Participants in the Pfizer trial who received the vaccine had a 36 percent higher risk of a serious adverse event, while participants in the Moderna trial who received the vaccine had a 6 percent greater risk, according to the study, which was published after peer review in the journal Vaccine on 31 August.
A minor one analysis of the data from initial clinical trials for the Pfizer and Moderna vaccines for COVID-19 found that those vaccinated were at higher risk of serious side effects relative to the placebo arms; such as disability or even death.
The participants in the test Pfizer who received vaccine were 36% more likely to have a serious adverse event; while the test participants Modern who received vaccine were at risk 6% more, according to the analysis, which was published after peer review in the journal Vaccine on Aug. 31.
As serious side effects were defined events resulting in serious conditions such as death, hospitalization and permanent disability.
Vaccinated participants were also at higher risk of a subset of serious adverse events called special adverse events of special interest, which were identified as being of particular interest by the Brighton Collaboration’s Safety Platform for Emergency Vaccines project.
The project separated the special events of particular interest into three categories.
Those recorded after infection with COVID-19,
Those with a proven or possible link to vaccines and
Those linked to specific vaccines.
The list of events includes:
– acute cardiovascular damage such as myocarditis,
– severe allergic shock and,
– blood coagulation.
Pfizer vaccinated participants were 10% more likely to suffer one of the events and Moderna vaccinated participants were 15% more likely to suffer one of the events.
In total, vaccinated volunteers suffered 333 serious adverse events per 10,000 participants; including 139 of special interest.
Placebo recipients in all 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 preprint earlier this year.
The FDA disagrees
A spokesperson for the US 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 detailed evaluation of the safety and efficacy data for the COVID-19 mRNA vaccines, as well as ongoing vaccine safety surveillance, we continue to find that their benefits far outweigh their risks in preventing COVID- 19, including the most serious outcomes of hospitalization and death,” the spokesman said.
The FDA does not believe that the reanalysis of the original study information provides new information about vaccine safety and questioned some of the methods, such as not including COVID-19 as a serious adverse event.
Dr. Joseph Fraiman, a physician at Thibodaux Regional Health System and one of the researchers, challenged that thinking.
“We struggle to understand why the FDA has a problem with excluding COVID-19 as a serious adverse event when it allowed it for Pfizer,” Fraiman told The Epoch Times, adding that “we don’t understand why the FDA allowed Moderna to exclude Effectiveness results of COVID-19 from their serious adverse effects.”
Dr. Josef Ladapo, Florida’s surgeon general, said in a statement that the study “shows the rate of serious adverse events after mRNA vaccination,” adding, “Why are doctors blindly following Big Pharma?”
Pfizer and Moderna vaccines both made with messenger RNA technology – Early research results withheld
Fraiman and the other researchers said the paper “indicates the need for formal benefit-harm analyses, particularly those stratified by risk of severe COVID-19 effects,” but that analyzes “will require public publication of participant-level datasets. ”
In an open letter published on the same day as the study, the researchers asked Pfizer CEO Albert Bourla and Moderna CEO Stéphane Bancel to release all data related to the trials so that further analyses.
Data “can answer persistent questions about what the trials have shown about the benefit-harm balance in December 2020, questions that are difficult to answer with what has been made public,” the researchers said.
The team notified Bourla and Bancel of their findings, acknowledging that their estimates “suffer” because no key data disclosed.
The group said it asked the FDA to repeat the analysis it did using individual participant electronic data from the trial, which has not been made public, but that hasn’t happened.
The group reiterated its request to the FDA.