The Federal Government has granted provisional approval to the R21/Matrix malaria vaccine.
The announcement was made by the director-general of the National Agency for Food and Drug Administration and Control (NAFDAC) Mojisola Adeyeye, during a press briefing on Monday. The vaccine is manufactured by the Serum Institute of India Pvt Ltd.
This decision is coming days after Ghana became the first country to approve the vaccine
“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 the 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 the NAFDAC DG, The R21/Matrix malaria vaccine upon delivery was subjected 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,” a joint review was called.
According to Adeyeye, the joint review committee concluded that the data on the R21 malaria vaccine were robust and met the criteria for efficacy, safety, and quality. It was also determined that the vaccine’s known and potential benefits outweighed 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, she said.
“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 immunization 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.
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