Dr. Anthony Fauci said in a new interview that a coronavirus vaccine could become available sooner than expected — as long as clinical trials produce overwhelmingly positive results.
Two trials of 30,000 volunteers are expected to wrap up by the end of the year, but the independent Data and Safety Monitoring Board has the authority to end them earlier both if interim results are overwhelmingly positive or negative, Fauci told Kaiser Health News.
The board could say “the data is so good right now that you can say it’s safe and effective,’” said the director of the National Institute of Allergy and Infectious Diseases.
In that case, Fauci told the nonprofit news service, scientists would have “a moral obligation” to end the trial early and make the inoculation available to everyone in the study, and speed up the process to distribute it to millions.
Fauci, the nation’s top infectious diseases expert, has warned against fast-tracking a vaccine through an emergency use authorization before it is proven safe in large trials — saying it could have a chilling effect on testing of other inoculations.
“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” Fauci told Reuters last month.
“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 trial,” he added.
Scientists and health experts have voiced concerns that President Trump might apply pressure on the Food and Drug Administration to approve a vaccine before November to increase his chances of winning another term.
In his interview with KHN, Fauci said he trusts the independent members of the DSMB — typically experts in vaccine science and biostatistics who are not government workers — to hold vaccines to high standards without political influence.
“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 told KHN. “I’m not concerned about political pressure.”
Three vaccines are currently undergoing large-scale trials in the US.
Two studies began in late July — one led by Moderna and the National Institutes of Health and the other led by Pfizer and BioNTech, according to KHN.
AstraZeneca, which has been running large-scale clinical trials in the UK, Brazil and South Africa, has also launched a large-scale study in the US, with additional trials expected to begin this month.