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US FDA’s Search For Class-Wide Vaccine Blood-Clot Effect Makes Scientific Sense, But Raises Questions

 
• By Derrick Gingery

Several adenovirus vaccine developers say the products cannot be compared, potentially complicating the US FDA and CDC’s decision on ending the recommended pause in the use of Janssen’s vaccine.

Box of AstraZeneca COVID-19 vaccine
The US FDA could use data on the AstraZeneca COVID-19 vaccine to inform its review of rare blood clots seen with the Janssen vaccine. • Source: Alamy

The US Food and Drug Administration likely is using safety evidence from one or more unapproved products to inform its response to the rare blood clots seen with Janssen Biotech Inc.'s coronavirus vaccine, a move that could complicate lifting the recommended pause in administration that some argue already is too long.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is expected to receive additional data during...

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