The European Medicines Agency (EMA) has granted the Oxford vaccine against the Nipah virus a PRIME designation. This program, launched in 2016, aims to support medications addressing conditions with unmet medical needs. Currently, there are no licensed vaccines or treatments for the Nipah virus. The ChAdOx1 NipahB vaccine, which is in a Phase I clinical trial in Oxford, will benefit from this additional support.
Nipah virus, related to measles, is recognized by the World Health Organization as a research priority due to its potential to cause pandemics. The disease can be fatal in up to 85% of cases and was first identified after an outbreak in Malaysia. It causes small outbreaks annually in Bangladesh and occasionally in India. Since 1999, there have been 750 recorded cases resulting in 415 deaths.
The virus is carried by fruit bats and primarily transmitted through contaminated date palm sap. Infection can also occur via intermediate animal hosts or person-to-person spread, including among healthcare workers. Symptoms start with fever, headaches, muscle pain, vomiting, and sore throat but can progress rapidly to severe conditions like encephalitis and pneumonia.
In a letter to Oxford investigators, the EMA noted: "Nipah virus disease in humans is associated with significant morbidity and a high mortality rate and consequent public health impact." They emphasized the need for close regulatory interactions due to the complexity of conducting clinical efficacy trials.
Dr. Daniel Jenkin from the University of Oxford expressed satisfaction with receiving PRIME status: "Our team is extremely pleased... It highlights the University of Oxford’s strength in all aspects of vaccine development." Professor Brian Angus added that this support boosts efforts against Nipah 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."
Dr. Kent Kester from CEPI remarked on the significance of PRIME recognition: "Nipah virus has significant outbreak potential... making it a clear priority for pandemic preparedness." He noted that this step would accelerate vaccine development by facilitating interaction with regulators.
Funding for vaccine development and trials comes from CEPI.