Researchers are, more than ever before, closer to the dream of showcasing the world's first malaria vaccine. This follows the successful mobilisation of stakeholders including clinicians, laboratory scientists, field workers, data entry personnel, African children, chiefs and local communities, backed by a heavy investment in infrastructure and technology.
Feverish preparations are taking place to introduce the vaccine soon, if all goes well with the ongoing trials in Ghana, Burkina Faso, Kenya and four other African countries. It has not been without sweat and grit, considering that the research has lasted well over 20 years since the vaccine was first invented.
Latest data, however, from the large-scale phase 3 trials on the RT,S,S malaria candidate vaccine show that the most clinically advanced vaccine continues to protect young children and infants from malaria up to 18 months after vaccination. And there is still more good news, as reports indicate that the World Health Organization (WHO) has given signals that a policy recommendation for the vaccine is possible as early as 2015, if it receives a positive scientific opinion.
Eleven trial sites, including those at Kintampo in Ghana, Kombewa in Kenya and Bagamoyo in Tanzania, in the seven African countries are conducting the trials in collaboration with GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative (PATH/MVI), with funding from the Bill & Melinda Gates Foundation. A statement from PATH/MVI said with these promising data on the RTS,S vaccine, GSK
would submit a regulatory application to the European Medicines Agency (EMA) in 2014.
“These latest results demonstrated that over 18 months of follow-up, RTS,S was shown to almost halve the number of malaria cases in young children, aged 5-17 months at first vaccination and to reduce by around a quarter, the malaria cases in infants aged 6-12 weeks at first vaccination,” it added.
These results were made known at the largest scientific forum, which saw scientists presenting up-to-date groundbreaking research on preventing, controlling and eliminating malaria.
The forum, the 6th Multilateral Initiative on Malaria (MIM) Pan African Conference, held in South Africa, recently brought together various stakeholders including national malaria control programme managers, policymakers, health care workers and community members, among others.
MIM is an international alliance of organizations and individuals seeking to maximize the impact of scientific research against malaria in Africa to ensure that research findings yield practical health benefits.
In an interview with the African Media and Malaria Research Network (AMMREN) on how to get the vaccine licensed locally in Africa to benefit children through the Expanded Programme on Immunisation (EPI), Ms Carla Botting, Director of Product Development and Access, PATH/ MVI said, prior to consideration by national regulatory authorities in African countries, results of the trial of the RTS,S malaria vaccine candidate must be submitted to the European Medicines Agency (EMA) for review which will take place under the Article 58 process.
“If the EMA provides a positive scientific opinion on RTS,S, it will then be considered by the WHO for what is called a policy recommendation, which outlines strategies and recommendations for use, and prequalification. Assuming a WHO prequalification is granted, GSK, the regulatory sponsor, would then submit dossiers to individual countries for their regulatory review,” Ms Botting said On how the vaccines would be made vailable for use in the countries and funding it, she explained that “once there is a WHO policy recommendation and WHO prequalification, there will be a regulatory review by national regulatory authorities in each country. If approved, a country will have to decide whether or not to adopt it into her health system.”
According to Ms Botting, “If RTS,S is approved by EMA and receives prequalification by WHO, we hope that GAVI and/or other funding agencies will fund the purchase of the vaccine.”
One efforts to get local communities to accept the vaccines following licensure, Ms Botting said, “Preparation is essential to pave the way for the acceptance of any new vaccine, including a malaria vaccine. At this stage, MVI has worked with researchers and local entities to conduct community studies in four countries to explore a wide range of factors related to people's attitudes, beliefs and perceptions about malaria, generally and a new intervention like a malaria vaccine.”
“These studies have been shared with EPI and malaria control programmes, as well as the national technical advisory groups and the communities that participated in the research. Should RTS,S be approved for use, the community perceptions findings would be a cornerstone in the development of communications plans for the deployment of the malaria vaccine,” she added.
The success stories associated with the on-going vaccine trial has brought lots of optimism and excitement. Ghanaian researcher in the RTS,S trials at the Kintampo Health Research Centre (KHRC) in the Brong Ahafo region of Ghana, Dr Kwaku Poku Asante, is all joy as he projects into the future.
“On the African side, I am so excited that for the first time we are testing a vaccine in Ghana for Ghanaian children and this is being conducted with the highest scientific
standards. We will ride on this to test other vaccines that come along,” he said in an interview in Accra.
On how Ghana is preparing to receive the vaccine if licensed, he said all data coming in on the performance of the vaccine trials at Kintampo and Agogo in Ghana and other
countries are made available to the Ghana Food and Drugs Authority (FDA).
“The FDA has got a technical group that looks at the data on the vaccine to decide if it is okay to be given to Ghanaian children for protection against malaria,” Dr Asante said. According to him, once the FDA, the national regulator, gives the nod for the use of the vaccine, the National Malaria Control Programme would pick this up, and based on the recommendation of the WHO, implement the administration of the vaccines among the children in collaboration with those in charge of the Expanded Programme on Immunisation.
Dr Asante explained that there is on-going community engagement whereby the people around Kintampo are being prepared for the introduction of the vaccine and how their cooperation is crucial to its success. “We link up with them as and when we get new information to help them understand the processes, how far we have come, what they should expect and who will receive the vaccine.”
On funding, he said governments and global partners working on the vaccine are committed to ensuring that it becomes accessible once it is licensed.
Sir Andrew Witty, Chief Executive Officer of GSK, in a press statement by PATH/MVI, said they were very “encouraged by these latest results, which show that RTS,S continued to provide meaningful protection over 18 months to babies and young children across different regions of Africa.”
“While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impresive," he noted.
“These data support our decision to submit a regulatory application for the vaccine candidate which, if successful, would bring us a step closer to having an additional tool to fight this deadly disease. We are grateful to the scientists across Africa and GSK and to our partners who have worked tirelessly for almost 30 years to bring us to this point,” he added.
Dr David C. Kaslow, Vice President of Product Development at PATH, is also quoted saying: “Given the huge disease burden of malaria among African children, we cannot ignore what these latest results tell us about the potential for RTS,S to have a measurable and significant impact on the health of millions of young children in Africa.”
According to the PATH/ MVI statement, “the efficacy and public health impact of RTS,S were evaluated in the context of existing malaria control measures, such as insecticide treated bed nets, which were used by 78% of children and 86% of infants in the trial.”
The vaccine, when it eventually makes an appearance would impact significantly on the public health landscape of the African continent, which s been reeling under the of malaria for centries.