How to Expand Access to COVID Vaccines without Compromising the Science
By Donald W. Light, Visitor in the School of Social Science & Peter Doshi, University of Maryland School of Pharmacy:
"The colder months have arrived, and COVID-19 infections and deaths are rising once again—but Americans are breathing a sigh of relief nonetheless, as the first authorized vaccine is finally rolling out. Perhaps surprisingly, though, that will actually make it increasingly difficult for public health officials to judge whether any of the vaccines will work well enough to tame the pandemic.
That’s because the emergency use authorization (EUA) the Food and Drug Administration (FDA) recently granted to Pfizer will begin to undermine the scientific integrity of the double-blinded clinical trial the company—and other companies—have been conducting, before statistically valid information can be gathered on how effectively the vaccines prevent hospitalizations, intensive care admissions or deaths. All that effort to recruit tens of thousands of volunteers and randomly give them either the vaccine or a placebo will get compromised as people in the placebo half are offered the opportunity to “cross over” and get the vaccine itself."
Read more at Scientific American.