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Serum Institute & CEPI: H5N1 Pandemic Prep Boost

CEPI and Serum Institute of India Partner to Rapidly Develop H5N1 Vaccine, Prototype for ‘Disease X’

A new collaboration between the Coalition for Epidemic Preparedness Innovations (CEPI) and the Serum Institute of India (SII) aims to accelerate pandemic response capabilities using a novel baculovirus vaccine platform targeting H5N1 avian influenza, serving as a crucial prototype for responding to a future, unknown pandemic threat – frequently enough referred to as “Disease X.”

OSLO/PUNE, October 14, 2024 – CEPI will provide up to $79.4 million USD to SII to develop and manufacture a next-generation vaccine against H5N1,utilizing both a traditional,wild-type antigen and an AI-optimized,broad-spectrum H5 antigen developed by researchers at the Houston Methodist Research Institute. This innovative approach seeks to generate immune responses effective against multiple strains of H5 viruses, a critical advantage in unpredictable outbreak scenarios.

The project is designed to rigorously test the baculovirus platform’s speed and efficiency in producing new antigens in response to evolving H5 viruses, effectively simulating a rapid response to a future pandemic. furthermore, the work will validate the potential of artificial intelligence (AI) in designing vaccine antigens capable of inducing broadly protective immunity – a meaningful step forward in proactive pandemic preparedness. “Antigens are proteins that trigger an immune response and are a critical part of an effective vaccine,” explained a senior official involved in the project.

According to Dr.Richard Hatchett, CEO of CEPI, “this new project-which deepens our collaboration with SII, one of CEPI’s preferred vaccine manufacturing partners-is designed to power up global readiness to tackle pandemic threats, from early-stage vaccine progress through to global manufacture and supply.” He added that with a potential influenza vaccine candidate already in development and SII’s substantial manufacturing capacity,the world could be poised to respond with new vaccines within 100 days of a pandemic’s emergence.

Baculovirus-based vaccines offer a promising solution for rapid response due to their production process. These vaccines utilize a harmless insect virus that is genetically modified to produce a specific viral antigen. once the genetic sequence of a virus is available, these vaccines can be created relatively quickly, making them ideal candidates for combating potential pandemic diseases. This aligns directly with the 100 Days Mission, a commitment from G7 and G20 leaders to accelerate vaccine development timelines.

Adar Poonawalla, CEO of Serum Institute of India, stated, “We are pleased to strengthen our collaboration with CEPI through this significant initiative targeting H5N1. Our validated baculovirus platform gives us the ability to rapidly develop and produce vaccines for emerging threats.” He emphasized that the project will rigorously test this readiness, reinforcing SII’s dedication to pandemic preparedness and ensuring effective vaccines reach vulnerable populations without delay.

SII,a leading vaccine manufacturer supplying over 170 countries,has a proven track record of rapid response during infectious disease outbreaks. The company possesses extensive experience in recombinant protein-based vaccine production utilizing similar baculovirus technology.In 2024, SII joined CEPI’s vaccine manufacturing facility network, furthering the expansion of pandemic response preparedness and supporting equitable access to outbreak vaccines, particularly in the Global South. The current funding is a direct result of that initial agreement.

The project will also draw upon the expertise of the UK Health Security Agency, the Medicines and Healthcare products Regulatory Agency, and the Francis Crick Institute – all members of CEPI’s Preclinical model Network and Centralized Laboratory Network – to conduct critical testing and ensure the efficacy of both the wild-type and AI-optimized H5 vaccines.

A core tenet of the collaboration is a commitment to equitable access.CEPI and SII have agreed to prioritize the availability of any resulting vaccines to at-risk populations in the Global South, offering them at an affordable price should further development and funding occur. Project data, excluding sensitive manufacturing facts, will be published openly to benefit the global scientific community.

This initiative represents a significant investment in proactive pandemic preparedness, leveraging cutting-edge technology and global collaboration to safeguard against both known and unknown threats.

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