New Malaria Vaccine Shows Potential

Malaria vaccine creators to seek regulatory approval for new vaccine after successful trials

(RxWiki News) Malaria is an international problem and, as of yet, no successful vaccine for this mosquito-borne illness has been developed. Preliminary results for a new vaccine show that the situation might be changing.

The new vaccine, called RTS,S, has shown promise in trials, leading developers to announce that they will be seeking regulatory approval for the vaccine.

If approved and developed, it would be the first approved vaccine for malaria, which caused an estimated 219 million cases and 660,000 deaths worldwide in 2010, according to the US Centers for Disease Control and Prevention (CDC).

"Ask your doctor about health precautions when traveling."

According to CDC, malaria can cause fever and flu-like illness, including symptoms like headache, chills, muscle aches and fatigue. If not treated quickly, the infection can develop into severe malaria, which may lead to kidney failure, seizures, coma and death.

It is possible for patients to develop malaria more than once. CDC noted that most malaria cases occur in children in Africa.

The abstract for the study examining RTS,S was presented October 8 at the 6th Multilateral Initiative on Malaria (MIM) Pan-African Conference by lead author Lucas Otieno, MD, of the PATH Malaria Vaccine Initiative in Washington DC and GlaxoSmithKline (GSK) Vaccines in Wavre, Belgium.

The vaccine is currently in trials at 11 research centers in seven different African countries.

The study has followed 6,537 infants (aged 6 to 12 weeks at the time of their first vaccination) and 8,923 children (aged 5 to 17 months at the time of their first vaccination). The participants were given three doses (one month apart) of either RTS,S or a control vaccine.

After 18 months, Dr. Otieno and colleagues found that across all 11 centers, children who received vaccination with RTS,S developed 46 percent fewer cases of malaria as compared to those who received the control vaccination.

The researchers also found that the vaccine reduced severe malaria cases in children by 36 percent and malaria hospitalizations by 42 percent.

Infants who received the RTS,S vaccine experienced 27 percent fewer malaria cases than their peers who received the control vaccine. Four out of 11 centers showed significant differences between the two groups. 

The researchers estimated that the vaccine helped prevent 941 cases of malaria and 21 cases of severe malaria per 1,000 vaccinated children and 444 cases of malaria and 8 cases of severe malaria per 1,000 vaccinated infants. 

"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 percent of children and 86 percent of infants in the trial," GSK noted in a news release.

It is important to note that the study has not yet been published in a peer-reviewed journal. However, GSK is moving forward with the approval process for RTS,S.

"Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). The World Health Organization (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," GSK reported.

Review Date: 
October 8, 2013