A landmark peer-reviewed study appears to be the first of its kind to provide hard data on the “excess risk” of adverse side effects of Pfizer-BioNTech and Moderna mRNA vaccines in an independent “randomized clinical trial.”
The results of the accepted scientific study confirm that the concerns that many patients had about the mRNA vaccines were well-founded.
“In the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (6.4 per 10,000 participants),” the study found.
“In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (2.3 per 10,000 participants),” the study added.
The study was published on ScienceDirect on August 31, 2022. The authors include researchers from Stanford University, the University of Maryland, and UCLA. The study provides the following list of confirmed adverse events (or side effects) of the respective mRNA vaccines. It also provides the risk ratios versus Covid-19 (over 1 is a factor increase, under 1 is a factor decrease). This is the list for Pfizer:
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And the following are the adverse events for Moderna:
The study also provided known complications for Covid-19.
“Although the randomized trials offer high level evidence for evaluating causal effects, the sparsity of their data necessitates that harm-benefit analyses also consider observational studies,” the authors state. “Since their emergency authorization in December 2020, hundreds of millions of doses of Pfizer and Moderna COVID-19 vaccines have been administered and post-authorization observational data offer a complementary opportunity to study AESIs. Post-authorization observational safety studies include cohort studies (which make use of medical claims or electronic health records) and disproportionality analyses (which use spontaneous adverse event reporting systems).”
“In July 2021, the FDA reported detecting four potential adverse events of interest: pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation following Pfizer’s vaccine based on medical claims data in older Americans.” the researchers add. “Three of these four serious adverse event types would be categorized as coagulation disorders, which is the Brighton AESI category that exhibited the largest excess risk in the vaccine group in both the Pfizer and Moderna trials. FDA stated it would further investigate the findings but at the time of our writing has not issued an update.”
Joseph Fraiman announced the study results on Twitter:
Our study examining mRNA vaccine serious adverse events study is now peer-reviewed in the Journal Vaccine
Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adultshttps://t.co/PlUZZZePKB
— Joseph Fraiman (@JosephFraiman) August 31, 2022
“Our study examining mRNA vaccine serious adverse events study is now peer-reviewed in the Journal Vaccine,” Fraiman wrote. “Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults.”
Thus, the objection to Americans’ concerns that the mRNA vaccines may have adverse side effects has come to a close, despite the initial advertisements that the vaccines were “100% safe and effective,” prevented infection and transmission, and had no known serious side effects.
Editor’s note: This is a “randomized clinical trial” with a “placebo-controlled” group, but some have suggested this may not be a “randomized controlled trial,” so the precise language of the study has been adopted here.
OPINION: This article contains commentary which reflects the author's opinion.