CEPI, Oxford, and Serum Institute Establish 100,000-Dose Nipah Virus Vaccine Reserve for Emergency Response
核心洞察
The Coalition for Epidemic Preparedness Innovations (CEPI), University of Oxford, and Serum Institute of India announced a collaboration to create the world's largest investigational reserve of Nipah virus (搜索) vaccine doses.
CEPI will provide up to $7.3 million in funding to support manufacturing of 100,000 doses of the ChAdOx1 NipahB vaccine candidate for Phase II trials and emergency outbreak response.
The initiative addresses a critical unmet medical need, as Nipah virus (搜索) has a fatality rate of up to 75 percent with no currently approved countermeasures.
The Coalition for Epidemic Preparedness Innovations (CEPI), the University of Oxford, and the Serum Institute of India have announced a groundbreaking collaboration to establish the world's largest investigational reserve of Nipah virus (搜索) vaccine doses. The partnership will create a stockpile of up to 100,000 doses of the ChAdOx1 NipahB vaccine candidate, designed to support Phase II clinical trials and provide rapid response capability for future outbreaks.
Critical Need for Nipah Virus Countermeasures
Nipah virus (搜索) represents one of the world's most dangerous viral pathogens, belonging to the paramyxovirus (搜索) family with a reported fatality rate of up to 75 percent. Since its identification in Malaysia in 1999, outbreaks have primarily occurred in India and Bangladesh, yet no approved countermeasures currently exist to combat this deadly pathogen.
"By advancing clinical testing and manufacturing thousands of vaccine doses against one of the world's deadliest viral pathogens, in a region where the virus persistently occurs, we're creating a state of readiness against Nipah outbreaks," said Dr Amadou Sall, CEPI's Executive Director of Manufacturing and Supply Chain.
Leveraging Proven Platform Technology
The ChAdOx1 NipahB vaccine utilizes the same viral vector platform as the Oxford-AstraZeneca COVID-19 vaccine, providing a foundation of established safety and manufacturing experience. The Serum Institute of India, which produced over 2 billion doses of the ChAdOx COVID-19 vaccine, will leverage this proven manufacturing capability to produce the Nipah vaccine reserve at its facilities in Pune.
CEPI funding of up to $7.3 million will support the Serum Institute in process development and manufacturing of the University of Oxford's vaccine candidate. The company will manufacture doses for Phase II clinical trials while simultaneously building the emergency reserve stockpile.
First-in-Class Clinical Development
The planned Phase II trials represent a significant milestone, as they are expected to be the first mid-stage trials for a Nipah virus (搜索) vaccine candidate globally. The Serum Institute will supply clinical trial material to the University of Oxford, which is conducting the CEPI-funded clinical trials in Nipah-affected countries.
"Developing a Nipah vaccine that can be tested and used in regions where Nipah outbreaks occur regularly is a vital step toward ensuring communities most at risk are protected," said Professor Brian Angus, University of Oxford and Chief Investigator of the trial at the Oxford Vaccine Group.
Addressing Regulatory Challenges
The unpredictable nature of Nipah outbreaks presents unique challenges for traditional vaccine development pathways. Because Nipah outbreaks are typically small and unpredictable, traditional large-scale efficacy trials are unlikely to be feasible. Phase II data combined with outbreak-associated safety and immunogenicity data may help support regulatory pathways in affected regions.
Global Health Impact and Equitable Access
Dr Umesh Shaligram, Executive Director of the Serum Institute of India, emphasized the global health significance of the initiative: "The collaboration with CEPI and the University of Oxford to develop and manufacture an investigational reserve of the ChAdOx-Nipah vaccine candidate marks a significant step forward in our pandemic preparedness efforts. Our aim is to ensure that life-saving doses reach those most in need, particularly across the Global South."
The collaboration aligns with CEPI's 100 Days Mission to accelerate vaccine development and represents part of CEPI's broader commitment of around $150 million to Nipah virus (搜索) vaccine, biologics and enabling science programmes. All partners have committed to equitable access in line with CEPI's Equitable Access Policy, including availability of vaccines to populations at risk in the Global South.