A key problem with the clinical trial is that the definition of vaccinated and unvaccinated is unclear, the paper says.
Researchers allege that biases and manipulation of Pfizer and Moderna COVID-19 vaccine clinical data have exaggerated vaccine efficacy and underestimated vaccine adverse events.
While most clinical trials would evaluate the effects of a drug from the day it is administered, these COVID-19 mRNA vaccines are not being evaluated from the first day the vaccines are given. A later date is chosen, which inflates the vaccine’s perceived efficacy and safety, researchers say.
It could make an ineffective vaccine—a COVID vaccine with zero efficacy—have a perceived vaccine effectiveness of up to 48 percent, said researcher Raphael Lataster on Feb. 26, citing a paper co-authored by professor Peter Doshi from the University of Maryland.
Unclear Definitions of Vaccinated vs. Unvaccinated
Mr. Lataster, associate lecturer at the University of Sydney, spoke at Sen. Ron Johnson’s (R-Wis.) Feb. 26 roundtable discussion on COVID-19 vaccines and public health messaging. He summarized findings from a collection of four commentaries published in a peer-reviewed journal, of which two were authored by him.
“We have found in the studies varying definitions of fully vaccinated and unvaccinated. Generally what we find is that they are ignoring COVID infections in the partially vaccinated,” Mr. Lataster said.
“In randomized trials, it is customary to define ‘time zero’ as the point in time, for each trial participant, when eligibility criteria are met, treatment is assigned, and follow‐up begins,” Mr. Doshi and another author wrote in one of the papers.
Instead, COVID cases in vaccinated individuals are only counted weeks after a person is vaccinated. In Pfizer’s clinical trials, a person is considered vaccinated and their COVID cases are counted a week after they received the second dose, whereas in Moderna’s clinical trials, a person is considered vaccinated two weeks after their second dose.
By substituting some of Pfizer’s phase 3 clinical data and defining a person as vaccinated or unvaccinated according to Pfizer’s criteria in the clinical trials, Mr. Doshi and his authors found that Pfizer clinical trial could inflate a vaccine with zero efficacy to 48 percent. Their finding was published in the Journal of Evaluation in Clinical Practice.
By Marina Zhang
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