Brendan Griffin
Ceist:488. Deputy Brendan Griffin asked the Minister for Health the position regarding the plans to introduce a drug (details supplied); and if he will make a statement on the matter. [59858/21]
Amharc ar fhreagraTuesday, 7 December 2021
Ceisteanna (488)
Freagraí scríofa
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.
Four vaccines have been authorised by the European Medicines Agency (EMA) to date; Comirnaty (Pfizer/BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca) and Janssen.
The Valneva vaccine has yet to receive regulatory authorisation and is currently under rolling review by the EMA. 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.