EU will give final verdict on safety of AstraZeneca vaccines on Tuesday
The Medicines Agency in Spain have ruled in favour of suspending the administration of the AstraZeneca vaccine after detecting cases of adverse reactions related to thrombosis, and this has been relayed to the Minister of Health, Carolina Darias. After studying the report of the Drug Agencies, they have approached the inter-territorial Health Council for a joint decision in this regard.
The Ministry of Health have announced that it is due to the appearance of these cases of thrombosis and thromboembolism, especially among women, and if the Interterritorial Council decides to suspend the administration of this vaccine, Spain would join the ten countries that have also taken this measure, the last ones being Germany, France and Italy earlier today.
This decision represents a serious setback to the vaccination plan that aims to immunize 70% of the Spanish population before the end of the summer. But health sources have said that despite this delay the most important thing is the health of the population. Spain, since the approval of this vaccine, decided to impose the precautionary principle and not administer it to people over 55 years of age, considering that they had not been sufficiently represented in clinical trials.
Currently this vaccine has been administered to people under 55 who are part of groups such as state security forces, teachers, health professionals who are not on the front line, and to citizens between 45 and 55 years old.
This decision comes days after the Committee for the Evaluation of Risks in Pharmacovigilance of the European Medicines Agency added serious allergies to the list of possible side effects of the vaccine against Covid-19 manufactured by AstraZeneca.
Through a statement made public on Friday, the EMA warns of these side effects after conducting a review of 41 case reports of possible anaphylaxis observed in around 5 million vaccines administered in the United Kingdom. "After careful review of the data, we believe there is likely a link to the vaccine in at least some of these cases," the agency said in a statement.
Anaphylaxis is a known side effect that can occur, very rarely, with vaccines, and is, in fact, included as a potential risk in the risk management plan for the AstraZeneca coronavirus vaccine, so the product information already contains a warning about anaphylactic reactions.
The EMA is claiming that the side effects are relating to just one batch delivered in the UK, and insists that the vaccines are safe to use. After further evaluation they will deliver a final verdict tomorrow on behalf of the European Commission.