LONDON, (PNA/Bernama) — The latest results from the clinical trial of the RTS,S malaria candidate vaccine, show that it protects African infants and young children against malaria, Mozambican news agency (AIM) reported.
The trial found that RTS,S almost halves the number of malaria cases in young children (aged 5-17 months at first vaccination) and reduce by around a quarter malaria cases in infants (aged 6-12 weeks at first vaccination).
The trial took place at 11 research centers in seven African countries, including the Manhica Health Research Centre in the southern Mozambican district of Manhica.
It covered over 15,000 infants and young children, and found that RTS,S continued to protect against clinical malaria up to 18 months after vaccination.
In the age group 5-17 months, there were 46 percent fewer cases of clinical malaria. As a child can contract malaria more than once, this works out as 941 fewer cases of clinical malaria for every 1,000 children vaccinated. Severe malaria cases were reduced by 36 percent and hospitalizations by 42 percent.
For infants, there were 27 percent fewer cases of clinical malaria. Over the 18 months of follow-up, 444 cases of clinical malaria were prevented for every 1,000 infants vaccinated.
The drug company, GSK has spent US$ 350 million to develop the vaccine and expects to invest additional US$ 260 million. In addition, the Bill & Melinda Gates Foundation has donated US$ 200 million to fund the trial.
Following the positive findings, GSK plans to submit next year a license application to the European Medicines Agency (EMA). If the EMA grants a license, GSK will make an application to the World Health Organization for approval. If all goes smoothly, the vaccine could be introduced in 2015.
According to the chief executive of GSK, Andrew Witty, “we are 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 impressive.”
The RTS,S malaria vaccine candidate has been under development since the 1980s. The African countries involved in the research were Mozambique, Burkina Faso, Gambia, Ghana, Kenya, Malawi and Tanzania.