From Fred Ezeh, Abuja
The Federal Government has granted provisional approval for the use of R21/Matrix malaria vaccine developed by scientists at Oxford University.
Director General of National Agency for Food and Drug Administration And Control (NAFDAC), Mojisola Adeyeye, said at a press conference, in Abuja, yesterday, that the vaccine had passed through rigorous test in line with global standard, and the outcome of the tests were satisfactory, hence the approval for its use.
The approval by Nigerian comes days after Ghana became the first country to approve the vaccine that is said to be 80 per cent effective.
The malaria vaccine is manufactured by the Serum Institute of India Pvt Ltd.
The NAFDAC boss explained that R21 Malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution, and 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 ready to use liquid formulation for intramuscular injection.
She confirmed the vaccine is indicated for prevention of clinical malaria in children from five months to 36 months of age, with storage temperature of 2-8 °C.
She said: “NAFDAC received the dossier of the R21 Malaria vaccine and subjected it to independent review at two levels. External advisory committee was in place to advise upon invitation on certain functions of the agency.
“As a new biological molecule that is being given consideration for full registration, the independent review by an external body became imperative as a means to further safeguard public health.
“The external advisory body, namely, NAFDAC’s Vaccine Advisory Committee was made up of experts from Nnamdi Azikwe University, Awka, Anambra State; University of Lagos, Lagos State; University of Ibadan, Oyo State; and Usman Dan Fodio University, Sokoto, Sokoto State.
“The in-house review committee was a multi-disciplinary group drawn from NAFDAC directorates, namely, Drug Registration and Regulatory Affairs, Vaccines/Biologics/Medical Devices; Drug Evaluation and Research (for Clinical trial/Good Manufacturing Practices inputs; Pharmaco-vigilance; Post-Marketing Surveillance, Central Drug Control Laboratory, and Port Inspection.”
The NAFDAC boss said at the end of the process a provisional approval of the R21 Malaria vaccine was recommended in line with the the WHO’s Malaria vaccine implementation guideline, and the brief on the approval has been communicated to the Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunisation in the respective population.
She, however, restated NAFDAC’s commitment in ensuring only products that are safe, high quality and efficacy are made available for Nigerians.