Southeast Asia offers a unique opportunity for sponsors conducting clinical trials with vaccine candidates including faster recruitment, lower costs, and more favourable immunisation rates, according to Chris Chong, the clinical services senior director of the clinical research organisation (CRO) Novotech.
Regional specialities in clinical trials were a topic of discussion at the ongoing Outsourcing in Clinical Trials and Clinical Trial Supply East Asia meeting held in Seoul, South Korea, from 3 to 4 December. In a session on the first day, Chong outlined how East Asia – and Southeast Asia specifically – has a growing role in vaccine trials in a post-Covid-19 pandemic landscape.
Research by Novotech demonstrates that the Asia-Pacific region dominates prophylactic vaccine trials, with sites in the region accounting for 46% of trials in the space. This compares with 22% and 5% for North America and Europe respectively.
Chong said that Southeast Asia is a “perfect match” for vaccine trials, owing to a combination of a large vaccine naïve population with a high prevalence of emerging communicating diseases.
“Within Asia Pacific, Southeast Asia has strengths that make it a very unique and an unbeatable position for vaccine trials. A very large population with lower immunisation rates, very strong medical needs and interest from site investigators, and also very cost-effective for trials that require thousands of subjects,” Chong said.
A report by the Australian Government listed countries in Southeast Asia such as Malaysia, Indonesia and the Philippines as having low national Covid-19 vaccination rates in 2021. The Philippines was a region highlighted by Chong in a case study, where Novotech conducted a Phase II/III trial with 444 healthy volunteers – including infants and paediatric patients – recruited in ten weeks.
However, rates have been increasing since 2021 – with the World Health Organization (WHO) reporting the coverage rate for DPT3, the third dose of diphtheria, pertussis, and tetanus vaccines, which is used globally to assess vaccination rates, recovered to pre-pandemic levels of 91% in 2023.
Chong added that, generally, the clinical trial landscape has seen more activity since the Covid-19 pandemic. Key trials for therapeutics during the pandemic kickstarted the global vaccine trial topography by making trials more robust. From a trial design perspective, this coincides with the emergence of adaptive, challenge and platform trials that have accelerated vaccine development for infectious diseases.
Chong stated: “We believe that several vaccine bottlenecks were broadly addressed, including manufacturing site scalability, logistics and storage issues.
“Covid-19 also opened up the opportunities and the potential of many of the sites – that they are capable of doing trials and recruit very well in terms of healthy volunteers of different age groups and generate high-quality data, and this all together has maintained vaccine trials volume at very high post-pandemic level.”
Vaccines have been a hot topic conservation in the pharmaceutical sector following US President-Elect Donald Trump’s decision to appoint vaccine sceptic Robert F Kennedy Jr as secretary of the Department of Health and Human Services (HHS). In a September report released before the decision, Novotech said it expects the global vaccine market to reach $74bn by this year, with the US anticipated to be a top contributor.
