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CDC and FDA are recommending “pause” in J&J vaccine distribution


My admittedly non-expert reaction to this is, to use the technical epidemiological phrase, WTF?

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 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.”

We’re going to pause a critical aspect of the so-far fantastically successful vaccine rollout because of a literally less than one in a million event that might be causally related to vaccination???

And I am but a simple country lawyer*, but the idea of “an abundance of caution” here doesn’t seem to make a lick of sense. What about the flip side of the equation, i.e., all the people who are going to get COVID-19 and pass it on to other people because of this “pause?” Where’s the abundance of caution in regard to THAT?

Isn’t this just a replay of the disastrously wrongheaded European regulatory decision to shut down the Astra Zeneca vaccine?

*Warning: author is not a lawyer and does not live in the country. Do not mix with any other blog posts.

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