Róisín Shortall
Question:339. Deputy Róisín Shortall asked the Minister for Health the status of the strategy for deployment of a vaccine (details supplied) in Ireland; and if he will make a statement on the matter. [10938/21]
View answerThursday, 25 February 2021
Questions (339)
Written answers
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 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 EMA received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V on 16 February 2021.
The EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee may issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.