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CBER Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., Marks Says

 
• By Derrick Gingery

Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.

Pordee_Aomboon/Shutterstock.com
EUAs for the two pending COVID-19 vaccines could be granted within days of each other, based on CBER Director Peter Marks' prediction. • Source: Shutterstock

Assuming favorable advisory committee results, the US Food and Drug Administration could issue emergency use authorizations for the Pfizer Inc./BioNTech SE and Moderna, Inc. coronavirus vaccines before Christmas.

Center for Biologics Evaluation and Research Director Peter Marks said 3 December that the agency would need only a few...

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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

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

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.