A report by Novotech has identified emerging trends in the vaccine clinical trial sector, highlighting a shift towards adaptive trial designs.
Published last week, the whitepaper reported that prophylactic vaccines “are increasingly adopting adaptive and accelerated designs to meet urgent public health needs”, pointing out the advantage of rapid and flexible trials in response to global health emergencies.
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It added that advancements in mRNA vaccines are driving more adaptive and responsive clinical trial frameworks. The mRNA field “became a cornerstone of the global response” after the development of the Covid-19 vaccine, which demonstrated the need for a rapid and flexible process, says the report.
The successful production and mass rollout of Covid-19 vaccines drove further development of prophylactic vaccines, which “dominate the landscape”. Novotech identifies a 54.9% compound annual growth rate (CAGR) in the sector between 2019 and 2024, compared to a 21.2% CAGR in therapeutic vaccines. Prophylactic vaccine trials are often large and randomised, making them suited to adaptive designs, compared to targeted and personalised therapeutic vaccine trials.
Adaptive designs accelerate timelines by allowing modifications to clinical trials after their commencement, making them especially useful in pandemic situations, says the report. This advantage has seen them become increasingly popular in seasonal flu vaccine trials, offering flexibility in response to shifting flu strains.
The report offers the example of the novel therapeutic vaccine TherVacB, currently being trialled as a treatment for Hepatitis B. It states that the ongoing trials “utilise adaptive methodologies to adjust dosing based on real-time results, allowing faster progression through phrases.”
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By GlobalDatamRNA vaccines are also being investigated in oncology, with both Moderna and BioNTech having cancer vaccine candidates in the clinic.
Novotech’s report also considers the role of technology in shaping clinical trial approaches, specifically commenting on the developing role of artificial intelligence (AI). In adaptive trials, it reports that AI improves safety and efficacy by enabling real-time adjustments.
On AI, the report also notes the use of the technology in “transforming vaccine trials by improving participant selection, data analysis, and real-time monitoring.” It offers the examples of Pfizer and Moderna, which utilise AI-driven machine learning to assist in patient recruitment and trial diversity.
Looking forward, the report predicts that the vaccine market will reach $74bn this year, with the US expected to be the top contributor in terms of revenue. The vaccine market will see significant growth in the clinical trial landscape, which it says will be “fuelled by innovations in vaccine technology, the rising threat of global health crises, and a greater focus on strengthening public health systems.”
Despite Novotech’s prediction, earlier this month, the stock price for a number of vaccine developers dropped upon the news that President-elect Donald Trump had nominated vaccine-sceptic Robert F Kennedy Jr, popularly known as RFK Jr, as the secretary of the premier US health agency—the Department of Health and Human Services (HHS).
