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One Down, Two To Go: Pfizer/BioNTech Booster Decision Creates Pressure For More Extra Shot Authorizations

 
• By Sue Sutter

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.

Some CDC advisors are advocating for a mix-and-match approach to the currently available COVID-19 vaccines. • Source: Nielsen Hobbs

US regulators can expect to face increased pressure to allow mixing and matching of COVID-19 vaccines from different manufacturers following the authorization and recommendation for a booster dose of Pfizer Inc./BioNTech SE’s COVID-19 vaccine.

However, it appears the Food and Drug Administration and Centers for Disease Control and Prevention are more likely to prioritize authorizing and recommending product-specific booster doses for the other available vaccines – Moderna, Inc.’s two-dose mRNA vaccine and Janssen Biotech Inc

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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