Researcher and Professor Criticize COVID-19 Vaccine Trials at National Citizen’s Inquiry

A health worker prepares COVID-19 vaccine for injection in Boston, Mass., on March 4, 2021. Joseph Prezioso/AFP via Getty Images

A researcher and a professor criticized the way COVID-19 vaccine clinical trials were conducted in their testimony at the April 13 hearing of the National Citizen’s Inquiry (NCI) in Winnipeg, Manitoba. Drug companies rushed their trials and failed to account for factors such as long-term data, long-term safety and efficacy, and post-infection natural immunity and protection against severe disease, they said.

“These biological products being rushed like this is absolutely unprecedented,” said Jessica Rose, a Canadian researcher with master’s, PhD, and post-doctoral degrees in immunology, computational biology, molecular biology, and biochemistry.

“We don’t know the effects. We should have done studies for years, perhaps even decades, to see if this was going to become a problem from a genomic point of view.”

The NCI describes itself as a “citizen-led and citizen-funded initiative that is completely independent of government.” It is hearing from Canadians and experts in order to investigate governments’ COVID-19 policies in a “fair and impartial manner.”

The inquiry is examining how the pandemic measures put in place by all levels of government impacted Canadians in the four areas of health, fundamental rights and freedoms, social well-being, and economic prosperity.

Rose said that while conventional vaccines take approximately 10 years to get to market, the COVID-19 mRNA vaccines were “rushed through clinical trial testing” in less than a year.

“These trials were basically the foundations upon which all the decisions were made and the mantra that we’ve been hearing for three years, ’safe and effective,' were based on.”

According to Rose, the vaccines could not have been proven safe or effective because the exclusion criteria list for participation in the phase three trials was too large. She said only people who were healthy and of a certain age requirement were allowed to participate, and “there simply wasn’t enough time,” which meant “genuine safety testing was impossible.”

The federal government has said that even though the process to approve COVID vaccines was changed to allow people use them earlier, it has still been robust to ensure safety.

“We did not change the requirements in terms of the evidence standard,” Dr. Celia Lourenco, a Health Canada official, said in a court case last year related to federal travel vaccine mandates.

Adverse Reactions

Rose’s recent research efforts are aimed at analysis of the U.S. Vaccine Adverse Event Reporting System (VAERS) data in efforts to make this data accessible to the public.

She said when it came to adverse reactions to COVID vaccines, there was “enough of a safety signal” to have paused the vaccine rollout in January 2021, the first month after the rollout began on Dec. 17, 2020. In that first month, there were “almost 90,000 entries into the VAERS, spread across many age groups,” she said, and according to the VAERS COVID vaccine mortality reports webpage, there were 733 deaths.

The researcher said that VAERS data has previously been used as a pharmacovigilance tool, such as in 1999 when the rotavirus vaccine was pulled off the U.S. market after several cases of intussusception were found. Intussusception is a serious condition in which part of the intestine slides into an adjacent part of the intestine, often blocking food or fluid from passing through.

“What’s the cutoff for the number of people who are considered allowed to die, become disabled, or have neurological conditions etc. before the product is pulled?” Rose asked.

“An even better question might be, why aren’t we even asking questions?” she said, referring to the U.S. Centers for Disease Control and Prevention, Department of Health & Human Services, and Food and Drug Administration, which own the data. “Why aren’t they doing the assessments that they always had been doing in the past?”

Natural, ‘Recovered’ Immunity 

Jayanta Bhattacharya, a professor of medicine, economics, and health research and policy at Stanford University, said that while the mRNA COVID vaccine trials initially showed that it was 95% effective in preventing COVID-19, this was “not the key epidemiological endpoint that you care about from a policy perspective.”

Bhattacharya, who is also director of the Center on the Demography and Economics of Health and Aging at Stanford University, said the trials focused on preventing symptomatic infection when they should have made protection against severe disease and death from COVID-19 their primary outcomes.

“The trial did not answer that question because it didn’t have that as a primary endpoint and didn’t have sufficient numbers of people enrolled to be able to answer that question with any statistical confidence,” he said.

As an alternative, the trials would have needed to be conducted in a high-risk population, like the elderly, and it would not have been defensible, he added.

Bhattacharya also criticized the vaccine trials for explicitly excluding from their efficacy calculations patients who had previously contracted COVID-19 and recovered, thereby gaining natural immunity.

“The reason was simple. There’s a tremendous amount of evidence from 2020 on that the patients who get COVID and recover have very substantial protection against both subsequent infection and also severe disease on reinfection,” he said.

Vaccine Mandates

The professor also said that the necessary conditions for vaccine mandate were not present because the COVID vaccine did not stop transmission of the virus, and the protection provided by the vaccine was limited, especially for young people.

“The expected benefit of the vaccine for a low-risk person [younger people] is low, just by the basic math of it, because if you face a zero risk of dying from COVID, then the vaccine produces zero benefit,” Bhattacharya said. He added that this was especially true given the potential for serious side effects like myocarditis—inflammation of the heart muscle, which could result in death—in young men.

Bhattacharya cited two studies, done in Qatar and Sweden, which found that the COVID vaccine’s efficacy against infection dropped substantially after several months. He said “it’s very, very common” to get infected just a few months after being vaccinated. Using himself as an example, he said he was vaccinated with the Pfizer vaccine in April 2021 and got infected with COVID in August 2021.

The professor said that from a public health perspective, if a vaccine failed to stop disease transmission or had a limited effect on disease transmission, then “the idea that you need to vaccinate other people so that I’m protected is just false.”

He also decried the public health restrictions enacted in Western countries, including Canada, which he said caused “tremendous harm,” including economic, psychological, health, and physical harm. As evidence, he pointed to data showing that Sweden had the lowest rate of excess deaths from COVID despite having opted against widespread lockdowns throughout the pandemic.

“What you see is that the rate of cumulative all-cause excess deaths in Canada as of late 2022, was actually about 50 percent higher than that experienced by Sweden, which did not impose the kind of draconian lockdown policies that Canada followed,” he said.