CDC Vaccine Advisors Must Fill In Missing Holes On Pfizer’s COVID Booster Plan

ACIP will get a chance to further restrict and tailor the US booster plan for COVID vaccinations. Among other things, CDC's advisors may have to define what constitutes being at high risk of severe COVID-19 post-primary vaccination, occupations at high risk of COVID exposure, and whether people who didn’t receive Pfizer’s primary vaccine series could get the company’s mRNA booster shot.

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CDC’s vaccine advisors have numerous decisions to make on Pfizer’s COVID-19 booster vaccine this week. • Source: Alamy

A two-day Centers for Disease Control and Prevention vaccine advisory committee meeting this week could dramatically shape the scope of Pfizer Inc./BioNTech SE’s US booter rollout for their mRNA COVID-19 vaccine Comirnaty.

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US FDA Advisory Committee Meetings In Jeopardy After Layoffs, But Some Employees Called Back

 
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Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."

All US FDA Product Centers May Merge Under Planned Agency Reorganization

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

Pink Sheet Podcast: Understanding The US FDA Reduction-In-Force And Its Long-Term Impact

Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.