Global disparities in regulatory approval of prophylactic vaccines, 2005-2024.

BACKGROUND

Timely approval of prophylactic vaccines is essential to equitable access, especially in low- and middle-income countries (LMICs) disproportionately affected by vaccine-preventable diseases. In this cross-sectional analysis, we characterised the global landscape of regulatory approvals for new prophylactic vaccines over the past two decades.

METHODS

We retrieved data from Pharmaprojects for new prophylactic vaccines approved globally from 2005-2024. We quantified approval volume and delay - defined as the number of countries, territories, and areas (CTAs) approving each vaccine, and the time (in days) between global first approval and subsequent national approvals. We conducted an exploratory multivariable linear regression analysis to identify factors potentially associated with approval delays.

RESULTS

Of the 416 prophylactic vaccines, 67.8% received approval in only one CTA, and just 12.8% reached more than five CTAs between 2005 and 2024. By 2024, the European region had the highest total number of approvals (n = 2410), while Africa had the fewest (n = 56). Median global approval delay for prophylactic vaccines was 213 days (interquartile range (IQR) = 93.0, 768.8), ranging from 161.0 days (IQR = 84.0, 646.0) in Europe to 705.5 days (IQR = 183.3, 2220.3) in the Western Pacific region. Our multivariable models showed that a lower income level may be associated with longer delay. Other factors, such as the type of vaccine and regulatory designation, were also identified as potential correlates.

CONCLUSIONS

Disparities in vaccine approval volume and timing persist across regions. Targeted policy actions are needed to strengthen regulatory systems in LMICs and reduce structural barriers to equitable vaccine access globally.