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Fauci says he has confidence that approval will not be political



The director of the National Institute for Allergies and Infectious Diseases, Dr. Anthony Fauci, testifies ahead of the US Senate Committee on Health, Education, Labor, and Pensions hearing to investigate COVID-19, “with an emphasis on teaching to prepare for the next pandemic,” Hill in Washington, DC on Aug. June 2020.

Kevin Dietsch | Pool | AFP | Getty Images

White House coronavirus advisor Dr. Anthony Fauci said Thursday he was confident that approval for a coronavirus vaccine would not be motivated by politics.

The Food and Drug Administration has been “very explicit”

; that it will make a decision based on clinical trial data, Fauci said in an interview with CNN. The study results are also reviewed by the Data and Safety Monitoring Board, an independent group of experts that monitors patient safety and treatment data.

“We can have some confidence in what the FDA says,” said the director of the National Institute for Allergies and Infectious Diseases.

The Centers for Disease Control and Prevention has asked governors and health departments to prepare for a vaccine distribution as early as November 1st. In a letter dated Aug. 27, CDC Director Dr. Robert Redfield that states will soon receive approval requests from the health care company McKesson, which used HHS to distribute the vaccine. He said they may have to forego some licensing and approval requirements that could delay the process.

The deadline – just two days before the general election – raised concerns among public health experts and scientists that getting a vaccine approved will be politically motivated, and the White House could put pressure on regulators to get a vaccine before November 3 to bring to market.

Previously, Minister of Health and Human Services Alex Azar had insisted that the government’s November 1 deadline for states had nothing to do with the presidential election.

“It has nothing to do with elections. It has to do with getting safe and effective vaccines to the American people as soon as possible and saving people’s lives,” Azar said on CBS This Morning. “Whether it’s October 15th, if it’s November 1st, if it’s November 15th, it’s about saving lives but meeting FDA standards for safety and effectiveness.”

The FDA has announced that it will approve a coronavirus vaccine as long as it is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC. Dr. FDA commissioner Stephen Hahn previously said the agency would not approve a vaccine that is not safe, even if it is quite effective.

“We’re going to be very, very, very careful about this security data and be transparent about what we’ve seen,” he said on July 30th.

However, Hahn told the Financial Times earlier this week that the agency was ready to bypass the full federal regulatory process in order to make a Covid-19 vaccine available as soon as possible.

Hahn insisted that the agency wasn’t pressured by President Donald Trump to expedite a vaccine, saying emergency approval might be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.

The comment raised concerns that a vaccine could be approved before it’s ready.

When asked Thursday whether he would hesitate to take a vaccine, Fauci said, “Not at all.”

“I would look at the data and assume that a vaccine would only be approved for the public if it was safe and effective,” he said. “And I keep stressing both its safety and its effectiveness. If so, I wouldn’t hesitate for a moment to take the vaccine myself and recommend it to my family.”


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