Pfizer, Moderna Shots More Likely to Cause Serious Injury Than Reduce Risk of COVID-Related Hospitalization By
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.
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.
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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.
The study’s other authors are:
- Robert Kaplan, Ph.D., who leads Stanford University’s Clinical Excellence Research Center and previously led the behavioral and social sciences programs at the National Institutes of Health and served as the chief science officer at the U.S. Agency for Health Care Research and Quality.
- Dr. Patrick Whelan, M.D., Ph.D., associate clinical professor of pediatrics in the division of rheumatology at the University of California at Los Angeles (UCLA).
- Sander Greenland, Ph.D., professor emeritus of epidemiology and statistics at UCLA who served as an advisor for the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), the Environmental Protection Agency, the Centers for Disease Control and Prevention and the National Academy of Sciences.
- Mark Jones, Ph.D., associate professor of health sciences and medicine at the Institute for Evidence-Based Healthcare, as well as a biostatistician at Bond University in Robina, Australia.
- Juan Erviti, Ph.D. Pharm. D., qualified hospital pharmacist at Navarre Health Service, Spain.
- Dr. Joseph Fraiman, emergency medicine doctor at Louisiana State University’s Lallie Kemp Regional Medical Center.
“This important study uses actual Pfizer and Moderna clinical trial data to show that the risks of serious adverse events outweigh the benefits of these vaccines against COVID-19 hospitalization,” said Brian Hooker, Ph.D., Children’s Health Defense chief scientific officer and associate professor of biology at Simpson University in Redding, California where he specializes in microbiology and biotechnology.
“The public, and public health officials, need to immediately consider the implications of these study results,” Hooker added.
What the researchers did, and why
The researchers analyzed data from the clinical trials the FDA used as the basis for granting Emergency Use Authorization of the Pfizer and Moderna vaccines “to investigate the association between FDA-authorized mRNA COVID-19 vaccines and serious adverse events identified by the Brighton Collaboration.”
According to the researchers, the Brighton Collaboration in March 2020 created and later updated a priority list of “potential adverse events of special interest relevant to COVID-19 vaccine trials” in collaboration with the Coalition for Epidemic Preparedness Innovations partnership, Safety Platform for Emergency Vaccines.
