In 2020, prior to the 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.
The list comprised adverse events of special interest (AESIs), adverse events associated with prior vaccines in general, theoretical associations based on animal models, and Covid-19 specific immunopathogenesis; the process of disease development involving an immune response or components thereof.
The World Health Organization’s Global Advisory Committee both endorsed and recommended the reporting of AESIs based on this priority list.
Scientists then sought to investigate the association between FDA-authorized mRNA COVID-19 vaccines and serious adverse events identified by the Brighton Collaboration, using data from the still ongoing phase III randomized, placebo-controlled clinical trials on which emergency authorisation was based.
Scientists discovered that in the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) greatly surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group (6.4 per 10,000 participants). This means recipients of the Modern injection were and are 140% more likely to suffer a serious adverse event than they are to be hospitalised with Covid-19.
In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) surpassed the risk reduction for COVID-19 hospitalisation relative to the placebo group (2.3 per 10,000 participants). This means recipients of the Pfizer injections were and are 339% more likely to suffer a serious adverse event than they are to be hospitalised with Covid-19.
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).
The combined risk reduction for Covid-19 hospitalisation equates to 4.35 per 10,000 participants. Therefore, recipients of mRNA Covid19 injections were and are on average 187% more likely to suffer a serious adverse event than they are to be hospitalised with Covid-19.
The scientists who conducted the study noted how when the FDA reviewed serious adverse events (SAEs) in relation to the Pfizer vaccine they concluded that SAEs were “balanced between treatment groups”.
But in contrast to the FDA’s questionable review, the scientists who conducted the W.H.O. endorsed study found an increased risk of all-cause serious adverse events in the Pfizer trial.
The full World Health Organization endorsed study can be viewed in full here, but the scientists concluded that a systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups.
However, they note that to do this full transparency of the COVID-19 vaccine clinical trial data is needed to properly evaluate these questions. But unfortunately, well over a year after the widespread use of COVID-19 vaccines, participant-level data remain inaccessible. With the FDA attempting to delay the release of some of this data for 75 years.
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