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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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More from Vaccines

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.

Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service

 
• By Eliza Slawther

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

More from Pink Sheet

Malaysia Clarifies Drug Shortage Reporting Rules And Penalties For Non-Compliance

 
• By Neena Brizmohun

New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.

Dutch HTA Calls For “Socially Acceptable” Price For Gene Editing Therapy Casgevy

 
• By Francesca Bruce

Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.