Ireland has temporarily halted using AstraZeneca’s Covid-19 vaccine Sunday, which came after a report from Norway of patients developing blood clots post inoculation.
The Norwegian Medicines Agency on Saturday said there were four new cases of serious blood clotting in adults after taking the vaccine, CNN reported. The Irish National Immunization Advisory Committee (NIAC) said in a statement that it has made the directive as a precaution though it “has not been concluded that there is any link between the AstraZeneca vaccine and these cases.”
Following a recent concern raised around thrombotic events, AstraZeneca said in its own statement that it offers reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence.
AstraZeneca said that 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.
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, the company said. AstraZeneca said that that 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, AstraZeneca said, adding that there has also been no evidence of increased bleeding in over 60,000 participants enrolled.
Ann Taylor, Chief Medical Officer, AstraZeneca, said that around 17 million people in the EU and UK have now received its vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population. Taylor said that the nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.
In terms of quality, AstraZeneca said that there are also no confirmed issues related to any batch of its vaccine used across Europe, or the rest of the world. Additional testing has, and is, being conducted by ourselves and independently by European health authorities and none of these re-tests have shown cause for concern.
The company noted that during the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories. All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.