Index Entries

Elisabeth Paul, Garrett W. Brown, Valéry Ridde, and Joachim P. Sturmberg
March 29, 2024
Public Health in Practice

"Methods

Based on a targeted literature survey, we first clarify the known limits of traditional scientific methods and then reflect on how the scientific reporting about Covid-19 mRNA vaccines has evolved ...

4. An illustration: Covid-19 vaccines 

... First, science – through the clinical trials of mRNA vaccines – showed efficacy above 90% (see above). Yet, this is calculated in terms of relative risk reduction – that is, the percentage of reduction in adverse outcomes between the vaccinated and the unvaccinated. However, 'the most useful way of presenting research results to help your decision-making' is absolute risk reduction – that is, actual difference in risk between two groups. When calculating Covid-19 vaccines’ absolute risk reduction based on the same reported outcome data, it is far less convincing1.2% for the Moderna and 0.84% for the Pfizer vaccine.

Second, science – through observational data – showed that a third dose of the Pfizer vaccine was 93% (relative) effective against admission to hospital, 92% (relative) effective against severe disease, and 81% (relative) effective against COVID-19-related death. Of note, these results were found after a median follow-up time of only 13 days which is a clinically meaningless timeframe, being a short-term outcome irrelevant to policymaking, and even if 'true', pragmatically impossible to apply as it would require vaccination twice a month.

Third, science – based on the individual clinical trials – showed a good safety profile of Covid-19 mRNA vaccines. However, a re-examination of pooled safety data to get more statistical power, showed that the mRNA vaccines were associated with an excess risk of 'serious adverse events of special interest' (as defined by the Brighton Collaboration) of 12.5 per 10,000 vaccinated – that is, one in every 800 vaccinated. Such an adverse event rate must be contextualised in relation to risk-benefit estimates, which we regard as an imperative from a research and policy ethics perspective.

Fourth, even with increasingly reported waning effectiveness, science suggests that the Covid-19 vaccines remain effective in preventing severe Covid-19 among at-risk populations. Yet, science – in a risk-benefit analysis – also showed that adolescents do not benefit from the Pfizer vaccine, except for non-immune girls with comorbidities. Unstratified effectiveness measured by only a single performance measure, should not be the only criterium to inform clinical and policy decision-making, equally important are considerations of efficiency, equity, and acceptance.

Fifth, while the clinical trials were not designed to evaluate the vaccine's effect on mortality, a systematic review of observational data showed an effect of the vaccines reducing 'Covid-19 related death'. Yet, the Pfizer study's supplementary material shows there was one more death ('overall mortality') in the vaccine than placebo group. Albeit a statistically insignificant result, hiding this finding is not 'responsible conduct of research', nor ethically defensible. It indeed may damage the trustworthiness of science, given that the pooled mRNA trial results showed a statistically significant relative 'all cause' risk increase for mRNA vaccination (hazard ratio 1.03) ... 

Conclusion

By trying to reduce 'science' – which, by definition, explores doubts, complexity, and is in constant evolution – to simple messages set in stone, scientists can become the worse enemies of science. The independence of science should be paramount, however, the pervasive influence of political expediency, industrial interests and corruption in healthcare and medicine does not serve its inquiries. To regain public trust in science, it is high time scientists acknowledge the limitations of their methods and of their results, and to provide decision-makers, populations and healthcare providers with appropriate tools to judge how to best apply particular research results to individuals and communities. Science can never provide insights that allow the imposition of a universal blueprint to all. What it requires is reinvigorated commitments to deliberative science and politics, democratic procedures, open contestation without epithets, genuine reason-giving, and, most importantly, humility."

document
adverse events,bioethics,censorship,clinical trials,COVID-19,health statistics,health statistics misleading practices,manufacturers,mRNA,vaccines