Dáil Éireann Debate, Tuesday - 12 October 2021
530. Deputy Mary Lou McDonald asked the Minister for Health if there are plans under way to assess additional Covid-19 vaccines for validation or accreditation with the European agencies or the European Medicines Agency; and if he will make a statement on the matter. [49434/21]
View answerIreland is participating in a Procurement Exercise being operated by the European Commission on behalf of Member States to procure suitable, safe and effective vaccines, in sufficient quantities, to combat COVID-19.
Four vaccines have been authorised by the EU to date; Comirnaty (Pfizer/BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca) and Janssen.
A number of vaccine candidates are currently under rolling review by the EMA including NVX-CoV2373 (Novavax), CVnCoV (CureVac) and Sputnik V (Gam-COVID-Vac).
When medicines are under rolling review, the European Medicines Agency’s (EMA) human medicines committee CHMP evaluates clinical trial data as soon as these become available until it decides there is enough evidence for the developer to apply for marketing authorisation
The EMA cannot provide exact timelines as these depend on when developers provide the necessary data for CHMP review. The EMA updates the status of each medicine under rolling review when the developer applies for marketing authorisation.
