US FDA Advisors' Push For BA.4/BA.5 COVID-19 Boosters Sets Up Regulatory, Manufacturing Crunch
If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.
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US FDA Wants Global COVID-19 Vaccine Update System, But Says May Not Be Possible
The agency’s Vaccines and Related Biological Products Advisory Committee will consider simplifying and harmonizing the vaccine composition, as well as formalizing a system for likely annual US updates.
COVID-19 Vaccine Boosters Targeting Omicron BA.4/BA.5 To Launch As Clinical Trials Continue
Pfizer/BioNtech’s and Moderna’s updated bivalent Omicron booster doses will be available in coming days. Pfizer/BioNtech has an ongoing study in individuals 12 and older and are preparing EUA application for those 6 months and older. Moderna completed enrollment of 512 participants in a Phase 2/3 trial.
A Pivotal September For US FDA And Commissioner Califf
The month of September will be a crucial time for the US Food & Drug Administration and the legacy of its commissioner, Robert Califf. The agency will be taking several significant regulatory actions – but also crossing its fingers that legislation to assure its funding is secured.