Nigeria has granted provisional approval to Oxford University’s R21 malaria vaccine, its drug regulator announced Monday, becoming the second country to do so after Ghana last week.
The approval is unusual because it came before the vaccine’s final-stage trial data were made public.
“Provisional approval of the R21 malaria vaccine has been recommended, which is in line with the WHO malaria vaccine implementation guidelines,” said Nigeria’s National Food and Drug Administration (NAFDAC).
Malaria is a mosquito-borne disease that kills more than 600,000 people each year, mostly babies and children in Africa.
Nigeria, the continent’s most populous country, is the world’s most affected country, accounting for 27% of global infections and 32% of global deaths, according to a World Health Organization (WHO) report in 2021. country that received
It is unclear when the R21 vaccine will be deployed in Nigeria or Ghana, as other regulatory bodies, including the WHO, are still evaluating its safety and efficacy.
Childhood vaccines in Africa’s poorest regions are usually co-funded by international organizations such as the Vaccine Alliance Gavi, but only after WHO approval.
NAFDAC Director Mojisola Christianah Adeyeye said: “While granting approval, the FDA needs to expand the clinical trials conducted to include a Phase 4 clinical trial/pharmacovigilance study conducted in Nigeria. I also told her my gender,” he said. statement.
Interim data from the R21 trial, which included more than 400 infants, was released in September and showed vaccine efficacy of 70% to 80% 12 months after the fourth dose.
Data from an ongoing Phase 3 clinical trial of 4,800 children in Burkina Faso, Kenya, Mali and Tanzania are expected to be published in the coming months.
Oxford has a contract with India’s Serum Institute to produce up to 200 million doses of R21 per year.
The first malaria vaccine, Mosquirix from British pharmaceutical company GSK GSK.L, was approved by the WHO last year, but lack of funding has hampered GSK’s ability to produce sufficient doses.
