A recently published study, “Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials,” by Fraiman et al., is a mainstream medical paper casting doubt upon the mantra that the benefits of the mRNA vaxxes outweigh the risks, risks that the Covid mainstream seldom discuss. The paper is somewhat technical, and the abstract is reproduced below, but a good summary has been given by epidemiologist Martin Kulldorff. No, the vaxxes are not safe as advertised by the establishment.

https://brownstone.org/articles/are-the-covid-mrna-vaccines-safe/

“The Fraiman study uses data from the same Pfizer and Moderna-sponsored randomized trials presented to the FDA for vaccine approval, but with two innovations that provide additional information. 

First, the study pools data from both mRNA vaccines to increase the sample size, which decreases the confidence intervals’ size and the uncertainty about the estimated harms. 

Second, the study focuses only on the severe adverse events plausibly due to the vaccines. Serious adverse events such as gunshot wounds, suicide, animal bites, foot fractures, and back injury are unlikely to be due to a vaccine, and cancer is unlikely to be due to a vaccine within a few months after vaccination. By removing such random noise, the ability (statistical power) to detect genuine problems increases. If there is no excess risk, shorter confidence intervals bolster confidence in the safety of the vaccines. 

Classifying adverse events into the two groups is not a trivial task, but Fraiman et al. do an excellent job to avoid bias. They rely on the pre-defined Brighton Collaboration definitions of adverse events of special interest (AESI). Founded in 2000, the Brighton Collaboration has two decades of experience using rigorous science to define clinical outcomes for vaccine safety studies. 

Moreover, Fraiman and colleagues blinded the process where they classified the clinical events as AESIs. Adjudicators did not know whether the individual had received the vaccine or the placebo. Hence, any criticism of so-called p-hacking is unwarranted. 

So, what are the results? There were 139 AESIs among the 33,986 people vaccinated, one for every 244 people. That may sound bad, but those numbers mean nothing without comparison against a control group. There were 97 AESIs among the 33,951 people who received a placebo. Combining these numbers implies 12.5 vaccine-induced AESIs for every 10,000 people vaccinated, with a 95% confidence interval of 2.1 to 22.9 per 10,000 people. To phrase it differently, there is one additional AESI for every 800 people vaccinated (95% CI: 437-4762). 

That is very high for a vaccine. No other vaccine on the market comes close. … Fraiman and colleagues have produced the best evidence yet regarding the overall safety of the mRNA vaccines. The results are concerning. It is the responsibility of the manufacturers and FDA to ensure that benefits outweigh harms. They have failed to do so.”

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239

“Abstract

Introduction: In 2020, prior to COVID-19 vaccine rollout, the Coalition for Epidemic Preparedness Innovations and Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We leveraged the Brighton Collaboration list to evaluate serious adverse events of special interest observed in phase III randomized trials of mRNA COVID-19 vaccines.

Methods: Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines (NCT04368728 and NCT04470427), focusing analysis on potential adverse events of special interest identified by the Brighton Collaboration.

Results: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).

Discussion: The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes such as hospitalization or death.”