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Work Package:

WP2 – Preparation for future RSV product assessment

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Understanding the efficacy, effectiveness, and safety of RSV preventive products (i.e., monoclonal antibodies and vaccines) is relevant to a wide variety of health authorities, from regulators to public health institutes and international health agencies. The PROMISE Consortium has undertaken consultations with public health stakeholders about their data needs when getting ready to make decisions on the introduction of new RSV preventive products. The Consortium’s outputs that in particular have been subjected to external review are the evaluation of clinical endpoints in RSV studies and the generic product effectiveness study protocols. In conclusion, consultations with health authorities have resulted in important feedback. Given that many member states have not yet decided how RSV products will be assessed and that it will take time before PROMISE’s generic research protocols can be applied in practice, further consultations may be necessary in the future, possibly even during the remaining contract period of the PROMISE Consortium.

Published On: July 6, 2023