Pink Sheet Podcast: Top US FDA Vaccine Leaders Retire, COVID-19 Booster Shots, JAK Inhibitor Safety
Pink Sheet reporters and editors consider the leadership shake-up at the FDA Office of Vaccines Research and Review, the COVID-19 vaccine booster shot debate, and the impact of new safety measures for several JAK inhibitors.
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Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.
Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough
Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear Pfizer has made the case to FDA that a booster dose is need at this time or that they provided enough safety data.
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.