Oxford, Serum initiative: Anti-malaria vaccine’s Phase 3 trials conclude

The R21 malaria vaccine, which is also known as Matrix-M, was designed at the Jenner Institute, University of Oxford, which collaborated with SII in 2020 to manufacture and develop the jab for large-scale supply.

Oxford University and the Serum Institute of India have completed Phase 3 trials for the R21 anti-malarial vaccine in Africa, company officials said on Monday.

According to WHO, malaria is a life-threatening disease caused by Plasmodium parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes.

The vaccine is expected to be approved by regulators next year, SII representatives said.

“Phase-3 trial for R21, which is a cost-effective multi-stage malaria vaccine, is completed in Africa,” said Umesh Shaligram, executive director of Serum Institute of India, on Monday.

The R21 malaria vaccine, which is also known as Matrix-M, was designed at the Jenner Institute, University of Oxford, which collaborated with SII in 2020 to manufacture and develop the jab for large-scale supply. The makers said that the aim of the vaccine was to ensure the provision of “high volumes of low-cost vaccine, and access in countries where it is required the most.”

“SIIPL has confirmed its commitment to the provision of >200 million doses per year after licensure, which will be an adequate supply for children most at risk of malaria in sub-Saharan Africa,” Jenner Institute said in a statement released earlier this year.

Malaria kills around 600,000 people around the world every year. World Health Organization (WHO) approved Masquirix, an anti-malaria vaccine last October, which has an efficacy of 40-50%. The new vaccine has an efficacy closer to 80%. An anti-malaria vaccine has for long been one of science’s holy grails.

Shaligram, who was speaking at a two-day international meet on ‘Preparedness for future epidemics—is India ready to meet the CEPI (The Coalition for Epidemic Preparedness Innovations) 100 days vaccine challenge’, organised by the Translational Health Science and Technology Institute (THSTI), said that the vaccine will primarily target three critical stages in the Plasmodium lifecycle—sporozoite stage (R21 and Rv21), blood stage (Rh5.2) and transmission-blocking stage (Pfs230).

“The work on blood and transmission-blocking stage are in developmental stages. SII plans to address the malaria problem by formulating a single vaccine comprising of R21, Rh5.2 and Pfs230 to target all three stages in the Plasmodium lifecycle,” Shaligram said.

In a research paper published in the Lancet Infectious Diseases in September , researchers from Oxford University claimed that a vaccine booster dose at one year following a primary three-dose regime maintained high efficacy against malaria, and continued to meet the World Health Organization’s malaria vaccine technology roadmap goal of a vaccine with at least 75% efficacy.

According to WHO, malaria is a life-threatening disease caused by Plasmodium parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes. In 2020, there were an estimated 241 million cases of malaria worldwide and 627,000 deaths.

Experts said that India should also create a conducive environment for manufacturers to partner with Indian academic research institutes to bring their own research into the market.

“Collaboration between research institutes and makers needs to happen in the beginning stage. This is how we will be able to translate science into the product ,” said Dr NK Arora, chief of the National Technical Advisory Group on Immunisation (NTAGI).