THE HEAD OF the body that regulates medicines in Ireland has said that a rigorous process is ongoing to monitor the safety of Covid-19 vaccines and that the benefits of these vaccines “continue to outweigh the risks”. 

At this evening’s briefing of the National Public Health Emergency Team, Dr Lorraine Nolan from the Health Products Regulatory Authority (HPRA) that there’d been 81 instances up to 11 January of suspected side effects reported in Ireland. 

As of last Thursday 14 January, 77,000 Covid-19 vaccines had been administered in Ireland. 

All reports of suspected side effects from the Pfizer/BioNTech Covid-19 vaccine so far were consistent with the mild side effects found during clinical trials, Dr Nolan said. 

Her comments came after Norway’s health regulator adjusted its advice for Covid-19 vaccines for older people who are frail. In a statement, the Norwegian Medicines Agency said that 13 autopsies had been carried out on those who had died, and suggested that common side effects to mRNA vaccines, such as a fever, nausea and diarrhoea, may have contributed to their deaths.

However, Norwegian authorities said there was no certain connection between these deaths and the vaccine. 

Speaking at tonight’s briefing, Dr Nolan outlined the process for analysing the safety of vaccines, and the situation in Ireland so far.

She said: “Safety monitoring is where we continue to check and verify that the vaccines in widespread use in the population continue to be as safe and as effective as possible.”

She said that such actions are central to the remit of the HPRA. 

The work involves identifying and comparing new and emerging data from multiple sources alongside data already coming from the clinical trials. 

Dr Nolan said the process of examining safety of vaccines has four key components.

This includes analysis of suspected side effects and adverse reaction events, the monitoring of safety reports and post-approval studies, and engagement with other bodies such as the World Health Organization to ensure access to the latest global safety information. 

She said: “From this Thursday, we intend to publish a regular update on our website of the number and nature of reports we receive as vaccination rollout continues.

“Up to 11 January, the HPRA received a total of 81 reports of suspected side effects associated with the BioNTech Covid-19 vaccine. 

All reports are generally consistent with those typically observed with other vaccines and included events of mild to moderate nature, which resolved, or were resolving at the time of reporting. Among those most frequently reported were abdominal pain, nausea, fatigue, joint pain and pains in the arms, some experiences of digging neck dizziness, headache, itching and rash. 

All [are] consistent with the known and anticipated side effects as emerged during clinical trials and clearly outlined for patients in the approved package.

“While the relatively mild effects described are of course uncomfortable for those who experienced them, they do pass quickly, and generally do not require medical treatment.”

Dr Nolan emphasised that from the evidence so far, it was clear the benefits outweigh the risks in terms of the vaccine. 

“Internationally, there have been reports of anaphylaxis associated with the use of messenger RNA vaccines,” she said. “Anaphylaxis is a known effect that can happen with vaccination, particularly for those with a history of serious allergic reaction. It is important to stress that this is very rare. And as is the case for all vaccines, vaccination centres are well prepared for such events.

As always, when discussing potential side effects, we must remember the risks they present is significantly outweighed by the health risk posed by the virus itself.

However, it is vital that this information is not misconstrued, or inadvertently interpreted to become misinformation.

“As to the safety of the vaccines. The number of reports in isolation does not signal that these vaccines are unsafe. I wish to stress that report submissions are not confirmed side effects to the vaccine, they are suspected, and they cannot state categorically that the side effects reported were caused by the vaccine.

“The safety profile remains positive and the benefits continue to outweigh the risks.”