Serum - Protection from birth onwards
OSLO/ PUNE, October 14, 2025 - CEPI is collaborating with the world’s largest vaccine manufacturer, Pune-based Serum Institute of India (SII) Pvt. Ltd., part of Cyrus Poonawalla Group, to boost pandemic response preparedness using a baculovirus vaccine platform to target H5N1 bird flu as a prototype for a potential Disease X—an as-yet-unknown pathogen with pandemic potential.
Supported by CEPI funding of up to US$16.4 million, SII will use its validated baculovirus-based platform to produce and compare two H5 antigens for a recombinant protein vaccine: a wild-type and an AI-optimised, broad-spectrum H5 antigen designed by scientists at Houston Methodist Research Institute. The broad-spectrum approach is designed to elicit immune responses across multiple strains of H5 viruses, rather than just one, making it particularly suited for use in unpredictable outbreak situations.
The collaboration will ultimately pressure-test the baculovirus platform's ability to quickly produce new antigens against H5 viruses, simulating a fast response to a future pandemic threat. The work will also serve as proof of concept for using AI to design vaccine antigens capable of inducing broadly protective immunity. Antigens are proteins that trigger an immune response and are a critical part of an effective vaccine.
"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 development through to global manufacture and supply", said Dr Richard Hatchett, CEO of CEPI.
"With a potential pandemic influenza vaccine candidate already in development on a validated platform, and with a vaccine manufacturing juggernaut ready to go, the world’s disease defences will be poised to respond swiftly with new vaccines, potentially in 100 days, should a flu virus erupt into a potentially deadly and fast-spreading human pandemic".
Baculovirus-based vaccines use a harmless insect virus that has been genetically modified to produce an antigen of a given virus. As they can be quickly created once a viral sequence is available, they are an ideal candidate for faster responses against potential pandemic diseases. This aligns with CEPI’s 100 Days Mission — a goal embraced by leaders of the G7 and G20 to accelerate vaccine development to within 100 days of identifying a pandemic threat.
Adar Poonawalla, CEO, Serum Institute of India, said, "We are pleased to strengthen our collaboration with CEPI through this important initiative targeting H5N1. Our validated baculovirus platform gives us the ability to rapidly develop and produce vaccines for emerging threats. This project will test that readiness in real terms, reinforcing our commitment to pandemic preparedness. The learnings will not only support faster response times but also ensure that effective vaccines can reach vulnerable populations without delay".
SII, which supplies vaccines to more than 170 countries, is well known for its rapid response work during infectious disease outbreaks. It has extensive experience with processes for recombinant protein-based vaccines with similar baculovirus technology.
In 2024, SII joined CEPI’s vaccine manufacturing facility network, which aims to expand pandemic response preparedness aligned to the 100 Days Mission and support equitable access to outbreak vaccines, particularly in Global South countries. This funding is awarded as part of that initial agreement.
The project will also leverage the expertise of CEPI's Preclinical Model Network and Centralized Laboratory Network members—the UK Health Security Agency and the Medicines and Healthcare products Regulatory Agency—alongside the Francis Crick Institute, to conduct key testing activities to demonstrate that the wild-type and AI-optimised H5 vaccines are fit for purpose.
Commitment to equitable access
CEPI and SII have agreed to enabling equitable access to the outputs of this CEPI-supported programme, in line with CEPI's Equitable Access Policy. This ultimately includes a commitment to vaccines being available first to populations at risk particularly in the Global South, when and where they are needed at an affordable price should a related vaccine be developed further using CEPI funding. Where possible, project results including data generated as part of this project (other than sensitive CMC data) will be published open access for the benefit of the global scientific community.
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Notes to editors
About HMRI AI antigen technology
The Houston Methodist Research Institute (HMRI) has combined its cutting-edge artificial intelligence (AI) technology with established laboratory techniques to accelerate the development of broadly protective H5 vaccine candidate antigens. The AI technology employed by HMRI involves advanced machine learning algorithms that analyse vast datasets of viral genetic sequences and immune responses. These algorithms identify potential vaccine candidates by predicting the most effective antigens that can elicit a strong and broad immune response.
About CEPI
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 70 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating plan is the ‘100 Days Mission’ to accelerate the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.
Learn more at CEPI.net
About Serum Institute of India
Serum Institute of India Pvt. Ltd, part of Cyrus Poonawalla Group is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SIIPL's multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.
Founded in 1966, SIIPL's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosiil,' the world's most affordable PCV, 'Cervavac' the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second Malaria vaccine to be authorized for use in children in malaria-endemic regions, ‘MenFive’, the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric population. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.
To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide.
www.seruminstitute.com
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