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FDA, CDC Recommend U.S. Pause Of Johnson & Johnson Vaccine

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) intend to stop administering the Johnson & Johnson COVID-19 vaccine at federal sites during investigation of 6 US cases of rare blood clot disorders linked to the vaccine.

The federal agencies announced the decision for an immediate pause of the one-shot vaccine while advising states distributing the product consider doing the same, as 6 women aged 18-48 years old reported cerebral venous thrombosis, an extremely rare disorder associated with blood clotting, 6-16 days following their vaccination.

As of Tuesday morning, 1 woman afflicted with the condition has died, and a second woman in Nebraska is hospitalized and in critical condition.

The FDA reiterated the importance of an indefinite pause during this investigation in a statement shared on Twitter Tuesday morning.

“This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot,” they wrote.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will hold an emergency meeting on the matter this Wednesday, according to The New York Times.

Per the CDC, more than 6 million people in the US have received the vaccine thus far, and another 9 million doses have been shipped to different states.

Comparatively, Pfizer-BioNTech and Moderna have delivered 23 million-plus doses weekly of their two-dose mRNA vaccines to the US, comprising a significant majority of the US’ vaccine distribution. No significant safety concerns have emerged from either product.

 

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