Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

COVID-19 Vaccine ‘Booster’ Or Simply A Third Dose? US FDA’s Marks Starts To Reframe The Issue

Executive Summary

It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.

You may also be interested in...



US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot

Advisory committee meeting reflected internal tensions among FDA staff on need for boosters and adequacy of the data; mRNA vaccine Comirnaty should be authorized for a third dose in populations at high risk for severe disease or exposure, panel says after overwhelmingly rejecting Pfizer's bid for booster approval in the 16-and-older population. 

Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough

Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear if Pfizer has made the case to FDA that a booster dose is needed at this time or that they provided enough safety data.

Real-World Evidence Will Take Center Stage At US FDA Advisory Committee On COVID Boosters

If regulators agree with Pfizers conclusions – and briefing documents suggest thats a big if – about real-world studies showing Comirnatys effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144961

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel