Mojisola Adeyeye, Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), on Monday announced that the R21/Matrix malaria vaccine, developed by scientists at Oxford University, has been granted provisional approval by the federal government. This announcement follows Ghana's recent approval of the vaccine, which has been reported to be 80% effective.

The vaccine is manufactured by the Serum Institute of India Pvt Ltd and is indicated for the prevention of clinical malaria in children between the ages of five and 36 months. The storage temperature of the vaccine is between 2-8 °C.

According to Adeyeye, NAFDAC received the R21 dossier and subjected it to independent review by experts from Nigeria's tertiary institutions and the agency's in-house vaccine review committee. After assessing the vaccine as "adequate" and "satisfactory," a joint review was conducted.

The joint review committee concluded that the R21 malaria vaccine dossier complied with best international standards and that the data were robust and met criteria for efficacy, safety, and quality. The vaccine's known and potential benefits were also deemed to outweigh its known and potential risks, thereby supporting the manufacturer's recommended use.

A provisional approval of the R21 malaria vaccine was recommended in line with the WHO's malaria vaccine implementation guideline.

Adeyeye communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/pharmacovigilance study to be carried out in Nigeria while granting the approval. The brief on the approval of the R21 malaria vaccine has been communicated to the Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunisation in the respective population.