1. Pink Sheet

Full US FDA Independent Review Of Janssen Booster Data May Not Continue Post-EUA

 
• By Derrick Gingery

The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.

Vaccine under a magnifying glass
Janssen submitted data from multiple clinical trials involving thousands of patients as part of its booster shot EUA request. • Source: Alamy

The US Food and Drug Administration based its decision to authorize booster shots for the Janssen Biotech Inc. vaccine on the submitted data, but it appears a large swath of the package may not be reviewed.

The FDA on 20 October amended the Janssen COVID-19 vaccine emergency use authorization to allow the second shot without a full verification of all the data the company included in the

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