Brendan Howlin (Wexford, Labour)
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525. To ask the Minister for Health the relative accepted efficacy rate of the authorised vaccines for Ireland (details supplied); the understood effectiveness of each of these vaccines for new variants of Covid-19; and if he will make a statement on the matter. [22688/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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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. Any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).

The EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission.

Following the recommendation for use of vaccines against COVID-19 by the European Medicines Agency (EMA) and authorisation for use by the European Commission, the National Immunisation Advisory Committee (NIAC) develops guidance for their use in Ireland which is contained in the Immunisation Guidelines for Ireland. These guidelines are continuously updated and includes guidance on all new vaccines as they are approved for use in Ireland.

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 safety and efficacy.

Recently, the Commission has engaged in negotiations with Pfizer/BioNTech with a view to securing a Purchase Agreement for 900m doses of its vaccine on behalf of Member States, with provision for an additional 900m doses, for 2022/2023. Pfizer/BioNTech's vaccine is based upon mRNA technology, providing scope for it to be adjusted to deal with variants of Covid-19.

In conjunction with this, the new European bio-defence preparedness plan against COVID-19 variants called “HERA Incubator” will work with researchers, biotech companies, manufacturers and public authorities in the EU and globally to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.

The WHO weekly Epidemiological Update provides an overview of the global, regional and country-level COVID-19 cases and deaths, highlighting key data and trends; as well as other pertinent epidemiological information concerning the COVID-19 pandemic including the efficacy of vaccines against variants:

Brendan Howlin (Wexford, Labour)
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526. To ask the Minister for Health the recommended time interval between first and second doses as advised by the vaccine manufacturers for vaccines (details supplied); and if he will make a statement on the matter. [22689/21]

Brendan Howlin (Wexford, Labour)
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527. To ask the Minister for Health further to his response during a debate in Dáil Éireann on 22 April 2021, if he has re-examined the time interval between doses of a vaccine (details supplied); his views on whether it is contrary to health policy to have less vulnerable groups fully vaccinated before more vulnerable cohorts; his plans to ensure that persons are vaccinated with their first and second doses of the vaccine in accordance with the schedule published; and if he will make a statement on the matter. [22690/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 526 and 527 together.

Ireland’s COVID-19 vaccination programme strategy is to distribute all available vaccine as quickly as is operationally possible, prioritising those who are most vulnerable to COVID-19.

The programme is based on the principles of safety, effectiveness and fairness, with the objective of reducing severe illness, hospitalisations and deaths from COVID-19 infection.

The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The Committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation. It makes recommendations on vaccination policy to my Department. The NIAC review all data relating to COVID-19 vaccines on a rolling basis.

Following the recommendation for use of vaccines against COVID-19 by the European Medicines Agency (EMA) and authorisation for use by the European Commission, the National Immunisation Advisory Committee develops guidance for their use in Ireland which is contained in the Immunisation Guidelines for Ireland. These guidelines are continuously updated and includes guidance on all new vaccines as they are approved for use in Ireland.

You can read the guidelines at:

The recommended time interval between the first and second doses of Comirnaty (Pfizer) is 21-28 days apart.

The recommended time interval between the first and second doses of COVID-19 Vaccine Moderna is 28 days apart.

Vaxzevria (AstraZeneca) is authorised as a two-dose course 4-12 weeks apart.

As alternative vaccines are available, mRNA vaccines are preferable for those aged under 50 years including those with medical conditions with very high or high risk of severe COVID-19 disease.

- Those who have received a first dose of Vaxzevria:

- aged 50 and older should receive their second dose 12 weeks later as scheduled. A shorter interval of 4 - <12 weeks may be used in exceptional circumstance

- aged under 50 years with a very high risk or high risk medical condition should receive their second dose 12 weeks later as scheduled

- aged under 50 years without a very high risk or high risk medical condition should have their second dose scheduled at 16 weeks, pending the availability of further evidence to permit better assessment of the benefits and risks. However, there may be others aged under 50 years who, fully informed of the very rare risk and symptoms of TTS, wish to receive their second dose after 12 weeks and they should be facilitated where feasible.