©
Getty images, PB Floyd
Launched in 2016, PRIME provides targeted scientific and regulatory support to medications designed to address conditions with an unmet medical need; there are currently no licensed vaccines or treatments for Nipah virus. The additional support offered by EMA PRIME has been granted on the basis of compelling preclinical data and preliminary clinical evidence, and will help to accelerate the development and regulatory approval of the ChAdOx1 NipahB vaccine, which is currently in a Phase I clinical trial in Oxford led by the Oxford Vaccine Group.
Nipah virus is a deadly disease from the same family as measles, and is recognised by the World Health Organization as a research priority due to its pandemic potential. A vaccine is urgently needed as the disease can be fatal in up to 85% of cases. First identified after an outbreak in Malaysia, it causes small outbreaks in Bangladesh every year, and occasionally in India. Of the 750 cases recorded since 1999, there have been 415 deaths.
The zoonotic virus is carried by fruit bats and its main route of transmission is through drinking contaminated date palm sap. Humans may also be infected via an intermediate animal host, or by person to person spread including healthcare workers. Initial symptoms include fever, headaches, muscle pain, vomiting and sore throat. These can quickly progress to acute encephalitis, pneumonia and severe respiratory problems.
In its letter of confirmation to Oxford investigators, the EMA said: “Nipah virus disease in humans is associated with significant morbidity and a high mortality rate and consequent public health impact. The increasing frequency of human encounters with fruit bats and spillover into densely populated areas is expanding opportunities for Nipah virus transmission, heightening its outbreak potential.”
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 on 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."
The vaccine development and trials are being funded by CEPI.