Malaria Vaccine RTS,S Receives Positive Opinion From European Regulators

Malaria candidate vaccine ‘Mosquirix’ RTS, S receives positive opinion from European regulators. This is a milestone in the fight against malaria in Sub-Saharan Africa.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive scientific opinion for Mosquirix’ RTS, S,  which trigger the body’s immune system to defend against the malaria parasite among children aged 6 weeks to 17 months. 

Prof. Francis Martinson

UNC Project Country Director, Prof. Francis Martinson, also the Principle Investigator for the vaccine trial in Malawi, says “We have played one of the biggest headways” 

Prof. Martinson said the opinion from CHMP of the EMA made on 24th July, 2015 agrees that the vaccine is good enough to be used “everywhere” where there is malaria transmission. 

He said the Mosquirix’ RTS, S, S is a noticeable milestone and a plus for number of existing malaria prevention tools that includes bed nets and sanitation as this vaccine will hopefully increase the efficacy of prevention programmes so that less people get infected with Malaria.

“We strongly believe that as fewer and fewer people have the parasite in them then the eventual dream of having eradication of malaria will come true.” He said

A lot of people die of Malaria in sub-Saharan Africa (SSA). In 2013, there were an estimated 584,000 deaths with around 90 percent of these occurring in SSA, and 83 percent in children under the age of five in SSA.

“If you visit any hospital during the malaria season, many of the cases that the clinicians are seeing or are on admission are malaria cases. So if we can prevent that many from appearing in the hospital, that will be a lot of time for the doctors and nurses to provide a better care to those who find themselves in the hospital.” Added Prof. Martinson 

Prof. Martinson further said, following this positive opinion, the documentation has been forwarded to Word Health Organisation (WHO) whose committees will also look at the information.

“Once they will agree which we hope will be before the end of the year, we will see a report from them that will eventually lead to request various national regulatory authorities to start looking at possibility of including the vaccine in their vaccination programmes” he said

The UNC Project Country Director said for now, the vaccine is for the children since were targeted in the trial due to frequent cases among them.

But he expressed hope that once the vaccine minimizes the problem in the children there will be another clinical trial for adults. 

“We are already in contact with sponsors about the possibility of doing this study again in adolescent and adults.” He disclosed

The positive opinion for young children was based on the review of data assessing the candidate vaccine’s safety, efficacy and quality from a Phase III clinical trial programme involving more than 16,000 young children that was conducted by 13 African research centres in eight African countries including Malawi at Area 18 Health Centre in Lilongwe.

Data from this Phase III clinical trial programme demonstrate that over the first 18 months following three doses of RTS,S, malaria cases were reduced by almost half in children aged 5-17 months at the time of first vaccination and by 27% in infants aged 6-12 weeks. 

At study end, four doses of RTS,S reduced malaria cases by 39% over four years of follow-up in children, and by 27% over three years of follow-up in infants. In areas of the highest malaria burden more than 6,000 clinical malaria cases were prevented over the study period for every 1,000 children vaccinated.