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US FDA’s COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

 
• By Nielsen Hobbs

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

FDA entrance sign 2016

If ever a US FDA advisory committee could be very dramatic but also just a complete formality, the review of Pfizer Inc.’s COVID vaccine slated for 10 December would fit that bill. The company announced it would file for emergency use authorization on the morning of 20 November, FDA announced that evening it had scheduled an advisory committee, and Operation Warp Speed chief science officer Moncef Slaoui went on TV on 22 November to say that the vaccine could be cleared the day after the advisory committee.

“Our plan is to be able to ship vaccines to the immunization sites within 24 hours from the approval,” Slaoui...

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More from Approvals

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
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EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

More from Product Reviews

New EU Approvals

 
• By Neena Brizmohun

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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.