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The Danish National Health Authority has suspended the administration of the AstraZeneca vaccine as a precautionary measure after reporting some serious cases of blood clots. The Authority itself announces it in a press release.
Investigations are being carried out into these cases to establish some connection with the administration of the vaccine, according to the Minister of Health Magnus Heunicke through Twitter.
As a precautionary measure, health authorities have suspended vaccination with AstraZeneca following a sign of a possible serious side effect in the form of fatal blood clots. Currently it is not possible to conclude if a connection exists. We act early, needs to be investigated thoroughly # COVID19dk
– Magnus Heunicke (@Heunicke) March 11, 2021
“We are in the middle of the largest and most important vaccination launch program in Danish history. And right now we need all the vaccines we can. Therefore, stopping one of the vaccines is not an easy decision. But precisely because we vaccinate so much, we must also respond promptly when we are aware of potential serious side effects. We need to clarify this before we can continue to use the AstraZeneca vaccine, ”says Soren Brostroem, director of the National Health Authority.
In recent days, following the example of other EU countries such as Germany and Belgium, Danish health authorities had extended their recommendation to use the AstraZeneca / Oxford anti-Covid vaccine to people over 65, based on a Scottish study. . Copenhagen had not recommended this vaccine for people over 65 so far, arguing that the scientific data was not enough.
“We are aware of Sundhedsstyrelsen’s statement released today that they are currently investigating potential adverse events related to Covid-19 vaccination. Patient safety is the highest priority for AstraZeneca ”. Thus in a note from the pharmaceutical company, following the announcement by the Danish health authority of the suspension of administration due to reports of possible clotting problems. Regulators – the statement continues – have clear and rigorous standards of efficacy and safety for the approval of any new drug, including AstraZeneca’s anti-Covid vaccine. The safety of the vaccine has been studied extensively in phase III clinical trials and the peer-reviewed data confirm that the vaccine was generally well tolerated. “
“We will follow the indications and opinion of the EMA, which is closely monitoring the use of vaccines in different countries.” A spokesman for the European Commission said it answered questions about the suspension of the AstraZeneca vaccine in Denmark. The spokesman also recalled that “yesterday the authority already issued an opinion on the case of a death in Austria, saying that there were no concrete indications that the cause was the vaccine.” “One of the advantages of centralized authorization at the EU level – recalled the spokesperson – is the follow-up and we will follow the instructions of the EMA. In making the decision, the Danish authorities explained that it is not an exclusion of the vaccine from the campaign, but a “suspension” for “reports of serious cases of blood clots in people vaccinated with the drug AstraZeneca.”
The news of the suspension of the AstraZeneca vaccine in Denmark was commented on by Francesco Vaia, Health Director of the Spallanzani Institute in Rome, during the conference organized by Uil, ‘Vaccine for all!’. “There is uncomfortable news from Denmark about the suspension of a vaccine (by Astrazeneca, ed) and that does not help us”, because “it increases the uncertainty of citizens regarding the use of this or that vaccine or a supposed classification of such so-called vaccines of series A and series B, ”said Vaia.
On Sunday, the Austrian Federal Office for Health Security announced that it had suspended the administration of a batch of AstraZeneca vaccines (number ABV5300) following the death of a nurse and the hospitalization of another for a pulmonary embolism. After the administration of two doses of the vaccine. Based on a preliminary investigation, the EMA has announced in recent hours that there has been no link between the vaccine and death in Austria so far.
“Currently there is no indication that the vaccine has caused these conditions, which are not listed as side effects of this vaccine,” the European Medicines Agency said in a statement, also referring to the case of the second nurse admitted to the hospital.
Following the suspension of the vaccine in Austria, Estonia, Lithuania, Luxembourg and Latvia, the use of vaccines from the same batch, which has one million doses, was also suspended as a precaution and distributed in 17 countries (excluding Italy). In addition to Denmark, Austria, Estonia, Lithuania, Luxembourg, and Latvia, the other countries that have received vaccines from batch number ABV5300 are Bulgaria, Cyprus, France, Greece, Iceland, Ireland, Malta, the Netherlands, Poland, Spain, and Sweden.
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