The company has also given given itself four chances to get a preliminary result. Some trial experts say the company appears to be looking for a leg up in a race to be first with a vaccine.
“I’ve never seen a trial where there were four interim analyses; that may be the Olympic record,” said Eric Topol, editor-in-chief of Medscape, a website offering clinical information for health-care professionals, and director of the Scripps Research Translational Institute in La Jolla, California. “It’s obvious why it is being done: so you can just keep looking at the data to try to win a race.”
All the drugmakers’ trials will count people with Covid-19’s most common symptoms—such as cough and fever—as cases, if they test positive for the virus. The rush for results raises the concerns that a vaccine may be authorized mostly on the basis of whether it prevents mild symptoms.
“We want to know this vaccine has strong efficacy,” Topol said. “And that means two things: that it works in the majority of people and that it works to prevent serious infections, not sore throats or muscle aches.”
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