World Health Organization (WHO) Director General, Dr Tedros Ghebreyesus, as well eminent health experts and scientists have hailed the new malaria vaccine developed by Oxford University researchers, as a major breakthrough in the global war against the deadly parasitic disease.
The latest vaccine is the first to achieve WHO-specified 75percent efficacy goal.
Dr. Ghebreyesus, in a tweet described the feat as ‘good news – a new #malaria vaccine, R21, shows promise in an area where malaria transmission is highly seasonal. Larger studies will tell more.’
Dr Michael Makanga, EDCTP Executive Director, congratulated ‘the Multi-stage Malaria Vaccine Consortium on these highly promising results from the Burkina Faso trial of R21.’
‘This study represents a key advance in the clinical development of the R21 malaria vaccine towards licensure, and an important step closer to malaria control and elimination,’ Makanga stated.
Gareth Jenkins, Director of Advocacy, Malaria No More UK, said ‘the effective and safe malaria vaccine would be a hugely significant extra weapon in the armoury needed to defeat malaria, which still kills over 270,000 children every year.’
The institution yesterday, confirmed its efficacy of 77 percent in African children, in its Twitter handle.
‘Vaccine, trialled in 450 children, shows favourable safety profile and was well-tolerated. Vaccine candidate, R21/Matrix-M, has excellent potential for large-scale manufacturing and low-cost supply.’
The researchers and their partners in a statement announced that ‘findings from a Phase IIb trial of a candidate malaria vaccine, R21/Matrix-M, demonstrated high-level efficacy of 77 percent over 12-months of follow-up.’
In a report, published in The Lancet, they revealed that they are ‘the first to meet the WHO Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75 percent efficacy.’
The results, they further explained, ‘were from a Phase IIb randomised, controlled, double-blind trial conducted at the Clinical Research Unit of Nanoro (CRUN) / Institut de Recherche en Sciences de la Santé (IRSS), Burkina Faso. 450 participants, aged 5-17 months, were recruited from the catchment area of Nanoro, covering 24 villages and an approximate population of 65,000 people.’
‘The participants were split into three groups, with the first two groups receiving the R21/Matrix-M (with either a low dose or high dose of the Matrix-M adjuvant) and the third, a rabies vaccine as the control group. Doses were administered from early May 2019 to early August 2019, largely prior to the peak malaria season.’
The trials also recorded ‘vaccine efficacy 77 percent in the higher-dose adjuvant group and 71 percent in the lower dose adjuvant group, over 12 months of follow-up, with no serious adverse events related to the vaccine.’
‘Following these results, the Phase IIb trial, which was funded by the EDCTP2 programme supported by the European Union (grant number RIA2016V-1649-MMVC), was extended with a booster vaccination administered prior to the next malaria season one year later.’
‘About 229 million cases of clinical malaria were reported in 2019,’ even as WHO estimates that ‘malaria causes over 400,000 deaths each year globally.’
According to the agency, progress in reducing malaria mortality has stalled in recent years.
‘Most deaths are amongst children in Africa where very high transmission rates are found in many countries.’
‘Over 100 malaria vaccine candidates have entered clinical trials over recent decades but none has shown the 75 percent efficacy targeted by World Health Organization’s Malaria Vaccine Technology Roadmap.’
Halidou Tinto, Professor in Parasitology, Regional Director of IRSS in Nanoro, and the trial Principal Investigator said ‘the researchers, in collaboration with Serum Institute of India Private Ltd., and Novavax Inc., have now started recruitment for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children, aged 5-36 months, across four African countries.
‘These are very exciting results showing unprecedented efficacy levels from a vaccine that has been well tolerated in our trial programme. We look forward to the upcoming phase III trial to demonstrate large-scale safety and efficacy data for a vaccine that is greatly needed in this region.’
Adrian Hill, Director of the Jenner Institute and Lakshmi Mittal and Family Professor of Vaccinology at the University of Oxford, and co-author of the paper, explained that ‘the new results support our high expectations for the potential of this vaccine, which we believe is the first to reach the WHO’s goal of a vaccine for malaria with at least 75percent efficacy.
‘With the commitment by our commercial partner, the Serum Institute of India, to manufacture at least 200 million doses annually in the coming years, the vaccine has the potential to have major public health impact if licensure is achieved.’
Lynsey Bilsland, from Wellcome, which helped fund the research, said ‘despite global efforts against malaria, too many lives are still lost to this disease, especially babies and young children. Vaccines could change this.’
‘This is an extremely promising result showing high efficacy of a safe, low-cost, scalable vaccine designed to reach the huge numbers of children who are most at risk of the devastating impact of Malaria.’
‘Whilst further studies are required, this marks a significant and exciting step forward on an critical global health challenge.’
Professor Charlemagne Ouédraogo, Minister of Health, in Burkina Faso said ‘malaria is one of the leading causes of childhood mortality in Africa.’
‘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.’
Professor Alkassoum Maiga, Minister of Higher Education, Scientific Research and Innovation in Burkina Faso, said ‘I am proud of Burkina Faso researchers who made a great contribution to reach this important milestone.’
He expressed ‘hope that the upcoming phase III trial will confirm these exciting findings and that this vaccine could have a real impact on this disease affecting millions of children every year.’
Similarly, Dr Cyrus Poonawalla and Mr Adar Poonawalla, Chairman and CEO of the Serum Institute of India said ‘we are highly excited to see these results on a safe and highly effective malaria vaccine which will be available to the whole world through an excellent collaborative effort between Serum Institute, the University of Oxford and Novavax Inc.
Serum Institute demonstrated its commitment ‘to global disease burden reduction and disease elimination strategies, by providing high volume, affordable vaccines.’
‘We are highly confident that we will be able to deliver more than 200 million doses annually in line with the above strategy as soon as regulatory approvals are available.’
For decades, Jenkins noted, ‘the British scientists have been at the forefront of developing new ways to detect, diagnose, test and treat malaria, and we must continue to back them.:
‘A world without malaria is a world safer both for the children who would otherwise be killed by this disease, and for us here at home.’
‘Countries freed from the malaria burden will be much better equipped to fight off new disease threats when they inevitably emerge in the future,’ she added.
.Ojukwu is a Fellow of Hubert H Humphrey Fellowship journalist and advocate for improved socio-economic services for all citizens, as articulated in the Sustainable Development Goals(SDGS).
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