Vaccinated at Higher Risk of Serious Adverse Events: Reanalysis of Original Trial Data

By Zachary Stieber
Zachary Stieber
Zachary Stieber
Reporter
Zachary Stieber covers U.S. and world news. He is based in Maryland.
September 2, 2022 Updated: September 5, 2022

A secondary analysis of the data from the original clinical trials for the Pfizer and Moderna COVID-19 vaccines has found that the vaccinated arms were at higher risk of serious adverse events than the placebo arms.

Pfizer trial participants who received a vaccine were 36 percent more at risk of a serious adverse event, while Moderna trial participants who received a vaccine were six percent more at risk, according to the analysis, which was published after peer review in the journal Vaccine on Aug. 31.

Severe adverse events were defined as events that resulted in serious conditions such as death, inpatient hospitalization, and persistent disability.

Vaccinated participants were also at higher risk of a subset of serious adverse events called special adverse events of special interest, identified as being of special interest by the Brighton Collaboration’s Safety Platform for Emergency vACcines Project.

The project separated special events of special interest into three categories. One is those recorded after COVID-19 infection, one is those with a proven or posited link to vaccines, and one is those linked with specific vaccine platforms. The list includes acute cardiovascular injury such as myocarditis, severe allergic shock, and blood clotting.

The vaccinated Pfizer participants were 10 percent more likely to suffer from one of the events, and the vaccinated Moderna participants were 15 percent more likely to suffer from one of the events.

In total, vaccinated trial volunteers suffered from 333 serious adverse events per 10,000 participants, including 139 of special interest. Placebo recipients across the trials experienced 288 serious adverse events, including 97 of special interest.

Pfizer and Moderna have not responded to requests for comment on the study, which was released in a preprint version earlier this year.

FDA Disagrees

A spokesperson for the U.S. Food and Drug Administration (FDA) told The Epoch Times via email that the agency disagrees with the paper’s conclusions.

“Based on the agency’s thorough evaluation of the safety and effectiveness data for the mRNA COVID-19 vaccines, as well as the ongoing safety surveillance of the vaccines, we continue to find their benefits far outweigh their risks in preventing COVID-19, including its most serious outcomes of hospitalization and death,” the spokesperson said.

The FDA does not think the reanalysis of the original study information proves new information about the safety of the vaccines and questioned some of the methods, such as not including COVID-19 as a serious adverse event.

Dr. Joseph Fraiman, a doctor at the Thibodaux Regional Health System and one of the researchers, challenged that thinking.

“We have trouble understanding why the FDA has a problem with excluding COVID-19 as a serious adverse event when they allowed this for Pfizer,” Fraiman told The Epoch Times, adding that “we do not understand why the FDA allowed Moderna to exclude COVID-19 efficacy outcomes from their serious adverse events.”

Dr. Joseph Ladapo, Florida’s surgeon general, said in a statement that the study “shows concerning rate of serious adverse events after mRNA vaccination,” adding, “Why are doctors blindly following Big Pharma?”

Both the Pfizer and Moderna vaccines are built on messenger RNA technology.

Call for More Information

Fraiman and the other researchers said that the paper “points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes” but that the analyses “will require public release of participant level datasets.”

In an open letter published the same day the peer-reviewed study was, the researchers asked Pfizer CEO Albert Bourla and Moderna CEO Stéphane Bancel to make public all the data related to the trials so that further analyses can be conducted.

The data “can answer lingering questions regarding what the trials indicated regarding the balance of benefit to harm in December 2020, questions which are difficult to answer with what has been made public,” the researchers said.

The group alerted Bourla and Bancel to its findings, acknowledging the estimates in the paper suffer because key data has not been disclosed.

The group said it asked the FDA to repeat the analysis it did using electronic individual participant data from the trial, which has not been made public, but that to its knowledge, that has not occurred. The group repeated its request to the FDA.

Correction: A previous version of this article described serious adverse events as severe adverse events. The Epoch Times regrets the error.

Zachary Stieber
Zachary Stieber covers U.S. and world news. He is based in Maryland.