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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It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.
As questions of political interference continue to swirl around the issue of whether additional vaccine shots will be needed, the Biden administration is facing communication challenges commonly seen with his predecessor, Donald Trump.
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.