Oxford's Malaria Vaccine Receives Approval From Nigerian Regulator

Nigeria granted provisional approval to Oxford University's R21 malaria vaccine on Monday, becoming the second country to do so after Ghana last week. The approvals are unusual in that they came before the vaccine's final-stage trial data was published. "A provisional approval of the R21 Malaria Vaccine was recommended, and this shall be done in accordance with the WHO's Malaria Vaccine Implementation Guideline," said Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC). Malaria, a mosquito-borne disease, kills over 600,000 people each year, the vast majority of whom are African babies and children.

According to a 2021 World Health Organisation (WHO) report, Nigeria, the continent's most populous country, is the world's worst-affected country, accounting for 27% of global cases and 32% of global deaths. It is unclear when the R21 vaccine will be available in Nigeria or Ghana because other regulatory bodies, including the World Health Organisation, are still evaluating its safety and effectiveness. Childhood vaccines are typically co-funded by international organisations such as Gavi, the vaccine alliance, only after receiving WHO approval.

"While granting the approval, the Agency also communicated the need for an expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria," said NAFDAC's director-general, Mojisola Christianah Adeyeye, in a statement. In September, mid-stage data from the R21 trial involving over 400 young children were published, revealing vaccine efficacy of 70-80% at 12 months after the fourth dose.

In the coming months, data from an ongoing phase 3 clinical trial involving 4,800 children in Burkina Faso, Kenya, Mali, and Tanzania will be published. Oxford has agreed to produce up to 200 million doses of R21 per year in collaboration with the Serum Institute of India. The WHO approved the first malaria vaccine, Mosquirix from British drugmaker GSK, last year, but a lack of funding is impeding GSK's ability to produce enough doses.