NAFDAC grants provisional approval for malaria vaccine, aiming to reduce child mortality
The provisional approval for R21/Matrix malaria vaccine by the National Agency for Food and Drug Administration And Control (NAFDAC), has raised hope in Nigeria as stakeholders in the health sector believe that the vaccine will drastically reduce child mortality in the country.
NAFDAC, on Monday granted provisional approval for the vaccine days after Ghana became the first country to approve the vaccine, which is manufactured by the Serum Institute of India Pvt Ltd.
Director-General of NAFDAC, Prof. Mojisola Adeyeye, who spoke at a press briefing in Abuja, said the vaccine is indicated for prevention of clinical malaria in children from five months to 36 months of age.
“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.
“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,” she said.
On clinical trial, Adeyeye said the Joint Review Committee for the vaccine have recommended clinical trial in Nigeria.
“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 explained.
Data from the 2018 Nigeria Demographic and Health Survey (NDHS) shows that the prevalence of malaria parasitaemia in children under five years of age was 23 percent.
The World Health Organisation (WHO) report indicates that globally, malaria claims the lives of over 274,000 children under 5 years every year, with 750 dying daily and one in every two minutes.
WHO says malaria remains a primary cause of childhood illness and death in sub-Saharan Africa, with more than 260,000 African children under the age of five dying from malaria annually.
Malaria is endemic in Nigeria, with 97 per cent of the population at risk. 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.
Meanwhile, the president of the Nigerian Association of Resident Doctors (NARD), Dr. Emeka Innocent Orji, told newsmen that “If the vaccine is effective, it is going to help a lot because malaria is one of the diseases affecting us especially children.
“One of the causes of under-5 mortality and morbidity. So it is a good one, the last time I studied the statistics, deaths from malaria is even much more than all these newer diseases like COVID-19 and the rest, so it is a very important breakthrough for us if the vaccine is actually effective.”
Stressing the importance of the vaccine, a professor and consultant medical parasitologist at the College of Medicine, University of Lagos, Wellington Oyibo said the latest World malaria report revealed that there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020, with the WHO African Region carrying a disproportionately high share of the global malaria burden.
The parasitologist told newsmen that in 2021, the region was home to 95 per cent of malaria cases and 96 per cent of malaria deaths, adding that four African countries accounted for just over half of all malaria deaths worldwide, with Nigeria leading with 31.3 per cent, followed by the Democratic Republic of the Congo with 12.6 per cent, United Republic of Tanzania with 4.1 per cent and Niger with 3.9 per cent.
He, however, called for a pre-trial of the malaria vaccine, saying “It will not be out of place if a pre-trial is done in Nigeria that has the highest burden of Malaria in Africa.”
He applauded Oxford University for coming up with a malaria vaccine that has up to 75 per cent efficiency against malaria.
“It is a great opportunity to have a vaccine that has higher protection again malaria on board. With this vaccine, we are closer to moving malaria endemic countries from the control stage to elimination stage.
“However, I am calling on Oxford University to do a pre-trial in Nigeria, so that we can further assess the efficacy of the vaccine against malaria in the country. We will like to see how the vaccine, with other malaria interventions, can move Nigeria from the control stage to eliminate stage.
“If the trial can be done in Nigeria, it will facilitate the rollout of the vaccine in the country. Recall that Nigeria was not part of the first malaria vaccine, Mosquirix from British drugmaker GSK. It won’t be out of place if a pre-trial of malaria vaccine by Oxford University is being done in Nigeria, that shares the largest burden of Malaria in Africa. We can then use the assessment from the pre-trial to draw a rollout map,” he posited.”
To eliminate malaria in Nigeria, the parasitologist called on the Nigerian government to align with the recommendations of World Health Organisation (WHO), by ensuring that the Nigerian children are vaccinated with the Malaria vaccine.
“The government should also put in place all other intervention tools like treated Malaria net and insecticide. This is crucial because the Malaria vaccine from Oxford University has 75 per cent protection against Malaria. We need to still deploy malaria intervention tools to fully protect our children,” he stated.
He however disclosed that the agency in charge of Malaria Control and Elimination programme in Nigeria has set up a team, adding that the team has commenced the process of purchasing the malaria vaccine for the Nigerian children.
In the same vein, the president, Association of Medical Laboratory Scientists of Nigeria (AMLSN)
Prof. Damen James, told Newsmen that though it is a welcomed development, it is necessary to carry out clinical trial in-country to ascertain the efficacy of the vaccine.
He said “We shouldn’t just depend on foreigners to be bringing things to the country. Our position has always been that the government should be able to create structures within the country .We shouldn’t just be depending on what people are doing outside the country, what have we done? we cannot just be accepting vaccines from other countries to come in to Nigeria .
“Like most of these malaria parasites, there is always variation in the antigen and so it is very important that clinical trial should be done in-country so that we will be able to know how the immune system of our people can actually respond to the vaccine.
“Malaria is endemic in Nigeria and it’s a very big concern for all professionals to ensure that this is actually adequately handled. If you look at the population of people that die as a result of malaria, it is actually very high. It is in record that more than 350,000 children die annually as a result of malaria and in every 10 pregnant women that die, two are caused as a result of malaria”, he cautioned.
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