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


US FDA Faces ‘Daily Challenge’ From Complexities Of EUA Fact Sheets For COVID-19 Vaccines

Executive Summary

Doran Fink says FDA wants to transition the pandemic vaccines to more flu-like labeling under BLAs.

You may also be interested in...

COVID Vaccines: US FDA Should Play More Activist Role In Development Of Modified Formulations

Advisory committee tells FDA that the agency, not vaccine manufacturers, should dictate the conversation around variants and reformulations; panelists also want better government research on immune correlates of protection ahead of any decision on a composition change.

COVID-19 Vaccine Second Booster Authorization A ‘Stopgap Measure,’ US FDA’s Marks Says

CBER director says agency understands 'we simply can't be boosting people as frequently as we are,' but wants to give older and immunocompromised individuals extra protection now while FDA considers whether and when formulations should be modified ahead of an expected surge this fall.

US FDA Bypasses Adcomm In Authorizing Second COVID Booster Because Decision ‘Straight-Forward’

Advisory committee member says FDA's decision to authorize extra shots of Pfizer and Moderna vaccines for those 50 and older was a short-term solution and that VRBPAC should prioritize long-term issues related to the coronavirus.


Related Companies

Latest Headlines
See All



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