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General Category => News => Topic started by: Idowu Olabode on July 25, 2015, 01:25:16 PM

Title: World’s First Malaria Vaccine Approved for Use
Post by: Idowu Olabode on July 25, 2015, 01:25:16 PM
The world’s first malaria vaccine has received approval for use among young children in malaria endemic regions together with established antimalarial interventions.


The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced on Friday that it has ‘adopted the positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), for use outside the European Union (EU)’.


Mosquirix is intended for use in areas where malaria is regularly found, for the active immunisation of children aged 6 weeks to 17 months against malaria caused by the Plasmodium falciparum parasite, and against hepatitis B.
“After decades of research into malaria vaccinations, Mosquirix is the first vaccine for the disease to be assessed by a regulatory agency” a statement on its website said.


The CHMP highlighted in its opinion that Mosquirix is for use in line with official recommendations that take into account the risk of Plasmodium falciparum malaria in different geographical areas and available malaria control interventions. These recommendations will be defined by the World Health Organization (WHO) and regulatory authorities in the non-EU countries where the vaccine would be used.

The malaria vaccine Mosquirix, also known as RTS,S/AS01, was submitted to European Medicines Agency(EMA) under a regulatory procedure that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. This means that EMA can help facilitate access to new medicines for people living outside the EU.


The CHMP towards approval worked closely with other experts, including from WHO and regulatory authorities from the relevant countries. In its assessment, the CHMP applied the same rigorous standards as for medicines to be marketed within the EU, the statement said.


Policy for use

The approval which came at its July 2015 meeting is a pre-requisite for policy recommendations by World Health Organization(WHO) to Mosquirix in vaccination programmes. National regulators in the countries where the vaccine will be used including Ghana will take a decision on licensing the vaccine in their jurisdictions.


WHO is expected to provide its recommendations on use of Mosquirix by November 2015. The policy recommendations take into account several additional factors not addressed by EMA. These include feasibility of implementation, affordability and cost-effectiveness, and the public health value of the vaccine in relation to other available malaria control measures and vaccines.



About the Mosquirix
Mosquirix which was produced and marketed by GlaxoSmithKline, is intended to protect against malaria caused by Plasmodium falciparum.Because of the vaccine’s composition it also protects against hepatitis B.

Evidence leading to its approval was derived from a large clinical trial conducted in seven African countries; Ghana, Burkina Faso, Gabon, Kenya, Malawi, Mozambique and Tanzania.


The results showed that Mosquirix provides modest protection against Plasmodium falciparum malaria in children in the 12 months following vaccination. The vaccine was effective at preventing a first or only clinical malaria episode in 56% of children aged between 5-17 months and in 31% of children aged 6-12 weeks.


Although the efficacy of the vaccine decreased after one year, the safety profile of the vaccine was considered acceptable.


Based on the results of the trial the CHMP concluded that despite its limited efficacy, the benefits of Mosquirix outweigh the risks in both age groups studied. The CHMP considered that the benefits of vaccination may be particularly important among children in high-transmission areas in which mortality is very high.


Because the studies showed that Mosquirix does not offer complete protection, and the protection it provides decreases in the longer term, it is important that established protection, and the protection it provides decreases in the longer term, it is important that established protective measures, for example insecticide-treated bed nets, continue to be used in addition to the vaccine.


The vaccination reports say gives protection against hepatitis B, however, it should not be used to protect against hepatitis B in settings that do not require malaria prevention.
The CHMP also agreed a follow-up programme with the drug makers to ensure that the safety and effectiveness of Mosquirix is continuously monitored as described in the risk management plan.