FDA Issues Guidance on COVID-19 Vaccines

July 1, 2020

The U.S. Food and Drug Administration (FDA) announced Wednesday that it is taking action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.

The FDA strongly encourages the inclusion of diverse populations in all phases of clinical development, including populations most affected by COVID-19, specifically racial and ethnic minorities, as well as adequate representation in late phase trials of elderly individuals and those with medical comorbidities. The guidance also discusses the importance of ensuring that the sizes of clinical trials are large enough to demonstrate the safety and effectiveness of a vaccine. The FDA says it would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated.