Serum Institute rolls out new high efficacy malaria vaccine in Africa

Vaccine was granted WHO approval last year, and is said to have undergone a rigorous regulatory process and clinical assessment and was found to be highly effective and affordable

A new high efficacy malaria vaccine co-developed by the Serum Institute of India (SII) and the University of Oxford was officially rolled out on Monday when Cote d'Ivoire in West Africa became the first country to begin administering R21/Matrix-M.

The vaccine, which was granted World Health Organisation (WHO) approval last year, is said to have undergone a rigorous regulatory process and clinical assessment and was found to be highly effective and affordable. As a low-dose vaccine, it can be manufactured at speed and scale which is seen as critical to stemming the spread of the mosquito-borne disease.

Reducing the malaria burden is finally within sight. Today's start of the R21/Matrix-M vaccine roll-out marks a monumental milestone after years of incredible work with our partners at Oxford and Novavax, said SII CEO Adar Poonawalla.

 

At Serum, we believe that it is every person's right to have access to affordable and essential disease prevention. That's why we have committed to producing 100 million doses of R21, which will protect millions of lives and alleviate the burden of this deadly disease for future generations, he said.

In anticipation of the roll-out, SII said it has manufactured 25 million doses of the vaccine and is committed to scaling up to 100 million doses annually. In keeping with its aim of delivering vaccines at scale and low cost, the Pune-headquartered company said it is offering the vaccine at less than $ 4 per dose.

The roll-out of the R21/Matrix-M malaria vaccine marks the start of a new era in malaria control interventions with the high efficacy vaccine now accessible at a modest price and very large scale to many countries in greatest need. We hope that this vaccine very soon can be provided to all African countries who wish to use it, said Professor Adrian Hill, Director of the Jenner Institute at Oxford University.

R21/Matrix-M was co-developed by the university and SII leveraging Novavax's Matrix-M adjuvant technology. In December 2023, WHO granted it prequalification status after trials demonstrated that the vaccine was well tolerated, with a good safety profile, with injection site pain and fever as the most frequent adverse events.

Although the number of malaria-related deaths has fallen from 3,222 in 2017 to 1,316 in 2020 in Cote d'Ivoire, the deadly disease still kills four people a day, mostly small children, and "remains the leading cause of medical consultations", according to the country's Ministry of Health.

A total of 656,600 doses have been received, which will initially vaccinate 250,000 children aged between 0 and 23 months across 16 regions of Cote d'Ivoire. The R21/Matrix-M vaccine has also been authorised by Ghana, Nigeria, Burkina Faso and the Central African Republic.

R21 is the second malaria vaccine available in Sub-Saharan Africa following RTS,S and wide implementation of the malaria vaccines, in conjunction with existing prevention methods like bed nets, is expected to save tens of thousands of young lives each year. In total, 15 African countries are expected to introduce malaria vaccines with Gavi support in 2024, and countries plan to reach around 6.6 million children with the malaria vaccine in 2024 and 2025.

Dr Sania Nishtar, Chief Executive Officer of Gavi, the Vaccine Alliance, said: "Africa has borne the brunt of malaria for far too long, and Cote d'Ivoire has suffered more than most. With two safe and effective vaccines now available alongside other interventions, we can finally turn the tide against this killer disease.

John Jacobs, President and Chief Executive Officer, Novavax, added: "The introduction of the R21/Matrix-M malaria vaccine in Cote d'Ivoire marks a breakthrough in the fight to protect vulnerable children against a leading cause of death across the region while reinforcing our mission to create innovative vaccines that improve public health.