By Suzanne Burdick, Ph.D.
A new analysis of Pfizer and Moderna COVID-19 vaccine trial data shows the risk of serious injury following the vaccine is greater than the reduction in COVID-19 hospitalizations, according to a study posted June 23 on Social Science Research Network.
“Combining the trials, there was a 43% increased risk of serious adverse events of special interest and an absolute risk increase of 12.5 serious adverse events of special interest per 10,000 vaccinated participants,” the authors of the pre-print paper wrote.
Based on their findings, the authors called for a harm-benefit analysis of COVID-19 vaccines.
The researchers — among them Peter Doshi, Ph.D., senior editor at The BMJ and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy — concluded:
“A systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups. Full transparency of the COVID-19 vaccine clinical trial data is needed to properly evaluate these questions. Unfortunately, well over a year after widespread use of COVID-19 vaccines, participant-level data remain inaccessible.”
Doshi leads the Restoring Invisible & Abandoned Trials (RIAT) initiative, which seeks to ensure clinical trial publications are accurate and complete, and data are publicly available.