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LONDON: First the good news — after 30 years of research, the world finally has a viable vaccine ready for use to fight malaria.British pharma company GlaxoSmithKline announced on Friday that their vaccine Mosquirix — the world's first vaccine against the most dreaded vector borne disease in the world which has taken £360 million to develop, has been recommended to be licensed for use in babies in Africa.The European Medicines Agency has endorsed the drug and will now need the approval of health officials in sub-Saharan Africa where the disease affected 198 million people in 2013.The World Health Organization will also examine the vaccine, which could cost as little as $5.Speaking to TOI, GSK officials here said "The vaccine targets a particular type of malaria ( plasmodium falciparum ) which is found almost exclusively in sub-Saharan Africa. It has not been shown to be efficacious against the plasmodium vivax malaria parasite, which is predominant in Asia. It will not be a vaccine for India. However, we do have a treatment in development for malaria vivax (tafenoquine which is in phase 3 development)".GSK announced 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 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 immunization programmes once approved by national regulatory authorities.The final results had showed that vaccination with RTS,S, followed by a booster dose administered 18 months after the primary schedule, reduced the number of cases of clinical malaria in children (aged 5-17 months at first vaccination) by 36% over an average follow-up of four years. This however was a fall in efficacy from the 50% protection against malaria which was seen in the first year after the vaccine was administered.In infants (aged 6-12 weeks at first vaccination) it reduced malaria cases by only 26% to the end of the study (an average follow-up of 38 months). Efficacy decreased over time in both age groups.Without the booster dose, the three-dose vaccine only reduced clinical malaria cases by 28% in children and 18% in infants to the study end.In an exclusive interview to TOI from Ghana, Dr Kwaku Poku Asante, the chair of the Clinical Trial Partnership Committee, which managed the RTSS Phase 3 trial in Africa had said "The good news is that this a first generation malaria vaccine candidate and actually the first human parasite vaccine that has been developed to this level. This trial was conducted at 11 African research centres in seven countries. The RTSS malaria vaccine has now been shown to prevent 1,700 cases of clinical malaria per 1000 children vaccinated on average and more than 6,000 cases averted in an area of high malaria transmission".He added "It is true that the efficacy fell off over the four year period. But what we learned from the trial is that the booster dose enhanced efficacy over the longer term for both age groups. It will be up to the regulatory authorities to determine what efficacy is sufficient for recommendation, but it is likely that they will also look at the public health impact and the large number of cases averted through the use of the vaccine".GSK hopes that WHO would recommend the use of RTS,S as early as October this year.Sir Andrew Witty, CEO of GSK said: "Today's scientific opinion represents a further important step towards making available for young children the world's first malaria vaccine. 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 on children in those African communities that need it the most".Following the CHMP positive scientific opinion, two of the WHO's independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) will now jointly review the evidence base for RTS,S and make a joint policy recommendation for how it might be used alongside other tools to prevent malaria in the event the vaccine candidate is approved by national regulatory authorities in SSA.Following the WHO policy recommendation, GSK will also submit an application to the WHO for pre-qualification of RTS,S.Once a WHO pre-qualification is granted, GSK would then apply for marketing authorization in countries in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin implementation of RTS,S through their universal immunization programmes.