Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has approved the use of R21/Matrix malaria vaccine developed by scientists at Oxford University.
Nigeria approved use of the vaccine days after Ghana became the first country to approve the vaccine adjudged to be 80 percent effective.
“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,”
Director-general of the National Agency for Food and Drug Administration And Control (NAFDAC), Mojisola Adeyeye, made the announcement at a press briefing on Monday.
“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.”
Adeyeye said 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.”
The only vaccine previously endorsed for malaria by the World Health Organisation (WHO) is the RTS, S/AS01 (RTS,S) vaccine which is 29 percent effective in preventing severe malaria.
Adeyeye said NAFDAC alongside experts from tertiary institutions conducted a joint review on the vaccine and passed it as adequate and satisfactory by the committee.
“Overall, the R21 malaria vaccine dossier complied substantially with best international standards with which the dossier was benched-marked 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,” Adeyeye 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.”
Adeyeye said a provisional approval of the R21 malaria vaccine was recommended and will 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,” Adeyeye said.