GSK seeks approval for world’s first malaria vaccine




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malariaLONDON – GlaxoSmithKline (GSK.L) said on Thursday it is applying for regulatory approval for the world’s first vaccine against malaria, designed for children in Africa.

The British drugmaker said the shot, called RTS,S, is intended exclusively for use outside the Union but will be evaluated by the Medicines Agency (EMA) in collaboration the ().

Malaria, a mosquito-borne parasitic disease, kills more 600,000 people a year, mainly babies in the poorest parts of sub-Saharan Africa.

Experts have long hoped that scientists would be able to develop an effective vaccine against the disease, and scientists at GSK have been working on this one for 30 years.

Yet hopes that RTS,S would be the final answer to wiping out malaria were dampened when results from a final-stage trial in babies aged six to 12 weeks showed the shot provided only modest protection, reducing episodes of the disease by 30 percent compared to immunization a control vaccine.

GSK said data from that and other final-stage Phase III trials – conducted at 13 African centers across Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania – have also been included to support the application. [eap_ad_2] “An effective vaccine for use alongside other such as bed nets and anti-malarial medicines would represent an advance in malaria control,” the company said in a .

The has previously indicated it recommend use of RTS,S from as early as 2015 if EMA regulators back its license application.

GSK has been developing RTS,S the non-profit PATH Malaria Vaccine (MVI), with grant from the Bill & Melinda Gates to MVI.

The vaccine also contains an adjuvant, or booster, made by U.S. biotech company Agenus (AGEN.O), which received an undisclosed milestone payment for the regulatory submission. in Agenus rose 7 percent in premarket Nasdaq trade.

If approved, the vaccine is unlikely to be anything other neutral for GSK’s bottom line. The firm has promised it will be priced at cost of manufacture plus a 5 percent margin, and the margin would be reinvested in on malaria and other neglected tropical diseases.

“This is a key moment in GSK’s 30-year journey to develop RTS,S and brings a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria,” Sophie Biernaux, head of GSK’s malaria vaccine franchise said in the . (Reuters)[eap_ad_3]