Nigeria approves R21 Malaria Vaccine manufactured by Serum Institute of India

Abuja, Nigeria – The National Agency for Food and Drug Administration and Control (NAFDAC) has granted approval for the R21 malaria vaccine, manufactured by the Serum Institute of India, according to Prof Mojisola Adeyeye, the Director General of NAFDAC. This makes Nigeria the second country in Africa to approve the vaccine, after Ghana. Prof Adeyeye made the announcement during a press briefing on Monday in Abuja.

The R21 malaria vaccine is indicated for the prevention of clinical malaria in children aged 5 months to 36 months. Nigeria is expecting to receive at least 100,000 doses of the vaccine through donations, and the market authorization process will commence thereafter in collaboration with the National Primary Health Care Development Agency.

In her statement, Prof Adeyeye explained that NAFDAC reviewed the dossier of the vaccine independently at two levels. The review was conducted by NAFDAC’s Vaccine Advisory Committee, following the standards of the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and the European Medicines Agency guidelines. The assessment was scored as adequate and fully compliant with standards.

The Joint Review Committee, which assessed the data on the R21 malaria vaccine, concluded that the vaccine’s benefits outweigh its risks and supported the manufacturer’s recommended use. The Committee also recommended additional phase four clinical trials and pharmacovigilance studies in Nigeria, considering the unique and diverse nature of malaria in the country. The vaccine was provisionally approved in line with WHO’s Malaria Vaccine Implementation Guideline.

Malaria remains a significant health challenge in Nigeria, with the country accounting for 31.3% of all malaria deaths worldwide. According to The Punch, a Nigerian newspaper, 97% of the population in Nigeria is at risk of malaria. The approval of the R21 malaria vaccine by NAFDAC is seen as a crucial step towards reducing the burden of malaria and improving public health outcomes in Nigeria.