Dáil Éireann Debate, Wednesday - 13 January 2021
929. Deputy Neale Richmond asked the Minister for Health the status of all Covid-19 vaccine authorisations currently being assessed by the European Medicines Agency; and if he will make a statement on the matter. [1111/21]
View answer991. Deputy Neale Richmond asked the Minister for Health the engagement he has had with the European Commission on the roll-out of the Covid-19 vaccination; and if he will make a statement on the matter. [1297/21]
View answer992. Deputy Neale Richmond asked the Minister for Health the engagement he has had with the European Medicines Agency about its approval of Covid-19 vaccinations; and if he will make a statement on the matter. [1298/21]
View answer1095. Deputy Dara Calleary asked the Minister for Health the interaction he had with the European Medicines Agency, EMA, about the approval process for a Covid-19 vaccine (details supplied); his understanding of the delay in the EU approval process versus that of the UK and the USA; and the likely approval date and subsequent roll-out plan for this particular vaccine in Ireland. [1802/21]
View answerI propose to take Questions Nos. 929, 991, 992 and 1095 together.
Ireland is taking part in a Procurement Exercise being operated by the European Commission (EC) on behalf of Member States to procure suitable, safe and effective vaccines, in sufficient quantities, to combat COVID-19.
On 21 December, the EC granted approval for conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease (COVID-19) in people from 16 years of age following recommendation by the European Medicines Agency. Supplies of Comirnaty are being delivered to the State and utilised in the current vaccination programme.
On 6 January, the EC granted approval for conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent coronavirus disease (COVID-19) in people from 18 years of age.
The EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted.
The EMA are also currently undertaking a rolling review of the Janssen Vaccine, which began on 1 December 2020.
For more information on COVID-19 Vaccines in development, are available on the EMA website:
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines-development-evaluation-approval-monitoring
