Novotech, the global full-service clinical contract research organization (CRO), has published its report «Vaccines: Global clinical trials overview 2024», which reveals strong growth in vaccine development worldwide. According to the report, Prophylactic vaccine trials lead with 72% of the total, while Therapeutic vaccines, although less common, are gaining ground with a focus on diseases such as cancer.
Regional distribution and growth rates
Asia-Pacific region consolidates global leadership with 46% of prophylactic vaccine trials, compared to 22% in North America and 15% in Europe. For therapeutic vaccines, North America ranks first (36%), followed by Asia-Pacific (31%) and Europe (29%). These figures reflect a competitive advantage of Asia-Pacific in terms of rapid trial recruitment and execution.
Similarly, in Africa, significant progress is being seen in innovative trials, such as the recent permit granted for a Pioneering Ebola vaccination trial in Uganda.
Furthermore, prophylactic vaccines are experiencing impressive growth with a CAGR of 54.9%, while therapeutics are advancing at 21.2%. This highlights the growing global demand for disease prevention and continued innovation in immunotherapies.
Key differences between prophylactic and therapeutic vaccines
The prophylactic vaccines, designed to prevent disease in healthy populations, move more quickly through the regulatory phases due to clear processes and large-scale demand.
On the other hand, therapeutic vaccines, which target patients with pre-existing conditions, face greater challenges. These trials are often left in early phases (I or II) due to stricter safety requirements and limited patient groups.
Innovations in clinical trial designs
The clinical trial landscape is evolving rapidly thanks to new designs such as adaptive trials, which allow real-time adjustments based on interim results, and challenge trials, which have been widely used during the COVID-19 pandemic.
In addition, artificial intelligence is transforming the detection and treatment of diseases. An example is a New UK trial for early detection of breast cancer.
Other approaches, such as basket and umbrella trials, have optimized therapeutic trials by testing multiple treatments under a single protocol, accelerating the development of vaccines against complex diseases such as cancer.
Regulations and responses to health emergencies
The report highlights the Evolution of regulatory frameworks that speed up vaccine development. Agencies such as the FDA, EMA and WHO have implemented accelerated processes, such as Emergency Use Authorizations (EUA), that allowed COVID-19 vaccines to be approved in a matter of months rather than years. Asia-Pacific has adopted similar models, strengthening its position as a global leader in clinical trials.
The response to emerging threats such as Mpox, RSV and Zika is redefining the landscape. mRNA platforms, which played a crucial role in the COVID-19 pandemic, are leading the development of vaccines for new infectious diseases.
Transformative technologies in vaccine development
Advances such as artificial intelligence (AI) for participant recruitment, microarray patches (MAPs) for managing needle-free vaccines and adaptive trial designs are revolutionizing the industry.
In particular, the MAP offers affordable solutions for mass vaccination in low-resource regions, with significant investment from China. These innovations are reducing development times and increasing efficiency in vaccine administration.
Challenges and opportunities in clinical trials
Despite progress, significant challenges remain. Efficient recruitment remains an obstacle, especially in therapeutic trials, where patient groups are smaller.
Furthermore, while adaptive designs provide flexibility, they also require stricter oversight. Overcoming these barriers will depend on the integration of advanced technologies and greater collaboration between regulators, governments and private industry.
