The R21 Malaria Vaccine (Recombinant, Adjuvanted) has received registration approval from the National Agency for Food and Drug Administration and Control.
According to ThisDay, Serum Institute of India Pvt. Ltd. is the company that produces the vaccine.
In an interview with journalists yesterday in Abuja, NAFDAC Director-General, Prof. Mojisola Adeyeye stated that the vaccination was intended to prevent clinical malaria in children between the ages of five and 36 months. The vaccination should be stored between 2 and 8 °C.
“NAFDAC is granting registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. in accordance with its mandate as set forth by its enabling law, NAFDAC Act CapN1, LFN 2004,” she added.
According to the Agency’s Drug and Related Products Registration Regulation 2021, the Marketing Authorization Holder is Fidson Healthcare Ltd.
“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 ready to use liquid formulation for intramuscular injection.
“The vaccine is recommended for use in children between the ages of 5 and 36 months for the prevention of clinical malaria. the temperature of storage of the vaccine is 2-8 °C.”
R21 Malaria Vaccine, according to Adeyeye, is an adjuvanted protein vaccine delivered as a sterile solution.
She explained that a dose which is 0.5ml was composed of R21 Malaria antigen 5 mg and Matrix-M1 50 mg as an adjuvant filled in a vial as a ready-to-use liquid formulation for intramuscular injection.
“While giving its clearance, the agency also expressed the necessity for the clinical trial’s scope to be expanded to include a phase 4 clinical trial and pharmacovigilance research to be done in Nigeria. “The Minister of Health and National Primary Health Care Development Agency have been informed regarding the approval of the R21 Malaria vaccine for appropriate actions toward immunization in the respective population,” she added.
Adeyeye claimed that NAFDAC has reviewed the R21 Malaria dossier independently twice after receiving it from Serum Institute of India Pvt Ltd. She added that a mature regulatory body should expect to have an external advisory council in place as part of global benchmarking to provide advice when asked about certain functions of the agency.
Adeyeye continued by stating that the NAFDAC Committee’s review process has always been governed by the same international standards and best practices, with the same modality of an independent review by members followed by extended plenary sessions where the rigorous evaluation of each review took place.
According to her, the Committee gave the evaluation an additional independent score of Satisfactory and transmitted it to the Director General.
According to the DG, the agency conducted a joint review session last Friday, which gave the chance to harmonize the assessments.
According to him, the R21 Malaria Vaccine dossier largely conformed with the highest international criteria against which the dossier was benchmarked as previously noted.
According to the Joint Review Committee, the R21 malaria vaccine’s data were reliable and satisfied standards for efficacy, safety, and quality. Additionally, it was determined that the vaccine’s known and potential advantages outweigh its known and possible drawbacks, justifying the manufacturer’s advised use.
“The Joint Review Committee was also interested in reviewing data of the human malaria parasite dynamics of the 25% not covered to understand issues concerning non-protection that could guide future research.”
“Precise cases where questions, explanations, and/or extra data were needed have been duly compiled for the manufacturers.
“These have no bearing on the dossier’s overall suitability. The need for an efficient malaria vaccine (with a 75% protection rate) was acknowledged by the Joint Review Committee as an additional interventional tool, as a critical need in Nigeria with the highest malaria burden.
She also added that given the distinctive and varied character of malaria in Nigeria, the Joint Review Committee also recommended that further phase 4 clinical trials and pharmacovigilance studies be conducted in-country throughout implementation.
