Malaria: Nigeria okays R21 vaccine for children
By Matthew Denis
Barely few days after Ghana gave its nod, the Federal Government of Nigeria has approved the use of R21 Malaria Vaccine (Recombinant, Adjuvanted).
This was disclosed by the the Director General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye in a press briefing on Monday.
According to her, the vaccine is manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
Prof. Adeyeye, said the approval is made by the Agency in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004.
She explained that 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,” she said.
Adeyeye also said NAFDAC has several pathways for the registration of vaccines, and are in line with the Agency’s guideline for registration of imported drugs, vaccines and IVDs under collaborative registration procedure.
Speaking further, the DG stressed that the outcomes of the reviews were discussed, and the recommendations and queries/clarifications were consolidated to be referred to the manufacturers.
She said, “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. 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.
“Specific instances where queries/ clarifications and or additional data were required have been duly compiled to the manufacturers. These did not affect the overall adequacy of the dossier. The Joint Review Committee recognised the importance of an effective malaria vaccine (with a 75 per cent protection) as an additional interventional tool, as a critical need in Nigeria with the highest malaria burden.”
According to her, the Joint Review Committee also recommended additional phase 4 clinical trial/Pharmacovigilance study in-country in the implementation given the peculiarity and heterogeneous nature of malaria in Nigeria.
She said, “The joint Review Committee was also interested in reviewing data of the human-malaria parasite dynamics of the 25 per cent not covered to understand issues bothering on non-protection that could inform further research. This has created a potential research collaboration opportunity between NAFDAC and the affiliated respective universities of the NEVAC members.”
Prof. Adeyeye noted that a provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the 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 Honourable Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunization in the respective population.”
She reassured that NAFDAC remains committed to ensuring that only products that are safe, high quality and efficacy are made available for Nigerians.
