Researchers in Britain have developed the world’s most effective malaria vaccine, with it becoming the first to achieve the World Health Organization-specified 75 per cent efficacy goal.
Researchers from the University of Oxford and their partners have reported findings from a Phase IIb trial of a candidate malaria vaccine, dubbed ‘R21/Matrix-M’, which demonstrated 77 per cent efficacy over 12 months of follow-up.
They hope the vaccine can be approved for use within the next two years, building on the speed and lessons learned through the rapid development of the COVID-19 vaccine.
Professor Adrian Hill, who is director of the Jenner Institute, and Lakshmi Mittal and Family Professor of Vaccinology at the University of Oxford, also led the research behind the AstraZeneca and Oxford coronavirus vaccine.
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“Malaria killed at least four times as many more people in Africa last year as COVID did,” Hill told the PA news agency.
“And nobody for a moment questioned whether COVID should have an emergency use review and authorisation in Africa – of course it did, very quickly.
“So why shouldn’t a disease that firstly kills children rather than older people, certainly killed an awful lot more, be prioritised for emergency use authorisation in Africa?
“Nobody’s really ever asked that question before COVID, but we’re going to do so, and have been doing so, and regulators are sounding interested.
“Normally this would take three to five years to do a phase three trial – in that time 300,000 children in Africa will die every year of malaria.”
“Why should it take that long? We think that there is a similar case for deploying malaria vaccines early to save lives, that there is for deploying COVID vaccines.”
Hill and the team say that commitment from a commercial partner, the Serum Institute of India, should enable them to manufacture at least 200 million doses annually in the coming years.
“The vaccine has the potential to have a major public health impact if licensure is achieved,” said Hill.
The team still have the last phase of testing to go through and the latest reported findings have yet to be peer-reviewed.
Hill said researchers hoped to report the results of the final stage of the trial next year.
Asked how confident he was that the efficacy could be replicated in the next phase of the trial, Hill told the PA news agency the researchers were “pretty confident”.
“And we and others have found that if you vaccinate just before the malaria season, you get maybe a 10 per cent improvement or something like that in efficacy – that’s not published yet but will be coming out fairly soon from another group.”
When asked if this was the most effective malaria vaccine in the world, Hill said: “It is in the sense that no other vaccine has had a primary endpoint with over 75 per cent efficacy, yes.”
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The first scientific report for a malaria vaccine was published in 1910, while the first trial of a malaria vaccine took place in the 1940s, and 140 malaria vaccines have gone into clinical testing.
Hill said there had been no shortage of effort, but it had just been incredibly difficult.
He was in the room when the World Health Organization (WHO) set the target of 75 per cent, and suggested the percentage when there was discussion on what number to settle on.
“They gave a target and the WHO is famous for giving targets that would be, to be polite, aspirational,” said Hill.
“This one was 75 per cent efficacy by 2030. Here we are in 2021 aiming for licensure in two years.
“So for once we might get there, well before the target, which would be very, very good.”
Hill has been working on malaria vaccines since 1994. For him, this is “a great day”.
“We need to build on this, we need to keep all our ducks in a row, we need to avoid any safety signal, but I think the odds are now on our side, we can get this through.”
“Malaria is one of the leading causes of childhood mortality in Africa,” said Professor Charlemagne Ouedraogo, minister of health in Burkina Faso.
“We have been supporting trials of a range of new vaccine candidates in Burkina Faso and these new data show that licensure of a very useful new malaria vaccine could well happen in the coming years.
“That would be an extremely important new tool for controlling malaria and saving many lives.”
The randomised, controlled, double-blind trial was conducted at the Clinical Research Unit of Nanoro/Institut de Recherche en Sciences de la Sante, Burkina Faso.
There were 450 participants, aged five to 17 months, who were split into three groups, with the first two groups receiving either a low dose or a high dose of the vaccine candidate.
The third group received a rabies vaccination as the control group.
Doses were administered from early May 2019 to early August 2019, largely prior to the peak malaria season.
The study, published on SSRN/Preprints with The Lancet, reports a vaccine efficacy of 77 per cent in the higher-dose adjuvant group, and 71 per cent in the lower-dose adjuvant group, over 12 months of follow-up.
Researchers did not note any serious adverse events related to the vaccine.