Anti-malaria vaccine RTS,S reduces malaria risk in children, policy outcomes by 2015
A policy recommendation for the RTS,S malaria experimental vaccine is possible as early as 2015, paving the way for decisions by African nations regarding large scale implementation of the vaccine through their national immunisation programmes.
The policy outcome will however be dependent the following: if the required public health information, including safety and effectiveness data from the Phase 3 programme, is deemed satisfactory, the World Health Organisation (WHO) has indicated.
Of significance however is that the initial result from the on-going Phase 3 trials into the experimental RTS,S malaria vaccine show that the vaccine reduces the risk of malaria by half in African children aged 5 to 17 months.
The initial result was announced in a statement released at the on-going Malaria Forum, which began last Monday and is being hosted by the Bill & Melinda Gates Foundation in Seattle, Washington, USA.
The result indicates that the candidate RTS,S vaccine is capable of providing young children significant protection against clinical and severe malaria with an acceptable safety profile.
The Forum is being attended by malaria experts, government officials and researchers and principal investigators from Ghana, Malawi, Gabon, Burkina Faso, Kenya, Mozambique, Tanzania and Senegal, where the trials are taking place.
The malaria vaccine study is being conducted among two groups of children aged 5 -17 months and 6-12 weeks old in 11 clinical trial centres in the seven African countries including the Kintampo Health Research Centre, in the Brong Ahafo Region and the Malaria Research Centre of Ghana in Agogo.
The study was conducted to determine the efficacy and safety of the RTS,S malaria vaccine, which was discovered over 20 years ago.
The trial is ongoing and the efficacy and safety results in infants who are 6 to 12 weeks old are expected by the end of 2012. These data will provide an understanding of the effectiveness of RTS,S in this age group, for both clinical and severe malaria.
The RTS,S malaria vaccine candidate is still under development. Further information about the longer-term protective effects of the vaccine, should be available by the end of 2014. This will provide evidence for national public health and regulatory authorities, as well as international public health organisations, to evaluate the benefits and risks of the malaria vaccine.
Dr Tsiri Agbenyega, a Principal Investigator of the trial at the Malaria Research Centre in Agogo and Chair of the Clinical Trials Partnership Committee, is quoted as saying: “The publication of the first results in children aged 5 to 17 months marks an important milestone in the development of RTS,S. These results confirm findings from previous Phase II studies and support ongoing efforts to advance the development of this malaria vaccine candidate”
“Having worked in malaria research for more than 25 years, I can attest to how difficult making progress against this disease has been. Sadly, many have resigned themselves to malaria being a fact of life in Africa. This need not be the case. Renewed interest in malaria by the international community, and scientific evidence such as that we are reporting today, should bring new hope that malaria can be controlled,” he added.
The vaccine is being developed in partnership by GSK and the PATH Malaria Vaccine Initiative (MVI), together with prominent African research centers. The partners are all represented on the Clinical Trials Partnership Committee, which is responsible for the conduct of the trial. Major funding for clinical development comes from a grant by the Bill & Melinda Gates Foundation to MVI. An extended team of organisations continues to work on RTS,S, including scientists from across Europe, North America and Africa.
Should it be approved by regulatory authorities and recommended by the World Health Organisation (WHO), it will be used for African children, who are most at risk from the disease. Successful development of an effective vaccine to be used alongside other measures such as bed nets and anti-malarial medicines would represent a decisive step toward sustained malaria control.
With more than US$200 million in grant monies from the Bill & Melinda Gates Foundation, MVI contributes financial, scientific, managerial, and field expertise to the development of RTS,S. GSK Company takes the lead in the clinical development and in the interactions with regulatory agencies and has invested more than $300 million to date and expects to invest another $50-100 million before the completion of the project.
By Eunice Menka