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
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...



Hahn Says COVID Vaccine Review Could Take Months As Trump Floats Rejecting New EUA Guidance

Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.

Vaccine Hesitancy May Drive Distribution Priorities For Early COVID-19 Supply

ACIP defers vote on who should be inoculated first until it has data on a specific product, but vaccine acceptance among different groups could be weighed as factor in setting distribution priorities, committee members suggest.

Could A COVID-19 Vaccine Gain EUA Without Sponsor Cooperation?

The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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