Timeline for mRNA Vaccine Development for Rift Valley Fever
Caryn Fenner and Petro Terblanche outline Afrigen's clinical trial plans, local partnerships, and vaccine pipeline.
Afrigen Biologics, a South African biotechnology company, has secured a $6.2 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop the first mRNA-based vaccine for Rift Valley fever (RVF). This funding will advance the vaccine candidate through preclinical development and into Phase I clinical trials, with testing planned in South Africa or another outbreak-affected country.
Rift Valley fever, a mosquito-borne disease affecting humans and livestock in Africa and the Middle East, has long been a concern due to its potential to cause epidemics and pandemics. While vaccines for animals exist, no licensed human vaccine is currently available. CEPI’s investment marks the fourth commitment to RVF vaccine development and the first to support an mRNA-based candidate. This project aligns with CEPI’s mission to accelerate the development of vaccines for epidemic threats, particularly in low- and middle-income countries.
Afrigen’s mRNA technology, developed through its role in the WHO and Medicines Patent Pool (MPP) mRNA Technology Transfer Programme, aims to offer a faster response to RVF outbreaks than traditional vaccines. The company also plans to build local vaccine production capacity across Africa to address urgent needs and strengthen regional preparedness for future outbreaks.
In a recent interview, Caryn Fenner, leader of Afrigen’s mRNA program, and CEO Petro Terblanche shared their insights on developing this crucial vaccine and its broader impact on global health. The conversation highlighted the aggressive timeline for clinical trials and the critical focus on safety, immunogenicity, and rapid manufacturing.
The timeline reflects Afrigen's commitment to moving quickly, especially given the urgency of the global need for vaccines against emerging diseases, “We have quite an aggressive timeline for this project. It's about 18 months to get us into a clinical trial. Something very important in terms of milestones for clinical trials is to demonstrate the safety of the vaccine, so that it is immunogenic and that your vaccine is stable. So those are the three key things that have to be at the forefront of your development work as you go along.”
Terblanche outlined the importance of aligning the vaccine's development with local needs, emphasizing the role of regional manufacturing and public health collaboration, “The development of a new vaccine is safety and immunogenicity, but also that the public health system supports this vaccine. So part of the vaccine development, thermal stability, and other properties of the vaccine are quite important. And, of course, price—it is important that the vaccine that is developed is affordable and that the public health system can absorb it. But what is also important for us is that we have vaccine manufacturers located in the regions where we now know the disease occurs."
She continued, "If we look at the current epidemiology and the distribution of the disease in Western Africa, Saudi Arabia, Yemen, and a few countries where we had some incidences over the last few years, it's important for us to make sure that the technology we develop here could be transferred to a manufacturer in that region. And that is very aligned with the African continent’s strategy to build the sector on the continent and to ensure that we also localize the production of vaccines that are developed on the continent or which are needed by the continent. So, as the product develops and as the product matures and moves into clinical trials, we have to work very carefully with public health and the authorities to ensure that the probability of support and the probability of introduction of the vaccine in areas where it is needed is optimally achieved. So, it has to be integrated."
"It has to be also worked with communities, understanding what a target product profile is, understanding how the public health sector can absorb this vaccine, and how it can be distributed. It has to be a very integrated approach to the vaccine innovation," Terblanche concluded.
Fenner outlined a pipeline that includes not only RVF but also vaccines targeting RSV, bacterial diseases like gonorrhea and TB, and high-priority pathogens like HIV and MERS,“The pipeline of products that we are working on does not only include zoonotic diseases like Rift Valley fever, but we will also work on diseases that touch across different pathogen categories to demonstrate the utility of the platform. As for Rift Valley fever, it is caused by a virus. We’re also working on Respiratory Syncytial Virus (RSV), which is important in the aged and in other very young infants. Then we are working on some bacterial pathogens, which include gonorrhea and tuberculosis (TB). And then the last ones are HIV, which is, as you know, we have a very high burden of disease in Africa, and MERS, which again, has the risk of causing a huge epidemic.”
