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...



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.

For Emergency Use, US FDA May Visit Rather Than Inspect COVID-19 Vaccine Manufacturing Sites

Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.

COVID Vaccine Postmarket Monitoring Will Depend On Which Adverse Events US FDA Wants To Watch

US FDA has the unenviable task of picking the most important adverse events to track once coronavirus vaccinations begin; CDC's list will need to be winnowed to 10-20 to make the surveillance feasible, and which AEs make the cut may be informed by the vaccine trials, as well as clinical experience with COVID infections.

Related Content

Topics

Latest News
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