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

US FDA Signals New COVID-19 Vaccines Could Be Authorized With Just Immunogenicity Studies

Executive Summary

As FDA lowers some expectations on timing of booster shots, agencys outgoing vaccine chief says second-generation COVID vaccines may be authorized without efficacy studies. Marion Gruber's conclusion was supported by many of her international regulatory peers during a WHO meeting.

You may also be interested in...



Pfizer’s Quest For COVID Vaccine Correlates Of Protection Running Into Roadblocks

Pfizer scientists said they are having trouble identifying an immune correlate of protection for the company's COVID-19 vaccine, while other scientists expressed optimism that neutralizing antibodies might eventually be able to be used as a correlate, though there were some questions raised about using them for booster decision making.

COVID-19 Vaccines: Regulatory Consortium Addresses Way Forward With Immunobridging Studies

Drug regulators from five countries have outlined their joint expectations on the data companies must submit for the approval of next-generation COVID-19 vaccines if they opt for immunobridging studies instead of large-scale efficacy trials. 

Pfizer: Plans For Boosters Will Not Divert Supplies From Poorer Nations

Pfizer has pledged to supply 41% of its COVID-19 vaccine output to developing nations – but warns that these countries still need to sign contracts on time to guarantee supplies.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS144898

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