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.
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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.
The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.
New data released ahead of 10 December advisory committee is raising questions about whether the US government’s plan to hold back doses of Pfizer/BioNTech’s vaccine is the right move. Still, most experts don’t expect this to be a one-and-done vaccine. But testing the hypothesis might help FDA solve its dilemma on when to vaccinate placebo patients.