Washington — Dr. Anthony Fauci, the nation’s leading infectious disease expert, said clinical trials on a coronavirus vaccine could be stopped early if they provide positive results that show it is safe and effective.
In an interview with Kaiser Health News published Tuesday, Fauci, the head of the National Institute of Allergy and Infectious Diseases, said a Data and Safety Monitoring Board, which is composed of research experts that review data from clinical trials, has the power to end the trials early.
The independent board, Fauci said, could decide “the data is so good right now that you can say it’s safe and effective.” If the clinical trials were to produce results that are overwhelmingly positive, scientists would have a “moral obligation” to stop the trial early and make the vaccine available to all participants in the study, speeding up the process to make it more widely available.
“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said. He added that he is “not concerned about political pressure.”
The Trump administration has set a goal to deliver 300 million doses of a coronavirus vaccine by January through its initiative Operation Warp Speed. Phase 3 vaccine trials are currently underway in three of six vaccine candidates backed by the project.
While President Trump has touted the administration’s work in supporting the development of a coronavirus vaccine and other therapeutics, there have been rising concerns that some of the nation’s public health agencies overseeing the coronavirus response are facing heightened political pressure from the White House.
Last month, Mr. Trump suggested in a radio interview a coronavirus vaccine could be ready before November 3, Election Day. He has also claimed without evidence that the Food and Drug Administration (FDA) is slow-walking testing on vaccines and therapeutics to harm his reelection prospects.
Adding to the concerns was the revelation by FDA Commissioner Dr. Stephen Hahn in a recent interview with the Financial Times that he would be open to approving a vaccine before Phase 3 trials are completed.
But Fauci said all data used to make decisions about vaccines is made public, which bolsters public trust.
“The only time you get concerned is if there is any pressure to terminate the trial before you have enough data on safety and efficacy,” he said.
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