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

By Zachary Stieber

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 severe adverse events per 10,000 participants, including 139 of special interest. Placebo recipients across the trials experienced 288 severe 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 severe adverse event.

Dr. Joseph Fraiman, a doctor at the Thibodaux Regional Health System, and the other researchers who performed the study said they excluded severe adverse events such as COVID-19 that had “known efficacy outcomes.”

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.

Affiliate News Feeds

  • Washington Examiner
  • The Federalist
  • The Epoch Times
  • The Guardian
  • The Gateway Pundit

CHANTILLY, Virginia — A group of roughly 70 students at Chantilly High School in northern Virginia marched out of class and off school grounds without adult supervision to protest Republican… [...]

President Joe Biden's plan to forgive hundreds of billions of dollars in student loan debt is facing its first serious legal challenge alleging it violates federal law and the Constitution,… [...]

As inflation weighs on the public, 71% of workers claimed their salary and wage growth is being outpaced by a rise in the cost of living. [...]

Historical setbacks and the proliferation of broken homes hurt black Americans, but there’s also something else: Marxism.  [...]

A woman’s death in Iran has sparked mass protests but little response from the Biden administration or ‘the squad’ of congresswomen. [...]

Ryan Busse claims to be a gun industry insider, but he has no interest in advocating for America's hunters and riflemen. [...]

A measure that would reform the Electoral Count Act of 1887 and make it harder for members of Congress to object to or decertify presidential election results has advanced in the… [...]

Sen. Bernie Sanders (I-Vt.) on Monday highlighted the declining state of the economy under President Joe Biden and said he does not believe the passage of the Inflation Reduction Act is… [...]

A federal appeals court in Manhattan handed former President Donald Trump a procedural victory Tuesday in a defamation lawsuit, after famed columnist E. Jean Carroll claimed that Trump had raped… [...]

Bank’s emergency move brings relief to bond market, but fails to stabilise UK currencyOver here, chancellor Kwasi Kwarteng is due to meet bankers again today in an effort to calm… [...]

Threadneedle Street will buy UK government bonds as pound continues to tumble in response to Truss and Kwarteng’s mini-budgetBusiness news today – live updatesThe Bank of England has intervened in… [...]

Will PM and chancellor ignore advice under mounting pressure, which is also coming from US and Germany?IMF urges UK government to reconsider tax-cutting plansLiz Truss and Kwasi Kwarteng have taken… [...]

The night before the line was damaged, thousands of people in Gera in Germany marched against Socialist Olaf Scholz’s policy and the explosion of energy and gas prices in Germany. … [...]

President Trump said Senator Joe Manchin is “off the rails” and “who the hell can blame him?” in a recent post on Truth Social. Manchin agreed on Tuesday to drop… [...]

Remember three weeks ago when Putin and the Russian military were on the ropes and the Ukrainian army was steamrolling through Kharkov? That was then and Urkaine’s promised victory failed… [...]

USNN2020

USNN World News (USNN) USNN World News Corporation is a media company consisting of a series of sites specializing in the collection, publication and distribution of public opinion information, local,...