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

US FDA Expects COVID-19 Vaccines To Meet ‘EUA Plus’ Standards, Marks Says

Executive Summary

CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.

You may also be interested in...



Vaccine Irony: COVID Complicates Review, Uptake Of New RSV Vaccines

COVID vaccines saved the world and then became a liability. US FDA vaccine advisors cited COVID experience as they urge agency to slow down on approval of new RSV vaccines, due to worries of declining public vaccine confidence and coadministration complications.

Next-Gen Vaccine Makers Want Up-Front Discussions With US FDA To Expedite Development

Early conversations on clinical trial endpoints were particularly helpful in developing Comirnaty, a Pfizer executive said. Whether sponsors can continue to get such discussions may go a long way in determining whether a new generation of products is developed.

Pfizer’s Expected 2020 COVID-19 Vaccine Production Fell By 50% After Scaleup Delays

Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS142893

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