As the malaria vaccine continues to prove sceptics wrong, the next obstacle for the World Health Organisation is cost
Malaria is a mass killer, taking just under 800,000 lives a year. Most of them are babies and children under five. A significant number are pregnant women. It is an entirely preventable disease, caused by a parasite transmitted by mosquito bite, but the millions who live under its curse are too poor and have too few options to be able to avoid it.
The malaria vaccine that now appears to be within reach, following successful large-scale trials in seven African countries, is a potential game changer for the rural villagers whose children are the main victims of this ancient disease, which was named "mal'aria" for the bad air medieval Italians thought caused it.
Early results from 6,000 babies aged 5-17 months show that their risk of malaria was reduced by slightly more than half (56%) and their chance of severe malaria – the kind that affects the brain, kidneys and blood and often kills – by slightly less than half (47%).
Malaria is so common in sub-Saharan Africa that families think any fever in a baby must be the killer disease. Too often it is, and the hospitals are full of listless babies with vacant eyes on drips.
Vast numbers of bed nets impregnated with insecticide have been provided by donors and distributed in malaria-endemic regions. Every small child and pregnant woman should sleep under one to keep away the mosquitoes in the night. New drugs – compounds involving artemisinin – have been developed and widely distributed to replace older antimalarials, which have been failing as the parasite develops resistance to them.
Malaria deaths have come down from more than a million to an estimated 780,000 a year, according to the latest report from the Roll Back Malaria partnership of the World Health Organisation. Three countries were certified malaria-free in the past four years, and nine more are preparing to move towards elimination – but that is out of 108 where the disease is endemic.
Since bed nets are not always effective, and not always used as they should be – there have been reports of some employed as fishing nets – and drugs can become ineffective, a vaccine could massively improve children's chances.
While researchers started work on a potential Aids vaccine with extraordinary and, as it turned out, misplaced optimism, many in the scientific community thought a malaria vaccine was a non-starter. Nobody had ever made a vaccine against a parasite-borne disease.
Twenty-five years on, a clutch of indomitable scientists – veterans such as Joe Cohen, who has been on the case for the past 23 years – has proved the sceptics wrong. According to Andrew Witty, chief executive of GlaxoSmithKline, the British company that has developed and trialled the vaccine, there were tears among the team when the results of the large-scale trial results came out. "It was the emotion of what they had achieved," said Witty. "The first vaccine against a parasite-borne infection. They were overwhelmed."
The results show conclusively that it is possible to prevent many cases of malaria in babies aged 5-17 months. Most of these children still got malaria, but less frequently and less severely. There were 750 cases for every 1,000 vaccinated children over a year, compared with 1,500 cases for 1,000 children among those who were given dummy injections.
That could make a big difference in sub-Saharan Africa. There are 200m cases of malaria every year. Many children are damaged – sometimes brain-damaged – by it. Even stopping half of those cases would save millions of lives over the long term. But there is a way to go yet, with more results from the trial to come, and many uncertainties, including how much this vaccine will cost and who will be persuaded to pay.
The trial is continuing in seven countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. It is big: there are 15,460 babies and infants involved. The data published so far in the New England Journal of Medicine concerns 6,000 of the older babies, those aged 5 to 17 months. Next year, results are expected for newborns, which are crucial, because the three-dose vaccine, which needs cold storage, must be incorporated into the routine infant vaccination schedule. All the signs are, though, that the response in newborns will be similar.
A bigger question is over the duration of the protection, which appears to have dropped from 47% to 35% for cases of severe malaria after 22 months. Some of the babies will be given a booster, to see whether this helps. While most side-effects were similar in children given the vaccine and given dummy jabs, there were significantly more with meningitis among those given the vaccine. "There seems to be no plausible explanation for this and it may well turn out to be a chance finding, but it cannot be ignored," wrote malaria expert Prof Nick White in a commentary otherwise warmly welcoming the vaccine to the armoury of weapons against the disease.
Most of those involved with malaria will agree with White when he continues: "All the investigators who have laboured long and hard in the development and evaluation of this malaria vaccine deserve congratulations. It is a great achievement and an important advance, but they know that this partially protective vaccine is not the sole solution to the control and elimination of malaria."
In three years' time, when the final results are in and the WHO has recommended its use, the scientists may hit the biggest stumbling block of all: money to roll it out. At a press conference to discuss the results, Dr Regina Rabinovitch, director for infectious diseases at the global health programme of the Bill and Melinda Gates Foundation, was asked whether they would fund it. They would want to look at the data on efficacy, duration and safety in 2014, she said. "Would I prefer to see a 100% vaccine? Certainly," she added.
The arguments over value for money will be starting even now. Donors will want to figure out whether bednets or artimisinin drugs are a better investment than a vaccine that will reduce the number of malaria cases but not stop the disease in its tracks.
Price will be a critical factor in these considerations. Witty says they will do everything they can to get it down. He is looking at the costs involved in manufacturing and supply – even at the price of the vial. He is prepared to offer licences to get the vaccine produced cheaply in India or in Africa itself.
"I have got every confidence that we can get this price to a level that makes it very viable for donors to consider," he said. "I don't want people to think this is an alternative to bed nets. This is about doing all we can to shut the door on malaria."
He recalls the children's hospital wards he has seen in Africa, overwhelmingly full of malaria cases: "If you could take that burden away, imagine what the health capacity would be."
