Covid-19 vaccines were responsible for seven out of every 10 reports of suspected adverse reactions to human medicines in Ireland last year.
New figures published by the Health Products Regulatory Authority show 17,946 reports of adverse reactions filed with the regulatory body for medicines in 2021 were related to Covid-19 vaccines out of a total of 25,622 reports received.
The total number of adverse reactions reported to the HPRA last year by healthcare professionals and the public was more than three times the annual total for 2020.
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The latest annual report of the HPRA, which was previously known as the Irish Medicines Board, said the substantial 231% increase in reports in 2021 was expected given the national rollout of Covid-19 vaccines and how people were strongly encouraged to report any suspected adverse reactions.
It said the 17,946 reports of suspected side effects from the use of Covid-19 vaccines arose from approximately 7.5 million doses that had been administered during 2021.
The HRPA said a total of 229 patients were reported to have died following treatment with a suspect medicine last year, including 104 from vaccines which would have included Covid-19 vaccines.
It said the majority of cases involving Covid-19 vaccines related to individuals aged 75 years and over,
In many cases where a fatality was reported, the HPRA stressed that the patients were described as already having a significant underlying illness and were treated with multiple medicines and/or surgery
According to the HPRA, 45% of all reports last year came from members of the public, with 26% from healthcare professionals and 29% from marketing authorisation holders.
The HPRA said the frequency of reports about any medicine cannot be taken as an indicator of either safety or risk nor as a basis for determining the incidence of a reaction.
It said the level of adverse reports in relation to other medicines was largely unchanged compared to 2020.
HPRA chairman, Michael Donnelly, said the organisation had immediately launched a dedicated system to monitor the safety of Covid-19 vaccines following the commencement of Ireland’s national vaccination programme in late 2020.
“The very transparent and open way in which vaccine safety issues were addressed, working with national and European partners, was a key element in building public trust in the vaccination programme,” said Mr Donnelly.
He said the receipt of reports on suspected side effects was central to the HPRA’s monitoring system which helped to increase its knowledge of the safety profile of all medicines, including vaccines.
Mr Donnelly also welcomed the greater understanding and recognition of the role played by the HPRA in regulating medicines and devices for the benefits of people and animals that had arisen from its work coming under the public eye during the pandemic.
HPRA chief executive, Lorraine Nolan, said the pandemic showed the regulatory system needed to demonstrate an incredible level of agility and foresight to ensure the continued safety and trust in vaccines during the roll-out of Covid-19 vaccination campaigns.
“The pandemic has demonstrated in a very meaningful way the opportunity but also the feasibility of safe and rapid acceleration in innovative product development, from concept to market authorisation and global uptake in a period of less than 12 months,” said Dr Nolan.
She said it had become increasingly evident throughout 2021 for the need for a global and coordinated approach by health products regulators which had many benefits in terms of avoiding duplication, providing greater certainty and making the best use of resources.
The HPRA said it also worked together with gardaí and Revenue’s Customs officials to proactively monitor the supply chain for unauthorised or falsified Covid-19 health products as well as the advertising and promotion of unauthorised and non-compliant treatment and devices purporting to be for the detection, cure or prevention of Covid-19.
The HPRA annual report shows it received 107 applications for new clinical trials last year including five related to Covid-19.
The report also revealed that a total of 117 human medicines were recalled last year including 33 products which were contaminated.
In addition, the HPRA detained over 1.6 million dosage units including tablets, capsules and vials of falsified and illegal medicines during 2021, of which 46% related to sedatives.
The HPRA said it initiated 10,596 enforcement cases last year, representing an annual increase of 32%.
Enforcement activity also resulted in the amendment or shutdown of 461 websites, e-commerce listings and social media pages.
* Article from: The Irish Mirror
