Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Pfizer/BioNTech COVID-19 Vaccine's Positive Advisory Committee Complicated By Pediatric Issues

Executive Summary

US FDA expected to quickly clear the first emergency use authorization for a COVID-19 vaccine following 17-4 VRBPAC vote, but a disorganized committee ending made it unclear why some members voted no. Pediatric data was at issue for at least two voters, though.

You may also be interested in...



US FDA Still Discussing Ideas For Pediatric Development Of COVID-19 Vaccines

J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.

We Still Can’t Hear You: 11 Months Into Pandemic, Virtual US FDA Meetings Still Challenging

With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.

US FDA Vaccines Adcomm May Be Called To Review COVID-19 Vaccine Strain Changes

CBER Director Peter Marks said the VRBPAC may need to opine on the immunogenicity data gathered for vaccine updates.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143448

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