Nigeria has become the second country after Ghana to approve the use of R21/Matrix malaria vaccine that was developed by Oxford University. The vaccine is reported to be 80 percent effective against malaria.
Nigeria had been criticised for missing the first and second application windows for the RTSS/AS01 malaria vaccine, being the first malaria vaccine. The first window of application for the vaccine was opened by GAVI the vaccine alliance in July 2022, covering three countries; Kenya, Ghana and Malawi.
The second window was opened to all other countries including Nigeria from the end of 2022 to January 17, 2023. By the approval that was announced on Monday, Nigeria is taking advantage of third window of application which is currently open.
Mojisola Adeyeye, director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), made the announcement at a press briefing on Monday.
“The National Agency for Food and Drug Administration and Control (NAFDAC) in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004, is granting registration approval for R21 malaria vaccine,” Adeyeye said.
“The vaccine is indicated for prevention of clinical malaria in children from five months to 36 months of age. The storage temperature of the vaccine is 2-8 °C,” the NAFDAC DG said.
NAFDAC said it had conducted independent review of the product when it received the dossier of the R21.
Overall, Adeyeye said “the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was benchmarked as mentioned above. The joint review committee concluded that the data on the R21 malaria vaccine were robust and met criteria for efficacy, safety, and quality,” she said.
“It was also adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
“A provisional approval of the R21 malaria vaccine was recommended and this shall be done in line with the WHO’s malaria vaccine implementation guideline.
“While granting the approval, the agency has also 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.”
According to her, the brief on the approval of the R21 malaria vaccine has been communicated to the minister of health and National Primary Healthcare Development Agency for appropriate actions towards immunisation in the respective population.
