Monday, April 17, 2023 will go down in history as one of the most important days in Nigeria. The giant of Africa accomplished a major step towards saving the lives of children. The National Agency for Food and Drug Administration and Control (NAFDAC) granted approval to a malaria vaccine that is 77 per cent effective in clinical trials for use in children from 5 months to 36 months of age, the group most vulnerable to dying from the disease. NAFDAC announced the provisional approval of the R21 vaccine at a media briefing in Abuja on Monday. The decision marks a milestone in the efforts to combat a disease that killed 619,000 people in 2021, most of them young children. The R21/Matrix-MTM malaria vaccine developed by Oxford University and the Serum Institute of India PvT Ltd vaccine has been licensed by the National Agency for Food, Drug Administration and Control. Prof. Mojisola Adeyeye said, “The National Agency for Food and Drug Administration and Control (NAFDAC) in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004 is granting registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
“The Marketing Authorization Holder’s (MAHs) is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021. “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”. Nigeria is one of the four African countries that account for over half of all malaria deaths worldwide. Other countries include the Democratic Republic of Congo, Tanzania and Niger. According to the World Malaria Report 2022, Nigeria accounted for about 31.9 per cent of the 619,000 deaths recorded globally. Of this number, Africa recorded a total of 599,000 global malaria deaths; with approximately 200,000 deaths in 2021. Over 60 million people are infected yearly. According to the 2022 world malaria report, the World Health Organization’s ‘African Region’- with an estimated 234 million cases recorded in 2021- accounted for about 95 per cent of global cases. Children younger than five accounted for about 80 per cent of all malaria related deaths in Africa. Nigeria approved use of the vaccine days after Ghana approved the vaccine adjudged to be 80 percent effective.
The only vaccine previously endorsed for malaria by the World Health Organisation (WHO) is the RTS, S/AS01 (RTS, S) vaccine which is 29 percent effective in preventing severe malaria. Prof. Adeyeye said NAFDAC alongside experts from tertiary institutions conducted a joint review on the vaccine and passed it as adequate and satisfactory by the committee. “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,” the NAFDAC DG stated. “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.” According to Prof. Adeyeye, a provisional approval of the R21 malaria vaccine was recommended and will be done in line with 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.” She added. The R21/Matrix-M vaccine is the second ever to be approved by the WHO and the first to exceed the WHO threshold of 75 per cent efficacy over 12 months in a phase 2b trial involving young West African children, following an initial three-dose course of injections.
It was designed and developed at the University of Oxford and has undergone clinical trials in the United Kingdom and Thailand. Across African countries, including Burkina Faso, Kenya, Mali and Tanzania, an ongoing phase III trial has seen the enrolment of 4,800 children. The results from these trials are expected to be reported later this year. The first-ever malaria vaccine, RTS, S or mosquirix, from British drugmaker GSK, was approved by the WHO in 2021 after decades of work. But lack of funding and commercial potential thwarted the company’s capacity to produce as many doses as were needed. Various researches also show that the effectiveness of GSK’s vaccine is approximately 60 per cent, and significantly wanes over time, even with a booster dose. When the mosquirix vaccine was approved, the WHO said it was based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019. It added that it recommends widespread use of the vaccine, “among children in sub-Saharan Africa and other regions with moderate to high plasmodium falciparum malaria transmission. Ghana was the first country in the world to approve the new malaria vaccine before the publication of final-stage trial data. On 13 April, Ghana’s Food and Drug Administration announced the approval, clarifying its position and mandate as a regulator and defended the vaccine’s approval. However, NAFDAC did not say when the vaccine will be rolled out.