As we are moving closer to the end of the year and the start of 2021, we can expect to hear more talk about a coronavirus vaccine. But what does it take for a coronavirus vaccine to be approved?
According to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, we can expect a coronavirus vaccine sometime closer to the end of the year, and more likely at the start of next year. Even if that roadmap is accurate, and researchers manage to develop a vaccine, what does it take for it to be approved and rolled out to the public? That's where the Food and Drug Administration (FDA) comes into play.
The FDA released a downloadable document this past Tuesday that outlines all of the data the FDA would need to receive to approve of a COVID-19 vaccine. According to FDA Commissioner Stephen M. Hahn, M.D who said in a recent press release, "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's Peter Marks also said, "Right now, neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials. Once data are generated, the agency is committed to thoroughly and expeditiously evaluating it all. But make no mistake: the FDA will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency."
The FDA requires several sets of data for a COVID-19 vaccine to be approved, and the document outlines that diverse populations most affected by COVID-19 are included in every single phase of clinical trials. These trials should also include racial and ethnic minorities, as well as elderly people, and also people who have preexisting conditions. On top of that, the sample size of the clinical trial should be large enough to demonstrate the safety and effectiveness of the vaccine, and "would prevent disease or decrease its severity in at least 50% of people who are vaccinated."
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