Guardian

A MALARIA vaccine, RTS, S that could help protect young children and infants in malaria- endemic areas against infection and clinical disease caused by plasmodium falciparum, the most deadly species of the malaria parasite, may become available globally by the end of 2014.

But funding and innovation  are critical to sustain progress in malaria fight, according to  African leaders.

Significant progress has been made in scaling up malaria control efforts and the African Leaders Malaria Alliance (ALMA), an alliance of 43 African Heads of State and the African Union working to end malaria-related deaths on the continent, says Africa is better prepared to defeat malaria now than at any other time in history.

During the African Union Summit, President Ellen Johnson-Sirleaf of Liberia, chair of ALMA, said to achieve universal access to life-saving tools and continue the drive toward eliminating malaria deaths, an additional  $3.2 billion in funding over the next three years would be needed.

“A share of these resources will come from Africa. We can’t ask the world to invest in Africa’s health if we won’t make the same investment ourselves, but we will need the world’s help,” said Johnson-Sirleaf.

According to a fact sheet on phase three safety and efficacy trial of the RTS, S malaria vaccine candidate, made available to The Guardian by the National Malaria Control Programme (NMCP), the trial is ongoing, and efficacy and safety results in infants six to 12 weeks old are expected by the end of 2012.

These data will provide an understanding of the efficacy profile of the RTS,S malaria vaccine candidate in this age group, for both clinical and severe malaria.

An additional data set, which will include information about the vaccine’s longer-term protective ability for both groups of children, should be available by the end of 2014 and will provide evidence for national and international public health organisations to evaluate the vaccine candidate’s full potential for use.

The RTS,S malaria vaccine candidate is currently under development and subject to the evaluation of its safety, quality, and efficacy, as well as its benefits and risks, by regulatory and public health authorities. If the required regulatory with public health information, including safety and efficacy data from the phase three programme is deemed satisfactory, the World Health Organisation (WHO) has indicated that a policy recommendation for the RTS,S malaria vaccine candidate 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.

RTS,S is the most clinically advanced malaria vaccine candidate in the world today; it is being developed in partnership by GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative (MVI), together with prominent African research centres.

The Minister of Health, Prof. Onyebuchi Chukwu, said the success of RTS S/AS01 vaccine, which is the first vaccine against a parasitic disease has been encouraging and it is expected to revolutionise the war against malaria, reduce all cause mortality and also facilitate the global efforts to eradicate malaria.

“I am also aware that some sites were included in the phase three trial in the country,” Chukwu said.

The launch of the phase three efficacy trial of the RTS,S malaria vaccine candidate marked an important milestone after more than 20 years of research and development. The trial started in May 2009 and is now underway at 11 sites in seven African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania). Together, the 11 sites completed enrolment in January 2011, with 15,460 infants and young children participating, making this the largest malaria vaccine trial in Africa to date.

As one of the final stages of testing before regulatory file submission, the phase three efficacy trial is designed to continue monitoring safety and potential side-effects, while evaluating the efficacy of the vaccine in infants and young children on a large scale.

To this end, researchers enrolled two groups of participants: children aged five to 17 months and infants aged six to 12 weeks. The phase three trial is a double-blind study, in which participants initially received three doses of either RTS,S or a ‘control vaccine.’ After a year and a half, some participants will receive a fourth RTS,S dose to evaluate the potential benefit of a booster. The trial has been designed in consultation with appropriate regulatory authorities and the WHO and is conducted according to the highest international standards for safety, ethics, and clinical practices.