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

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

Executive Summary

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

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.

McKesson Tapped For COVID-19 Vaccine Kits To Meet 1 October Distribution Goal

US HHS turns to COVID-19 vaccine distributor to assemble vaccine administration kits, citing revised vaccine delivery schedule.

US FDA Expects COVID-19 Vaccines To Meet ‘EUA Plus’ Standards, Marks Says

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.

Related Content

Topics

UsernamePublicRestriction

Register

ID1132356

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