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CHMP gives positive opinion on Mosquirix (RTS,S) vaccine for Malaria- Glaxo Smith Kline

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Last updated:25th Jul 2015
Published:25th Jul 2015
Source: Pharmawand

Glaxo Smith Kline received a positive opinion for its Malaria vaccine candidate from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The vaccine candidate, named Mosquirix (RTS,S) is the first QS-21 Stimulon containing product to receive a positive regulatory decision.

Following the CHMP positive opinion, two of the World Health Organization´┐Żs (WHO) 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 the vaccine candidate and make a joint policy recommendation for how the vaccine should be used in the event that it ultimately is approved by the national regulatory authorities in the sub-Saharan African countries for which the vaccine is intended. The WHO has indicated that such a policy recommendation may be possible by end of this year.

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