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 Vaccines In Five And Younger Could Get Earlier FDA Advisory Committee Review

Executive Summary

Peter Marks says agency will proceed to meeting once Pfizer and/or Moderna complete their submissions and that the two may be considered at the same VRBPAC panel. FDA's effectiveness standard has not changed, CBER director says, but acknowledges that vaccines might be a little less effective than 50% in subpopulations.

You may also be interested in...



CBER’s Goal To Reach Normal Ops In 2023 Includes Clearing IND, Meeting Backlogs In 2022

CBER director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.

Novavax’s Pending EUA Likely Less Important Than Future Updates

Upcoming booster, adolescent data may be more commercially significant for the vaccine, which would enter a US market with few willing adults still unvaccinated. The tough prospects for one of the first COVID vaccines in development is a lesson in the importance of avoiding regulatory delays.

Seeking To Provide ‘The Best Clarity Possible,’ ACIP Votes For COVID Vaccine Booster In Children 5-11

CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS146154

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