Thomas Pringle (Donegal, Independent)
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403. To ask the Minister for Health the reason a vaccine (details supplied) is not being allowed as an authorised vaccine under the Irish system requiring those who have been vaccinated to spend time in mandatory hotel quarantining despite the fact that this is a WHO approved vaccine and there is no liability to the State in the event of any side effects given that the State has never supplied the vaccine; and if he will make a statement on the matter. [31391/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 Commission acting on behalf of Member States. Emergency Support Instrument (ESI) funding has been leveraged by the Commission to facilitate its negotiations with vaccine manufacturers, including with regard to production costs and securing a reduced per dose cost for Member States.

This process has provided Ireland with access to vaccines (at a reduced cost) that it would find it difficult to access otherwise within a year after the declaration of a Public Health Emergency of International Concern by the WHO. Four of the vaccines in the EU portfolio have already been awarded Conditional Marketing Authorisation (CMA) by the Commission.

Ireland supports efforts made by the Commission to safeguard the production and delivery of doses of vaccine in the quantities agreed with vaccine suppliers and to ensure that up-front funding provided through ESI has been properly used.

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 delivery of vaccines under APAs that the Commission has negotiated on behalf of Member States are predicated upon a CMA being obtained from the Commission (on the basis of a positive recommendation being awarded by the EMA).

The awarding of a CMA provides a high level of assurance that a vaccine has undergone rigorous testing and has met the requirements of the independent regulatory process as regards demonstrating its quality, safety and efficacy.

The Sinopharm vaccine has not been awarded a CMA to date.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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405. To ask the Minister for Health if music and dancing will be permitted when weddings increase to 50 and subsequently to 100 guests. [31393/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, on 29 June, Government announced the next phase of reopening the economy and society in line with Recovery and Resilience: The Path Ahead.

While significant progress is being made in relation to the roll-out of our vaccination programme and the position had been broadly stable over the earlier part of June, the prevalence of the more transmissible Delta variant is rapidly increasing in Ireland and this poses a significant risk, in particular to those who are not yet fully vaccinated. For this reason, a number of higher risk indoor activities will not recommence as planned on 5 July, pending the implementation of a system to verify vaccination or immunity status. However, as an exception, weddings already planned will be allowed to proceed with the planned increase in the number of guests to 50 at the wedding reception with protective measures from 5 July. Live music and dancing are not currently permitted at weddings as outlined in the Fáilte Ireland guidelines. These guidelines can be found online: covid19.failteireland.ie/operational-guidelines/.

Unfortunately, due to current uncertainties with regard to the Delta variant there is not yet an indication of when live music and dancing will be permitted. The epidemiological situation will be monitored on an ongoing basis and the level of restrictions will be kept under review by Government.

Significant and sustained progress has been made on suppressing the virus over recent months due to the huge effort of people across the country. By working together, we have saved lives and limited the impact of the disease on society in Ireland. To protect the gains of recent months we must continue to practice basic preventative behaviours and to follow public health guidelines.