AstraZeneca Plc on Sunday said it had conducted a review of people vaccinated with its Covid-19 vaccine, which has shown no evidence of an increased risk of blood clots.
The review covered more than 17 million people vaccinated in the European Union and United Kingdom.
“A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with Covid-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” the statement said.
The drugmaker said that during production of the vaccine, more than 60 quality tests are conducted.
Additional testing has and is being conducted by the company and the European health authorities, and no re-tests have shown cause for concern, it added.
Batch quality
The company said there are no confirmed quality issues related to any batch of the vaccine used across Europe and rest of the world.
“We are going beyond standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” it added.
The drugmaker said that events of pulmonary embolism reported among those given the vaccine were much lower than would be expected to occur naturally in the general population of this size.
Ireland on Sunday temporarily suspended use of the AstraZeneca vaccine “out of an abundance of caution”.
Authorities in Denmark, Norway and Iceland have also suspended the use of the vaccine over clotting issues, while Austria stopped using a batch of AstraZeneca shots last week while investigating a death from coagulation disorders.
Ireland’s medicines regulator has received a small number of reports associated with blood clots following vaccination with the AstraZeneca vaccine, but added there is currently no indication that vaccination was the cause.
AstraZeneca said that in clinical trials, though the number of thrombotic events was small, these were even lower in the vaccinated group.
There was also no evidence of increased bleeding in over 60,000 participants enrolled.
A monthly safety report will be made public on the European Medicines Agency (EMA) website in the following week, the drugmaker said.
