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Delay in Vaccine Access in ASEAN Countries.

Nilubon Subsittipong1, Junjeong Choi1, Tae Hyun Kim2

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Summary

Vaccine approval lags in Asia-Pacific countries are significantly longer than in the US and EU, delaying patient access to new vaccines. This study highlights a critical gap in vaccine availability across the region.

Keywords:
Asia-Pacificapproval lagvaccine

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Area of Science:

  • * Pharmaceutical Sciences
  • * Public Health
  • * Regulatory Affairs

Background:

  • * New vaccine introduction has been delayed in some Asia-Pacific countries, impacting patient access.
  • * The extent of vaccine approval lag in this region remains largely unassessed.
  • * This study addresses the need to evaluate vaccine availability and approval timelines in Asia-Pacific nations.

Purpose of the Study:

  • * To assess and compare vaccine approval lags in Asia-Pacific countries against the United States (US) and Europe (EU).
  • * To analyze the availability of World Health Organization (WHO) prequalified vaccines across different regulatory environments.

Main Methods:

  • * Analyzed 61 WHO prequalified vaccines (2010-2019) approved in Australia, India, South Korea, Thailand, Singapore, Malaysia, the US, and EU.
  • * Categorized vaccines based on initial approval by Stringent Regulatory Authorities (SRAs) or non-SRAs.
  • * Calculated median approval lag (relative lag) and used Mann-Whitney U test for statistical comparison.

Main Results:

  • * Over 50% of analyzed vaccines were first licensed by non-SRAs.
  • * Median approval lags were substantially longer in Asia-Pacific countries (e.g., Australia: 30 months, Thailand: 52 months) compared to the US and EU (0 months).
  • * Statistically significant differences in approval lags were found between SRA-first and non-SRA-first vaccines in South Korea and Thailand (p < 0.05).

Conclusions:

  • * A notable vaccine approval lag exists in the Asia-Pacific region, creating an access gap compared to the US and EU.
  • * Further research is needed to identify factors contributing to these delays and their impact on public health.
  • * Addressing these lags is crucial for improving timely access to essential vaccines in the Asia-Pacific region.