Europe’s medicine regulator backs WHO assessment, says AstraZeneca vaccine is safe
Europe’s drug regulator, namely the European Medicines Agency (EMA) has defended the use of the Coronavirus vaccine developed by AstraZeneca/Oxford University, despite growing fears over blood clots in some people inoculated with the jab.
“The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population,” EMA said in a statement issued on Tuesday, backing the assessment by the World Health Organisation (WHO), which said there was no indication the clotting events were caused by the vaccine.
The head of the Amsterdam-based company, Emer Cooke insisted that the “benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects”.
Speaking to a press conference, EMA’s Executive Director voiced her concerns over the vaccine rollout suspensions, arguing that they could have “an effect on the trust of the vaccines … but our job is to make sure the products we authorize are safe.”
An extraordinary meeting has been scheduled for Thursday to assess all information gathered and to issue any necessary recommendations for further action. The review is being carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
The announcement by the EMA came after several EU nations announced they had suspended the use of the jab as a “precautionary measure” until an investigation over blood clot concerns is concluded.
Early on Monday, Germany, France, Italy and Spain had suspended their rollout of the jab and Portugal, Luxembourg and Slovenia followed later in the day, while Latvia and Sweden followed suit on Tuesday morning.
