Peadar Tóibín (Meath West, Aontú)
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1347. To ask the Minister for Health if a vaccine (details supplied) will be made available in Ireland; and if so, when this will be the case. [62959/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Ireland is participating in a Procurement Exercise being operated by the European Commission on behalf of Member States to procure suitable, safe and effective vaccines, in sufficient quantities, to combat COVID-19. Ireland has entered into seven Advance Purchase Agreements (APAs), subject to regulatory approval, for the purchase of Covid-19 vaccine from a range of manufacturers including Valneva.

Five vaccines have been authorised by the EU to date; Comirnaty (Pfizer/BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca), Nuvaxovid (Novavax) and Janssen.  A number of vaccine candidates are currently under rolling review by the European Medicines Agency (EMA) including VLA2001 (Valneva), CVnCoV (CureVac) and Sputnik V (Gam-COVID-Vac).

When medicines are under rolling review, EMA’s human medicines committee CHMP evaluates clinical data as soon as these become available until it decides there is enough evidence for the manufacturer to apply for market authorisation.