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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.'
Read the full story on the University of Oxford website.