Thursday, 21 Jan 2021

Fauci: UK didn’t scrutinize Pfizer vaccine trial data as carefully as FDA

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Dr. Anthony Fauci said British health regulators did not scrutinize trial data as carefully as the US Food and Drug Administration before approving the use of Pfizer’s coronavirus vaccine, according to a report.

“The way the FDA is, our FDA is doing it, is the correct way,” Fauci, the director of the National Institute of Allergy and Infectious Diseases, told Fox News, according to CNN.

“We really scrutinize the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine,” Fauci said.

“I think if we did any less, we would add to the already existing hesitancy on the part of many people to take the vaccine because they’re concerned about safety or they’re concerned that we went too quickly,” he added.

The top US infectious diseases doctor said it was important for Americans to feel good about a potential vaccine against the deadly bug.

“So, it’s almost a damned if you do and you’re damned if you don’t, because if you go quickly and you do it superficially, people are not going to want to get vaccinated,” he said.

“We have the gold standard of a regulatory approach with the FDA. The UK did not do it as carefully and they got a couple of days ahead,” he said. “I don’t think that makes much difference. We’ll be there. We’ll be there very soon,” Fauci added.

The top doc’s comments came after the White House said it wasn’t notified before Britain gave the green light to the jab – an unexpected move that put it at least a week ahead of the US in dispensing the vaccine developed by Pfizer, a US drugmaker, and Germany’s BioNTech.

The FDA isn’t scheduled to consider authorizing emergency use of the vaccine until Dec. 10. 

President Trump has been demanding to know why the FDA wasn’t moving faster to approve the shot, according to Politico.

FDA Commissioner Stephen Hahn defended the agency’s review process, saying a thorough vetting is required to make sure the public believes in the vaccine’s safety and effectiveness.

Hahn told The Wall Street Journal that the FDA has had 150 people working days, nights and weekends to review the test data submitted by Pfizer and BioNTech.

“We realize there is an issue in the U.S. around vaccine hesitancy. There have been concerns raised about the speed with which COVID-19 vaccines have been developed,” Hahn told the Journal.

“This will meet our gold standard of safety and efficacy that the American people have come to trust,” he added.

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