Dáil Éireann Debate, Wednesday - 3 February 2021
700. Deputy Seán Haughey asked the Minister for Health if he has concerns in relation to the efficacy and efficiency of the vaccine produced by a company (details supplied); and if he will make a statement on the matter. [5319/21]
View answerI welcome the announcement from the European Commission (EC) that the AstraZeneca vaccine has been authorised for use across member states, including Ireland on 29 January.
The EC granted approval for conditional marketing authorisation (CMA) for a COVID-19 Vaccine developed by AstraZeneca and Oxford University to prevent coronavirus disease (COVID-19) in people from 18 years of age following recommendation by the European Medicines Agency.
The EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission.
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. Any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).
Following the recommendation for use of vaccines against COVID-19 by the European Medicines Agency (EMA) and authorisation for use by the European Commission, the National Immunisation Advisory Committee (NIAC) develops guidance for their use in Ireland which is contained in the Immunisation Guidelines for Ireland. These guidelines are continuously updated and includes guidance on all new vaccines as they are approved for use in Ireland.
