Nigerian medicines regulators have granted provisional approval for a new malaria vaccine, as final testing continues in three other African countries.
Authorities expect to take delivery of millions of doses this year and begin administering them to children at risk of catching malaria, without any need for further tests.
The move by Nigeria’s drug administration also comes before the approval of the World Health Organisation (WHO). The National Agency for Food and Drug Administration and Control (NAFDAC) says it has reviewed the vaccine and found it “adequate” and “satisfactory”.
The vaccine, known as the R21/Matrix malaria vaccine developed by Oxford University, is undergoing a final “pilot” test rollout in Ghana, Kenya, and Malawi.
Already 1.5 million children have been vaccinated across these three countries, and the pilot programme has just been extended with more funding from philanthropists in the US, funding a further 10 million doses, enough to vaccinate another 3.3 million children in those countries alone.
Nigeria was excluded from the pilot despite accounting for 31.3 per cent of malaria deaths worldwide.
This was because of the country’s failure to ensure the high coverage of long-lasting insecticidal-treated nets (LLINs), lack of well-functioning malaria and immunisation programmes, and not participating in the phase 3 clinical trial.
Results coming back to testers conducting the pilot would be unclear under these conditions.
The country has been eager to approve the jabs since.
Nigeria is hoping to get 11 million doses later this year, Dr Oyeladun Okunromade, the Head of Department of surveillance and epidemiology at the Nigeria Centre for Disease Control (NCDC) says.
But it is unclear how the purchase of the doses of vaccine will be funded. Nigeria missed an opportunity to apply for funding from international vaccine financing organisation Gavi, the Vaccine Alliance.
Another opportunity to apply has just closed and it is not known if Nigeria took advantage of it. Without this funding support, the government will have to front the cost through the budget, it is believed.
One estimate of the cost of purchasing the vaccine and administering it, put the likely cost of putting 11 million jabs into children’s arms at $82 million. But other estimates put the cost closer to $102 million.
Children need at least three doses, with a fourth booster dose extending protection for another 1-2 years. So, initially, the country hopes to vaccinate between 2.8 and 3.7 million children.
Dr Okunromade said that once Nigeria got their allocation of the vaccine, it would be given to children without further testing.
“After procurement, there will not be any trial in the country and the vaccine will be introduced into the immunisation schedule for children after a rollout campaign,” she said.
About malaria vaccines so far
In Dec. 2021, the first malaria vaccine – a recombinant protein-based shot– was recommended by the World Health Organisation (WHO) and was slated to be given to malaria endemic countries such as Ghana, Kenya, and Malawi for final tests before becoming available more widely.
By April 2022, over a million children in these countries reportedly received one or more doses of the WHO-backed RTS,S vaccine.
But the RTS,S malaria vaccine was reported to be only 29 per cent effective in preventing the Plasmodium Falciparum, which is known as the deadliest malaria parasite globally and the most prevalent in Africa.
The currently approved R21/Matrix-M vaccine is the second vaccine ever developed for the disease which targets the Plasmodium Sporozoite, the first form of the malaria parasite entering the human body.
It is said to be 80 percent effective. Mojisola Adeyeye, the director-general of NAFDAC states that, “the vaccine is indicated for prevention of clinical malaria in children from five months to 36 months of age.”
She added that, “It was also judged that the vaccine’s potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.” Nigeria is the second country globally to approve the vaccine.
What’s next?
While this approval comes days after Ghana also approved the vaccine for use, there have not been reports of robust clinical trials in Nigeria unlike its West African counterpart.
Due to the vaccine’s efficacy and its ability to reduce morbidity and severe complications of malaria especially for children in other African countries where the vaccine has been tried, Nigeria’s approval comes as a way to fast track universal health coverage target for the year 2030.
However, there are some safety measures that will be put in place to make sure there are no adverse effects on the eligible population. “There is a process we call AEFI known as the Adverse Effect Following Immunisation group which is a survey to review the complaints following the introduction of a new vaccine,” Dr Okunromade said.
There are already plans to strengthen AEFIs to make sure information comes in from every immunisation site and it is well documented as well as followed through. She explained that, “from the pilot there has not been a significant record of adverse effects except pain at injection spot and mild fever which is usual. Apart from that, there has not been any severe complication.”
World Malaria Day
April 25 marks the 16th annual World Malaria Day. The commemoration of the day is an effort of global healthcare awareness and a global call to health authorities and policymakers to promote the action required to combat and eradicate malaria.
“Malaria has been a stubborn public health enemy,” Dr. Matshidiso Moeti, the WHO Regional Director for Africa, notes in her message.
“In 2021, it killed 619,000 people, of whom approximately 96 per cent lived in Africa. It is six to 20 times more likely to spread in mosquito-prone environments than the Omicron variant of sars-cov-2.”
Her statement also added that, “it is an appropriate time for us to take stock of malaria’s devastating impact on people’s lives and economic development in this region [Africa]. Concerted efforts yield positive results.”
She urged both local and global health authorities, including governments, to strengthen efforts and investments, and make sure no one is left behind. She explained that more resources and technical capacities are required at domestic and international levels to help prevent and improve coverage of malaria case management services.
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