Dáil debates

Tuesday, 8 December 2020

Saincheisteanna Tráthúla - Topical Issue Debate

Covid-19 Pandemic

10:00 pm

Photo of Frank FeighanFrank Feighan (Sligo-Leitrim, Fine Gael) | Oireachtas source

I thank the Deputies for giving me the opportunity, on behalf of the Minister, Deputy Donnelly, to update the House on the Covid-19 immunisation programme. The Government is committed to the roll-out of a Covid-19 vaccination programme as soon as suitable products have been authorised and supplies are available. In this regard, a high-level task force has recently been established, under the chairmanship of Professor Brian MacCraith, to support and oversee the development and implementation of the programme. The task force is working on a national Covid-19 vaccination strategy and implementation plan, and aims to submit this by Friday, 11 December. The Minister, Deputy Donnelly, will then bring the output of the task force's work to Government for consideration, and subject to the outcome of this discussion, it is the intention that the vaccination strategy and implementation plan will be published.

Today, the Minister, Deputy Donnelly, announced the allocation strategy for Covid-19 vaccines, following sign-off from Cabinet. The allocation process that should apply to the vaccination of the population is based on the advice of national experts on immunisation and the National Public Health Emergency Team, NPHET. The Covid-19 vaccine allocation strategy is based on a Department of Health and National Immunisation Advisory Committee paper. It sets out a provisional priority list of groups for vaccination once a safe and effective vaccine has received authorisation from the European Medicines Agency. This paper was endorsed by NPHET on 3 December.

In terms of procurement of vaccines, Ireland is taking part 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. Although Ireland has secured large numbers of doses of candidate vaccines, the initial availability will be limited if authorised for use. Therefore, a prioritisation strategy had to be developed.

So far, Ireland has opted into five advance purchase agreements, APA, with pharmaceutical companies and a process is in place to opt into a sixth APA. 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 Products Regulatory Authority.

Ireland, similar to all other member states, is awaiting conditional market authorisation by the EMA for the Pfizer-BioNTech vaccine and other vaccine candidates such as Moderna and AstraZeneca. It has been agreed at EU level that this is the most appropriate process regarding those new and rapidly-developed vaccines.

The EMA has stated that it wishes to take the time and make sure that the quality, effectiveness and safety is assured and matches EU standards.

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