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COVID-19 vaccine must protect 50% of people to receive approval, FDA says

FDA has set rules and guidelines for a potential vaccine

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In this May 4, 2020 photo provided by the University of Maryland School of Medicine, the first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection.

The first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection on May 4, 2020.

University of Maryland School of Medicine via Associated Press

The Food and Drug Administration announced Tuesday that a COVID-19 vaccine must help 50% of people in order to receive approval.

The FDA announced this in a new set of guidelines, which are being used to help stop the spread of the novel coronavirus.

These new guidelineslook to halt any concern that the FDA will rush to get a vaccine that will have negative side effects.

FDA Commissioner Stephen Hahn said in a statement: “We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19. While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards.”

The FDA said it will continue to issue emergency use authorization for certain vaccines and medications on a case-by-case basis. The authorization would be used after the agency looks into “the target population, the characteristics of the product, and the totality of the relevant, available scientific evidence, including preclinical and human clinical study data on the product’s safety and effectiveness.”

According to Ars Technica, the FDA released these guidelines after it faced concerns that the Trump administration pushed it to approve hydroxychloroquine and the related drug, chloroquine, back in March.