Freedom of Information Act

From the study: “Drug and medical device product failures and the stability of the pharmaceutical supply chain” we found out that 85.1% (166/195) of drug recalls between January 2017 and September 2019 in USA were quality related, while 14.9% (29/195) were because of labelling issues. Regarding the quality-related recalls, lack of sterility was the most frequent issue 83.7% (139/166).

We contacted the HPRA to find out if some of the adverse reactions which occurred repeatedly, were associated with quality issues.

The HPRA (Health Products Regulatory Authority) regulates medicines and medical devices in the Republic of Ireland. In their statement we can read: “We continuously monitor medicines, medical devices and other health products, responding quickly to any safety or quality concerns”.

We asked about the numbers of batches associated with adverse reactions such as: death, COVID-19, myocarditis, blood clots, cardiac arrests, strokes and miscarriages. We discovered that there is no database where batch numbers can be matched with adverse reactions .
“The request as presently formulated, specifically in relation to the batch numbers,would, by reason of the high number and nature of the records concerned, cause a substantial disruption to the work of the Human Products Monitoring (HPM) Department.
While the HPRA routinely receives COVID-19 vaccine batch numbers as a part of suspected adverse reaction reports, which are recorded in the national database to retrieve this information, each individual report needs to be opened and the information extracted.
This is an extremely time-consuming activity and therefore considered voluminous. It is therefore not possible to process such requests and not at the volume covered in your request at this time.“

The last “Vaccination status of laboratory confirmed cases of COVID-19 in those age ≥12 years, notified in Ireland… ” was published on 17th of December 2021.

Since this data did not get released in the regular timeframe, we sent a Freedom of Information Act request to HPSC on the 8th of May 2022.

We asked: ” How many people died with COVID-19 in the Republic of Ireland from 1st December 2021 to 1st March 2022 and what was their vaccination status?” The answer was refused under Section 15(1)(f) of the Act. This means that the HPSC intended to publish statistics within six weeks.
To date this has not happened.
We sent one more FOI request on the 18th of October 2022 and received another refusal: “While HPSC does intend publishing further reports on Vaccination status of laboratory confirmed cases of COVID-19 unfortunately the data has not been entered onto the Computerised Infectious Disease Reporting System (CIDR) and therefore the report cannot be extracted. An IT solution is currently in development and once tested and implemented will allow the transfer of data to CIDR…I am therefore refusing your request under Section 15(1)(a) which states that request may be refused if the information sought does not exist or cannot be found…”

Please note that no other COVID-19 statistics are affected. All other COVID-19 statistics are published on a regular basis.

10 months later, the statistics still weren’t published, so we sent another email on the 22nd of March 2023, and this is the answer we received: “Unfortunately, the vaccination status data reports continue to be unavailable. This matter has been referred to the Office of the Information Commissioner and you can read their decision in full here
HPSC is in the process of developing an ICT solution which will allow for the production and publication of vaccination status reports on the HPSC website.

Following this reply, we sent multiple emails to HPSC employees asking them to publish the statistics in the same format used in 2021. None of them answered our request.

To date (2nd of April 2024) it has been 29 months since the removal of the reports on vaccination status of laboratory confirmed COVID-19 cases, deaths and hospitalizations. As the National Immunisation Advisory Committee has an advisory role to the Chief Medical Officer and the Department of Health, it would have been expected that they would review data such that provided by the above mentioned reports, before approval of vaccines and boosters.

No reports were passed to the National Immunisation Advisory Commitee (NIAC) relating to vaccination status of COVID-19 cases or deaths.

The National Immunisation Advisory Committee is a body created within the Royal College of Physicians and its role is to advise the government on national vaccination plans. 

From their website: “The National Immunisation Advisory Committee (NIAC) provides evidence-based advice to the Chief Medical Officer and Department of Health on vaccines, immunisation and related health matters to inform health policies in Ireland. NIAC prepares this advice through extensive review of the latest clinical and scientific information.

NIAC’s work also includes:

reviewing newly authorised vaccines and vaccine technologies and assessing their role in Ireland

updating the Immunisation Guidelines for Ireland

answering queries from health care professionals and the Department of Health

advocating for best immunisation practices.”

We requested copies of whatever COVID-19 reports were sent to NIAC by HPSC, specifically regarding the vaccination status of COVID-19 cases, hospitalizations and deaths. We were informed that NIAC did not receive any such reports to date (2nd of April 2024) and we therefore conclude that the COVID-19 booster guidelines for Ireland were released without reviewing vaccine effectiveness.

From FOI request:

“the record concerned does not exist or cannot be found after all reasonable steps to ascertain its whereabouts have been taken,

In an effort to locate the records that you are seeking I requested that our staff leads for Covid-19 and our staff member who was responsible for liaising with NIAC furnish me with any records they are in possession of which are relevant to this request. I found that no records of reports sent to NIAC were created and the lead contact with NIAC in HPSC stated that no reports went from HPSC to NIAC relating to vaccination status of Covid-19 cases or deaths. I also requested of NIAC that they search for any reports received by HPSC relevant to this request and their response is contained in the next paragraph. Therefore, during my searches, no records were found that were relevant to this FOI request. 

In accordance with the requirements of section 15(1)(a) I am satisfied that all reasonable steps have been taken to identify and locate the records requested [or to identify any records in relation to your request as they do not exist]. I am unable to locate the records concerned and must therefore refuse your request on this basis.”

We requested the following information: how many people did not receive the second dose of the two-dose COVID-19 vaccine between December 2020 and March 2023?

“It has been confirmed that 43.3k people did not receive a second COVID-19 primary vaccination dose in the period between 30th December 2020 and 31st March 2023. In total 3,864,145 received first dose and 3,820,825 received second dose. All figures quoted are representative of all administration including deceased people.”