Pharmaceutical giant AstraZeneca has said that following a careful review of all available safety data of more than 17 million people vaccinated in the EU and Uk, they've found no evidence of an increased blood clot risk associated with their vaccine.
In a statement that was released this evening, they said: "Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine.
"A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country."
Earlier today, the National Immunisation Advisory Committee recommended the suspension of the use of the AstraZeneca vaccine in Ireland.
The decision was made after reports in Norway of four serious blood clotting events in adults who received the vaccine - although it is not clear if it is linked.
Dr Ronan Glynn said in a statement: "Following new information received from the Norwegian Medicines Agency on Saturday evening 13 th March 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, Sunday 14 th March.
"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."
"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."
Later this evening, AstraZeneca provided further information in their statement which said: "So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March.
"This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.
"Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled."
Speaking with RTE this afternoon, Dr Glynn was asked about the small number of reports that the Irish health products regulatory authority has received about blood clots relating to the vaccine.
"Any report like this is a matter of concern and yes, the HPRA in Ireland has received some reports that are similar to what we heard across Europe earlier this week but what's different is that the HPRA has not received any reports of the complex and unusual nature of those that we received from Norway last night," he said.
When asked to elaborate on the symptoms to note that could develop after taking the AstraZeneca vaccine, Dr Glynn said: "What we are talking about here is likely a very rare event and we can not say there is a cause and effect here.
"Anybody who has had received a Covid vaccine of any type, it is not usual to feel tired, have muscle and joint pain or fever in the 24 to 48 hours after receiving the vaccine.
"For those that have received the AstraZeneca vaccine, if they feel unwell three days after receiving the vaccine or if they notice blue spots on their skin, they should consult a doctor or an out of office medical service immediately. These are rare, rare events and no cause of link has yet been established."
An EMA meeting this Wednesday will provide more clarity on the issue of Ireland using the AstraZeneca vaccine, with further information and research set to be provided.
