COVID-19 Vaccines: Pediatric Effectiveness Bridging Not Dependent Upon Immune Correlates
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...
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.
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.