GlaxoSmithKline (GSK), one of the world’s leading research-based pharmaceutical and healthcare companies and is under assessment by European Medicines Agency (EMA) in collaboration with the World Health Organisation (WHO), has announced its malaria vaccine candidate, RTS,S, designed to fight against Plasmodium falciparum malaria parasite, prevalent in Malawi.
The worldwide drug and healthcare maker’s submission raises hope of bringing the world’s first Malaria vaccine closer to afflicted African countries, including Malawi where Phase III of the vaccine’s trials were conducted.
“The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a disease recognised by the World Health Organization (WHO) as of major public health interest, but intended exclusively for use outside the EU.
“This assessment is done by the EMA in collaboration with the WHO, and requires products to meet the same standards as vaccines or medicines intended for use in the EU. Eligibility for the application was granted by the CHMP after agreement from WHO that RTS,S met criteria for such an evaluation,” said GSK.
The EMA submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an addition to existing tools currently recommended for malaria prevention, it said.
“An effective vaccine for use alongside other measures such as bed nets and anti-malarial medicines would represent a advance in malaria control. To-date there is no licensed vaccine available for the prevention of malaria,” said GSK.
If the vaccine candidate passes through a battery of approval processes at EMA and World Health Organisation (WHO) levels, it could become ready for administering through respective immunisation policies of countries by 2015.
Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise, GSK said: “This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria.”.
RTS,S is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90 per cent of estimated deaths from malaria occur in SSA, and 77 per cent of these are in children under the age of 5.
If a positive opinion from the EMA is granted, the WHO has indicated a policy recommendation may be possible by end of 2015. A policy recommendation is a formal review process by WHO designed to assist in the development of optimal immunisation schedules for diseases that have a global public health impact, such as malaria.
A review by a European medicines agency is required by the majority of African countries prior to registration of a medicinal product manufactured in Europe. If positive, these regulatory decisions would help pave the way toward the large-scale implementation of the vaccine through African national immunisation programmes.
Data from the phase III vaccine trial programme conducted at 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) including over 16,000 infants and young children have also been included to support the filing.
Malaria is a leading cause of death and morbidity among under-five children in Malawi. According to research findings published by the College of Medicine, a constituent college of University of Malawi, 40 percent of all deaths for children under the age of five are attributed to Malaria.
“Malawi provides a perfect climate and geography for anopheles mosquitoes. In some districts infants already are infected with P.falciparum by 3 months of age,” reads a research paper by Dr Fraction Dzinjalamala, lecturer in Clinical Pharmacology, and Medicinal Chemistry at the College of Medicine, and researcher at the Malawi Liverpool Wellcome Trust, Blantyre.Follow and Subscribe Nyasa TV :