All eyes will be on the US Food and Drug Administration and its vaccine advisors this week as they evaluate Pfizer Inc./BioNTech SE’s supplemental application for a third dose of its COVID-19 vaccine amidst ongoing debate at to whether the Biden administration jumped the gun – and the data – in calling for universal booster availability by 20 September.
US FDA Likely To Leave Harder Decisions On COVID-19 Boosters To CDC
With potentially less flexibility and a simpler calculation on the benefit-risk of approving COVID vaccine boosters, FDA could punt the more challenging questions like whether boosters are needed now and for which populations, along with global equity and public health considerations to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
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Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
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Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.