Adverse Events Risk in COVID Vaccine Trials Was One in 565, Doctor Tells National Citizen’s Inquiry

People walk past a vaccine clinic during the COVID-19 pandemic in Mississauga, Ont., on April 13, 2022. The Canadian Press/Nathan Denette

The Pfizer and Moderna COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest in about one in every 565 people, a U.S. doctor testified at the National Citizen’s Inquiry (NCI).

“That is quite a high number of serious adverse effects from a vaccine. We typically have withdrawn vaccines for one in 10,000,” said Dr. Joseph Fraiman, an emergency physician based in Louisiana who was the lead author of a peer-reviewed study that re-examined the original Pfizer and Moderna clinical trials for the COVID-19 vaccines.

Fraiman spoke virtually at the NCI on March 17, the second day of the hearings, which are currently being held in Truro, N.S., and will move next to Toronto. The NCI describes itself as a “citizen-led and citizen-funded initiative” examining how pandemic measures put in place by all levels of government impacted Canadians in four categories: health, fundamental rights and freedoms, social well-being, and economic prosperity.

The study Fraiman led adopted a “priority list” of potential adverse events related to COVID-19 vaccines in order to evaluate serious adverse events of special interest observed in COVID-19 vaccine trials.

The authors found that the Pfizer and Moderna COVID-19 vaccines were, respectively, associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest in 12.5 per 10,000 vaccinated, or one in 565.

Out of the 43,252 participants in the trials, a total of 27 percent of vaccine participants reported an adverse event, while just 12 percent of placebo participants did. Sixty-four vaccine recipients (0.3 percent) and six placebo recipients (<0.1 percent) reported lymphadenopathy (swelling of the lymph nodes), while four related serious adverse events were reported among vaccine recipients.

Two participants in the trials died, one from arteriosclerosis, and one from cardiac arrest. None of the deaths were considered by the investigators to be related to the vaccine.

Fraiman testified that the original data from the New England Journal of Medicine COVID vaccine trials, which found the vaccines were 95 percent effective in preventing symptomatic infection, were “one of the most amazing results that I had ever seen.”

Fraiman also highlighted that the original study showed that nobody in the vaccinated group was hospitalized, but said there were not enough deaths in either group to determine if it was the vaccine that was reducing COVID-19 mortality.

However, when it came to the observational data on the trial after the vaccines had been given an Emergency Use Authorization, Fraiman said, a total of 82 percent of COVID tests were given to the unvaccinated, while just 18 percent were given to the vaccinated.

“So that imbalances the groups. I’m not trying to say that that means that the vaccine doesn’t work, just that if you adjusted for that, it would show the vaccine efficacy somewhere in the 75 to 80 percent range,” he said.

Vaccinated People Hospitalized for COVID Counted as Unvaccinated

Fraiman, who worked in a hospital in Louisiana throughout the pandemic, said he was “shocked” to see breakthrough COVID cases among vaccinated people in April 2021. He also testified that at multiple hospitals, the miscategorization of vaccine statuses made it difficult to know how effective the vaccines were at reducing hospitalizations.

“What I was seeing was if the patient received the vaccine outside of the hospital system, there was a good probability that they weren’t reported as vaccinated,” he said, adding that this happened in multiple states.

“It was systematically biased in that sense in that you would never have a hospitalized unvaccinated person categorized as a vaccinated person. The only way the miscategorization would happen was in one direction.”

Fraiman said that after February 2021, he didn’t see a single patient with a “clear presentation of COVID-19.” He claimed to have seen COVID cases that were “incidental,” meaning they came into the hospital for other reasons but also tested positive for the disease.

“This was a disaster because the best metric to measure vaccine efficacy is through hospitalization rates and mortality rates. Without a good metric, and if a majority of COVID cases are incidental, then that makes it incredibly unreliable,” he said.

Fraiman told the inquiry he wasn’t attempting to argue that the vaccine was causing more harm than benefit, but said it’s “important to put this into context and understand the limitations of what this analysis gives you and how to interpret it.”

He said the detractors of his study on serious adverse events claimed that it was not possible to do a proper harm-benefit analysis with only two months of data post-vaccine.

“We completely agree with that. But the larger question there is, if it’s not proper to do harm-benefit analysis with only two months of data, then why did ... our governments decide to authorize a vaccine without the ability to do a proper harm-benefit analysis?”