OBJECTIVES: Most national regulatory authorities (NRAs) have established regulations and guidelines on post approval changes (PACs) for vaccines with the manufacturer usually submitting PACs to all the respective NRAs in the countries of license. The multiplicity of PACs evaluation processes adopted by different NRAs requires the generation and submission of similar evidence as part of distinguished applications, possibly leading to delays in patient access. The objective of this study is to estimate the socioeconomic impact of vaccines’ PAC requirements in Brazil and Mexico and compare them with the processes in EU and US.

METHODS: Secondary and primary data were collected and analysed. A literature review was conducted, followed by interviews with regulatory experts to understand the regulatory landscape and identify potential sources of cost to society. Two vaccines were used as case studies. A health economic model was built to analyse the implication of delayed PAC approvals. Different scenarios (including shortage of vaccine due to delayed approval) were considered to account for direct and indirect costs of PAC delays.

RESULTS: Across the four regulatory authorities in the study regions (ANVISA, COFEPRIS, EMA, FDA), PACs are broadly divided into three categories relating to major, moderate, or major changes. The case studies revealed that PAC delays do not have a significant socioeconomic impact (e.g. supply shortage), but predominantly solely on manufacturers’ (e.g. supply complexity). Consequently, a supplementary literature review on vaccine delays showed a number of direct and indirect health effects and a model estimated the socioeconomic impact of hypothetical PACs scenarios (shortage of vaccine, indication extension, delayed approval), revealing that a significant societal burden might be posed by delays.

CONCLUSIONS: There are a number of regulatory redundancies in the evaluation of vaccines’ PACs. International harmonization of regulations and information sharing networks would support a more efficient supply of high quality vaccines.