NAFDAC Gives Regulatory Approveal for R21 Malaria Vaccine for Malaria Treatment

The National Agency for Food and Drug Administration and Control (NAFDAC), has granted registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. (SIIPL) for use in Nigeria.

The Director General of NAFDAC, Prof. Mojisola Adeyeye disclosed this on Monday in Abuja, and noted that the Marketing Authorization Holder’s (MAHs) is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.

According to Prof. Adeyeye, 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.

She also said, “The vaccine is indicated for prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.”

The DG revealed that NAFDAC has several pathways for registration of vaccines. These pathways she said, are in line with the Agency’s guideline for registration of Imported Drugs, Vaccines and IVDs under Collaborative Registration Procedure, or the Agency’s guideline for registration of imported Drug and Vaccines.

According to Her, the NAFDAC’s Joint Review Committee has always been guided by the same international standards and best practices with the same modality of independent review by members followed by long hours of plenary where rigorous assessment of each review took place.

She further said the Committee independently scored the assessment as Satisfactory and forwarded to the Director General upon submission and were called for a joint review session on Friday, April 14.

The joint review process provided the opportunity for harmonising 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 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.

Prof. Adeyeye also said the Joint Review Committee recognised the importance of an effective malaria vaccine (with a 75% protection) as an additional interventional tool, as a critical need in Nigeria with the highest malaria burden.

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.

“The joint Review Committee was also interested in reviewing data of the human-malaria parasite dynamics of the 25% not covered to understand issues bothering on non-protection that could inform further research.

She further said, ” 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.

“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.”

Prof Adeyeye reiterate NAFDAC’s commitment in ensuring that only products that are safe, high quality and efficacy are made available for Nigerians.

According to the latest WHO World Malaria Report, Malaria is transmitted throughout Nigeria, with 97% of the population at risk of malaria.

The duration of the transmission season ranges from year-round transmission in the south to three months or less in the north.

According to the 2021 World Malaria Report, Nigeria had the highest number of global malaria cases (27 % of global malaria cases) and the highest number of deaths (32 % of global malaria deaths) in 2020.

The country accounted for an estimated 55.2% of malaria cases in West Africa in 2020.
Case numbers increased 5.3% between 2017 and 2020, from 298 to 314 per 1000 of the population at risk. Deaths increased 4.7%, from 0.92 to 0.97 per 1000 of the population at risk during that same period. Data from the 2018 Nigeria Demographic and Health Survey (NDHS) show that the prevalence of malaria parasitaemia in children under five years of age was 23% (a decrease from 27% in 2015 and 42% in 2010), although there are significant regional, rural-urban, and socioeconomic differences: prevalence ranges from 16% in the South and Southeast Zones to 34% in the Northwest Zone.

In rural populations, prevalence is 2.4 times than in urban populations (31% vs. 13%). Compared to the highest socioeconomic group, prevalence among children in the lowest socioeconomic group is seven times higher (38% vs. 6%).