From Fred Ezeh, Abuja
The National Agency for Food and Drugs Administration and Control (NAFDAC) has granted registration approval for the R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
NAFDAC explained that the 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.
The Agency confirmed that the vaccine is indicated for the prevention of clinical malaria in children from five months to 36 months of age, with a storage temperature of 2-8 °C.
Director General of NAFDAC, Prof. Mojisola Adeyeye, told journalists at a press conference, in Abuja, on Monday, that the vaccine has passed through the rigorous test in line with global standards, and the outcome of the tests was satisfactory, hence the approval for use.
She further explained: “NAFDAC received the dossier of the R21 Malaria vaccine and subjected it to independent review at two levels. An 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 (NEVAC) was made up of experts from Nnamdi Azikiwe 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; Pharmacovigilance; Post-Marketing Surveillance, Central Drug Control Laboratory, and Port Inspection.
“The dossier was reviewed by NEVAC independently using standards of the World Health Organization (WHO) across relevant domains, in addition to the ICH guidelines, European Medicines Agency guidelines (where appropriate), scientific rigour on the vaccine and the context of malaria generally and specifically to Nigeria and best research and manufacturing governance.
“NEVAC members reviewed all sections independently using best review practices and met physically in plenary to assess and debate the reviews by sections, raised queries and made recommendations. The assessment was scored as fully compliant with standards.
“The review of NAFDAC’s Committee guided by the same international standards and best practices with the same modality of an independent review by members also independently scored the assessment as satisfactory.
“Upon submission of the independent reviews of both committees, a joint review session met to harmonise the assessments. The outcomes of the reviews were discussed, and the recommendations and queries/clarifications were consolidated to be referred to the manufacturers.
“Overall, the R21 Malaria Vaccine dossier complied substantially with best international standards. 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 adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.”
The NAFDAC boss said that at the end of the process, a provisional approval of the R21 Malaria Vaccine was recommended in line with 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 (NPHCDA) for appropriate actions toward immunization in the respective population.
She, however, restated NAFDAC’s commitment to ensuring that only products that are safe, high quality and efficacy are made available for Nigerians.
