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Characterising the benefits and risks of vaccines approved through accelerated pathways

Cracknell Daniels, B.; Endy, T.; Lewnard, J.; Di Fabio, J. L.; Cortes-Azuero, O.; Breugelmans, G.; Cauchemez, S.; Precioso, A.; Ko, A. I.; Chandler, R. E.; Thomas, S. J.; Lurie, N.; Salje, H. J.

2025-06-01 infectious diseases
10.1101/2025.05.31.25328649 medRxiv
Show abstract

Alternative regulatory pathways for vaccine licensure without traditional Phase III efficacy trials are of increasing priority for epidemic pathogens. Using IXCHIQ, a chikungunya virus vaccine licensed through an accelerated pathway, we demonstrate that prior understanding of disease risk from infection can inform risk-benefit assessments for new vaccines. The mass deployment of IXCHIQ during an ongoing outbreak in La Reunion was suspended in those aged 65y+ following three deaths in vaccine recipients, although two appear unlikely to have been vaccine-linked. For individuals aged 18-64y, we find the vaccine benefits outweigh risks across epidemiological settings. In those aged 65y+, we estimate a net benefit in large outbreaks, which includes the La Reunion outbreak, and endemic settings. There is insufficient evidence of a net benefit in smaller outbreaks or in travellers. Our generalizable approach can help guide trial recruitment, inform vaccine implementation, and provide a foundation for weighing potential benefits against vaccine-associated risks.

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