For Immediate Release: June 30, 2020

Today, the U.S. Food and Drug Administration took important 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 guidance, which reflects advice the FDA has been providing over the past several months to companies, researchers, and others, describes the agency’s current recommendations regarding the data needed to facilitate the manufacturing, clinical development, and approval of a COVID-19 vaccine.

“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

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