Karachi: After nearly 30 years of research and development, GSK’s malaria candidate vaccine, Mosquirix™ (RTS,S), receives positive opinion from European regulators for the prevention of malaria.
UK’s drug giant GSK announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive scientific opinion for its malaria candidate vaccine Mosquirix™, also known as RTS,S, in children aged 6 weeks to 17 months. Following this decision, the World Health Organization (WHO) will now formulate a policy recommendation on use of the vaccine in national immunisation programmes once approved by national regulatory authorities.
When contacted, a spokesperson for GSK Pakistan highlighted this as an important breakthrough achievement by GSK Global Vaccines in combating Malaria. He added that Malaria, which is a huge health burden in the country and afflicts approximately 1.6 million Pakistanis annually, has now become a disease that can be prevented through vaccination.
Malaria is an entirely preventable and treatable mosquito-borne illness. In 2014, 97 countries and territories had ongoing malaria transmission. An estimated 3.3 billion people are at risk of malaria, of whom 1.2 billion are at high risk. In high-risk areas, more than one malaria case occurs per 1000 population.
There were an estimated 198 million cases of malaria worldwide (range 124-283 million) in 2013, and an estimated 584,000 deaths (range 367,000-755,000). 90% of all malaria deaths occur in Africa.
In 2013, globally, the disease caused an estimated 453 000 under-five deaths.
RTS,S, which was developed in partnership with the PATH Malaria Vaccine Initiative (MVI), is the first candidate vaccine for the prevention of malaria to reach this milestone. While other vaccines tackle viruses or bacteria, RTS,S has been designed to prevent malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa (SSA).
GlaxoSmithKline, the British pharmaceutical giant that has spent more than £235 million since 1987 developing the vaccine, will now apply to the World Health Organization for permission to approach individual states.
Sir Andrew Witty, the company’s chief executive, hailed an “important step towards making available for young children the world’s first malaria vaccine”. He added: “ While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available, such as bed nets and insecticides, would provide a very meaningful contribution to controlling the impact of malaria.
Data from this 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. The efficacy of RTS,S was evaluated in addition to existing malaria control measures, such as insecticide treated bed nets, which were used by approximately 80% of the children and infants in the trial.
GSK has yet to reveal how much the vaccine will cost, but some news outlets have recorded that it may be as little as £3 a shot. GSK has pledged to make a profit of no more than 5 per cent.
The agency’s committee for medicinal products for human use said that the vaccine’s side-effects included fever and irritability, but overall it had reached a positive opinion after reviewing clinical trials involving more than 15,000 children from seven countries.