After decades of clinical trials, the world has potentially found a new silver bullet against malaria, one of the oldest and deadliest infectious diseases. BENJAMIN SAMSON in this report examines how the vaccine will contribute to the fight against malaria.
According to the World Health Organisation (WHO), malaria kills about half a million people yearly, nearly all of them in sub-Saharan Africa, including 260,000 children under-five.
In a historic announcement on Wednesday October 6, 2021 the WHO for the first time, approved for general use in children in sub-Saharan Africa, and other regions with moderate to high rates of plasmodium falciparum malaria transmission, the RTS,S/AS01 (RTS,S) malaria vaccine with the brand name Mosquirix.
The WHO director-general, Tedros Ghebreyesus, in a statement said, “This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control.”
The vaccine, historical perspective
According to the European Medical Agency (EMA), Mosquirix was developed by PATH Malaria Vaccine Initiative (MVI) and GlaxoSmithKline (GSK), with support from the Bill and Melinda Gates Foundation. Mosquirix is not just the first approved vaccine for malaria, it is the first developed for any parasitic disease.
Parasites are much more complex than viruses or bacteria, and the quest for a malaria vaccine has been underway for many decades. The malaria vaccine is the result of 30 years of research and development by GSK and through a partnership with PATH, with support from a network of African research centres.
It has faced several challenges including funding and lack of sustained clinical successes.
In November 2012, a Phase III trial of the vaccine found that it provided modest protection against both clinical and severe malaria in young infants.
As of October 2013, preliminary results of the phase III clinical trial indicated that RTS, S or Mosquirix reduced the number of cases among young children by almost 50 per cent and among infants by around 25 per cent. The study ended in 2014.
In a bid to accommodate a larger group and guarantee a sustained availability for the general public, GSK applied for a marketing license with the European Medicines Agency (EMA) in July 2014. GSK treated the project as a non-profit initiative, with most funding coming from the Gates Foundation, a major contributor to malaria eradication.
On July24, 2015, Mosquirix was recommended by the EMA to be used to vaccinate children aged 6 weeks to 17 months outside the European Union. A pilot project for vaccination was launched on 23 April 2019 in Malawi, on 30 April 2019 in Ghana, and on 13 September 2019 in Kenya.
On October 6, 2021, the vaccine was endorsed by the World Health Organization for ‘broad use’ in children, making it the first malaria vaccine candidate to receive this recommendation.
How it works
According to the EMA, “The Mosquirix was designed to rouse a child’s immune system to thwart plasmodium falciparum, the deadliest of five malaria pathogens and the most prevalent in Africa. Infection is prevented by inducing high antibody titers that block the parasite from infecting the liver. Mosquirix requires up to four doses, and its protection fades after several months.”
Meanwhile, health experts who spoke with Blueprint Weekend were excited about the breakthrough.
A virologist, Dr. Mustapha Angie, of the University of Abuja Teaching Hospital Gwagwalada, said the vaccine will save the lives of thousands of children in sub-Saharan Africa.
He said, “This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control. Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.
“Its effect on morbidity, especially in the prevention of severe malaria anaemia in children, gives the malaria vaccine additional value. Though the coverage rate may not have reached the desired level, its utility is appreciated in an inequitable world where other diseases appear to be more important than the others to receive the desired attention.
“According to the WHO, malaria is a life-threatening disease caused by parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes. It is preventable and curable.”
He added: “In 2019, there were an estimated 229 million cases of malaria worldwide. The estimated number of malaria deaths stood at 409 000 in 2019.
“Children aged under five years are the most vulnerable group affected by malaria; in 2019, they accounted for 67 per cent (274 000) of all malaria deaths worldwide. So, you can see the level of death that can be prevented from malaria vaccination.
“We need to intensify efforts through enforcing environmental hygiene, sanitation, and provision of pipe-borne water. Cleanliness of our surroundings and elimination of stagnant water is critical. Our government needs to welcome the vaccine.”
Likewise, Dr. Ernest Nwokolo, the project director, Society for Family Health Global Fund Malaria, said Nigeria, being one of the worst-hit by malaria, has every reason to be proactive and ensure early deployment of the vaccine.
“Early engagement, planning and deployment is expected to be critical in harvesting the good outcomes of the new vaccine,” he said.
He explained that it was also expected that the government would facilitate the deployment of this vaccine as an additional preventive resource rather than a one-shot, single bullet replacement strategy.
“Accordingly, weaving the roll out within the confines of already existing successful interventions as well as ensuring that the other preventive and curative actions are sustained seems to be the best way to tap the positive outcomes of this new vaccine development.
“Early actions, such as policy adjustments, vaccine advocacy, integrated and sustained deployment through already successful intervention models, appropriate quantification as well as fund mobilisation are key steps that Nigerian implementers must be pushing now.
“Articulated stratification of effective interventions targeting different épidémiologies and groups might also be considered in the face of resource constraints. Opportunities and excitement created by the arrival of this new vaccine must be explored to revive and expand all levels and layers of partnership,” he said.
Nwokolo added that with sustained efforts, Nigeria and other affected sub-Saharan African countries might well be taking definite last steps towards malaria elimination.
“This might just be it! It’s an exciting period! Let’s live it.”
However, in spite of the cheering news about the vaccine, there are concerns that Nigeria does not have the infrastructure needed for immediate administration of the vaccine.
It is against this backdrop that the United Nation Children’s Fund (UNICEF) urged Nigeria to spend the next two to three years building its immunisation infrastructure to enable the country to access and administer the WHO malaria vaccine.
The UNICEF Nigeria Representative, Peter Hawkins, stated this in an interview with the News Agency of Nigeria in Abuja.
Hawkins said although it would take some time before the vaccines were rolled out publicly, the federal government needed to build the infrastructure to accommodate the vaccine.
He said, “WHO’s recommendation is very good news but it will take some time before the vaccines are available publicly. The immunisation structure in Nigeria is still evolving and it is a very robust structure.
“There is routine immunisation for children under five years, there are vaccines for polio, measles, pneumococcal disease, and the Covid-19 vaccines; the next one will be a vaccine for malaria.
“In the next two to three years, we need to build the infrastructure further so that it can accommodate the malaria vaccine, flu vaccine, and other vaccines that are coming.
“The key issue will be the cost, the cold chain, and the distribution system. The cost of the vaccine will be the fundamental decider for a country with a high malaria burden as Nigeria to push this forward.”
Hawkins said further that for countries like Nigeria, the vaccine would greatly help to reduce the burden of the disease as over 2,300 children under-five years die every day from various diseases, including malaria.
He expressed optimism that the government would decide to adopt the vaccine as part of the national malaria control strategy, noting that “each country will decide on whether they want to adopt the vaccine or not
“I think that Nigeria will agree to use the vaccine and in time, see how it can accommodate it in the whole immunisation programme. All the diseases facing children are preventable. It is very important to look at the statistics; for instance, pneumonia is another problem which is where pneumococcal disease is being introduced.
“UNICEF is working to reduce child mortality and disease burden on children in Nigeria; this will continue to evolve with time.”
The UNICEF country representative said the role of the UN agency in Nigeria’s immunisation programme was in vaccine management and supporting behaviour change at the community level.
He added that to achieve vaccine management, “the agency continually focuses on developing market-shaping for the procurement of vaccines to enable more vaccines to get to Nigeria at cheaper rates.”
“We do this to see how we can bring vaccines to countries like Nigeria at cheaper rates and a supply that allows the country to be able to use effectively. When the vaccine is rolled out, it will be massive for children in terms of reducing the malaria burden and mortality rate from malaria.
“The vaccine will also have a significant impact on other diseases such as measles, pneumonia, diarrhea, and cholera.”
Meanwhile, a public health expert, Charles Ekwaelor, in a chat with this reporter, urged Nigerians not to jettison both pharmaceutical and non-pharmaceutical measures in the fight against.
He said, “Although some positive and valuable effects of the malaria vaccine have been recorded, the caveat is that it must be used alongside other interventions such as integrated vector management, effective case management, malaria prevention in pregnancy and seasonal malaria chemoprevention.
“What this means is that investment in these interventions must continue and the government and all of us will have to keep making these interventions available. The vaccine prevented death in every four out of 10 children and this is important for us in a country where annual deaths from malaria are over 70,000 every year.
“Yes, the vaccine is another bullet in the armoury against malaria, but certainly not yet the magic bullet. We must continue with the age-old and new drug therapies and most importantly the prevention methods -antiseptic nets, vector control, and environmental sanitation.
“The environment has to be properly managed and everyone, including the government, has a role to play. Materials such as empty cups, used tyres, uncleared bushes around the homes must be cleared regularly.”
Similarly, the Minister of State for Health, Olorunnibe Mamora, said the federal government would consider looking into the procurement of the malaria vaccine after the full trials.
In an interview with Punch, the minister said, “The vaccine is still in the trial stage. After undergoing trial, we will look out for procurement. After full trial, it will be given full certification and be made available for all.”