The University of Oxford has become the first UK academic institution to receive support from the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) scheme for its vaccine targeting the deadly Nipah virus
Nipah virus is a fatal zoonotic disease, which the World Health Organization (WHO) has highlighted as a research priority due to its pandemic potential. There are currently no licensed vaccines or treatments for the Nipah virus.
Oxford researchers have garnered support from PRIME, which provides targeted scientific and regulatory support to medications designed to address conditions with an unmet medical need. This status is a significant milestone in the development of the Nipah virus vaccine, as it signifies the recognition and support of a leading regulatory body in the field of medicine.
The Nipah virus, a member of the Paramyxoviridae family, is fatal in up to 85% of cases
Fruit bats, particularly the Pteropus genus, carry the virus, and its primary route of transmission is through the consumption of contaminated date palm sap. The virus can also be transmitted to humans through an intermediate animal host or by person-to-person transmission, including among healthcare workers.
The Nipah virus was first identified after an outbreak in Malaysia. Since then, the virus has caused small outbreaks in Bangladesh every year and occasionally in India. This underscores the urgent need for a vaccine, as the disease can be fatal in up to 85% of cases.
Pandemic outbreak potential is high
The potential for a global pandemic is high, making it crucial for global cooperation in vaccine development and preparedness.
It added: ‘Given the complexity of conducting a sufficiently powered clinical efficacy trial, close regulatory interactions with the EMA-Emergency Task Force to define a sensible pre-licensure evidence-generation pathway are essential.’
Dr Daniel Jenkin, who leads the clinical development of the Nipah vaccine at the Pandemic Sciences Institute, University of Oxford, 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 Program at the Oxford Vaccine Group, said: ‘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 for us to be able to protect some of the populations most at risk, while also helping the world avoid a future global pandemic.’
Dr Kent Kester, Executive Director of Vaccine Research and Development at the Coalition for Epidemic Preparedness Innovations (CEPI), 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 virus vaccine candidate will help accelerate the development of this urgently needed vaccine by facilitating earlier and closer interaction with regulators, and reflects a crucial step towards ensuring people can be protected against future deadly outbreaks of the virus.’
CEPI is funding the vaccine development and trials.
