The National Immunisation Advisory Committee (NIAC) has recommended the temporary deferral of the administration of the Astra Zenica vaccine.
It follows a new safety alert from the Norwegian Medicines Agency late yesterday after 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.
The NIAC met with the HPRA and HSE representatives to consider this new information and full committee meeting was held this morning.
Over 117,000 doses of Covid-19 Vaccine AstraZeneca have been given in Ireland. The NIAC said to date, no reports of similar events have been received by the HPRA.
The European Medicines Agency (EMA) has also 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.
In statement it said that 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."
It said that 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.”
Meanwhile, a spokesperson for AstraZeneca said: “An analysis of our safety data that covers reported cases from more than 17 million doses of vaccine administered has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia with Covid-19 Vaccine AstraZeneca. In fact, the reported numbers of these types of events for Covid-19 Vaccine AstraZeneca are lower than the number that would have occurred naturally in the unvaccinated population.
“In clinical trials, no trends or patterns were observed with regard to pulmonary embolism, deep vein thrombosis, or events possibly related to thrombocytopenia.
A careful review of all available safety data including these events is ongoing and AstraZeneca is committed to sharing information without delay. We also note that the European Medicine Agency (EMA) has asked for an assessment of events related to thrombocytopenia from other COVID-19 vaccine manufacturers (per communication 11 March).”
The National Immunisation Advisory Committee (NIAC) has recommended the temporary suspension of the use of the Astra Zenica vaccine.
In a statement this morning, Deputy Chief Medical Officer, Dr. Ronan Glynn said that following new information received from the Norwegian Medicines Agency on Saturday evening and following discussions with the Health Products Regulatory Authority (HPRA), the National Immunisation Advisory Committee (NIAC) has recommended that the administration of Covid-19 Vaccine AstraZeneca be temporarily deferred from this morning.
This recommendation has been made following a report from the Norwegian Medicines Agency of four new reports of serious blood clotting events in adults after vaccination with Covid-19 Vaccine AstraZeneca.
The statement said: “It has not been concluded that there is any link between the Covid-19 Vaccine AstraZeneca and these cases. However, acting on the precautionary principal, and pending receipt of further information, the NIAC has recommended the temporary deferral of the Covid-19 Vaccine AstraZeneca vaccination programme in Ireland.”
The NIAC is due to meet again this morning and a further statement is expected later.