News
EA to take part in historic malaria vaccine trials
A clinical officer takes a blood sample for a malaria slide. Some vaccine trial sites are located in areas where there is a year-round threat of malaria. Photo/ANTHONY KAMAU
Posted Monday, November 9 2009 at 00:00
Article 58 is a special review procedure that allows the European Medicines Agency, in close collaboration with the World Health Organisation, to issue a scientific opinion regarding the quality, the efficacy and the safety of a medical product that is intended for use exclusively outside the European Union.
Depending on the final clinical profile of the vaccine and the timetable of the regulatory review process, the first vaccine introduction could take place over the next three to five years.
The vaccine research was started in the late 1980s and as invented, developed and manufactured in laboratories at GSK headquarters in Belgium.
Funding for the development of this vaccine has been made possible through the support of the Bill & Melinda Gates Foundation, which has provided grants of more than $200 million since 2001.
GSK has invested more than $300 million to date and expects to invest at least another $100 million before the completion of the project.
The Malaria Vaccine Initiative, the WHO and the US Agency for International Development developed the Malaria Vaccine Decision-Making Framework to help countries prepare to make decisions related to future adoption of a malaria vaccine and thereby avoid unnecessary delay between the recommendation for use of a vaccine and its availability in low-income countries.
GSK and MVI signed a collaboration agreement in 2001 to pursue the paediatric clinical development of RTSS in Africa.
To advance the development programme, African research centres in five countries, and collaborating institutions, joined the partnership.
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