Last Minute Allocation Shake Up? Pfizer’s One-Dose Data Could Change COVID-19 Vaccine Rollout
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.
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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.
Initial allocation plans for the Pfizer/BioNTech vaccine may change after a month or so if manufacturing scaleup proceeds ‘perfectly,’ Operation Warp Speed’s Slaoui suggests.
Agency details a host of unknowns regarding the benefits and risks of the first COVID-19 vaccine to reach the advisory committee stage, including uncertainties about duration of protection, effectiveness against transmission and vaccine-enhanced disease.