BioCentury
ARTICLE | Regulation

The variables shaping FDA’s guidance for new SARS-CoV-2 strains

The flu is only a starting point, COVID-19 brings different factors into play

February 6, 2021 2:21 AM UTC

While FDA has made it clear that efficiency is a priority in adapting authorized COVID-19 products to new viral variants, questions remain about what circumstances would require a new vaccine launch, the surrogate markers it would rely on, and the epidemiological data needed to guide design of new products and trials.

The decades-long practice of serially updating influenza vaccines provides a useful template. But COVID-19 vaccines face some different headwinds and tailwinds — while there is less understanding of the virus and a weaker surveillance network, the pandemic response is deploying newer vaccine modalities that are quicker and easier to change and scale...