The most advanced trials for coronavirus vaccines cannot tell researchers if the shots will save lives, or even if they’ll prevent serious disease, a drug development expert pointed out Wednesday.
The ongoing trials are only designed to show if the vaccines prevent infection — and most infections are mild infections, Peter Doshi, an associate editor at the BMJ medical journal and a drug development specialist at the University of Maryland’s school of pharmacy, said.
“Hospital admissions and deaths from Covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people.
The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out. “
But that doesn’t mean the vaccines saved people from serious disease or death, Doshi argued.
Doshi said they should consider asking the companies to reconfigure their trials to include data on preventing severe illness and death.
“People expect that the most severe part of the Covid iceberg — the ICU admissions and hospitalizations and deaths — that’s what a vaccine would put an end to,” he said.
It’s possible to keep these current trials going and add onto them so that they will, eventually, answer the question of whether Covid vaccines save lives and prevent severe disease.