- Ghana’s Food and Drugs Authority approved Oxford University’s R21 shot for use in children between five and 36 months old – becoming first country to give the shot green light for use outside trials
- Scientists say the shot could help reduce malaria deaths by 70 per cent
- Nigeria is always the last to get involved in these important things – Prof. Oyewale Tomori
- Nigeria’s Child Malaria Vaccine: How Soon, How Effective
By Louis Achi and Gom Mirian
Ghana becomes the first country to approve a malaria vaccine developed by the UK University of Oxford. The vaccine, called R21, is only the second to be authorised for use by regulators, and there are high hopes that it will play a significant role in combating a pathogen that still kills more than 600,000 people every year – the vast majority children under five in Africa.
Checks by Africa Health, AHR, confirmed that Ghana’s Food and Drugs Authority approved the shot for use in children between five and 36 months old, becoming the first to give the shot a green light for use outside trials.
The Food and Drugs Authority (or FDA, formerly known as the Food and Drugs Board) is a Ghanaian government agency responsible for the inspection, certification and proper distribution of foods and food products as well as drugs in Ghana. The board was established by the Food and Drugs Law 1992, PNDC Law 305B.
According to the vaccine developer Oxford University, final data from an ongoing phase three trial in almost 5,000 children – which was set to help determine the length of protection and whether boosters will be needed – has yet to be published. But scientists said they have already shared findings with regulatory agencies.
“Previous data has been promising. A phase two trial in 450 volunteers found R21 was 77 per cent effective against the disease in areas where malaria is seasonal, with no safety red flags. Further data published last summer found that a booster dose a year after the initial three shots meant efficacy remained as high as 80 per cent 12 months later,” Oxford University said.
Though it is unusual for African countries to approve new vaccines before the World Health Organisation (WHO) – which is currently reviewing the data – Prof. Adrian Hill, Director of the Jenner Institute at the University of Oxford, said the pandemic vaccine scramble has shifted the dynamic.
“Particularly since Covid, African regulators have been taking a much more proactive stance, they’ve been saying…we don’t want to be last in the queue,” Hill told Reuters.
Developing shots to cage the ancient killer has been a tough call because the malaria parasite’s complicated life cycle and its ability to avoid detection by the immune system.
The Oxford team said it has also secured a deal with the Serum Institute of India to produce up to 200 million doses of R21 annually, with each shot costing a couple of dollars. Adar Poonawalla, the company’s chief executive, said Ghana’s approval was a “significant milestone in our efforts to combat malaria around the world”.
Although Prof. Hill of Oxford University’s Jenner Institute said the pandemic vaccine scramble shifted the dynamic in the quest by many countries to acquire malaria vaccine or domesticate its production, Nigeria is perceived to have unduly vacillated in this ‘scramble’.
Meanwhile, Javier Guzman, senior policy fellow and director of Global Health Policy at the Center for Global Development, added that while an “exciting” development from Ghana – which has a “stable, well-functioning, integrated regulatory system” – the next steps are unclear.
Efforts by AHR to get the Nigerian Minister of Health, Dr. Osagie Ehanire to react to Ghana’s recent audacious approval of the malaria vaccine ran into a brick wall as senior technical adviser to the minister, Dr. David Atuwo insisted AHR need not engage the minister directly on the subject.
Atuwo referred AHR to the Ministry’s agency – National Malaria Elimination Programme, NMEP. NMEP is domiciled in the National Malaria and Vector Control Division, in the Department of Public Health of the Federal Ministry of Health.
It is mandated to formulate, facilitate policy & guidelines, coordinate the activities of partners and other stakeholders on malaria control activities
Dr. Perpetual Uhomoibhi, the Director and National Coordinator of the National Malaria Elimination Programme (NMEP) explains to AHR correspondent that though efforts are ongoing to get the RTS, S vaccines for children under the age of two in the country, the malaria vaccine is not a stand-alone intervention and must be combined with the existing interventions to make it effective.
Her words: “The available malaria vaccines are only for children under the age of two and cannot be administered to adults.
“We have been told that if you use it alone the efficacy is about 30 to 40% but if you combine it with other interventions like the use of nets, use of seasonal malaria chemoprevention, and other interventions you can get efficacy up to 70 to 80 per cent, so, it is not recommended to be used alone. The vaccine is not a magic bullet/solution to the problem of malaria.
“Also, while we are anticipating the vaccines to be available, let us take these available interventions seriously knowing that these vaccines are short in supply since it is only one pharmaceutical company that is producing the vaccine at a moment.”
On his part, eminent Professor of Virology and infectious diseases expert and ex-Regional Virologist for the World Health Organisation Africa Region, Oyewale Tomori
told Africa Health Report that Nigeria is always the last to get involved in these important things.
His words: “You remember Nigeria is always the last to get involved these important things. When the trial was been done Nigeria was not part of it. They did in Malawi, Mali and Tanzania and I can’t remember the remaining countries. We never get involved in all those things; so when it is time to distribute the vaccine, they will give it to those who participated in the trials.
“Although Nigeria has the largest problem with malaria, you would expect your government to be proactive. But you saw what happened with COVID. So in hoping that we will make effort, we can’t see any evidence of them.”
Nigeria’s Child Malaria Vaccine: How Soon, How Effective
Dressed in brown hijab (Head covering worn by some Muslim women) and a spotted green wrapper. Her eyes were red, and she wore no shoes. Hajiya Fadimatu Yusuf tiredly reclined on the wall leading to the entrance of the pediatric children’s emergency ward of the Abuja Teaching Hospital, Gwagwalada.
Her hands were on her head. Her son’s lifeless body had just been wheeled to a parked vehicle outside the hospital ward.
For a couple expecting a son, the joy of having a male child multiplied when the scan test confirmed their heart’s desire.
But not for a 36-year-old mother of two whose joy was cut short. After giving birth to her baby boy, he died after two months due to malaria infections/ attacks during pregnancy.
Fadimatu who could barely talk told our correspondent that she had been expecting a boy after her two girls but all she had were stillbirths and miscarriages whenever her scan test confirms the pregnancy to be a boy.
“When I was pregnant with this boy, I prayed to Allah to help me keep him,” Fadimatu said, pensively.
“I suffered from malaria during this pregnancy. I could not feed well, and I knew it was going to affect my baby.
“With the treatment and my sleeping in a treated mosquito net did not still save my baby”, Fadimatu said shaking her head with tears rolling down her cheeks.
“I deliver the baby a month earlier. He was incubated for almost two months, but he was always having a fever. He could not suck breasts by himself, and he was on oxygen all through the period.
“And finally, we were transferred from Adamawa to Abuja here and he finally died after three weeks,” she said
Fadimatu’s case is one of the many pregnant women who have lost their babies to malaria infections.
Malaria is endemic in tropical African countries like Nigeria. It is the cause of hundreds of thousands of child deaths here.
The disease still kills more than 400,000 people a year even after dramatic progress with bed nets, insecticides, and drugs.
According to the World Health Organization (WHO), Every 2 minutes, a child dies of malaria. And each year, more than 200 million new cases of the disease are reported globally.
Speaking with African Health Report, AHR, Dr Simom-peter Terumbur, a consultant paediatrician/ Medical Director at the Rufkatu Danjuma Maternity/Kuru Danjuma Hospital for Children, Takum in Taraba State, Nigeria said malaria remains a very dangerous parasitic disease, particularly for children under the age of five years and pregnant women as it is a common cause of miscarriages.
Dr Terumbur said in 2020 Nigeria accounted for an estimated 55.2% of malaria cases in West Africa.
In 2020 there were about 241 million cases and 672,000 malaria-related deaths in the world.
According to him, this is a sharp increase from 2019, noting that 80 per cent of deaths caused by malaria are in children under the age of five years.
“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.
“Over the past five years, infant and under-five mortality rates have remained steady in Nigeria, at 74 and 117 deaths per 1,000 live births, respectively.
“At these mortality levels, one Nigerian child of every 13 born dies before reaching age 1, and one in every eight does not survive until their fifth birthday.
Speaking further on the ineffectiveness of malaria drugs in the country, the paediatric consultant says substandard and falsified antimalarials were estimated to be responsible for $892 million in costs annually in Nigeria and were attributable to 6%-23% of the health and economic burden of malaria in the country.
He said one in five antimalarials circulating in low- and middle-income countries are substandard or falsified.
“Fake and substandard antimalarial drugs lead to Increased hospital admissions, prolonged stay in the hospital, development of resistance (drug resistance or multi-drug resistance or cross-resistance), treatment failures, and death among other burdens on the healthcare system”.
According to him, with the current inflation of about 22%, one will spend an average of N5,000 to N15,000 for the treatment of malaria.
On the issue of the malaria vaccines for children, he said “The world’s first malaria vaccine, a product named RTS, S/A01 and branded Mosquirix, has been rolled out in a pilot programme in Ghana, Kenya, and Malawi since 2019.
“It is set to be available in Nigeria soon, the phase 3 trials showed that a four-dose series of RTS, S/A01 is capable of reducing clinical malaria cases by 39%, and severe malaria by 30%.
“That means that while the vaccine is set to save millions of lives, it’s hardly a silver bullet.
“Other methods of combating malaria have to be intensified to achieve a considerable improvement in eliminating malaria,” he said.
Key interventions by the Nigerian government
Dr. Perpetual Uhomoibhi, the Director and National Coordinator of the National Malaria Elimination Programme (NMEP). The NMEP has over the years through its ‘Roll-back’ malaria campaigns in collaboration with the Nigerian government and its partners put in place preventive diagnosis and treatment measures to ensure we reduce the huge number of deaths and cases of malaria in the country.
Some of these key interventions include the mass distribution of insecticide-treated nets (ITNs) to the most vulnerable populations (pregnant women and children) in the identified eligible states through immunization and antenatal exercise at the clinics.
Others are the behavioural change campaigns to sensitize Nigerians on the need to access and use the interventions where they are provided, treatment of malaria during pregnancy, malaria case management as well as administration of seasonal malaria chemoprevention medication to children under five years for every four months during the peak malaria transmission seasons (rainy seasons) in regions identified with high malaria burden.
“It is encouraging to know that these interventions are yielding much fruit from our previously conducted Malaria Indicator survey (MIS) overall malaria prevalence fell from 42% in 2010 to 22% in 2021 ” Uhomoibhi disclosed.
For Fadimatu who just lost a precious son, these statistics are cold comfort. She would like the vaccine to be available for children soon.
