The world's first anti-malaria vaccine may be approved for use within two years, after encouraging results from a large-scale trial of a vaccine candidate.
UK drug maker GlaxoSmithKline (GSK) is seeking regulatory approval for the vaccine after trial data showed that it had cut the number of cases in African children.
Results from a large-scale Phase III trial, presented in Durban, show that the most clinically advanced malaria vaccine candidate, RTS,S, continued to protect young children and infants from clinical malaria up to 18 months after vaccination.
"Based on these data, GSK now intends to submit a regulatory application to the European Medicines Agency (EMA)," GSK said in a statement.
The World Health Organisation (WHO) has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015 if it is granted a positive scientific opinion by EMA, it said.
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).
Vaccine efficacy was also assessed separately at each of the trial sites, which represent a wide range of malaria transmission settings; efficacy was found to be statistically significant at all sites in young children and at four sites in infants, according to the statement.
Eleven African research centres in seven African countries are conducting this trial, together with GSK and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI.
If the EMA gives a positive opinion, and the public health information is satisfactory, including safety and efficacy data from the Phase III programme, the WHO has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015, GSK said in a 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 per cent of children and 86 per cent of infants in the trial.
In these latest results over 18 months of follow-up, children aged 5-17 months at first vaccination with RTS,S experienced 46 per cent fewer cases of clinical malaria, compared to children immunised with a control vaccine.
An average of 941 cases of clinical malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated in this age group, noting that a child can contract more than one case of malaria, the statement said.
Severe malaria cases were reduced by 36 per cent; 21 cases of severe malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated. Malaria hospitalisations were reduced by 42 per cent, according to the statement.Source
8 Oct 2013,