The University of Oxford’s vaccine candidate against the deadly Nipah virus has received PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA)—a significant regulatory milestone that makes Oxford the first UK academic institution to secure this status.
Launched in 2016, the EMA’s PRIME scheme supports the development of medicines that target conditions with high unmet medical need. Currently, there are no approved vaccines or treatments for the Nipah virus, which has a mortality rate of up to 85%. The EMA’s support for Oxford’s ChAdOx1 NipahB vaccine is based on promising preclinical results and preliminary clinical trial data. The vaccine is currently undergoing Phase I trials at the Oxford Vaccine Group.
Nipah virus, a zoonotic disease related to measles, is listed by the World Health Organization as a research priority due to its high fatality rate and pandemic potential. Since its first outbreak in Malaysia, Nipah has caused repeated epidemics in Bangladesh and sporadic cases in India, with 415 deaths from 750 known cases since 1999.
Transmitted primarily through contact with fruit bats or consumption of contaminated date palm sap, the virus can also spread via intermediate animal hosts or from human to human, including among healthcare workers. Early symptoms—such as fever, muscle pain, and vomiting—can escalate rapidly to encephalitis, pneumonia, and severe respiratory issues.
In its confirmation letter to Oxford, the EMA emphasized the growing public health threat posed by Nipah, citing increased contact between humans and fruit bats and the virus’s potential to spread in densely populated regions. It also underscored the importance of close regulatory collaboration to navigate the complex development and approval pathway for the vaccine.
Dr Daniel Jenkin, who leads the Nipah vaccine’s clinical development at Oxford’s Pandemic Sciences Institute, said:
“Our team is extremely pleased to have been awarded PRIME status by the EMA for our Nipah virus vaccine, following a review of our early trial data.
It is exceptionally rare for an academic institution to achieve this designation, and it highlights the University of Oxford’s strength in all aspects of vaccine development. We are fully committed to advancing this vaccine and look forward to the enhanced interaction with the EMA that PRIME designation will enable.”
Professor Brian Angus, Chief Investigator of the Oxford Nipah Vaccine Programme, added:
“This targeted regulatory support for our vaccine programme is a huge boost to the search for a solution to Nipah virus outbreaks. We are hopeful that the results of these trials will pave the way to protect populations most at risk—and help prevent a future global pandemic.”
Dr Kent Kester, Executive Director of Vaccine Research and Development at the Coalition for Epidemic Preparedness Innovations (CEPI), which is funding the project, said:
“Nipah virus has significant outbreak potential, a high fatality rate, and no approved vaccines, making it a clear priority for pandemic preparedness.
PRIME recognition of Oxford’s CEPI-supported Nipah vaccine candidate will help accelerate its development through earlier and closer engagement with regulators. This is a vital step toward protecting communities from future deadly outbreaks.”
