As Biden presses parents to vaccinate healthy young children
An analysis of Pfizer and Moderna COVID vaccine trials found the mRNA shots are more likely to land a recipient in the hospital than to provide protection from a severe adverse event.
In a pre-print study, meaning the paper has not yet been peer-reviewed, British Medical Journal Editor Dr. Peter Doshi and several other medical scientists looked for serious adverse events, as defined by the trial protocols, the U.K. website Daily Sceptic reported.
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The adverse events they focused on were based on the World Health Organization’s list of events of special interest: death; life-threatening at the time of the event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgment.”
The researchers found the vaccines were associated with an increased risk of serious adverse events of special interest of 10.1 events per 10,000 vaccinated for Pfizer and 15.1 events per 10,000 for Moderna.
Significantly, that level of increased risk post-vaccine is greater than the risk reduction for COVID-19 hospitalization in both Pfizer and Moderna trials.
The risk reduction was calculated to be 2.3 per 10,000 participants for Pfizer and 6.4 per 10,000 for Moderna.
The researchers accounted for the difference in their findings with those of the FDA when it approved the vaccines. They argue the FDA’s analysis of serious adverse events “included thousands of additional participants with very little follow-up, of which the large majority had only received one dose.”
The FDA, the authors said, also counted “people affected” rather than individual events. That’s despite the fact that there were twice as many individuals in the vaccine group than in the placebo group who experienced multiple serious adverse events.
The researchers also point out that the FDA has failed to fulfill its promise to further investigation adverse events it detected during the trials. They include pulmonary embolism, acute myocardial infarction, immune thrombocytopenia and disseminated intravascular coagulation.
The findings were similar to those of a recent pre-print analysis of COVID-19 vaccine trials by Benn et al., that found “no evidence of a reduction in overall mortality in the mRNA vaccine trials.”
And a new study published in the New England Journal of Medicine found that two doses of the mRNA vaccines increased the risk of COVID-19 infection during the omicron wave.