During the roll-out of the COVID-19 vaccines, more developed countries were able to negotiate priority access, while developing countries, notably those in sub-Saharan Africa, had to wait for many months. This delay was a matter of considerable regret for the philanthropic Jenner Institute in Oxford, England, where the Oxford-AstraZeneca COVID-19 vaccine was developed.
The Jenner Institute is named after Edward Jenner, who created the smallpox vaccine – first demonstrated in 1796, which was the very first vaccine. The Jenner Institute is part of the Nuffield Department of Medicine at Oxford University. It was founded in 2005 and aims to develop vaccines for diseases of major global importance such as malaria, tuberculosis, and HIV.
2005 was also the year of the U.S. President’s Malaria Initiative, designed to drastically reduce malaria deaths and illnesses in target countries in sub-Saharan Africa, with a long-term vision of a world without malaria. This initiative focused on the delivery of proven interventions[1].
The U.S. President’s Malaria Initiative supported indoor spraying in over 5.7 million homes, and over 1.8 billion pyrethroid-based bed nets were distributed between 2010 and early 2020, of which close to 1.6 billion were distributed in sub-Saharan Africa.
This unprecedented quantity of insecticides has exerted exceptionally strong selective pressure for resistance and, unsurprisingly, insecticide resistance to most of the public health insecticides approved by the World Health Organization (WHO)[2].
The world is in desperate need of an effective malaria vaccine, but the acknowledged difficulty of vaccine development is reflected in the lack of mention of a malaria vaccine in the 2005 U.S. President’s Malaria Initiative.
First Country Approval for Effective Malaria Vaccine
On April 13, 2023, a key milestone in vaccinology was attained when a West African country, Ghana, became the first to approve a highly effective malaria vaccine, developed at the Jenner Institute. In Ghana, where malaria is both endemic and perennial, an estimated 5.3 million cases and 12,500 estimated deaths were recorded in 2021.
Ghana is among the fifteen most malaria-prone countries, with about two percent of global malaria cases and deaths. Although the whole population is at risk from malaria infection, children under five years of age are at higher risk of severe illness due to lower immunity.
The R21 malaria vaccine is a game-changing medical breakthrough. The vaccine’s Phase III trial is ongoing, but earlier trials have shown a high efficacy level of 77 percent, which meets the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75 percent efficacy.
This level of efficacy is maintained with a primary three-dose regime and a single booster dose given a year later. The vaccine has been approved for use in children aged 36 months to five years, which is the age group at the highest risk of death from malaria.
Professor Adrian Hill, director of the Jenner Institute, has noted that: ”This marks a culmination of 30 years of malaria vaccine research at Oxford, with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most.”
As with the Oxford-AstraZeneca COVID-19 vaccine, the partnership with the Serum Institute of India has been key to successful very large-scale manufacturing and rapid development.
The Serum Institute of India, which is manufacturing the R21 vaccine, has the potential to manufacture more than 200 million doses annually and is committed to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives.
The vaccine contains Novavax’s Matrix-M, an adjuvant that enhances the immune system response, making it more potent and more durable.
The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines.
The theme of the WHO’s 2022 World Malaria Day, on April 25 last year, was to harness innovation to reduce the malaria disease burden and save lives. Malaria mortality and incidence rates have not changed appreciably since 2015; COVID-19 diverted resources away from malaria, as well as tuberculosis and HIV.
According to the WHO, in 2021 more than 600,000 died from malaria, and the vast majority of them were children in sub-Saharan Africa.
For this year’s 2023 World Malaria Day, the regulatory approval in Ghana of the R21 malaria vaccine should be celebrated as a notable innovation in African healthcare leadership, as well as an affirmation of scientific confidence in vaccine development against deadly human disease.
[1] CDC - Malaria - Malaria Worldwide - CDC's Global Malaria Activities - President's Malaria Initiative (PMI)
[2] The need for practical insecticide-resistance guidelines to effectively inform mosquito-borne disease control programs | eLife (elifesciences.org)
