The National Immunisation Advisory Committee (NIAC) has today recommended the temporary deferral of the administration of the COVID-19 Vaccine AstraZeneca®.
Following a new safety alert from the Norwegian Medicines Agency received late on 13 March 2021, NIAC met with the HPRA and HSE representatives to consider this new information. A full committee meeting was held this morning.
The alert followed four new reports of serious, rare thromboembolic (clotting) events, including some complicated by thrombocytopenia (low platelet count) in adults under 65 years of age after vaccination with COVID-19 Vaccine AstraZeneca®. To date, no reports of similar events have been received by the HPRA. Over 117,000 doses of COVID-19 Vaccine AstraZeneca® have been given in Ireland.
The European Medicines Agency (EMA) has been investigating a number of reports of clotting events following vaccination with COVID-19 Vaccine AstraZeneca®. Further information is expected from the EMA in the next few days, which will include a review of the additional events.
The possible relationship between these events and the COVID-19 Vaccine AstraZeneca® is uncertain and is being investigated. It is very important that all potential rare events are rigorously and swiftly investigated so we can support public confidence.
In light of this new information and pending receipt of further information from the EMA, on a precautionary principle it is recommended to temporarily defer administration of COVID-19 Vaccine AstraZeneca® as of today, Sunday 14 March 2021.
In the rare event that someone who has received the COVID-19 Vaccine AstraZeneca® feels increasingly unwell more than three days after vaccination, and/or who notices larger or smaller blue spots in the skin (purpuric, non-blanching rash, skin haemorrhages) they should consult their doctor or out-of-hours medical service.
These rare events that have been reported have usually occurred within 14 days of the COVID-19 Vaccine AstraZeneca®.
Chair of NIAC, Prof Karina Butler said: “This is a precautionary move. We will continue to monitor the situation and if we can be satisfied that these events are coincidental and not caused by this vaccine we will reassess the situation. The HPRA will keep NIAC fully informed as the EMA investigation progresses and we will keep you updated”.
“This vaccine is proven to be very effective against severe COVID-19 disease, which is associated with a risk of clotting events. We have taken this step out of an abundance of caution.”