The director of the European Medicines Agency (EMA), Emer Cooke, stressed on Tuesday that the clinical and laboratory reports reviewed by his experts do not yet allow “definitively to rule out a link between the vaccine (from AstraZeneca) and the rare cases” of blood clotting detected in some European countries.
Based on the detailed analysis carried out by the safety committee (PRAC) and “reviewing all the cases, the laboratory results and the clinical reports”, the EMA “is not in a position to definitively rule out a link between the vaccine and the cases” rare and unusual detected, so it has reached a “point at which we need to launch additional research to understand more and also analyze specific observational studies.”
During his digital appearance before the Public Health committee of the European Parliament, Cooke recalled that the PRAC recommended “raise awareness of these possible risks and make sure they are included in the product leaflet” to help healthcare professionals monitor symptoms that may occur after vaccination with a dose of British pharmaceutical AstraZeneca.
This information, which is already included in the package leaflet after receiving the approval of the Committee for Human Medicines (CHMP), was determined after an investigation of almost two weeks, in which all the national health authorities of each country have been included. from the European Union (EU) and the United Kingdom, together with independent experts in blood disorders.
The vaccine remains “safe and effective”
The EMA continues to defend that these are very few cases and that the vaccine continues to be “safe and effective” in the fight against covid-19, a disease whose threat to society makes AstraZeneca’s drug have benefits that exceed any of its possible risks.
Cooke stressed that the possible risk that these rare cases of blood clotting may also exist with other already licensed covid-19 vaccines (Pfizer / BioNtech, Moderna and Janssen) is also being analyzed, but “so far none have been identified. signal during security monitoring, “emphasized the director.
“Confidence in what we do is paramount in the fight against covid-19 and we must continue to comply with our transparency initiative”urged the EMA.
In the same appearance, Cooke pointed out that “another important challenge” that this agency is working on is “improving the availability and supply of licensed vaccines”, and confirmed that it is in continuous contact with pharmaceutical companies “to see how we can approve points of additional manufacturing and distribution as part of post-approval commitments “of a vaccine.
“The data behind it is being submitted and reviewed continuously and expedited. We are also looking to improve the storage conditions for some of the vaccines to facilitate distribution and logistics, “said Cooke, who intervened from Amsterdam, where the EMA headquarters are located.
One of the points of contention between London and Brussels is the Dutch factory Halix, which has signed a contract with AstraZeneca for the supply of doses, but in which the British Government also participated with state funds, for which a large part of the vaccines they would be destined for the UK.
When the factory is located in community territory, the EU threatens to impose a ban on exports of vaccines manufactured in the Netherlands.
Halix still does not have the go-ahead from the EMA as a manufacturing center for COVID-19 vaccines that can be distributed in the EU, although AstraZeneca hopes to gain their endorsement in the coming weeks.
Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.