The Nigerian government has granted provisional approval for the R21/Matrix malaria vaccine developed by scientists at Oxford University.
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 development comes days after Ghana became the first country to approve the vaccine — which is said to be 80 percent effective.
The malaria vaccine is manufactured by the Serum Institute of India Pvt Ltd.
“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 at the press briefing.
“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.”
‘VACCINE SCORED AS SATISFACTORY AFTER REVIEW’
Adeyeye said NAFDAC received the dossier of the R21 and subjected it to independent review by experts from Nigeria’s tertiary institutions and the agency’s in-house vaccine review committee.
The director-general said a joint review was then called after the team assessed the vaccine as “adequate” and the in-house committee also assessed it as “satisfactory”.
“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,” 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.
“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.”
The only vaccine currently 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.