Louise O'Reilly
Ceist:213. Deputy Louise O'Reilly asked the Minister for Health if his attention has been drawn to a research paper (details supplied); and if he will make a statement on the matter. [21116/21]
Amharc ar fhreagraThursday, 22 April 2021
Ceisteanna (213)
Freagraí scríofa
As part of the Department of Health’s COVID-19 response, the Research Services and Policy unit have developed a weekly COVID-19 vaccine research bulletin that signposts recent research publications relevant to the vaccine rollout. The purpose of the bulletin is to ensure awareness of published research evidence that may support the COVID-19 vaccination rollout in Ireland. This is relevant to the co-ordination of communications on the vaccine rollout and aspects of the work of the sub-groups IEMAG (Irish Epidemiological Modelling Advisory Group) and CBAG (Communications and Behavioural Advisory Group). The bulletin supports the work of these groups by keeping abreast of emerging evidence from COVID-19 vaccine-related research publications.
This bulletin is circulated widely, including to the Minister for Health, individuals on the Senior Management Team, members of IEMAG, CBAG, and the Vaccines Taskforce, and other staff in the Chief Medical Officer (CMO), Research & Development & Health Analytics, and Health Protection divisions within the Department of Health. The study referenced was included in the latest issue of the bulletin, that was circulated on Tuesday 20th April 2021.
It is important to note that the study referenced is, as the Deputy points out, a preprint. This means that the findings are preliminary and have not been peer-reviewed, which is a significant step in evaluating and validating the quality and credibility of a research publication.
New evidence related to COVID-19 vaccines is routinely circulated to the Office of the Chief Medical Officer and is also taken into consideration by the National Immunisation Advisory Committee (NIAC). NIAC is an independent expert group that provides?evidence-based advice to the Department of Health on vaccines,?immunisation?and related health matters to inform health policies in Ireland.
The European Medicines Agency (EMA) has recently concluded an investigation into a number of reports of very rare, unusual blood clots occurring with low platelets in people following vaccination with Vaxzevria® COVID-19 Vaccine AstraZeneca. The EMA has added these unusual clotting events with low platelet counts as very rare side effects to the product information. This event is estimated to occur between 4 and 10 in every 1 million people. However, as so few events have been reported, there is a high level of uncertainty regarding the incidence of this extremely rare adverse event in any particular age group or gender. Although most cases of this rare event occurred in women under 60 years of age, this may be because of the higher rate of vaccination in healthcare workers who are predominantly female. In the UK the reported rate of events adjusted by sex and vaccination status was similar in men and women. A UK suggestion of a possible increasing incidence of this adverse event in the younger age groups has not been confirmed based on available European Economic Area (EEA) data. The EMA has requested new studies and amendments to ongoing ones to provide more information.
The risk/benefits of Vaxzevria® may vary by age. As alternative COVID-19 vaccines are available NIAC has revised the recommendations for use of this vaccine:
- Any authorised COVID-19 vaccine, including Vaxzevria®, is recommended for those aged 60 years and older including those with medical conditions with very high or high risk of severe COVID-19 disease
- Vaxzevria® is not recommended for those aged under 60 years including those with medical conditions with very high or high risk of severe COVID-19 disease
- A second dose of Vaxzevria® should not be given to anyone who developed unusual blood clots with low platelets after the first dose
- Those who have received a first dose of Vaxzevria®:
1. Aged 60 and older should receive their second dose 12 weeks later as scheduled
2. Aged under 60 years:
- with a very high risk or high-risk medical condition should receive their second dose 12 weeks later as scheduled
- without a very high risk or high-risk medical condition should have the scheduled interval between doses extended to 16 weeks to allow further assessment of the benefits and risks as more evidence becomes available.