Serum Institute of India joins CEPI for preparedness against ‘Disease X’

The world’s largest vaccine manufacturer, SII, has become the fourth member of the Coalition of Epidemic Preparedness Innovation’s (CEPI’s) global network after Aspen Pharmacare in South Africa, Institut Pasteur de Dakar in Senegal, and Bio Farma in Indonesia.   

SII has previously proven its epidemic track record through its swift response to the Ebola outbreak in Sudan in 2022, and CEPI’s funding will help in developing, stockpiling, and licensing vaccines against priority pathogens.

The deal builds on CEPI’s 100 Days Mission – a project that aims to produce safe and effective vaccines within 100 days of an epidemic.

BioProcess Insider spoke to Matthew Downham, director of manufacturing and supply chain network at CEPI, about this partnership, its 100 Day Mission, India, and the looming presence of ‘Disease X.’ 

BioProcess Insider (BPI): What does the addition of Serum Institute of India mean for CEPI? 

Matthew Downham (MD): In case of a new threat vaccine makers like SII, the world’s largest vaccine producer, may be called upon to respond swiftly to begin rapid production and equitable distribution of affordable vaccines to affected populations. Our collaboration will reduce the time taken to develop such vaccines and help contain an outbreak before it becomes a pandemic threat. In the event of a highly transmissible and deadly virus emerging, the ability to promptly manufacture and validate the first batch of experimental vaccines against it will be key to enabling a rapid response to the outbreak. 

BPI: Could you tell us more about CEPI’s ‘100 Days mission’? 

MD: One-hundred days is around a third of the time it took to develop a COVID-19 vaccine. If the world had delivered a vaccine in 100 days from the time when the COVID-19 viral sequences were released, a vaccine would have become available in April 2020, when there were cumulatively just over 2 million cases of COVID worldwide, rather than in December 2020, when there were almost 70 million. 

The 100 days mission is an ambitious goal, spearheaded by CEPI and embraced by the leaders of G7 and G20 nations – including India in its G20 presidency capacity last year – to develop a vaccine against a novel viral threat with pandemic potential in as little as 100 days from viral identification. Such rapid action could defuse the threat of a pathogen with pandemic potential. 

BPI: What are the diseases being targeted through this collaboration? 

MD: In an outbreak, members of CEPI’s vaccine manufacturing network, like SII, may be called upon to promptly supply investigational vaccines for preclinical and clinical testing as well as large-scale supply against pathogens with epidemic or pandemic potential prioritized by CEPI. This could include a novel or as-of-yet unidentified pathogen with pandemic potential known as ‘Disease X’. 

BPI: What does the addition of Global South Nations mean for CEPI? 

MD: CEPI is keen to help amplify the voice of the Global South in international pandemic prevention, preparedness and response forums. We are therefore promoting partnerships with the vaccine research, development, and manufacturing communities across the Global South, along with encouraging both north-south and south-south collaboration.  

And we have just launched a Global South Fellowship Program, an exciting opportunity for five exceptional fellows to collaborate closely with CEPI’s teams and contribute to our research, analyses, advocacy, and implementation efforts 

BPI: Has this move been aided by the Government of India in anyway? 

MD: CEPI has held an important relationship with India since our launch in 2017. India co-founded CEPI and we work closely with India’s department of biotechnology (DBT), ministry of science and technology and Indian Council of Medical Research (ICMR), ministry of health and family welfare to support rapid vaccine research, development and manufacturing, including through a dedicated IndCEPI program at the Biotechnology Industry Research Assistance Council (BIRAC). 

We were delighted that last year, India, holding the 2023 G20 Presidency, championed the 100 Days Mission and pushed for strengthened sustainable mechanisms and effective partnerships to ensure safe, effective, and affordable medical countermeasures. We look forward to continuing these discussions with the Government and in-country partners in the following months and years. 

BPI: What other avenues is CEPI collaborating on in India? 

MD: In addition to our new partnership with the SII, CEPI also holds existing partnerships with a range of vaccine and pandemic preparedness organizations. For example, India’s Translational Health Science and Technology Institute (THSTI) and the National Institute of Virology (NIV) are members of CEPI’s centralized laboratory network, the world’s largest vaccine testing group dedicated to the harmonized assessment of epidemic and pandemic vaccine candidates. 

CEPI also holds partnerships with multiple Indian biotech companies and pharmaceutical organizations advancing the development of COVID-19 vaccines, as well as vaccines that could provide broad protection across a range of Beta coronaviruses, like COVID-19, SARS, and MERS. 

BPI: What are the financials associated with this partnership? 

MD: CEPI will invest up to $30 million to expand SII’s world-leading vaccine manufacturing capabilities to help both remain sustainable during inter-epidemic periods and build on its outbreak response capacity in preparation for a future infectious disease outbreak. 

CEPI’s investment will also mean that, in an outbreak, CEPI-backed vaccine developers could quickly transfer their technology to SII within days or weeks of an outbreak to begin rapid production and equitable distribution of affordable vaccines to affected populations. 

This funding will also support the development, stockpiling and licensure of new vaccines against CEPI’s priority pathogens. CEPI and SII are exploring which CEPI-backed vaccines SII will support.