Dáil Éireann Debate, Wednesday - 30 June 2021
258. Deputy Holly Cairns asked the Minister for Health further to Parliamentary Question Nos. 914, 941, 945, 947, 954, 963, 981, 982, 983, 984, 988, 1002, 1003, 1004, 1005, 1041, 1069, 1078, 1083 and 1087 of 28 April 2021, the status of vaccines (details supplied) receiving EMA approval; and if he will make a statement on the matter. [28038/21]
Amharc ar fhreagraIreland is participating in an EU Procurement process with a view to accessing a portfolio of candidate vaccines against COVID-19 which are being negotiated with vaccine manufacturers by the Commission acting on behalf of Member States.
Four of the vaccines in the EU portfolio have already been awarded Conditional Marketing Authorisation (CMA) by the Commission.. The delivery of vaccines under Advance Purchase Agreements that the Commission has negotiated on behalf of Member States are predicated upon a CMA being obtained from the Commission (on the basis of a positive recommendation being awarded by the EMA). The awarding of a CMA provides a high level of assurance that a vaccine has undergone rigorous testing and has met the requirements of the independent regulatory process as regards demonstrating its quality, safety and efficacy.
The EMA has started a rolling review of the Sputnik V COVID-19 Vaccine but it has not been awarded a CMA to date. The Sinopharm vaccine is not under rolling review by the EMA at this time. www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-under-evaluation
