By Ollie Sayeed, PhD
1Day Africa is advocating for a target of distributing 200 million malaria vaccine doses by the end of 2025. This post explains the reasoning behind the 200 million dose target, which we expect is the maximum number of doses that could realistically be produced over the next year and a half.
RTS,S and R21 dose numbers
The RTS,S and R21 vaccines are produced by different manufacturers. The first vaccine to be developed, RTS,S, is produced by GSK, which is planning to roll out 14.4 million doses in 2024 and 2025. 1Gavi figure via Natasha Loder, personal communication
The second vaccine, R21, is produced by the Serum Institute of India (SII). R21 has a much greater potential production capacity, thanks to its design, formulation, and the fact that SII is the world’s largest vaccine manufacturer with experience producing large numbers of vaccines at low cost. In October 2023, SII reported having the capacity to produce 100 million doses a year, which could double to 200 million a year by the end of 2025. 2Serum Institute of India, October 2023 On top of this, SII had 25 million doses already on hand as of February 2024.3Oxford, February 2024
For the purposes of setting a dose target, we conservatively assume that SII’s production capacity won’t significantly increase from its current level of 100 million a year before the end of 2025. This means that SII can produce 100 million doses of R21 in 2025, along with around 50 million more in the remaining months of 2024. Together with the 25 million doses already on hand, this gives a conservative total of 175 million doses of R21 by the end of 2025. Adding 14.4 million doses of RTS,S over 2024 and 2025, we reach a total of 190 million doses of the two vaccines combined.
Considerations for increasing production
We believe there are grounds for optimism around the number of R21 doses that SII can deliver over the next year and a half. SII already has experience manufacturing large numbers of vaccines in response to shifting demand, which has recently included ramping up production of the Oxford-AstraZeneca COVID‑19 vaccine to a cumulative 3 billion doses over the past four years.4CNN, May 2024 Although the start-up costs of manufacturing a new vaccine may be high, marginal production costs are cheap at only a few dollars per dose,5UNICEF Supply Division, June 2024 so we expect that increasing production to levels above 175 million doses could be achievable. Given this expectation of increased capacity, we are advocating for a round number target of 200 million by the end of 2025. This would translate to approximately 300,000 lives saved, a huge step up from the 37,500 lives saved by the current roll-out plan of 25 million doses. Our assumptions in arriving at this number have been conservative, but we understand that this is a highly ambitious goal that will require the coordinated effort of multiple large organizations across borders. We believe the stakes are high enough for this effort to be worth it – under these numbers, the more ambitious target would save over 250,000 lives.
Whether this is achievable depends more on demand from funders than on supply from manufacturers. Like RTS,S, the R21 vaccine is perishable, and so creating a stockpile of R21 vaccine doses without a guaranteed buyer is not financially viable for SII. Currently, international buyers Gavi and UNICEF have secured only 25 million vaccine doses of R21 and RTS,S to distribute in Africa in 2024 and 2025,6Barron’s, March 2024 even though 1Day Sooner’s estimates suggest that 100 million doses a year or more could be put to valuable use to protect children at risk of malaria.7David Tellett, 1Day Sooner, March 2024
Our 200 million dose target is not intended as a prediction of how many will be produced but as a statement of how many can be produced, given the will from international funders. We expect that SII and GSK could reach around 175 million doses of R21 and around 11 million doses of RTS,S respectively with their current capacities, and that with enough funding, SII could even ramp up production above 100 million per year and cover the 200 million target with R21 alone.
The 25 million doses currently being distributed are an important first step, but the malaria crisis continues to be urgent, with 1,000 children under five dying every day from malaria.8UNICEF, January 2024 We call on Gavi, UNICEF, and other international funders to commit to buying and distributing 200 million doses by the end of 2025 – a commitment that will save hundreds of thousands of lives.91Day Africa, March 2024