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World’s first malaria vaccine: GAVI to launch 18 million doses in 12 countries, know how India’s Bharat Biotech and Serum Institute are going to play a crucial role

In April this year, the R21/Matrix-M vaccine for malaria, developed by Oxford University and manufactured by the Serum Institute of India, got regulatory approval for usage by the government of Ghana. SII has already established manufacturing capabilities for 200 million doses annually.

On 5th July Gavi, the vaccine alliance, announced that twelve African countries are set to receive 18 million doses of first-ever malaria vaccine in the next two years. Malaria is one of the leading causes of death in the African continent and these vaccines will play a critical role in saving lives.

As the vaccine supply will be limited in the beginning, priority has been given to the areas that are in the utmost need where the risk of malaria illness and death among children is the highest.

The Framework implementation group that has designed the process of delivering the vaccine includes representatives from Africa Centres for Disease Control and Prevention (Africa CDC), UNICEF, WHO, and the Gavi Secretariat along with representatives of civil society and independent advisors.

World’s malaria vaccines: manufactured by Indian companies

By 2026, the annual demand for malaria vaccine will reach 40-60 million doses and by 2030 it will reach 80-100 million doses. Bharat Biotech will be supplying the RTS, S/AS01 vaccine in the future.

In 2021, GSK, the British pharma giant that worked for over 3 decades with nonprofit group PATH, announced that the manufacturing of the protein part of the malaria vaccine RTS, S/AS01 will be transferred to India’s Bharat Biotech.

“Helping secure the long-term future of the only vaccine available by working with an established leader like Bharat Biotech is vital for the continued fight against this devastating disease,” GSK’s Thomas Breuer had said then. Hyderabad’s Bharat Biotech is currently the sole supplier of the RTS, S/AS01 vaccine and is expected to remain so till 2029.

GSK had committed to donate 10 million doses of the vaccine to WHO’s pilot program.

A second vaccine named R21/Matrix-M that has been developed by Oxford University will be manufactured and supplied by the Serum Institute of India (SII) and could also be prequalified by WHO soon, GAVI stated.

In April this year, the R21/Matrix-M vaccine for malaria, developed by Oxford University and manufactured by the Serum Institute of India, got regulatory approval for usage by the government of Ghana. SII has already established manufacturing capabilities for 200 million doses annually. R21/Matrix-M is a low-dose vaccine that is given to children between 5 to 36 months. It has been consistently meeting the WHO standards of 75% efficacy.

It is notable here that India is the world’s largest manufacturer of low-cost vaccines. Serum Institute of India and Bharat Biotech both played a crucial role in India’s fight against Covid.

Malaria vaccine program in African countries

Malaria vaccines are being delivered in Ghana, Kenya, and Malawi via WHO and funded by Gavi, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and United. Since 2019, 1.7 million children in these countries have received RTS, S/AS01 vaccine and it has shown notable results and a substantial reduction in severe malaria. The number of deaths among children due to malaria has come down as well. So far, 28 countries have shown interest in getting their hands on the malaria vaccine.

With the proposed supply of 18 million doses of the vaccine, nine more countries will get the vaccine that includes Benin, Burkina Faso, Burundi, Cameroon, the Democratic Republic of the Congo, Liberia, Niger, Sierra Leone, and Uganda. The vaccine will be introduced to the routine immunization programs in these countries for the first time.

The first round of allocation is being done to Gavi via UNICEF and the first doses of the vaccine will reach these countries between October and December 2023. The vaccine rollout will begin in early 2024.

Managing Director of Country Programmes Delivery at Gavi Thabani Maphosa said, “This vaccine has the potential to be very impactful in the fight against malaria, and when broadly deployed alongside other interventions, it can prevent tens of thousands of future deaths every year. While we work with manufacturers to help ramp up supply, we need to make sure the doses that we do have are used as effectively as possible, which means applying all the learnings from our pilot programmes as we broaden out to a new total of 12 countries.”

Malaria takes away the lives of millions of African children under the age of 5 every year

Every year, around a million children die under the age of 5 due to malaria in Africa making it one of the deadliest diseases. These deaths accounted for 95% of the global malaria cases and 95% of the malaria deaths in 2023. UNICEF Associate Director of Immunization Ephrem T Lemango said, “Nearly every minute, a child under 5 years old dies of malaria. For a long time, these deaths have been preventable and treatable; but the roll-out of this vaccine will give children, especially in Africa, an even better chance at surviving. As supply increases, we hope even more children can benefit from this life-saving advancement.”

WHO Director of Immunization, Vaccines, and Biologicals said, “The malaria vaccine is a breakthrough to improve child health and child survival; and families and communities, rightly, want this vaccine for their children. This first allocation of malaria vaccine doses is prioritized for children at the highest risk of dying of malaria. The high demand for the vaccine and the strong reach of childhood immunization will increase equity in access to malaria prevention and save many young lives. We will work tirelessly to increase supply until all children at risk have access.”

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