The Ministry of Health confirms the quarantine on 8 March and the cessation of vaccinations on 9 March with vials from batch number ABV5300 of AstraZeneca's COVID-19 vaccine, following the notification provided to the National Health Directorate (Division de la pharmacie et des médicaments - DPM) by the Austrian agency, on the occurrence of serious adverse events after the administration of doses from the same batch of COVID-19 AstraZeneca vaccine.
One nurse (49 years old) reportedly died ten days after vaccination with the diagnosis of multiple thrombosis and another woman (35 years old) has been hospitalised with a diagnosis of pulmonary embolism, but is currently recovering. Both patients were vaccinated, at the same time and in the same hospital, with the AstraZeneca COVID-19 vaccine, batch ABV5300.
The Austrian agency has decided to quarantine this lot while the two cases are investigated and treated with the highest priority. A quality review of the affected lot is underway to exclude a connection and allow further action to be taken.
However, the Ministry of Health would like to point out, that of the 4,800 doses of the incriminated batch, 4,141 doses had already been administered before the quarantine.
In Luxembourg, there have been no reported cases of thrombosis among people vaccinated with the AstraZeneca vaccine since it was first administered.
Based on the data available to date, it cannot be concluded that the AstraZeneca vaccine presents a greater risk of side effects than the other two vaccines that are also currently approved.
Tests are being conducted on the given batch at the official control laboratory in the Netherlands. In addition, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is currently investigating all cases of thromboembolic events and other conditions related to blood clots reported after vaccination with the AstraZeneca COVID-19 vaccine.
As a precautionary measure, 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, which is in charge for the release of the batches at European level.
In the meantime, the Luxembourg authorities are closely monitoring all side effects reported in relation to the AstraZeneca vaccine in the context of the vaccination campaign. The vaccination campaign is continuing with the other available vaccines.
The relevant information from the European Medicines Agency can be found on their website: COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events - vaccine's benefits currently still outweigh risks - Update | European Medicines Agency (europa.eu)
Press release by the Ministry of Health