In MalariaWorld this week there is a link to CBC Youtube Video entitled ‘Malaria vaccine rollout undercut by losses to global health funding’. The highlight of the video is a recent study that found that children who received three doses of Mosquirix™ (RTS,S/AS01) manufactured by GSK (Glaxo Smith Kline) were less likely to suffer from severe malaria.
The study ‘Effectiveness of the RTS,S/AS01(E) malaria vaccine in a real-world setting over 1 year of follow-up after the three-dose primary schedule: an interim analysis of a phase 4 study in Ghana, Kenya, and Malawi’ by Ndeketa et al was featured on MalariaWorld. It was published in Lancet in November 2025 and is also available to download there.
The headline results of this GSK sponsored study are that comparing vaccinated children from exposed clusters with unvaccinated children from unexposed clusters, country-adjusted incidence rate ratios were 0·70 (95% CI 0·67–0·73; p<0·001) for any malaria, 0·42 (0·30–0·60; p<0·001) for severe malaria, 0·64 (0·56–0·72; p<0·001) for malaria-related hospitalisations, 0·79 (0·74–0·84; p<0·001) for all-cause hospitalisations, and 0·83 (0·64–1·09; p=0·18) for all-cause mortality. The adjusted odds ratio for the prevalence of anaemia among children who were hospitalised (vaccinated children from exposed clusters vs unvaccinated children from unexposed clusters) was 0·81 (95% CI 0·73–0·90; p<0·001).
I always understood that a vaccine was supposed to make if very unlikely one would get the target disease. This reported result states that a vaccine recipient is still 70% as likely to get the disease as one who doesn’t. Is this reduction worthwhile? Note that the all-cause mortality improvement is not statistically significant. This means that the study did not statistically prove that vaccine recipients were less likely to die.
But this is a study paid for by the manufacturer. And of course, their paid scribes ignore the statistical uncertainty and interpret thus ‘These findings reinforce the continued use of RTS,S/AS01E vaccination in children as an effective public health measure to reduce malaria-related illness and mortality in endemic regions’.
However, now after all the COVID vaccine controversies many of us are aware that vaccine studies are often manipulated to benefit the sponsor, and I suspect this study is no different. The usual approach is to selectively exclude inconvenient subjects from the study. In this 20% of the 22,564 subjects in the six vaccinated clusters were excluded from the follow up and 5% of the unvaccinated. Many of of the exclusions were because the subject had not received three doses. Perhaps many of these suffered adverse reactions after the first or second dose. These would have been many of the weaker children of this cohort and their exclusion could significantly skew the results.