It has been a long journey to the new malaria vaccine

A crisis meeting has been called in the mosquito world. For decades, they have enjoyed biting and infecting both children and adults. But not anymore.

Now, human beings have found a solution that has been in the making for three decades; a malaria vaccine.

The long journey to the historic announcement made in the first week of this month started in 1987.

A young US Army soldier called Rip Ballou and his colleagues at the Walter Reed Army Institute of Research tried an experimental vaccine candidate for malaria. They literally went into a battle with gloves off.

Having been injected with the experimental vaccine, the Nature journal reports that Ballou used tape to firmly secure an ice cream carton with mosquitoes inside to his arm. His colleagues followed suit.

Some died in the process while others, like him, fell sick. One of their colleagues remained unaffected. But this was not enough, they knew their efforts had failed. 

In 2015 when the European Medicine Agency (EMA) gave a nod for the RTS,S malaria vaccine trials, it was a journey that was bound to have a beautiful ending. On October 6, the World Health Organization (WHO) recommended its use in children. And so for the first time, the world has an approved vaccine that could potentially slash malaria deaths by 30 per cent.

This follows a series of clinical trials and pilot programmes that were conducted in three African countries which have the highest burden of malaria.

Kenya was one of the three African countries that piloted the malaria vaccine. Since 2019, over 800,000 children in Kenya, Malawi and Ghana have been vaccinated against malaria. Kenya has administered over 450, 000 doses.

Kenya had five main investigators: Dr Mary Hamel, Dr Simon Kariuki, Dr Bernhards Ogutu, Dr Walter Ogutu and Dr Patricia Njuguna. Other co-investigators include Chris Odero, Martin Oneko, Lucas Otieno, Nekoye Otsyula, Allan Otieno, Charity Maingi and Stacey Gondi.

The country has eight malaria endemic areas and the National Vaccines and Immunisation Programme (NVIP) opted to roll out the vaccines in those regions. The counties are: Homa Bay, Kisumu, Migori, Siaya, Busia, Bungoma, Vihiga, and Kakamega.

During the trials, the vaccine was given to children in four doses; the first at six months, the second at seven months, the third at nine months and the last at two years (24 months).

The WHO in its update said that the known side effects of the malaria vaccine so far include pain and swelling at the injection site, and fever.

Before the vaccine, Kenya undertook several programmes to eliminate malaria. With President Uhuru Kenyatta at the helm of the African Leaders Malaria Alliance (Alma), even more goals have been set in the fight against the deadly disease.

In the year 2000, Supanet, a treated mosquito net, was launched in Kilifi. It was a new form of intervention as existing nets were not treated.

In April 2001, there was a rebrand as Supanet introduced a retreatment kit dubbed Power Tab. The tablet would be dissolved in water before the net was dipped in. Soon after though, long-lasting insecticide treated nets were developed.

Kenya began distributing treated nets in malaria endemic regions in partnership with the WHO to test their effectiveness.

In 2007, based on the promising results from Kenya, WHO issued a global guidance on the use of treated mosquito nets.

“Impressive results in Kenya, achieved by means of the new WHO-recommended strategy, show that free mass distribution of long-lasting insecticidal nets is a powerful way to quickly and dramatically increase coverage, particularly among the poorest people,” the WHO said.

The glowing results were thanks to the Kenya government’s commitment to end malaria, strong technical assistance from WHO, and adequate funding from bilateral and multilateral donors.

A number of government-led malaria organisations have been formed over the years, too. At the Health ministry, the main driver is the National Malaria Control Programme. Earlier this year, the End Malaria Council, which has stakeholders from different fields, was established. It was a recommendation by the President through Alma.

Monitoring and evaluation

In April 2019, Kenya launched the Kenya Malaria Strategy which, for the first time, included a financial plan to ensure Kenya is malaria-free. The Centres for Disease Control and Prevention, working with the Health ministry, have been focusing on six key areas in this line. These are: capacity building and technical support; surveillance, monitoring and evaluation; prevention; case management; transmission reduction research; and laboratory enhancement. To achieve this, the Kenya Medical Research Institute (Kemri) has been at the forefront in conducting research.

In an exclusive interview, Dr Patricia Njuguna who has been the Head of Clinical Research at the Kemri clinical trials facility where she oversaw the malaria vaccine trials before moving to WHO, said that the new vaccine is good news not just for her team but also for Africa and the rest of the world.

“It has been a long time coming and Kenya has made such a huge contribution to this vaccine,” she said.

The country has been involved in a lot of malaria research through Kemri and was involved in the early phase trials as well as phase 2 and phase 3 trials for the vaccine.

In the pilot phase, Kenya had three sites in Kisumu, Kilifi and Kericho.

Dr Njuguna says that the intensive research has finally paid off.

“We had researchers evaluating the vaccine on a smaller scale to provide more data that allowed widespread introduction of the vaccine.

Imperfect tools

“The research now continues so that we can make things better because in the field of malaria we know that we have imperfect tools – bed nets and drugs – and so we are working to make sure we develop better drugs, vaccines and nets as well as other interventions,” she said.

Dr Njuguna is confident about the future in this field.

“As WHO Director-General Dr Tedros said, we will now work with countries to make sure they get the vaccine and where to introduce it, but at the moment, we are making sure we have adequate approvals and supply. We are talking to funding agencies since we need support to supply the doses,” she said.

Leadership, according to the expert, continues to be very vital.

“Individual countries will have to look at the data and make a decision for themselves and their populations. WHO regional directors will be sending out an official communique to African leaders informing them that the recommendations for broader use have been approved.

“However, there have been official high-level briefings with Africa CDC and there are ongoing discussions with various countries as this wouldn’t have happened without the engagement and participation of leaders and governments,” the doctor highlighted.

 Dr Dan Masiga, an infectious diseases biologist and currently the head of human and animal health at the International Centre of Insect Physiology and Ecology (ICIPE) cautioned that the vaccine is not a silver bullet.

“The new malaria vaccine is most welcome but it is not a silver bullet. We have to continue to enhance vector control, do good diagnostics and provide authentic drugs to treat the disease,” he said in a telephone interview.

In an official statement, PATH, a nonprofit global health organisation based in the United States, said that it is gratifying to know that a malaria vaccine developed specifically for African children could soon be more widely available.

Malaria vaccine

“PATH is proud to have helped bring this first malaria vaccine to children at risk. RTS, S increases equity in access to malaria prevention, helping to reach children that may not be benefiting from other interventions,” said Dr Nathalie Mugala.

 Later this year, the board of Gavi, the Vaccine Alliance, is expected to consider financing a broader roll-out of the vaccine across Africa, PATH disclosed.

 Dr Ashley Birkett, Director of PATH’s Malaria Vaccine Initiative, said that using all the information generated by the malaria vaccine pilots, modelling groups have shown that RTS,S would be a cost-effective addition to the suite of currently available malaria interventions.

 “Additionally, this work has shown the vaccine could have considerable public health impact, averting approximately one death for every 220 children vaccinated with a minimum of three doses in areas of moderate to high malaria transmission,” she said.

The CDC Kenya Malaria Programme director, who is also a principal investigator for the malaria vaccine, Aaron Samuels, noted: “I think this is a historic event for the world and particularly Kenya where there is malaria that is systemic. This vaccine will be life-saving for children throughout sub-Saharan Africa.

“I wish to thank and celebrate Kemri who has been very instrumental in making this recommendation and vaccine a success. I am just proud to be alive to witness this. But now we have a lot of work to be done on implementation, how it will be funded, who will fund it and the role African leaders have to play because we need to come together to make these decisions,” he said.

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