Malaria kills about 400,000 people every year, with children under five disproportionately at risk. There are projections to suggest that malaria mortality in sub-Saharan Africa could dwarf the number of COVID-19 deaths, exacerbated by shortfalls in prevention and treatment efforts.
Although the World Health Organization (WHO) aims for at least 90% reduction in malaria incidence and deaths by 2030, meeting the targets, even without the pandemic, would be impossible without vaccines.
Efforts against malaria have been boosted recently with a number of vaccine candidates. One candidate, the R211, with essentially the same molecule as the RTS,S or Mosquirix, is in an ongoing study in Malawi, Kenya and Ghana.
The RTS,S has completed Phase 3 trials and has been shown to reduce the risk of malaria by 55% in the 12 months following primary vaccination and 39% over four years.
Larger Phase III trials of the R21 have started, launched in mid last month, and will enrol 4,800 children for one year with follow up from 2023 to2024 in Burkina Faso and Mali. “This will provide us with definitive efficacy and safety data for a regular licensing of the R21 vaccine,” says Halidou Tinto, a lead author of the study and a parasitologist at the Health Sciences Research Institute in Nanoro, Burkina Faso. “We look forward to seeing how these potentially transformative new tools perform in the next phase of trials and to how they could complement existing tools that are saving hundreds of thousands of lives every year from malaria,” said Abdourahmane Diallo, CEO of the RBM Partnership to End Malaria.
The R21 malaria vaccine has 77% efficacy, over the course of one year, in an initial study conducted in Burkina Faso, among children aged 5-17 months. Its effectiveness against malaria is above the required WHO 75% target.
Can the WHO expedite approval of a malaria vaccine like COVID-19 vaccines?
With the R21 on the table the world has two potential malaria vaccines and now some players want the WHO to expedite approval of the R21. However, some critics urge caution.
“I am in favour of the WHO Emergency Use Listing (EUL) for the R21 vaccine in 2022 after we get one year follow-up results in the Phase 3 trial,” Tinto told Nature Africa.
Tinto also argues that the R21 malaria vaccine should be used in the WHO defined ‘high-burden high-impact’ countries, which have failed to reduce the burden of malaria. He says the results of the R21 phase II trial done in Burkina Faso, which falls under the WHO high malaria burden countries, showed an effectiveness of 77% indicating it is a promising vaccine candidate for such a strategy.
“The first results of the R21 are encouraging and we expect better results and a breakthrough after the phase III trial, which if successful we expect WHO to start the process of accelerated approvals,” says Anthony Nuwa, the senior country technical coordinator of Malaria Consortium in Uganda.
Nuwa told Nature Africa that after WHO approval there would be hope for African countries like Uganda to start the process of rolling out the R21.
There are concerns about the vaccine being tested in one region, where malaria transmission happens during one season. “You have to test it in different settings and in areas with two different seasons of malaria,” says Stephen L Hoffman, the chief executive and scientific officer of the US Inc, in Maryland, US. The vaccine should be “reproducible in multiple settings,” he says.
If it were to be issued, the WHO EUL would go to the RTS,S whose development has spanned 40 years, has completed phase III trials, taken place in seven African countries, and received a positive opinion from the European Medicines Agency (EMA) and got what some term as a ‘conservative recommendation’ by the WHO in January 2016.
Tinto, who would support the WHO’s EUL also has doubts. “This will require a mini revolution in the world health leaders’ decision-making process,” says Tinto. “… to eradicate malaria is seen as an impossible dream.”
Malaria vaccine manufacturing in Africa for Africans
Africa’s vaccine-producing capacity is low with the continent consuming about one-quarter of global vaccines by volume, but manufacturing less than 1 percent of its routine vaccines. Thus, the continent relies heavily on imports, leaving African people exposed to supply chain and public health risks – a situation made clear by Africa’s current struggle to access COVID-19 vaccines.
However, developments in recent months by the African Union, African CDC and WHO Africa region, have made several initiatives to expand the continent’s pharmaceutical manufacturing capability. WHO is helping member states to lay the groundwork to build up vaccine manufacturing capacity.
African companies actively involved in vaccine production are limited to just five countries —South Africa, Morocco, Tunisia, Egypt, and Senegal — with only a few conducting value-adding upstream manufacturing activities. But many African countries want to strengthen local production, promote technology transfers and innovation, and there are discussions around trade-related aspects of intellectual property rights through the lens of boosting local production.
Self-reliance for a sustainable, secure supply of routine vaccines could give Africa better control over its own public health and vaccine supply chains, and improve sovereign security. John Nkengasong, Director of the Africa CDC said, “trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent.”