GlaxoSmithKline’s quest to find a malaria vaccine has survived two mergers, a succession of chief executives and lasted nearly 30 years.
But that effort is now on track to deliver the first vaccine against one of the world’s deadliest diseases.
Scientists working on the product will on Tuesday unveil the results of a trial on 15,000 African children, providing the strongest evidence yet that the shot nearly halves the number of cases of malaria in babies aged five to 17 months, and paving the way for its release.
One of those scientists is Joe Cohen, a Glaxo veteran who has dedicated the latter half of his career to developing the vaccine. Dr Cohen, now 70, admits he was no malaria expert when his employer, the then-SmithKline & French, asked him to lead a research unit dedicated to the programme in 1987.
But his team soon hit upon a “fundamental insight” which would inform their work for the next decade. They realised combining part of an already-existing Hepatitis B vaccine with a protein from the parasite which causes malaria could result in a successful shot.
The first tests, on US adults in the early 1990s, proved the concept worked, setting in motion a series of trials that have shown how effective the vaccine could be across Africa, where malaria is most prevalent.
In 2001, GSK teamed up with the PATH Malaria Vaccine Initiative, backed by $200m (£124m) from the Bill and Melinda Gates Foundation, to continue testing the vaccine. “Today, we can see the light at the end of the tunnel,” said Dr Cohen.
His words are far from a flippant cliché. Although the team could see their product had great potential as early as 1997, it has taken another 16 years to amass enough evidence that it is effective across age groups, in different settings, and for a clinically useful length of time.
Dr Cohen added that he never doubted the dedication of GSK, which has invested $350m in the programme. “I’ve met various chief executives over the years and found them extremely committed to the fact that GSK needed to be involved not just in projects that are financially rewarding but in projects that are meaningful in terms of medical need.”
Developing a vaccine for malaria is notoriously difficult since the disease is caused by a complex parasite. Scientists have been searching for a way of immunising against the disease for more than 60 years, but Dr Cohen’s team is the only one to have taken its project beyond early stage trials. .
Dr Cohen says the programme has suffered no major setbacks since it started trialling the vaccine in Africa in the late 1990s. Still, recent findings have shown the vaccine may not be as effective as first hoped.
In March, trial results showed the vaccine’s effectiveness waned over the course of four years. The findings released today indicate that the shot offers far less protection to very small babies, for reasons which are still largely unknown.
But the sheer scale of malaria, which killed 660,000 in 2010, means the vaccine does not need to be fully effective to make a huge difference.
The economic implications are also profound. Studies suggest a 10pc reduction in malaria could add 0.3 percentage points to GDP of countries which suffer from a high incidence of the disease.
This may be a major motivation for reducing malaria, but economics could also present a significant barrier, warns Eleanor Riley, professor of immunology at the London School of Hygiene and Tropical Medicine.
The vaccine could be “transformative” she said, but added: “This will only get used in low-income countries if the people who normally pay for these initiatives – NGOs and charitable foundations – do so”.
GSK has not yet revealed how much the vaccine will cost to make, but has said it plans to sell it at a 5pc margin, pumping profits back into further research on the vaccine programme. The answer to that cost question could be pivotal in determining where the vaccine gets rolled out, if and when it clears regulatory hurdles.
But for Dr Cohen, and the hundreds of people who have worked on the vaccine since its inception, today is a victory for the persistence of scientific endeavour. Whatever the hurdles to introducing their vaccine, they have taken the world a step closer to eradicating this deadly disease.
[Telegraph]