"The vaccination plan has been paused with regard to AstraZeneca's vaccine and will be put back on track from Monday (22 March). We will resume the plan, accelerating it and recovering the delay of these four or five days without vaccination from AstraZeneca," said the coordinator of the task force for vaccination against Covid-19, Vice Admiral Henrique Gouveia e Melo, at a press conference also attended by the president of Infarmed, Rui Ivo, and the Director-General of Health, Graça Freitas.
The decision was announced following the European Medicines Agency's (EMA) decision that AstraZeneca's vaccine "is safe and effective" and that it is not associated to the cases of blood clot formation that led to the suspension of its use in more than a dozen European countries.
The president of Infarmed highlighted the indications of the EMA's Pharmacovigilance Risk Assessment Committee and assured that they will be expressed as of 19 March in the information for health professionals and citizens.
"These conclusions are very clear in confirming that the benefits of AstraZeneca's vaccine far outweigh any risks that have been identified. The terms in which the evaluation was carried out and which allowed the vaccine to be used will now be set out in the documents that are approved by the EMA," said Rui Ivo, ensuring that the Portuguese entities have been "in articulation with their European counterparts.
After an investigation in recent days by the European regulator's Pharmacovigilance Risk Assessment Committee, EMA executive director Emer Cooke explained that the administration of AstraZeneca's vaccine "is not associated with an increased risk of thromboembolic events responsible for blood clots" in vaccinated people.
Emer Cooke stressed that these were "rare but quite serious" episodes out of a total of more than seven million people vaccinated in the European Union with AstraZeneca's drug and 11 million in the UK. "People can trust the vaccine", assured Emer Cooke, reinforcing that these are not "unexpected cases [...] because you are vaccinating millions and millions of people".
The EMA's endorsement came a day after the World Health Organisation (WHO) also recommended the continued administration of AstraZeneca's Covid-19 vaccine. "At this time, the WHO estimates that the risk/benefit balance is tilting in favour of the AstraZeneca vaccine and recommends that the vaccines continue" to be administered, the body said in a statement released on 17 March.