The federal government through the National Agency for Food and Drug Administration and Control (NAFDAC) has said Nigeria is awaiting donations of hundreds of thousands of donations of the newly approved R21 Malaria Vaccine from the Serum Institute of India.
The agency on Monday granted provisional approval for the vaccine in line with the World Health Organisation (WHO)’s Malaria vaccine implementation guideline, making Nigeria the second country to approve the vaccine after Ghana.
Mojisola Adeyeye, director general of NAFDAC, while addressing the press in Abuja, said that the agency is working in collaboration with other agencies to make the vaccine available to immunise the respective population, but Nigeria will receive a donation first.
“One of the things that the Serum Institute of India contact said is that Nigeria will get a donation first as quickly as possible. Our expectation is that the vaccine will come in very soon, at least hundreds of thousands of doses as donations first before the market authorization will start making other arrangements with the National Primary Healthcare Development Agency (NPHCDA).
“But What we do in NAFDAC is to ensure that the product is safe, of quality and efficacious. The pandemic has taught us a lesson, this is a national strategy, not just one parastatal working alone”, Adeyeye said.
The DG noted that Nigeria has the highest burden for malaria in the continent hence, having an efficacious vaccine was crucial to protect millions of children.
She also announced that the Marketing Authorization Holder’s (MAHs) is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
Read also: Nigeria approves new R21 malaria vaccine
Speaking on the processes that led to the approval of the vaccine, the DG explained that “NAFDAC received the dossier of the R21 Malaria manufactured by the Serum Institute of India Pvt Ltd (SSPL) and was subjected to independent review at two levels. Essentially, the dossier was reviewed by NAFDAC in-house review Committee and the external advisory body – NAFDAC’s Vaccine Advisory Committee (NEVAC) independently using standards of the WHO across relevant domains, in addition to the ICH guidelines, European Medicines Agency guidelines (where appropriate), scientific rigor on the vaccine and the context of malaria generally and specifically to Nigeria and best research and manufacturing governance.
Overall, the assessment was scored as: Adequate (Fully compliant with standards), and the report was submitted to me. Upon submission of the independent reviews of both Committees, I called for a joint review session on Friday, April 14. The joint review process provided the opportunity for harmonising the assessments.
“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.”
While granting the approval, she said 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.
“I have already started talking with academia in terms of clinical trials, looking out for the peculiarity of this vaccine in our own clime”, she added.
The DG further informed that the brief on the approval of the R21 Malaria vaccine has been communicated to the Minister of Health and NPHCDA for appropriate actions toward immunization in the respective population.
Malaria is one of the most important public health concerns in the world. According to the latest WHO World Malaria Report, there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020. The estimated number of malaria deaths stood at 619 000 in 2021 compared to 625 000 in 2020.
In Nigeria, Malaria is transmitted throughout the country with 97 percent of the population at risk of malaria. According to the 2021 World Malaria Report, Nigeria had the highest number of global malaria cases (27 percent of global malaria cases) and the highest number of deaths (32 percent of global malaria deaths) in 2020.The country accounted for an estimated 55.2 percent of malaria cases in West Africa in 2020.
Also, 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 percent. Compared to the highest socioeconomic group, prevalence among children in the lowest socioeconomic group is seven times higher (38 percent vs. 6 percent).
The R21 malaria vaccine, developed by the University of Oxford and manufactured and scaled up by the Serum Institute of India (SII), is only the second vaccine the world has seen for a disease that has caused untold suffering for millennia.
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 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.
