Recommendation on the Appropriateness for Mozambique to be a Candidate for the "MOSQUIRIX" Pilot Study

The note takes into consideration elements of context, including:

• the positive opinion for use by the European Medicines Agency (EMA)
• the SAGE recommendation to conduct a pilot study introducing the vaccine in 3-5 countries before a recommendation can be established
• the burden of the disease in Mozambique

CoPI does not recommend that Mozambique be a candidate / participate in the pilot study due to the current PNI activity overload generated by the recent introduction of new vaccines. It recommends that the MS and the PNI implement the necessary preliminary actions to create favorable conditions for the introduction of this new vaccine in accordance with its recommendation R03/01/2011.