Nigeria has granted approval for the R21 malaria vaccine, developed by Oxford University and manufactured by the Serum Institute of India. This move comes after Ghana became the first country to approve the vaccine, which has demonstrated an efficacy of 80% in trials. Nigerian health experts believe that the vaccine’s introduction will significantly reduce child mortality rates in the country.
Director-General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Mojisola Adeyeye, announced the approval on Monday. The vaccine is indicated for the prevention of malaria in children aged between five and 36 months. Nigeria expects to receive a donation of at least 100,000 doses before market authorisation begins and arrangements are made with the National Primary Health Care Development Agency.
The R21 vaccine is the second to be approved by the World Health Organisation (WHO) and the first to surpass the 75% efficacy threshold over a 12-month follow-up period. The previous vaccine, RTS,S (Mosquirix), developed by British drugmaker GSK, had an efficacy of approximately 60% and waned over time, even with a booster dose.
According to data (pdf) from the 2018 Nigeria Demographic and Health Survey (NDHS), the prevalence of malaria parasitaemia in children under five years of age was 23%. The WHO reports that malaria claims the lives of over 274,000 children under the age of five every year, with more than 260,000 of these deaths occurring in sub-Saharan Africa. Malaria is endemic in Nigeria, with 97% of the population at risk. The 2021 World Malaria Report revealed that Nigeria had the highest number of global malaria cases (27%) and deaths (32%) in 2020.
Adeyeye said that while approving the R21 vaccine, NAFDAC has also communicated the need for a Phase 4 clinical trial/pharmacovigilance study to be conducted in Nigeria. Health stakeholders in the country, including Prof. Wellington Oyibo, a consultant medical parasitologist at the University of Lagos, have called for a pre-trial of the vaccine in Nigeria, given its high malaria burden.
Oyibo applauded Oxford University for developing the vaccine and urged the Nigerian government to align with WHO recommendations, ensuring that children receive the malaria vaccine and that other intervention tools, such as treated malaria nets and insecticides, are implemented.
Nigeria’s decision to approve the R21 vaccine has raised hope for the country’s children, as health professionals and experts believe that it will contribute significantly to the reduction of child mortality rates due to malaria.
