FDA says COVID-19 vaccine would need to be at least 50% effective to be approved

pharmafile | July 1, 2020 | News story | Research and Development COVID-19, FDA, coronavirus 

The FDA announced that any COVID-19 vaccine that gets approval must show that it is at least 50% more effective than a placebo in treating the virus.

The regulatory body said this applies to vaccine manufacturers seeking to get a full approval, but have noted that a vaccine could be introduced to the general public under emergency use authorisation under less strict criteria.

Stephen Hahn, the FDA Commissioner, said: “While the FDA is committed to help expedite this work, we will not cut corners in our decision-making. This is particularly important, as we know that some people are sceptical of vaccine development efforts.”

“The American people should know that we have not lost sight of our responsibility to maintain our regulatory independence and ensure that our decisions related to all medical products, including COVID-19 vaccines, are based on sound science and the available data.”

The FDA’s guidelines also say that the companies or organisations conducting the trials must enrol at least 30,000 people to gain approval. They are also urged to use a diverse group of people, using the elderly and minority groups, and monitor patients being vaccinated after it receives approval.

Dr Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, believes a vaccine could be ready in early 2021. However, he does not believe the US will be able to achieve herd immunity due to a “general anti-science, anti-authority, anti-vaccine feeling” in the country. He said the lack of mask wearing in the nation worried him about people listening to health authorities.

A poll in May showed that half of Americans are sceptical of a vaccine, while a recent Washington Post survey showed that 27% would likely refuse a vaccine.

Conor Kavanagh

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