Operation Warp Speed officials cannot peek early at any data coming out of clinical trials of experimental coronavirus vaccine, an official told reporters Friday.
Paul Mango, deputy chief of staff for policy at the US Department of Health Human Services, sought to reassure reporters that the process of approving any eventual coronavirus vaccine will be the same as for any vaccine.
“There is a thing called a Data Safety Monitoring Board (DSMB), an independent body that is assigned to each clinical trial,” Mango said during a telephone briefing. “We have no insight into the data until the DSMB says we can look at it. They can come back and say, ‘This is not a good vaccine.’ They could come back before we even have 30,000 folks enrolled and say ‘We have enough. This looks great.’ ”
Adverse reactions to the vaccine could also trigger the DSMB to stop the trial.
Makers of vaccines in advanced clinical trials in the US are seeking to enroll at least 30,000 volunteers so they can tell whether the vaccine is really safe and protects people from infection. But there could be enough data even before 30,000 people are enrolled, Mango said.
“What we are really looking for is cases — the number of positive cases from both the placebo and the vaccine group,” Mango said. “Once we get to 150 or so, statistically that is significant regardless of how many enrollees we have in the trial.”
“That may be surprising to some, but really the number of events that have to occur … is relatively small,” added US Centers for Disease Control and Prevention Director Dr. Robert Redfield.