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How US FDA Explained The Difference Between Approved And EUA Pfizer/BioNTech COVID-19 Vaccine

 
• By Derrick Gingery

When Comirnaty was approved in 2021, the product in the vials was identical, but the agency still had to state that legally they were different without confusing people.

Same but different
The approved Pfizer-BioNTech vaccine, Comirnaty, is not legally the same as the product available under emergency use authorization, even though the products are interchangeable. • Source: Shutterstock

The BLA review of Pfizer Inc./BioNTech SE’s COVID-19 vaccine Comirnaty raised a regulatory question that was easy to answer, but difficult to explain.

In late August 2021, Comirnaty was about to receive full approval for use in adults 16 and older. But the...

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• By Eliza Slawther

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The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

Merck’s Clesrovimab Vote Reflects New ACIP Members’ Skepticism

 
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The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.

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Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

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Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.