GlaxoSmithKline has 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, is a QS-21 stimulon developed by Agenus that increases immune response to antigens in vaccines. Agenus is an immunology company discovering and developing innovative treatments for cancers and other diseases.
"This is a significant milestone for the field of Malaria and our QS-21 Stimulon, which is an integral component of the adjuvant contained in Mosquirix, the first malaria candidate vaccine to generate positive Phase 3 data, now awaiting the World Health Organization's recommendations and approvals by African Health authorities," commented Dr Garo Armen, Chairman and CEO, Agenus. "We look forward to seeing Mosquirix achieve the required final clearances so it can begin benefiting children at risk of contracting and dying from Malaria."
The CHMP scientific opinion is a key step in the regulatory process toward making a vaccine against Malaria available. Following the CHMP positive opinion, two of the World Health Organization's (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.
