Answer to Written Question: Vaccine doses

(Source: European Parliament)

EN
E-001654/2021
Answer given by Ms Kyriakides
on behalf of the European Commission
(31.5.2021)

On Friday 19 March 2021, AstraZeneca submitted to the European Medicines Agency (EMA) a notification for a variation to the terms of the marketing authorisation of the COVID-19 vaccine Vaxzevria. The variation was to introduce Halix B.V., Leiden (The Netherlands), as an alternative site responsible for manufacture of the active substance.

EMA completed the assessment to an accelerated timetable and, on 26 March 2021, issued a favourable opinion on the variation authorising the site. AstraZeneca could start using the Halix B.V., Leiden site from receipt of the favourable EMA opinion.

AstraZeneca provided the information needed and the variation was finalised quickly.

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