A new malaria vaccine developed at Oxford university has won approval by health authorities in Ghana, the first regulatory clearance for a jab that promises to reinvigorate the fight against a disease that is a leading cause of infant mortality worldwide.
The Serum Institute of India, which manufactures the vaccine called R21, said on Thursday that the preventive had received “full national licensure” from Ghana’s Food and Drugs Authority. The institute said R21 could be rolled out at “mass scale and modest cost, enabling . . . hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden”.
Adrian Hill, director of Oxford’s Jenner Institute where R21 was developed, said the regulatory approval marked the “culmination of 30 years of malaria vaccine research”. It would enable a “high-efficacy vaccine [to] be supplied at adequate scale to the countries who need it most,” he added.
A study published last year showed that a booster dose of the R21 vaccine showed efficacy as high as 80 per cent in one group, and 70 per cent in the other.
Malaria is one of biggest causes of child death globally, with countries in Africa disproportionately affected. An estimated 247mn malaria cases were recorded in 2021, according to the World Health Organization, 95 per cent of them in Africa. Children under the age of five accounted for about 80 per cent of African malaria deaths. Ghana, with a population of 33mn, recorded 5.7mn malaria cases in 2021, according to its health minister.
The new vaccine, which Ghana has authorised for use in children aged up to three, underwent trials in the UK, Thailand and a number of African countries. It is currently undergoing a late-stage study in 4,800 children, results of which are expected this year, the Serum Institute said.
The Indian institute, the world’s largest vaccine manufacturer, said it had established potential manufacturing capabilities for more than 200mn doses annually. Oxford university’s Hill has previously said the price of the vaccine would be “a few dollars a dose”.
R21 is still being evaluated for use by the World Health Organization. In 2021 it recommended another malaria shot, made by GSK, in children. Yet the manufacturing capacity for that shot is lower than that developed by Oxford.
Javier Guzmán, global health policy director at the US-based Center for Global Development think-tank, said the regulatory approval for R21 was “very exciting”, while stressing that it did not mean donors or international vaccine procurers such as Gavi or Unicef would fund the jab.
He also said it was “still uncertain” if R21 was value for money, “especially when compared to other cost-effective malaria interventions that have not been fully deployed across endemic countries, such as insecticide-treated nets or indoor residual spraying”.
He added: “While the vaccine might be heralded as a huge win in the fight against malaria, it is no silver bullet, and there are important points to consider before the R21 vaccine is rolled out for wider use.”
The Serum Institute was a significant manufacturer of the Oxford/AstraZeneca coronavirus vaccine. R21 includes an adjuvant made by Novavax, a vaccine company that developed a Covid-19 jab.