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The Food and Drug Administration has been “very explicit” that it is going to make a decision based on data from clinical trials, Fauci said in an interview with CNN. The trial results will also be reviewed by the Data and Safety Monitoring Board, an independent group of experts who monitor patient safety and treatment data, he said.
“We can have some confidence and some faith in what the FDA is saying,” said the director of the National Institute of Allergy and Infectious Diseases.
The Centers for Disease Control and Prevention has asked governors and health departments to prepare to distribute a vaccine as soon as Nov. 1. In a letter dated Aug. 27, CDC Director Dr. Robert Redfield said states will soon receive permit applications from medical supply company McKesson, which HHS tapped to help distribute the vaccine. He said they may need to waive some licensing and permit requirements that could delay the process.
The deadline — just two days before the federal elections — raised concerns among public health experts and scientists that approval of a vaccine will be politically motivated and the White House may be pressuring regulators to get a vaccine to the market ahead of Nov. 3.
Earlier in the day, Health and Human Services Secretary Alex Azar insisted that the government’s Nov. 1 deadline for states had nothing to do with the presidential election.
“It has nothing to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people’s lives,” Azar said on “CBS This Morning.” “Whether it’s Oct. 15, whether it’s Nov. 1, whether it’s Nov 15, it’s all about saving lives but meeting the FDA standards of safety and efficacy.”
The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces the risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the CDC. Dr. Stephen Hahn, the FDA’s commissioner, previously said the agency won’t authorize a vaccine that’s not safe, even if it is fairly effective.
“We’re going to be very, very, very carefully looking at those safety data and we’re going to be transparent about what we’ve seen,” he said on July 30.
However, Hahn told the Financial Times earlier this week that the agency is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible.
Insisting the agency wasn’t being pressured by President Donald Trump to fast track a vaccine, Hahn said an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.
The comment raised concerns that a vaccine could be authorized before it is ready.
When asked on 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 not be approved for the public unless it was safe and effective,” he said. “And I keep emphasizing both safe and effective. If that’s the case, I would not hesitate for a moment to take the vaccine myself and recommend it for my family.”