FDA to release first official guidance on making COVID-19 vaccine
Guidance covers trials and safety issues.
The Food and Drug Administration on Tuesday will release its first official guidance on developing a timely and safe COVID-19 vaccine, Just the News has learned.
“We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19 and continue to work collaboratively with industry, researchers, as well as federal, domestic, and international partners to accelerate these efforts,” FDA Commissioner Stephen M. Hahn said in a statement provided to Just the News.
The organization will not "cut corners" on making decisions on whether to approve future vaccines, the commissioner said. “This is particularly important, as we know that some people are skeptical of vaccine development efforts.”
The guidance includes specific requirements, such as large enough clinical trials, and the expectation that a vaccine “would prevent disease or decrease its severity in at least 50% of people who are vaccinated,” according to the statement.
The agency encourages the inclusion of diverse populations in all clinical phases, specifically racial and ethnic minorities, people with medical conditions, and that information be provided on whether a vaccine is safe for children and pregnant women.
The new guidance also addresses whether and how to authorize emergency use of an investigational vaccine.