CDC, FDA Recommend Pause for Johnson & Johnson Vaccine After 6 Reported Cases of Clots

The CDC and FDA said Tuesday they were recommending a “pause” in the use of the Johnson & Johnson vaccine “out of an abundance of caution,” despite the fact that the overwhelming majority of the 6.8 million doses administered so far have been done without issue.

In a joint statement, the agencies said they were reviewing data on six reported U.S. cases of a rare type of blood clot in individuals after receiving the Johnson & Johnson vaccine. To put that into perspective, that’s six reported cases out of 6.8 million doses.

Put another way, as Emory University School of Medicine’s Dr. Carlos del Rio said on CNN Tuesday morning, a person has a “much higher” chance of getting run over by a car than getting a clot after the Johnson & Johnson vaccine.

“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.”

The CDC and FDA’s recommended pause for the Johnson & Johnson vaccine, to be absolutely clear, has no impact on—and is in no way connected to—the continued rollouts for the Pfizer-BioNTech and Moderna vaccines.

Earlier this month, for example, Pfizer shared updated topline results showing that its vaccine was 91.3 percent effective against COVID-19, measured seven days through up to six months after the second dose. The vaccine is also 100 percent effective in preventing severe disease and has shown no serious safety concerns.