
According to CNN, the vaccine has been delayed in its European rollout.
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” the statement said in part.
The statement also said those who have had severe headache, abdominal pain, leg pain or shortness of breath within three weeks after the vaccination should contact their healthcare provider.
“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.
“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.”
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