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U.S. May Give Early Approval of COVID-19 Vaccine

How can we be sure that this is safe and effective?
by Ira Nopuente
Aug 31, 2020
Photo/s: RF._.studio/Pexels
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The rising number of COVID-19 cases globally has put pressure on pharmaceutical companies to produce a vaccine. The head of  the U.S. Food and Drug Administration, Stephen Hahn, says the agency may provide emergency approval for a future vaccine even before clinical trials are completed

He told the Financial Times the request for approval must still come from the developer. "It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," Dr Hahn said.

“If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

He also insisted that he was not pressured by U..S President Donald Trump, who is seeking re-election. 

"This is going to be a science, medicine, data decision," Hahn said. "This is not going to be a political decision."

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China and Russia have released vaccines without waiting for Phase Three trials. This stage is the most important and rigorous testing period. Many have criticized the said countries for this decision, including the U.S., because the vaccines' safety and effectiveness have not been properly examined.

Western drug companies developing the COVID-19 vaccine include Astra Zeneca (together with Oxford University), Moderna (in partnership with the US National Institutes of Health), and Pfizer and BioNTech.

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