The Federal Government of Nigeria, through its National Agency for Food and Drug Administration and Control (NAFDAC), has announced that Nigeria awaits donations of hundreds of thousands of the newly approved R21 malaria vaccine. The vaccine was developed by the University of Oxford and manufactured by the Serum Institute of India. The agency granted a provisional approval for the vaccine on April 10, 2023, in line with the World Health Organization (WHO)’s vaccine implementation guideline. This makes Nigeria the second country to approve the new vaccine after Ghana.
Mojisola Adeyeye, NAFDAC’s Director General, disclosed at a press briefing in Abuja that the agency is partnering with other government agencies to make the vaccine available to immunize the respective population. She said the country expects to get at least 100,000 doses of the vaccine in donations soon before the market authorization will start making other arrangements with the National Primary Health Care Development Agency (NPHCDA). She noted that the 2020 COVID-19 pandemic had taught the agency’s officials a lesson, hence, they have more insights on how to exercise the agency’s mandate, which is to ensure that the product is safe and high quality.
Nigeria’s malaria burden necessitates the vaccine to protect children.
Adeyeye noted that Nigeria has the highest burden of the sickness in the continent. According to the latest WHO World Malaria Report published in December 2022, Africa continues to carry a disproportionately high share of global burden. The report revealed that there were 247 million cases in 2021, as opposed to 245 million cases in 2020. There were also an estimated 619,000 related deaths in 2021, compared to 625,000 deaths in 2020. In 2021, Africa accounted for approximately 95 percent of all malaria cases and 96 percent of related deaths. Children under the age of five accounted for about 80 percent of all deaths being in the region. This illness also accounts for 60 percent of outpatient visits to Nigeria’s health facilities, 30 percent of childhood deaths, 11 percent of maternal deaths, and 25 percent of deaths in infants.
Furthermore, four African countries accounted for over half of all malaria deaths worldwide. Nigeria accounted for 31.3 percent, the Democratic Republic of Congo 12.6 percent, the United Republic of Tanzania 4.1 percent and Niger 3.9 percent. According to the report, this disease is transmitted in Nigeria and throughout the country, with 97 percent of the population at risk of the disease. Nigeria also had the highest number of global malaria cases (at 27 percent of all cases) and the highest number of related deaths (32 percent of global deaths) in 2020. The country accounted for an estimated 55.2 percent of malaria cases in the West African region in 2020. Hence, Adeyeye stressed that having an efficacious vaccine was crucial to protect millions of children.
NAFDAC calls for clinical trial to be conducted in Nigeria.
While speaking on the processes of the approval of the vaccine, DG of NAFDAC explained that the agency received the dossier of the R21 vaccine and subjected it to independent review at two levels: by NAFDAC’s in-house review committee and NAFDAC’s Vaccine Advisory Committee (NEVAC) independently using standards of the WHO across relevant domains as well as using he 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. The overall assessment was scored as adequate and a joint review session of the committees on April 14, 2023, provided the opportunity for harmonizing the assessments.
A Joint Review Committee concluded that the data on the vaccine were comprehensive and met criteria for efficacy, safety and quality. The committee also declared that the vaccine’s known and potential benefits outweigh its known and potential risks. While granting the approval, Adeyeye 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.
R21/Matrix-M is the second vaccine approved for malaria.
The R21 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. It is the second vaccine that the world has seen for a disease that has caused untold suffering and millions of deaths for millennia.