ChAdOx1 NipahB vaccine candidate – developed by scientists at the University of Oxford – has been granted access to the PRIority MEdicines (PRIME) scheme by the European Medicines Agency. Oxford is the first UK academic institution to be awarded this designation.
Nipah virus is a deadly disease recognised by the World Health Organization as a research priority due to its pandemic potential. Such a vaccine is urgently needed as the disease can be fatal in up to 85% of cases.
Nipah virus is carried by fruit bats (genus Pteropus), also known as flying foxes. in terms of affected areas, Nipah outbreaks have only been reported from Bangladesh, India, Malaysia, the Philippines, and Singapore.
Nipah virus is from the same family as measles. 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.
By being awarded PRIME designation, this recognises the vaccine’s potential to address the unmet medical need arising from this devastating disease, which can cause a pandemic.
PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. PRIME products benefit from enhanced support from EMA, tailored to the relevant stages of development.
This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.
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 research was performed at the Pandemic Sciences Institute is an interdisciplinary research institute at the University of Oxford dedicated to confronting the challenge of epidemic and pandemic infectious diseases. The researchers work with academia, industry and public health organisations across the world to create science-led innovations, accelerate understanding, and develop new diagnostics, treatments, vaccines and disease control tools. PSI is hosted by the University’s Nuffield Department of Medicine.
The ChAdOx1 NipahB vaccine is currently in a Phase I clinical trial in Oxford led by the Oxford Vaccine Group.
On granting the status, 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.”
The EMA has equivalent regulatory status to the US FDA within the European Union.
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.”
