PHOENIX (3TV/CBS 5) - If a COVID-19 vaccine is approved, it may not do what you would expect.
The Food and Drug Administration recently issued guidance detailing what is required for an emergency use authorization.The National Center for Health Research in Washington D.C. brought together health experts to discuss COVID-19 vaccine trails.
Dr. Peter Doshi, associate professor of Pharmaceutical Health Services Research at the University of Maryland, highlighted that under the guidance, clinical trials leave a lot of unknowns. The trials are designed to test whether vaccines reduce COVID-19 symptoms in people given the vaccine versus people given a placebo.
The World Health Organization recommends a vaccine should reduce COVID-19 symptoms in 70% of participants who receive the vaccine.
Health care experts question the FDA for setting a 50% efficacy rate. An acceptable margin lowers the efficacy rate to 30%.
Dr. Doshi points out the trials are not designed to test:
- Whether they reduce the risk of severe Covid-19
- Whether they reduce the risk of hospitalization, ICU use, or death
- Whether they reduce the spread of the disease
"I would argue that licensing a vaccine without knowing these things carries major risks, namely, that the vaccines may not perform and reduce the risk of serious complications," say Dr. Doshi.