‘Reassuring’ Covid-19 vaccine data as health body releases safety update

In a safety update issued on Thursday, the HPRA confirmed it had received 257 reports of suspected side-effects from the Pfizer and Moderna Covid vaccines by Monday this week, January 18
‘Reassuring’ Covid-19 vaccine data as health body releases safety update

On the Pfizer-BioNtech vaccine, the majority of side effects reported were ‘mild or moderate’ in intensity and resolved within a few days.

HPRA Safety monitoring data on the Pfizer and Moderna vaccines that are being rolled out across the country is “reassuring” and support their continued use in the fight against Covid-19, the Health Products Regulatory Authority (HPRA) has said.

The agency, which regulates medicines and health products in Ireland, said the benefits of taking the Covid-19 vaccines outweighed any risks based on safety monitoring data it is gathering on an ongoing basis.

In a safety update issued on Thursday, the HPRA confirmed it had received 257 reports of suspected side-effects from the Pfizer and Moderna Covid vaccines by Monday this week, January 18.

The latest figures on the number of vaccine doses administered amounted to more than 77,000 as of January 13, it added.

The HPRA stressed the safety data did not mean the suspected side-effects were caused by either vaccine and it was also not possible to compare the number of reported suspected side-effects for the two different vaccines.

The suspected side-effects reported to date were in line with those typically experienced after vaccination or those identified by manufacturers, it said.

On the Pfizer-BioNtech vaccine, the majority of side-effects reported were "mild or moderate" in intensity and resolved within a few days.

Common side-effects included dizziness, headache, numbness, tiredness, feeling unwell, chills, fever, itchiness, rash, nausea, diarrhoea, vomiting, joint pain, or muscle pain among others.

There was a “relatively small number” of reports of allergic reactions, although the regulator did not confirm any to be anaphylactic or severe allergic reactions.

There was also a “small number” of reports of facial paralysis or palsy in some individuals receiving the Pfizer vaccine, which was reported by the manufacturer as a possible rare side-effect. The authority said it was following up with each individual reporting palsy or weakness in the facial muscles.

In a safety update issued on Thursday, the HPRA confirmed it had received 257 reports of suspected side-effects from the Pfizer and Moderna Covid vaccines by Monday this week, January 18. Picture: Andy Gibson.

In a safety update issued on Thursday, the HPRA confirmed it had received 257 reports of suspected side-effects from the Pfizer and Moderna Covid vaccines by Monday this week, January 18. Picture: Andy Gibson.

The regulator did not provide specific details on suspected side-effects for the Moderna vaccine, given the very small number of doses administered to date.

HPRA chief executive Lorraine Nolan said the regulator expected to receive “thousands” of reports of suspected side-effects from the large-scale vaccination programme being rolled out but that care was needed when considering the data.

“Each individual report is not confirmation that the effect is due to the vaccine,” she stressed.

Ms Nolan said the overall global picture was “very positive”, with over 20m doses of Covid vaccines administered to date.

“No new safety concerns have been raised so far and that’s very reassuring and is very good news,” she added.

The HPRA encouraged members of the public to report any possible side-effects from the vaccines and will routinely publish safety updates on all Covid vaccines.

Suspected side-effects can be reported online via the HPRA website at www.hpra.ie/report and also by phone or by post.

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