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The Danish Directorate General for Health (SST) announced on Thursday the temporary suspension for 14 days from AstraZeneca vaccine after registering “serious cases of thrombi” in people who had received it, a situation similar to that reported in Austria although, in the latter case, associated only with a specific batch of the vaccine.
One of the cases in Denmark ended in the death of the patient, health authorities explained in a statement, highlighting that still it cannot be concluded that there is a direct relationship between the vaccine and thrombi.
The European Medicines Agency (EMA) has launched an investigation in this regard, according to the Danish Directorate General for Health, which has applied “a principle of prudence“and will carry out a new valuation in the penultimate week of March.
In Austria, vaccination with the batch ABV5300 vaccine by AstraZeneca. It was done after a person vaccinated with the drug developed multiple thrombosis and died 10 days after vaccination and another was hospitalized with pulmonary embolism shortly after being vaccinated, although he has already recovered.
But the Pharmacovigilance Committee (PRAC) of the EMA sent a statement on Wednesday informing that nothing indicates that the vaccine is responsible for the events registered in Austria. “The information available to date indicates that the number of thromboembolic events in vaccinated is not greater than that seen in the general populationl, “the statement said.
The EMA recognizes in this information that nine events of thromboembolism have been detected in three million vaccinated people throughout the European continent, which would support product safety.
“We are in the largest and most important vaccination campaign in the history of Denmark, we need all the vaccines we can get. That is why it is not an easy decision to suspend one. But we must react carefully when there is evidence of possible serious effects, “said SST Director Søren Brostrøm.
Brostrøm stressed that it is a pause and that there is “good documentation” that the AstraZeneca vaccine is “safe and effective”, but that the Danish authorities are forced to react to information of possible effects “from Denmark and other European countries”.
All appointments and invitations to request an appointment to receive this vaccine are suspended, and those who have already received the first dose will have to wait until further notice.
The measure implies changes in the vaccination plan, which will be delayed worst case four weeks until August 15, the date on which it is expected that the entire population that so wishes will have been immunized.
“First of all it is important that when risks arise in relation to a vaccine, these are investigated. Therefore, I think it is correct to suspend the vaccination of AstraZeneca, “said Danish Prime Minister Mette Frederiksen at a press conference.
Frederiksen was upset by the delay, but at the same time convinced that Denmark, one of the fastest countries vaccinating against covid-19 in Europe and one of the least affected, can normalize the situation in a few months.
“I believe in a summer with an almost normalized Denmark. I dare say it, as long as the Danes keep getting tested and vaccinated“said the prime minister.
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