Pfizer, Moderna vaccine more likely to cause serious injury, Study reveals

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.

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.”

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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.

“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.

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.

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Finally, the researchers used a simple harm-benefit framework to place their results in context by comparing the risks of excess AESIs against reductions in serious complications of COVID-19.

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The Pfizer trial reported a “36% higher risk of [SAEs] unrelated to COVID-19 in 175 vaccinated participants” compared with placebo recipients, the study’s authors reported.

“The Moderna trial reported a 5% higher risk of SAEs unrelated to COVID-19 in vaccinated individuals compared to those receiving placebo,” they wrote.

The researchers’ blind and independent review determined the majority of SAEs were AESIs — meaning most of these events were the type known to be of particular safety concern related to the COVID-19 vaccine.

The researchers’ findings contrast with Pfizer’s previous claim that nearly all SAEs during the vaccine trials were “not related” to the vaccine.