THE Federal Government has given a provisional approval for the use of R21/Matrix malaria vaccine produced by scientists at Oxford University.
The Nigerian government granted the approval after Ghana became the first country to approve the vaccine which is said to be 80 per cent effective.
Speaking to newsmen on Monday, April 17, the Director-General of the National Agency for Food and Drug Administration And Control (NAFDAC), Mojisola Adeyeye said the vaccine was produced by Oxford scientists in collaboration with the Serum Institute of India Pvt Ltd.
Adeyeye noted that the vaccine is adopted to mitigate and prevent clinical malaria among infants between five months to 36 months of age.
“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.
“The vaccine is indicated for prevention of clinical malaria in children from five months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.”
The NAFDAC boss stressed that the dossier of the R21 was subjected to independent review by researchers from tertiary institutions in Nigeria and the agency’s in-house vaccine committee.
The reviewers’ results were further assessed by a joint review which declared the dossier “satisfactory” and “adequate”.
“Overall, the R21 malaria vaccine dossier complied substantially with best international standards with which the dossier was benched-marked. 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.”
Adeyeye further emphasised that the provisional approval of R21 malaria vaccine was done in accordance 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.
“The brief on the approval of the R21 malaria vaccine has been communicated to the minister of health and the National Primary Healthcare Development Agency for appropriate actions towards immunisation in the respective population.
“The only vaccine currently endorsed for malaria by the World Health Organisation (WHO) is the RTS, S/AS01 (RTS,S) vaccine which is 29 per cent effective in preventing severe malaria,” she added.
The ICIR reported that Azerbaijan and Tajikistan were on March 29 declared malaria-free by the World Health Organization (WHO).
The two European countries were enlisted among 39 other malaria-free countries following century-long efforts at eradicating malaria.
A 2016 report revealed how the Global Fund accused the Nigerian government of embezzling and misappropriating the malaria funds it gave the country to fight the disease.
Consequently, Nigeria was suspended from accessing funding for the nation’s malaria programme.
Another report published in 2021 detailed how gross corruption hindered the country’s success in containing the malaria scourge.
The ICIR reported that the National Malaria Elimination Programme (NMEP) said malaria accounts for 30 per cent of deaths among children in Nigeria. NMEP also described malaria as one of the major public health challenges in the country.
“Malaria accounts for 60 per cent of outpatient visits to health facilities, 30 per cent of childhood deaths, 11 per cent of maternal deaths (4,500 die yearly), and 25 per cent of deaths in infants (children under a year old).
“To track progress being made as a result of these efforts, the National Malaria Elimination Programme, with support from partners/donors, conduct periodically the Nigeria Malaria Indicator Survey (NMIS), which is interspersed with the Nigeria Demographic and Health Survey (NDHS). So far Nigeria has conducted two rounds of NMIS in 2010 and 2015. The third round of MIS was implemented in 2021,” NMEP Coordinator, Dr Perpetua Uhomoibi said.
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