- Dr. Anthony Fauci, in an interview with Reuters, warned against fast-tracking the approval of any COVID-19 vaccine that has not undergone clinical trials.
- "The one thing you would not want to see with a vaccine is getting an EUA [emergency use authorization] before you have a signal of efficacy," Fauci said.
- The comment comes a day after the US Food & Drug Administration issued an EUA for plasma therapy, following pressure from the White House.
- "One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their [clinical] trial," Fauci said.
- "To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both," Fauci continued. "We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective."
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The US government's top infectious disease expert is warning against the fast-tracked approval of a COVID-19 vaccine, saying that doing so "prematurely" could actually set back efforts to immunize the population against the novel coronavirus.
In an interview with Reuters, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the "one thing you would not want to see with a vaccine is getting an EUA [emergency use authorization] before you have a signal of efficacy."
The warning comes a day after the US Food & Drug Administration issued an EUA for COVID-19 plasma therapy under political pressure from the White House, with President Donald Trump himself claiming that the "deep state" was thwarting efforts to treat and prevent the spread of the coronavirus, an apparent reference to normal clinical trials for new medicines and vaccines.
The Financial Times reported Monday that the Trump administration is considering "bypassing normal US regulatory standards" and issuing an EUA, ahead of the 2020 election, for an experimental vaccine being developed by AstraZeneca and Oxford University. That vaccine has yet to advance to large-scale clinical trials.
Such a move would mirror efforts by Russian President Vladimir Putin, who announced the release of a COVID-19 vaccine after less than two months of testing on fewer than 100 people.
A Trump administration spokesperson denied the report.
Speaking to Reuters, Fauci urged caution.
"One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their [clinical] trial," he said.
Public health experts have warned that an ineffective — or dangerous — vaccine, released before it has been fully vetted, could enflame the anti-vaccination movement and prolong the spread of the coronavirus.
"To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both," Fauci said. "We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective."
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