86% of Halted AstraZeneca Batch Already Used, No Serious Side Effects to Date

Following the news that Luxembourg, among other countries, has suspended the use of the AstraZeneca COVID-19 vaccine over blood clot fears, the Ministry of Health has provided some clarification.

Luxembourg's Ministry of Health confirmed the cessation of vaccinations (as of this week) with vials from batch ABV5300 of the AstraZeneca vaccine. The decision followed news from Austria of the occurrence of serious adverse events following the administration of doses from this same batch.

A 49-year-old nurse died ten days after vaccination with the diagnosis of multiple thrombosis and another woman (35 years old) was hospitalised with pulmonary embolism but is on the mend. Both patients were vaccinated at the same time in the same hospital with the AstraZeneca vaccine batch ABV5300. Austria's health authorities decided to put the batch concerned aside while investigating these cases. A quality review of the affected batch is underway so that a connection can be ruled out and further action can be taken.

That being said, Luxembourg's Ministry of Health has confirmed that 4,141 out of 4,800 doses of the incriminated batch had already been administered before this decision.

The Health Ministry stated that no cases of thrombosis have been reported among people vaccinated with the AstraZeneca vaccine since the start of its administration.

From the data available to date, it cannot be concluded that the AstraZeneca vaccine has a greater risk of side effects than the other two vaccines (BioNTech / Pfizer and Moderna) which are also currently authorised.

Tests on this batch are underway at the official control laboratory in the Netherlands. In addition, the Pharmacovigilance Risk Assessment Committee (PRAC) safety committee of the European Medicines Agency (EMA) is currently reviewing all cases of thromboembolic events and other conditions related to blood clots, reported after vaccination with the AstraZeneca vaccine.

As a precautionary principle, the remaining vials of this batch will remain "in quarantine" until the controls are completed by the EMA and the official control laboratory in the Netherlands responsible for batch release at European level.

In the meantime, the Luxembourg authorities are closely monitoring all the side effects notified in relation to the AstraZeneca vaccine as part of the vaccination campaign.