At the same time, the responsible authorities emphasize that at present it has not been established that vaccination with this series of vaccines in Latvia has caused serious health problems.
The alarming message came from Austria
The Health Inspectorate and the State Agency of Medicines 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.
The suspension is due to 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 shows that there is no causal link to vaccination with health problems, however, as a precautionary measure, the responsible authorities in Latvia 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 vaccine series 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 until a full evaluation of these cases has been carried out,” says Dita Okmane, a specialist at the State Agency of Medicines.
The vaccinee died of multiple thrombosis
The decision of the Austrian national competent authority to suspend one batch of AstraZeneca Covid-19 vaccine is due to the fact that
one person was diagnosed with multiple thrombosis and the person died 10 days after vaccination, while another person was hospitalized with pulmonary embolism after vaccination 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.
Dita Okmane from the State Agency of Medicines states that so far such health problems have not been known as side effects of this vaccine, and they are not mentioned in the instructions for use of the vaccine and in the summary of product characteristics. The most common side effects with AstraZeneca Covid-19 are usually mild to moderate and go away within a few days of vaccination. The European Medicines Agency is 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 vaccine series was delivered to 17 Member States of the European Union (Lithuania, Estonia, Luxembourg, Latvia, Ireland, Denmark, Bulgaria, Austria, Greece, Sweden, the Netherlands, Poland, Spain, France, Iceland, Malta and Cyprus) and totals 1, 6 million doses.
Another 1190 doses have not been used in Latvia
In deciding to suspend the batch, the Health Inspectorate and the State Agency of Medicines followed the standard of good practice for taking additional precautionary measures until all information was clarified and the cases were fully evaluated. The authorities emphasize that the temporary suspension of certain medicinal products or batches of vaccines is a standard precautionary procedure.
9600 doses of this vaccine series have been delivered in Latvia, most of which have already been used, and according to data on vaccination, 1190 doses have not yet been used. Vaccination offices that have been supplied with doses of this series of vaccines are requested not to continue vaccination with this series until all information on the case evaluation is available.
The circumstances of one death are also being investigated in Latvia
Last week, the State Agency of Medicines received information about a 90-year-old woman who died in the social care center “Selga” several days after vaccination. However, as Sven Henkuzen, director of the State Agency of Medicines, pointed out at the government meeting on Tuesday, preliminary results of the medical experts’ assessment do not indicate a possible link between allergic reactions and death and vaccination in the care center. The patient had a number of serious chronic illnesses with recurrent exacerbations, but the death investigation is still ongoing.
Both the State Agency of Medicines and the Health Inspectorate are conducting an in-depth examination of this case and have already requested additional data. The Health Inspectorate plans to get acquainted with the documents in person, and a repeated meeting of medical experts is planned.
Of the three vaccines currently available in Latvia, between 0.5 and 1.9 percent of cases are reported. The frequency of side effects also depends on whether it is the first or second dose. In general, mRNA vaccines – Pfizer / BioNtech and Moderna – have more frequent and more pronounced side effects after the second dose, while adenovirus, the AstraZeneca vaccine already mentioned, has more common side effects immediately after the first dose.
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