Duncan Smith (Dublin Fingal, Labour)
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141. To ask the Minister for Foreign Affairs and Trade his views on the signing by the European Commission of a €384 million contract for a Covid-19 vaccine with a company (details supplied) on 18 September 2020 despite the company not being advanced in its vaccine production and in view of the fact it has not produced a vaccine; if he has raised this matter with the Commission given it is a cause for concern here in view of the size of the contract; and if he will make a statement on the matter. [28408/21]

Simon Coveney (Cork South Central, Fine Gael)
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Ireland is participating in an EU procurement process with a view to accessing a portfolio of candidate vaccines against COVID-19 which are being negotiated with vaccine manufacturers by the European Commission acting on behalf of Member States. My colleague, the Minister for Health, has responsibility for securing the supply of vaccines for Ireland through the EU procurement process.

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 a Conditional Marketing Authorisation (CMA) from the European Medicines Agency (EMA) is obtained and any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Products Regulatory Authority (HPRA).

The Commission signed six Advance Purchase Agreements (APA) with manufacturers prior to any COVID-19 vaccines receiving authorisation for use in the EU. To date, four of those vaccines, BioNTech/Pfizer, Moderna, AstraZeneca, Janssen/J&J have received a CMA and are being supplied and administered as part of the rollout of Ireland’s COVID-19 vaccination programme. Ireland has the option to opt-in to the Sanofi APA, if and when the vaccine receives CMA.

Ireland supports the common EU approach to the procurement of vaccines, which ensures that our citizens get access to safe and effective vaccines against COVID-19. Without it, it is most unlikely smaller countries like ours would have the supply levels we are currently forecasting.