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Parliamentary question - P-003960/2021(ASW)Parliamentary question
P-003960/2021(ASW)

    Answer given by Ms Kyriakides on behalf of the European Commission

    The priority of the Commission has always been the safety and the efficacy of any COVID-19 vaccine authorised in the EU. A marketing authorisation is granted only after the quality, safety and efficacy of the product have been evaluated and a positive benefit-risk balance related to its use has been concluded.

    An enhanced pharmacovigilance system is in place for COVID-19 vaccines. It allows a close monitoring of their safety when used, providing additional re-assurances for their safety. Any new information will be included in the product information as soon as relevant scientific evidence is available.

    The Commission collaborates closely with the European Medicines Agency (EMA) and will take regulatory actions, if necessary. However, there is, currently no reason to suspend or withdraw any of the marketing authorisations granted by the Commission to the COVID-19 vaccines.

    Therapeutics will play a significant role in the response to COVID-19, complementing the successful EU strategy for vaccines. The Commission has published an EU strategy on COVID-19 therapeutics[1].

    It aims to put in place means to speed up all the process of the development of products, the clinical research and clinical trials, the manufacturing, the purchase and the availability of the products in EU.

    This will help bring safe and effective treatments earlier to patients. In addition, EMA publishes available information regarding treatments on its website. With regard to ivermectin, EMA advises against the use for the prevention or treatment of COVID-19 outside randomised clinical trials[2].

    Last updated: 24 September 2021
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