One Down, Two To Go: Pfizer/BioNTech Booster Decision Creates Pressure For More Extra Shot Authorizations
Inequity created by limiting the mRNA vaccine’s third dose to only those individuals who received a primary series of the same vaccine, as well as resulting operational complexities, warrant consideration of a mix-and-match approach with Moderna and J&J products, CDC advisors say; however, FDA appears most focused on vetting manufacturer-specific data on homologous boosting.
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Often data was not available from FDA, CDC or the sponsor to answer subgroup, safety and other questions that could have influenced the outcome of the advisory committee meeting.
The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.
The foundation is donating to help supply Merck/Ridgeback’s antiviral to low-income nations; also Pfizer got one step closer to full approval for booster shots of Comirnaty, while the FDA authorized Moderna and J&J boosters, and Daiichi Sankyo made progress on its own mRNA vaccine candidate. Shionogi's once-daily oral antiviral is also moving forward.