European Medicines Agency (EMA) Director Emer Cooke on Tuesday announced clinical and laboratory reports do not yet allow a link between the AstraZeneca vaccine and the blood clotting cases to be definitively ruled out.
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She recalled that the Pharmacovigilance Risk Assessment Committee (PRAC) recommended raising awareness of potential risks to help healthcare professionals follow up on symptoms that may occur after vaccination.
This recommendation followed an investigation involving experts in blood disorders and health authorities from the European Union (EU) countries and the United Kingdom.
Nevertheless, the EMA continues to defend that the vaccine remains "safe and effective" in the fight against COVID-19, a disease whose threat to society means that AstraZeneca's drug has benefits that outweigh any of its potential risks.
Cooke also confirmed she is in continuous contact with the pharmaceutical companies "to see how we can approve additional manufacturing and distribution points as part of post-approval commitments" for a vaccine.
Currently, one of the points of contention between the EU and the UK is the Dutch manufacturer Halix, which has a signed contract with AstraZeneca for the supply of doses.
This agreement, however, also included state funds from the British government, so that a large part of the vaccines would be destined for the United Kingdom.
Since the factory is on EU territory, European authorities are threatening to impose an export ban on vaccines manufactured in the Netherlands. The EMA has not yet approved Halix as a manufacturing site for the COVID-19 vaccines to be distributed in the EU.