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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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More from Vaccines

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

Valneva Expects UK And France to Lift Ixchiq Age Restriction Following EMA Decision

 
• By Anabel Costa-Ferreira

Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By Cathy Kelly

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

More from Pink Sheet

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By Vibha Sharma

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.