The director of the National Institute for Allergies and Infectious Diseases, Dr. Anthony Fauci, testifies ahead of the U.S. 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.
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White House coronavirus advisor Dr. Anthony Fauci said Thursday he was confident that a coronavirus vaccine approval would not be politically motivated.
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 who monitor 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 be receiving approval requests from the health care company McKesson, which the Department of Health and Human Services used 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 that the White House may be pressuring regulators to abandon a vaccine before November 3 bring the market.
Earlier Thursday, Minister of Health and Human Services Alex Azar insisted that the government's November 1 deadline for states was not linked to the presidential election.
"It has nothing to do with elections. It has to do with delivering safe and effective vaccines and saving lives to the American people as quickly as possible," Azar said on CBS This Morning. "Whether it's October 15th, whether it's November 1st, whether 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 approval 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 might get 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 in taking the vaccine myself and recommending it to my family."