Matt Shanahan (Waterford, Independent)
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1753. To ask the Minister for Health if death rates in the elderly have coincided with vaccination; if his Department is reviewing corollary data between vaccination and deaths occurring; the way data on deaths is compiled and any lag times pertaining; and if he will make a statement on the matter. [18894/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, Ireland experienced a third wave of COVID-19 infection in late 2020/early 2021 which led to significant mortality and hospitalisations in the initial months of this year. The epidemiological situation has substantially improved since the peak of that wave in January, with the 14 day incidence reducing from a peak of 1,534 cases per 100,000 to a current rate of 114 cases per 100,000 on the 20 April. This has led to a corresponding significant reduction in hospitalisations and mortality. In terms of mortality, to date, a total of 1,399 COVID-19 related deaths have been reported as having occurred during January 2021, 860 in February, 221 in March and 45 in April to date.

We are already seeing the benefits of the vaccination programme, especially in those groups that have been prioritised for vaccination. For example, in the month of April to date, no new COVID-19 cases have been linked to Nursing Home outbreaks. The proportion of cases accounted for by persons aged 70 years decreased from 11.7% of total new cases during the second week of January, to only 3.1% of new cases during the week ending 17 April. There is a similar picture for healthcare workers, who accounted for 13.4% of all new cases in the second week of January 2021, compared with 3.2% of all cases during the week ending 17 April. The proportion of overall deaths arising from those aged 7 and over and also those linked to nursing home outbreaks has also fallen substantially over the period.

The Health Products Regulatory Authority is responsible for managing the national pharmacovigilance (adverse reaction reporting) system, with healthcare professionals and members of the public encouraged to submit reports of any suspected adverse reactions. All adverse reaction reports received are individually assessed, with relevant follow up information requested as appropriate and reports entered into the HPRA’s national pharmacovigilance database. These reports are subsequently sent to EudraVigilance (EV), the European Medicines Agency’s (EMA’s) database of suspected adverse reactions, where the data are analysed to detect new safety signals. Monitoring of suspected adverse reactions is an important part of the EMA’s intensive monitoring plan for COVID-19 vaccines, so that any changes in benefit risk balance can be promptly detected and acted upon. This enables the EMA to continue to safeguard public health safety.

The HPRA cautions against attributing suspected side effects occurring after vaccination on the basis of temporal association alone, given the well-established limitations of spontaneous reports. The totality of data from all sources (e.g. clinical and epidemiological studies and literature) must be considered as part of ongoing safety monitoring to ensure evidenced based conclusions are drawn.

The HPRA publish regular safety update reports which provide an overview of national reporting experience with COVID-19 vaccines as well as key information arising from EMA reviews of worldwide safety data. To date, five safety updates have been published. The most recent published on 25 March reported that the HPRA had received 31 reports describing patients who passed away in the days or weeks following vaccination with authorised COVID-19 vaccines. The majority of these have been reported in association with mRNA vaccines. The reports mainly describe fatalities which are regularly seen due to natural causes or progression of underlying disease. In all cases, the patients concerned had underlying conditions and/or concurrent illness, with a small number having tested positive for COVID-19. All reports are being carefully reviewed. However, it can be expected that fatalities due to progression of underlying disease or natural causes will continue to occur, including following vaccination. The HPRA states that this does not mean that the vaccine caused the deaths.

The HPRA also participate in EMA coordinated reviews of worldwide safety data for COVID-19 vaccines. The EMA’s Safety Committee, the PRAC, reviews safety issues during monthly plenary meetings, the highlights of which are published. After careful review of these data, none of the reviews to date have identified a safety concern from cumulative analysis of reports of fatalities from all causes. In most cases, progression of (multiple) pre-existing diseases was considered a plausible explanation. The WHO Global Advisory Committee on Vaccine Safety (GACVS) has also reviewed available data on fatalities and concluded that current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals. Similar conclusions have been reached by other agencies responsible for safety monitoring, including in the US and the UK.

Legally, in Ireland, a death can be registered with the General Registrar’s Office (GRO) up to three months after the date of occurrence and in practice some deaths may be registered considerably later (See www.gov.ie/en/service/49c66f-registering-a-death-in-ireland/). A public consultation has recently been concluded by the Department of Social Protection on the process for notifying and registering deaths in Ireland with the aim of reducing the time period for registering a death and the results of the consultation are currently being reviewed by that Department. All COVID-19 deaths are reportable to the Coroner.

While the majority of COVID-19 related deaths are notified in a timely manner, in some instances, notification of a death may be delayed. The daily Department of Health Press Release includes all additional deaths that have been newly notified to it by the Health Protection Surveillance Centre (HPSC), regardless of the date of occurrence. The HPSC is Ireland's specialist agency for the surveillance of communicable diseases. As of February 2020, COVID-19 was added to the existing list of notifiable diseases. HPSC receives information regarding deaths from a number of sources. Its primary source of information is the national infectious disease surveillance system (CIDR).

CIDR is populated by data from eight regional Departments of Public Health (DPHs). Staff in regional DPHs populate CIDR data regarding deaths, either directly from clinical information they receive when investigating cases and outbreaks of COVID-19 or from Coroner’s files that they receive on a regular basis. HPSC may also receive Coroner’s files to cross reference with regional DPH data. In addition, HPSC receives a daily file from the General Registrar’s Office (GRO) as an additional source of data regarding COVID-19 deaths.