BRITISH DRUG MAKER GlaxoSmithKline is to to seek regulatory approval for the world’s first ever vaccine against malaria.
GSK hope to get the green light for the prototype vaccine after trials showed it offered children a partial shield against the disease.
Results for the latest trial stage of the closely-followed RTS,S vaccine were unveiled at a conference in Durban, South Africa which gathered experts on malaria in Africa.
It showed that 18 months after vaccination, children aged five to 17 months had a 46 per cent reduction in the risk of clinical malaria compared to unvaccinated peers.
But in infants aged six to 12 weeks at the time of vaccination, efficacy was lower: a 27 per cent reduction in risk.
A spokeswoman for GSK told AFP that the company would file an application to the European Medicines Agency (EMA) under a process aimed at facilitating new drugs for poorer countries.
Under that process, the European medications watchdog gives a “scientific opinion” on the safety and efficacy of the vaccine.
This opens the way for the vaccine to be considered by the World Health Organisation (WHO), which in turn can fast-track its licensing in individual countries in Africa.
“We will submit, in 2014, an application for a scientific opinion by the Committee for Medicinal Products for Human Use on RTS,S through the EMA Article 58 procedure,” the GSK spokeswoman said.
“The intent is not to make the vaccine available in the EU as it is being developed specifically for children in sub-Saharan Africa who are most at risk of malaria.”
Malaria death toll
RTS,S is a frontrunner in the race to develop the first vaccine for malaria, which according to WHO figures for 2010 — the latest estimates available — infected around 220 million people, killing 660,000 of them. The toll is highest among small children in Africa.
The new data presented in Durban showed far less protection for infants, as opposed to young children, and also pointed to declining effectiveness over time.
At the one-year mark, efficacy among the young children group was 47 per cent against clinical malaria and 56 perc ent against severe malaria.
Among the infants group, it was 46-percent effective against clinical malaria and 36-percent effective against severe malaria at the one-year stage.
But at the 18-month mark, effectiveness had fallen to 46 per cent and 36 per cent among young children and to 27 per cent and 15 per cent among infants.
“There are a number of possible hypotheses for these differences we are looking at,” said Lucas Otieno, one of the principal investigators in the trial who works for the Kenya Medical Research Institute.
The theories include possible interference with the vaccine by maternal antibodies and the impact of vaccines for other diseases that were administered to the infants at around the same time, he said.
Otieno stressed that the trial “is ongoing”.
“We hope to have more information on the long-term protection some time in 2014. In addition, we will also be evaluating the impact of a booster dose given at 18 months after the primary vaccination series.” The initial series comprised three shots.