Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday that he believes federal regulators will allow a coronavirus vaccine to be distributed this fall only if it’s based on science and “hard data.”
Fauci made the assessment after the disclosure of an Aug. 27 letter from the Centers for Disease Control and Prevention that told states to prepare for the “large-scale” distribution of a vaccine by Nov. 1, two days before the presidential election.
Fauci had previously said he believed a vaccine would likely be developed by the end of the year.
Asked Thursday if he worried the process had become too political, Fauci said there might be a perception of outside influence, “but I don't see that as being something that's going to be practically playing out,” he said.
Regulators at the Food and Drug Administration and experts at the independent Data and Safety Monitoring Board are “very, very committed to making sure that science prevails and not politics,” he said.
In an interview with National Public Radio Thursday, Dr. Moncef Slaoui, who’s leading Operation Warp Speed, the White House effort to fast-track vaccine development, said it was unlikely that distribution would reach the hundreds of millions of doses suggested in the CDC letter by fall.
"There is a very, very low chance that the trials that are running as we speak could read before the end of October," Slaoui told NPR. "And therefore, there could be — if all other conditions required for an Emergency Use Authorization are met — an approval. I think it's extremely unlikely, but not impossible."
Because such distribution is not impossible, he added, preparing states is "the right thing to do."
Slaoui, a former executive at GlaxoSmithKline, told NPR that he learned about the CDC letter "on the news."
He estimated that there could be enough doses to immunize between 20 million to 25 million people by the end of the year. Immunizing the rest of the country would likely take until the middle of 2021, he told NPR.
The CDC letter to governors told them to prepare for a “massive” effort to build the necessary infrastructure to distribute hundreds of millions of doses to local health departments and medical facilities across the country.
Earlier this week, FDA Commissioner Stephen Hahn told The Financial Times that the department may give a developer federal approval before rigorous Phase 3 clinical trials are completed.
"We may find that appropriate," he told the newspaper in a story published Sunday. "We may find that inappropriate. We will make a determination."
But speaking to NPR, Slaoui said a vaccine "will not be introduced before the clinical trials are completed."
“The requirements are very high, and there is no intent to file before the demonstration of efficacy and safety in the phase three trials,” he said.