UPDATED: Nigeria approves use of Oxford malaria vaccine

Our reporter/ The federal government on Monday granted provisional approval for the R21/Matrix developed by scientists at Oxford University.

The announcement was contained in a statement signed by Mojisola Adeyeye, director-general of the National Agency for Food and Drug Administration And Control (NAFDAC), at a press briefing with reporters.

The approval comes days after Ghana became the first country to approve the vaccine, said to be 80 percent effective in the treatment of malaria.

“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.”

According to Adeyeye, 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.

She further revealed that 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.