March 9, 2021
The information was prepared by Dita Okmane, Head of the Public Relations Department of the State Agency of Medicines.
The Health Inspectorate (VI) and the State Agency of Medicines (ZVA) have received information that the Austrian national competent authority for pharmacovigilance has suspended the use of one batch of Covid-19 vaccine developed by AstraZeneca (serial number ABV5300). The suspension is associated with health problems in two people that occurred long after vaccination with one series of AstraZeneca Covid-19 vaccines. An initial assessment by the European Medicines Agency (EMA) shows that there is no causal link to vaccination with health problems, however, as an additional precaution, the MA and the MAH have decided to temporarily suspend vaccination with this series of vaccines in Latvia.
As a precautionary measure, the Health Inspectorate and the State Agency of Medicines have temporarily suspended the use of this series of vaccines developed by AstraZeneca in Latvia. At present, it has not been established that vaccination with this series of vaccines in Latvia has caused serious health problems. However, this series has been suspended as a precautionary measure pending a full assessment of these cases.
In deciding to suspend the series, the MA and the MAA followed the standard of good practice for taking additional precautionary measures until all the information had been clarified and the cases had been fully assessed. The MA and the MAA emphasize that the temporary suspension of certain medicinal products or batches of vaccines is a standard precautionary procedure.
On February 11, 9,600 doses of this vaccine series were delivered in Latvia, most of which have already been used, and according to data on vaccination, 1,190 doses have not yet been used. At present, vaccination offices that have been supplied with doses of this series of vaccines are asked not to continue vaccination with this series until all information on the case evaluation is available.
The decision of the Austrian national competent authority to suspend one batch of AstraZeneca Covid-19 vaccine is related to the fact that one person was diagnosed with multiple thrombosis and died 10 days after vaccination, while another person was hospitalized with pulmonary embolism and continued hospital treatment. An initial assessment by the European Medicines Agency shows that there is no causal link between this vaccine series and the specific safety risks identified for this vaccine series.
To date, these conditions have not been known to be side effects of this vaccine and are not mentioned in the package leaflet or the summary of product characteristics.
The most common side effects with COVID-19 Vaccine AstraZeneca are usually mild to moderate and go away within a few days of being vaccinated.
The ESA is currently evaluating both cases to rule out any potential risks for this vaccine series, as well as any other reports of venous thromboembolic events following vaccination to determine whether they can be associated with vaccination.
This ABV5300 vaccine series was delivered to 17 EU Member States (Lithuania, Estonia, Luxembourg, Latvia, Ireland, Denmark, Bulgaria, Austria, Greece, Sweden, the Netherlands, Poland, Spain, France, Iceland, Malta and Cyprus) and includes 1.6 million devu.
EZA, ZVA and VI will provide further information after the evaluation.
Additional information:
Okmane fingers,
State Agency of Medicines
Head of Public Relations Department
Tel. 67078422, 25400181
E-pasts: [email protected]
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