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Parliamentary questions
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13 April 2021
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: P-001283/2021

In its recently published Communication ‘HERA Incubator — Anticipating together the threat of COVID-19 variants’, the Commission has outlined its strategy towards variants(1).

HERA Incubator will join up research, assessment and analysis carried out in the EU and beyond with a view to responding to emerging variants. Greater access to comprehensive datasets, research outcomes and reinforced data analysis coupled with genomic, epidemiologic and clinical data will inform the development of effective measures, vaccines and treatments. It will also pinpoint gaps where further research efforts are required.

The Commission will use existing advance purchase agreements to ensure rapid access to and delivery of the next generation of vaccines, if necessary. Existing agreements may have to be updated to cover protection against variants. Based on the lessons learned, a detailed and credible plan showing capability to produce vaccines in the EU on a reliable timescale will be a prerequisite to any new or updated agreement. This should not prevent the EU from considering sources from outside the EU if needed, provided they meet the EU safety requirements.

The Commission will also speed up the procedures for approving adapted versions of existing vaccines, in case new variants becoming less receptive to current vaccines. The framework will be based on that used for flu vaccines, which has worked successfully for many years. This means speedy approval based on a rolling review of data and clear guidance on data requirements from the European Medicines Agency. To make this happen, the Commission has recently adopted a Delegated Regulation that is amending the Variation Regulation (EC) No 1234/2008(2).

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