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.
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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.
Although differences in how sponsors have publicly disclosed demographic data for their enrolled trials make cross-study comparisons difficult, in general trial enrollment of Black and Hispanic participants has ranged from 10%-19% and 11%-45%, respectively, with one-quarter to one-third of study subjects falling into older age groups.