Dáil Éireann Debate, Wednesday - 5 May 2021
525. Deputy Brendan Howlin asked 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]
View answerCovid-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:
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
