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As SII Ships Malaria Vaccines to Africa: A Look at India’s Vaccine Industry

India’s prominence in vaccine manufacturing became globally recognized during the COVID-19 pandemic, as the country demonstrated its capability by supplying vaccines to over 1.4 billion people domestically and to 101 countries worldwide.

• By Pooja Chaturvedi Sah
• New Delhi
• May 22, 2024

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On Monday, the Serum Institute of India (SII) announced the shipment of its inaugural batch of the R21/Matrix-M malaria vaccine to Africa. The first consignment is destined for the Central African Republic (CAR), with subsequent deliveries planned for South Sudan and the Democratic Republic of Congo in the following days.

A total of 163,800 doses of the R21/Matrix-M malaria vaccine have been allocated for the CAR region, of which 43,200 doses were dispatched on Monday from SII’s Pune facility.

The R21/Matrix-M Malaria Vaccine

The R21/Matrix-M malaria vaccine was developed through a collaboration between the University of Oxford, the Serum Institute of India, and Novavax, which provided its saponin-based adjuvant technology. This collaborative effort received significant support from the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank (EIB).

According to SII, they have manufactured 25 million doses to date, with the capacity to scale up production to 100 million doses annually. This development is particularly significant given the WHO Africa region’s burden of malaria, which accounted for 94% of global malaria cases (233 million) and 95% of malaria deaths (580,000) in 2022. India, in comparison, had an estimated 3.38 million cases and 5,511 deaths in the same year. Currently, no malaria vaccine is used in India’s national program.

Eric Garcetti, the US Ambassador to India, hailed the development of the R21/Matrix-M malaria vaccine as a significant advancement in combating malaria. He emphasized that the partnership between Novavax and SII would produce quality, affordable vaccines to prevent hundreds of thousands of deaths annually worldwide.

Umesh Shaligram, SII’s executive director of R&D, highlighted the achievement as a testament to collaboration and the dedication of SII’s workforce, reaffirming their commitment to innovation, affordability, and accessibility. John C. Jacobs, President and CEO of Novavax, emphasized the vaccine’s potential to mitigate the health and economic impact of malaria, noting that collaborations are crucial to addressing unmet needs in preventable infectious diseases.

Vaccine Manufacturing in India

India’s prominence in vaccine manufacturing became globally recognized during the COVID-19 pandemic, as the country demonstrated its capability by supplying vaccines to over 1.4 billion people domestically and to 101 countries worldwide.

India’s vaccine manufacturing sector has grown steadily over the past two decades, driven by significant investments from major pharmaceutical companies. Today, India supplies approximately 60% of the global vaccine demand, including nearly 90% of the global demand for the measles vaccine. The Serum Institute of India (SII), the largest of these manufacturers, produces around 1.9 billion doses of vaccines annually, with plans to increase this to 4 billion doses.

India’s vaccines play a crucial role in global health initiatives as well. The country supplies 65-70% of the vaccines required by the World Health Organization (WHO). Also, Indian vaccine manufacturers collaborate with international organizations and pharmaceutical companies to enhance vaccine accessibility and efficacy. For instance, SII has agreements with AstraZeneca for the production of Covishield and with Novavax for the production of Covovax. Additionally, SII has partnered with the Gamaleya Research Institute to manufacture the Sputnik V vaccine in India, aiming to produce over 300 million doses annually.

Historical Contributions and Pioneering Efforts

India’s historical contributions to vaccine development have laid a strong foundation for its current capabilities. The country’s journey began with the development of the plague vaccine in 1897 by Dr. Haffkine. Since then, India has consistently innovated and expanded its vaccine portfolio, addressing both domestic and global health challenges.

   Diverse Vaccine Portfolio-- India’s vaccine portfolio is extensive, covering a wide range of diseases:

• Measles: India meets nearly 90% of the global demand for the measles vaccine.

• Polio: India developed its first indigenous oral polio vaccine in 1970 and achieved polio-free status in January 2011.

• Rabies: The Pasteur Institute of India has been producing rabies vaccines since 1907, evolving from neural tissue-based vaccines to modern tissue culture and DNA purified versions.

• Hepatitis B: The late 1990s saw the development of an indigenous recombinant Hepatitis B vaccine, which was launched by Biological E Limited and Indian Immunologicals Limited in the early 2000s.

• Swine Flu: The H1N1 influenza vaccine was developed in 2009, produced by companies including Sanofi Pasteur, Serum Institute, and Bharat Biotech. • Meningitis: The MenAfriVac vaccine, produced by SII, is widely used in Africa to combat meningococcal meningitis.

• Cholera: In 2009, Shantha Biotechnics developed the Shancol vaccine, an affordable bivalent oral cholera vaccine.

• Japanese Encephalitis: The JENVAC vaccine, developed in 2013 by Bharat Biotech and the Indian Council of Medical Research, is used to prevent Japanese encephalitis.

• Rotavirus: The ROTAVAC vaccine was launched in 2013 by Bharat Biotech to prevent rotavirus gastroenteritis.

These vaccines have not only improved health outcomes within India but have also had a profound impact on global public health.

Technological Advancements and Future Prospects

India’s vaccine manufacturing sector is poised for further growth through technological innovations and strategic investments. The vaccine manufacturing industry is a significant contributor to India’s economy. In fact, biologicals and formulations, including vaccines, account for 77.5% of India’s pharmaceutical exports.

This export strength is underpinned by India’s ability to produce high-quality, affordable vaccines at scale. Moreover, the vaccines produced in India prevent millions of deaths annually and reduce the burden of infectious diseases worldwide.

The success of India’s vaccine manufacturing during the COVID-19 pandemic highlighted the importance of a vibrant and responsive ecosystem. The development and distribution of vaccines like the R21/Matrix-M malaria vaccine underscore India’s role in addressing critical health challenges, particularly in low- and middle-income countries.

The future of vaccine production will likely incorporate advanced methodologies such as continuous flow processing, additive manufacturing, and integrative manufacturing. These technologies promise to enhance efficiency, scalability, and cost-effectiveness.

With its extensive production capacity, diverse vaccine portfolio, and innovative approach, India continues to play a pivotal role in preventing infectious diseases and improving health outcomes globally.