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Vaccination with the COVID-19 vaccine from AstraZeneca is put on hold until further notice

Reports of severe cases of blood clots in people who have been vaccinated with the COVID-19 vaccine from AstraZeneca has caused the European Medicines Agency and other drug regulatory authorities in Europe to launch an investigation into the vaccine. One such report concerns the death of a person in Denmark. At this stage, it is too early to conclude whether there is a link between the vaccine and the blood clots.

11 MAR 2021

Based on a precautionary principle and concerns raised by the pharmaceutical authorities, the Danish Health Authority has decided to stop vaccination with the COVID-19 vaccine from AstraZeneca for the next 14 days. The Danish Health Authority and the Danish Medicines Agency will re-evaluate this decision in week 12.

"We are engaged in the largest and most important vaccination rollout in Danish history. And right now, we need all the vaccine doses we can get. It is, therefore, not an easy decision to pause vaccination with one of the vaccines. However, because we vaccinate so many people, we also need to react with due diligence when we learn of possible and severe side effects. We need clarification before we can continue to use the vaccine from AstraZeneca," says Søren Brostrøm, Director General of the Danish Health Authority.

The Danish and European pharmaceutical authorities are keeping a close eye on the rollout of the vaccines against COVID-19 – both in terms of the more common and mild side effects and the rare but severe side effects.

The Danish health authorities consider it unacceptable that any preventative treatment, such as vaccinations, should cause severe side effects. Therefore, we react swiftly and promptly if there is the slightest indication of possible risks associated with the vaccine.

"It is important to stress that we have are by no means discarding the AstraZeneca vaccine. We are merely stopping using it for the time being. There is strong evidence that the vaccine is both safe and efficacious. However, The Danish Health Authority and the Danish Medicines Agency have to react promptly to reports from Denmark and other European countries of possible severe side effects. This is a clear indication that the monitoring system works."

"At the same time, it is important to us that the population have confidence in the available vaccines and trust us to vouch for the quality, efficacy and safety of the vaccines in our vaccination programme. Therefore, we are taking immediate action until we have fully investigated whether there is a link between the vaccine and any severe side effects.

The Danish Health Authority is now waiting for the pharmaceutical authorities in the EU to conclude their investigation into any possible links between the COVID-19 vaccine from AstraZeneca and the severe cases of reported blood clots.

The pause has an impact on the vaccine programme

Putting the vaccine on hold means that no more people will be injected with the AstraZeneca vaccine for the time being, regardless of whether they have already made an appointment. Those who have already received the first injection with the AstraZeneca vaccine and are waiting for the second injection will have to wait a little longer.

"We have come a long way towards vaccinating the frontline personnel in Group 4, but we are not yet at the finish line. I am very sorry that we will now have to tell staff who have already received the first injection – or who have already made an appointment or been invited to the first injection - that they will now have to wait until later in the spring or early summer before they can be fully vaccinated."

"But we still have to vaccinate almost 1 million seniors between the ages of 65 and 84, and we need to prioritise vaccinating those people with the other two vaccines available to us. We must protect the weakest among us in case the epidemic flares up again. We must also ensure that neither the national healthcare system nor our elderly care reaches the breaking point. Still, our assessment is that we have vaccinated enough frontline staff to prevent this from happening," says Søren Brostrøm.

All booked appointments and invitations to vaccination with the vaccine from AstraZeneca are cancelled. New time slots will be available on vacciner.dk at a later date.

Booked times for vaccination with either Pfizer or Moderna, respectively, remain unchanged.
We will continue to offer frontline personnel aged 65 or older vaccination with one of the remaining two vaccines.

To illustrate a worst-case scenario, a revised version of the vaccination calendar is now available in which AstraZeneca has been completely removed. According to the revised calendar, the entire Danish population aged 16 or older will now have been offered vaccination by week 28 (the second week of July) and will be fully vaccinated about 4 weeks later. However, it is important to stress that this timeline will improve significantly should we decide to resume the use of AstraZeneca following the review in week 12.

Read more

The Danish Health Authority's information on COVID-19 vaccine AstraZeneca®

Document: Pausing the use of COVID-19 Vaccine AstraZeneca in the Danish COVID19 vaccination language (in Danish)

Danish Medicines Agency: Drug regulatory authorities are investigating reports of blood clots after AstraZeneca vaccinations

Vaccination calendar (In Danish)

Have you booked an appointment for vaccination with AstraZeneca?

Your appointment will be cancelled.

You will be invited to a new vaccination at a later date.

Have you been vaccinated with AstraZeneca within the last 14 days?

Please consult your doctor if you experience symptoms that linger for more than three days.

If you experience new symptoms after the initial mild symptoms of the first few days, you should consult your doctor.