A peer-reviewed study published two days ago found that both the Moderna and the Pfizer vaccine trial data appeared to have a negative benefit/harm ratio. One of the authors of the paper is Peter Doshi, an associate editor of the British Medical Journal.
Using a prespecified list of adverse events of special interest (“AESI”) identified by the Brighton Collaboration, the study found a higher risk of serious AESI in the mRNA COVID-19 vaccine group relative to placebo in both the Pfizer and Moderna adult phase III trials.
“These results raise concerns that mRNA vaccines are associated with more harm than initially estimated at the time of emergency authorisation,” the study authors wrote.
dverse Events of Special Interest (“AESI”)
In 2020, before the mass Covid injection campaign, the Brighton Collaboration created a priority list of Covid injection AESIs. This list was endorsed by the World Health Organisation. “To our knowledge, however, the list has not been applied to serious adverse events in randomised trial data,” the study authors wrote.
So, the researchers adapted this list to evaluate AESIs observed in both the Pfizer and Moderna mRNA Covid-19 vaccine phase III randomised, placebo-controlled clinical trials on which the US Food and Drug Administration (“FDA”) emergency use authorisation was based:
We conducted a simple comparison of harms with benefits to illustrate the need for formal harm-benefit analyses of the vaccines that are stratified according to risk of serious Covid-19 outcomes. Our analysis is restricted to the randomised trial data, and does not consider data on post-authorisation vaccination program impact.
Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M. Kaplan, Peter Doshi, Serious adverse events of special interest following mRNA COVID-19 vaccination in randomised trials in adults, Vaccine, 2022, ISSN 0264-410X, https://doi.org/10.1016/j.vaccine.2022.08.036.
The authors found:
- a 57 % higher risk of serious AESI in vaccinated trial participants (Pfizer);
- a 36 % higher risk of serious AESI in vaccinated trial participants (Moderna);
- combining the trials, there was a 43 % higher risk of serious AESI in vaccinated participants; and,
- in both Pfizer and Moderna trials, the largest excess risk occurred in the category of coagulation disorders.
The authors also noted that “Cardiac disorders have been of central concern for mRNA vaccines; in the Pfizer trial more cardiovascular AESIs occurred in the vaccine group than in the placebo group, but in the Moderna trial the groups differed by only 1 case.”
Other key findings from the paper:
- In the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) was higher than the risk reduction for Covid hospitalisation relative to the placebo group (6.4 per 10,000 participants).
- In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) was higher than the risk reduction for Covid hospitalisation relative to the placebo group (2.3 per 10,000 participants).
