BioCentury
ARTICLE | Regulation

Borio, Dolsten say FDA’s COVID-19 vaccine guidance hits mark

Guidance lays groundwork for robust trials, but harmonization of endpoints, assays needed

July 2, 2020 3:08 AM UTC

FDA has laid the groundwork for robust, randomized, placebo-controlled trials of vaccines for COVID-19, but it will be up to groups such as NIH and Operation Warp Speed to encourage coordination among developers to harmonize endpoints and assays.

Vaccines to prevent the novel coronavirus will need to demonstrate disease prevention, not just meet surrogate immunogenicity endpoints, FDA made clear in guidance released Tuesday. ...