FDA: COVID Vaccine Trials Should Include Minorities, Pregnant Women

In a new guidance released Tuesday (June 30), FDA urges vaccine sponsors to include diverse populations in all stages of COVID-19 vaccine clinical trials. The agency is especially focused on ensuring trials include racial and ethnic minorities, elderly individuals, people with comorbidities and pregnant women. “FDA encourages the inclusion of diverse populations in all phases of vaccine clinical development. This inclusion helps to ensure that vaccines are safe and effective for everyone in the indicated populations,” the agency’s guidance, “Development...