Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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: HHS Advisory Committee Urges ‘Great Caution’ On Use Of EUA

Executive Summary

Biologics license application is preferred route to market, but if emergency authorization is given it should happen with full transparency and be communicated in a clear manner to strengthen public confidence, National Vaccine Advisory Committee says.

You may also be interested in...



US Label For COVID-19 Vaccine Will Not Recommend Against Use In Pregnancy

Although UK labeling for the Pfizer/BioNTech vaccine recommends against use in women who are pregnant or breastfeeding, the US FDA’s labeling under an emergency use authorization is not expected to follow suit; agency says developmental and reproductive toxicity studies for some early candidates are nearing completion, but data will not available for EUA decision-making.

EUA For COVID-19 Vaccine Would Mean Fewer Patient-Years Of Follow-Up But More Pharmacovigilance

US FDA plans to leverage large safety surveillance databases to make up for the fact that a vaccine authorized for emergency use likely would have only one-quarter to one-half as much safety data follow-up as a typical vaccine licensed under a BLA, says CBER director Peter Marks.

When It Comes To A COVID-19 Vaccine For Kids, It Will Be Awhile

US FDA will be cautious about development of a COVID-19 vaccine for children, Commissioner Hahn says at the Financial Times US Pharma And Biotech Summit.

Related Content

Topics

UsernamePublicRestriction

Register

PS142981

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