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

Adjuvanted H1N1 Vaccine Excites FDA Panel, But Jury Is Still Out

This article was originally published in The Pink Sheet Daily

Executive Summary

Pending further data on adjuvants from firms and NIH, FDA's Vaccines and Related Biological Products Advisory Committee is comfortable with FDA's plans to license unadjuvanted H1N1 flu vaccines under the strain change process.

You may also be interested in...



COVID-19 Vaccine Advisory Committee May Help Determine US FDA Approach To Licensure

The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.

US FDA COVID-19 Adcom: What Additional Members Are Needed?

Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application. 

FDA Lifts Clinical Hold On Dynavax's Hep B Vaccine Heplisav, Narrows Population

The firm is hoping to gain licensure for chronic kidney disease patients first, and eventually to expand the indication to the broader hepatitis B vaccination population.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS069733

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