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: Pediatric Effectiveness Bridging Not Dependent Upon Immune Correlates

Executive Summary

Ability to bridge from adult effectiveness data to children in the absence of an identified correlate of protection could be affected by proposed dosing regimen and expected similarity in pediatric response, US FDA official says.

You may also be interested in...



US FDA Not Yet Sold On COVID Vaccine Emergency Use Authorization For Children Under 12

Advisory committee will discuss merits of longer-term safety data for COVID-19 vaccines in children under 12, which could leave EUA pathway out of reach for this population. Immunobridging studies may also be more challenging in this population due to potential need for dose reductions.

Adolescent Results Put Pfizer/BioNTech Ahead Of COVID Vaccine Pack, For Now

An EUA would carve out a market advantage, although Moderna should be releasing similar data soon for its COVID-19 vaccine.

US Remains Conservative On Vaccine Dosing Regimens As CDC’s ACIP Highlights Minimal Comfort With Relying On Unproven Correlates

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices concerns about making COVID-19 vaccine dose regimen changes based on unproven immune correlates of protection could be a warning sign to sponsors about roadblocks they might face if updating vaccines to address viral variants or conducting pediatric studies relying on such surrogate endpoints.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143687

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