Wednesday, 30 June 2021

Ceisteanna (242)

John McGuinness


242. Deputy John McGuinness asked the Minister for Health the number of versions of a vaccine (details supplied) available; and if all versions are authorised for use in the EU. [27773/21]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

Ireland supports the EU Procurement Process, the purpose of which is to secure safe and efficacious vaccines for EU citizens.

Covid-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. No vaccine will be used until Conditional Market authorisation from the European Medicines Agency (EMA) is obtained and any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).

The delivery of vaccines under APAs 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 to Vaxzevria provides a high level of assurance that the vaccine has undergone rigorous testing and has met the requirements of the independent regulatory process as regards demonstrating its safety and efficacy. The AstraZeneca vaccine Vaxzevria (previously COVID-19 Vaccine AstraZeneca) COVID-19 Vaccine (ChAdOx1-S [recombinant]) is the sole version of AstraZeneca's vaccine approved for use in the EU.

Question No. 243 answered with Question No. 217.