FDA And CDC Recommend Pausing Johnson & Johnson Covid Vaccine During Investigation Of Reports Of “Extremely Rare” Blood Clots

The Food and Drug Administration and the Centers for Disease Control are recommending a pause on the Johnson & Johnson Covid vaccine after reports of what the agencies characterize as an “extremely rare” blood clot.

The FDA and the CDC will review “six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine,” out of 6.8 million doses administered, according to a statement from Peter Marks, the FDA’s director, Center for Biologics Evaluation and Research, and Anne Schuchat, principal deputy director of the CDC.

“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,” they said. “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.”

They said that right now, “these adverse events appear to be extremely rare.”

In February, the Johnson & Johnson vaccine was the third authorized for emergency use, following Pfizer and Moderna. The J&J vaccine has the advantage of requiring only a single dose for effectiveness.

The FDA and CDC said that in the six cases, a type of blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets. All of the cases occurred among women between the ages of 18 and 48, and the symptoms occurred 6 to 13 days after vaccination.

The report comes just as state and federal officials are expanding vaccination access, with President Joe Biden announcing last week that all adults will be eligible to receive the doses as of April 19. But there also have been concerns that a significant share of the population will not take the vaccine, as health officials hope to reach herd immunity to curb the spread of the virus.

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