SaharaReporters reported last week that Ghana became the first country in the world to approve the use of the vaccine after its Food and Drugs Authority licensed the use of the University of Oxford-developed and Serum Institute of India PvT Ltd (SIIPL)-manufactured and scaled up R21/Matrix-MTM malaria vaccine, leveraging Novavax's adjuvant technology.
Nigeria has become the second country in the world to approve the use of R21/Matrix-M malaria vaccine developed by the University of Oxford and manufactured by the Serum Institute of India.
SaharaReporters reported last week that Ghana became the first country in the world to approve the use of the vaccine after its Food and Drugs Authority licensed the use of the University of Oxford-developed and Serum Institute of India PvT Ltd (SIIPL)-manufactured and scaled up R21/Matrix-MTM malaria vaccine, leveraging Novavax's adjuvant technology.
On Monday, the Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye, at a press briefing in Abuja announced that the most populous African country has approved the use of the R21 malaria vaccine.
The NAFDAC DG during the press briefing said the vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.
According to her, Nigeria expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency (NPHCDA).
The PUNCH quoted Adeyeye as saying, “NAFDAC in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004 is granting registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd.
“The Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
“The R21 Malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution. A dose which is 0.5ml is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an adjuvant filled in a vial as a ready-to-use liquid formulation for intramuscular injection.
“The vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.”
According to her, the dossier of the vaccine was subjected to independent review at two levels.
Adeyeye explained that the dossier was reviewed by NAFDAC’s Vaccine Advisory Committee independently using standards of the World Health Organisation across relevant domains, in addition to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use guidelines, European Medicines Agency guidelines, scientific rigour on the vaccine and the context of malaria and specifically to Nigeria and best research and manufacturing governance.
She noted that the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was benched-marked, adding that the Joint Review Committee concluded that the data on the R21 Malaria vaccine was robust and met the criteria for efficacy, safety, and quality.
According to Adeyeye, 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.
According to the National Library of Medicine, Malaria is endemic in about 32 countries in Sub-Saharan Africa, which are responsible for almost 93 percent of malaria death worldwide. Nigeria is one of the countries with the highest burden of the disease and the leading country among the four African countries responsible for half of the malaria mortality all over the world.
The other countries are the Democratic Republic of the Congo, Tanzania and Niger Republic.