These Coronavirus Trials Don’t Answer the One Question We Need to Know
Second, Moderna and Pfizer acknowledge their vaccines appear to induce side effects that are similar to the symptoms of mild Covid-19. In Pfizer’s early phase trial, more than half of the vaccinated participants experienced headache, muscle pain and chills.
If the vaccines ultimately provide no benefit beyond a reduced risk of mild Covid-19, they could end up causing more discomfort than they prevent.
Third, even if the studies are allowed to run past their interim analyses, stopping a trial of 30,000 or 44,000 people after just 150 or so Covid-19 cases may make statistical sense, but it defies common sense. Giving a vaccine to hundreds of millions of healthy people based on such limited data requires a real leap of faith.
Declaring a winner without adequate evidence would also undermine the studies of other vaccines, as participants in those studies drop out to receive the newly approved vaccine. There may well be insufficient data to address the aged and underrepresented minorities. There will be no data for children, adolescents and pregnant women since they have been excluded. Vaccines must be thoroughly tested in all populations in which they will be used.
None of this is to say that these vaccines can’t reduce the risk of serious complications of Covid-19. But unless the trials are allowed to run long enough to address that question, we won’t know the answer.
The trials need to focus on the right clinical outcome — whether the vaccines protect against moderate and severe forms of Covid-19 — and be fully completed. It is not too late for the companies to do this, and the Food and Drug Administration, which reviewed the protocols, could still suggest modifications.
These are some of the most important clinical trials in history, affecting a vast majority of the planet’s population. It’s hard to imagine how much higher the stakes can be to get this right. Cutting corners should not be an option.
Peter Doshi is an associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and an associate editor of The BMJ, a medical journal. Eric Topol is a professor of molecular medicine at Scripps Research, where he founded and directs the Translational Institute, which is focused on individualized medicine.
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