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Denmark continues its vaccine rollout without the COVID-19 vaccine from AstraZeneca®

There is a possible link between very rare cases of unusual blood clots, bleeding, low blood platelets counts and the vaccine from AstraZeneca (Vaxzevria®). This, coupled with the fact that the COVID-19 epidemic in Denmark is currently under control and other vaccines are available against COVID-19, has been instrumental in the Danish Health Authority’s decision to continue its vaccination programme against COVID-19 without the vaccine from AstraZeneca.

On 11 March 2021, the Danish Health Authority paused the use of the COVID-19 vaccine from AstraZeneca due to worrying feedback from the ongoing safety monitoring of the COVID-19 vaccines. Since then, the Danish vaccination effort has continued with the vaccines from Pfizer/BioNTech and Moderna.

Since 11 March, EMA (European Medicines Authority) has completed their review of the very rare but severe side effects seen in people who received the COVID-19 vaccine from AstraZeneca. Concurrently, research and scientific studies – which has included the Danish cases - have been carried out in Denmark under the auspices of ENFORCE, the national cohort study of effectiveness and safety of SARS-CoV-2 vaccines. Furthermore, Danish-Norwegian registry studies have revealed a higher than expected frequency in the number of specific side effects, particularly blood clotting events occurring in veins in the brain (cerebral venous sinus thrombosis), particularly blood clots occurring in veins in the brain (cerebral venous sinus thrombosis) following vaccination with the COVID-19 vaccine from AstraZeneca. 

EMA concluded that the benefits of using the COVID-19 vaccine from AstraZeneca continue to outweigh the risks for people who receive it. However, EMA stresses that using the vaccine during vaccination campaigns at the national level should also consider the pandemic situation and vaccine availability in each individual country. 

The consequence of this decision is that anyone aged 16 or older can expect to receive an offer of vaccination in late June. Thus, everyone who accepts the offer will be fully vaccinated about five weeks later – in early August.

The Danish Health Authority's decision means that we will cancel all booked times and invitations to vaccination with the vaccine from AstraZeneca. Those who have received the first injection with AstraZeneca will later receive an invitation to vaccination with another vaccine. Those who have previously been invited to receive their first injection with the vaccine from AstraZeneca – but who had the invitation cancelled – will be re-invited based on an assessment of the current epidemic situation.

The Danish Health Authority has decided to continue the rollout at this time without AstraZeneca, but this does not exclude that we may re-introduce the vaccine at a later date if the situation changes. 

The continuation of the vaccine rollout without the vaccine Vaxzevria® (formerly COVID-19 Vaccine AstraZeneca®) raises many questions: 

FAQ about the COVID-19 vaccine from AstraZeneca

1. What just happened?

On 14 April 2021, the Danish Health Authority chose to remove the vaccine from AstraZeneca from the Danish vaccination campaign against COVID-19 due to reports of several severe cases of blood clotting, bleeding and low platelet counts.

On 11 March 2021, the Danish Health Authority paused using the COVID-19 vaccine from AstraZeneca due to worrying feedback from the ongoing safety monitoring of the COVID-19 vaccines. Since then, the Danish vaccination effort has continued with the vaccines from Pfizer/BioNTech and Moderna.

Since 11 March, EMA (European Medicines Authority) has completed their review of the very rare but severe side effects seen in people who received the COVID-19 vaccine from AstraZeneca. Concurrently, research and scientific studies – which has included the Danish cases - have been carried out in Denmark under the auspices of ENFORCE, the national cohort study of effectiveness and safety of SARS-CoV-2 vaccines. Furthermore, Danish-Norwegian registry studies have revealed a higher than expected frequency in the number of specific side effects, particularly blood clotting events occurring in veins in the brain (cerebral venous sinus thrombosis), particularly blood clots occurring in veins in the brain (cerebral venous sinus thrombosis) following vaccination with the COVID-19 vaccine from AstraZeneca. 

However, the Danish Health Authority's decision to continue the rollout without AstraZeneca does not exclude that we may re-introduce the vaccine later if the situation changes. 

 

2. Why does Denmark choose to take out the vaccine from AstraZeneca when many other countries keep it in their campaigns?

Given the current situation in Denmark, the Danish Health Authority's overall assessment is that the benefits of vaccination with the COVID-19 vaccine from AstraZeneca (Vaxzevria®) outweigh the disadvantages.

There is a confirmed link between rare but severe cases of blood clots, bleeding and low platelets and the COVID-19 vaccine from AstraZeneca. Denmark is able to halt the use of the vaccine because the epidemic is under control, and there are other vaccines available to us against COVID-19.  

3. The EMA upholds its approval of the vaccine. Why does Denmark think differently? 

The EMA maintains that the benefits of using the COVID-19 vaccine from AstraZeneca continue to outweigh the risks for people who receive it. However, EMA stresses that using the vaccine during vaccination campaigns at the national level should also consider the pandemic situation and vaccine availability in any given country. 

In Denmark, we have other vaccines available, and at this time, we have the epidemic under control. Furthermore, we have come a long way towards vaccinating the older age groups where vaccination has a tremendous potential impact on preventing infection. Age is the main risk factor for becoming severely ill from COVID-19, and the remaining population that have not yet been vaccinated are thus at lower risk of severe illness from COVID-19. 

Therefore, the Danish Health Authority assessment is that the risk of the vaccine is too high in relation to the overall risk of severe illness or death among the as yet unvaccinated population.

 

4. My first injection was with the vaccine from AstraZeneca. Should I be worried?

No, don't worry. The cases we have seen of rare blood clot events have occurred relatively shortly after vaccination (typically within the first 14-21 days). We put vaccination with the vaccine from AstraZeneca on hold on 11 March, and more than three weeks have elapsed since you received the vaccine. 

5. I got the first injection with the vaccine from AstraZeneca. How do I complete vaccination?

We are in the process of planning how to complete vaccination for those who received the first injection with the COVID-19 vaccine from AstraZeneca. You will later receive an invitation to vaccination with another vaccine.

6. My invitation to the first injection with the vaccine from AstraZeneca was cancelled. What is going to happen now? 

You will be offered vaccination with another vaccine and will be re-invited in due course.   

7. Can I choose which vaccine I want – for example, if I would like to be vaccinated with AstraZeneca? 

No, you cannot choose which vaccine you want. The COVID-19 vaccine from AstraZeneca has been removed from the Danish vaccination programme against COVID-19.

If you have had your course of vaccination cancelled, you will be re-invited and notified when you can book another appointment for vaccination.

8. What will happen to the vaccines from AstraZeneca that we have in Denmark?

The vaccines are currently being kept refrigerated at Statens Serum Institut. We have not yet decided what to do with the vaccine doses.

9. Is Denmark overreacting out of an abundance of caution? You can also get blood clots from many other medicines, e.g. birth control pills.

All medicines can cause side effects - this also applies to vaccines. And in the specific situation, we have assessed that the benefits of vaccination with the COVID-19 vaccine from AstraZeneca do not exceed disadvantages in the current situation in Denmark.

Taking into account the current infection pressure, control of the epidemic and the speedy rollout of the vaccine programme in Denmark, we assess that risk of severe illness and death caused by side effects of vaccination with the COVID-19 vaccine from AstraZeneca is unacceptably high.

Furthermore, it is important to bear in mind that special considerations apply when dealing with a national vaccination programme. Usually, doctors prescribe medicine based on a careful individual assessment of a given patient's disease, and they can precisely weigh the pros (efficacy) and cons (possible adverse side effect) of using a specific medicine to help his or her patient. This does not apply to a national vaccination programme where you are dealing with healthy people and cannot assess each person individually. Therefore, the threshold for acceptable adverse reactions is much lower. 

10. What about the other vaccines against COVID-19? Are they safe?

Vaccination with the other COVID-19 vaccines from Pfizer and Moderna continues. All vaccines are closely monitored both internationally and by the Danish authorities. There is no suspicion that the mRNA vaccines should cause side effects that we do not already know about. No evidence has surfaced of the same type of rare but severe side effects of blood clotting, low platelets, and bleeding that we have seen with the AstraZeneca vaccine.

The European Pharmacovigilance Risk Assessment Committee (PRAC) continuously reviews safety data for the COVID-19 vaccines from Pfizer and Moderna and have concluded that the vaccines are safe to use.

11. How will this affect the vaccination calendar?

Overall, the changes mean that we expect everyone in Denmark aged 16 or older to have received an offer of vaccination by early July. Thus, anyone who accepts the offer of vaccination will have completed the course of vaccination about five weeks later – i.e. in early August.

12. What about my corona passport? Does my first injection with the COVID-19 vaccine from AstraZeneca count?

We are currently planning the new course of vaccination for those who have received the first injection with the COVID-19 vaccine from AstraZeneca. In time, your corona passport will indicate that you have been fully vaccinated.  

13. What about the vaccine from Janssen? It is based on the same technology as the COVID-19 vaccine from AstraZeneca.

We are very aware of the safety signals coming from the United States – who have vaccinated about 7 million people with the Janssen COVID-19 vaccine – and where the FDA (Food and Drug Administration) and CDC (Centers for Disease Control and Prevention) are now recommending a pause in the use of the vaccine out of an abundance of caution. In addition, the manufacturer has determined that they will not deliver vaccines to Europe as planned while investigations continue.

It is essential to us that we uncover the efficacy and safety documentation for all the vaccines we use against COVID-19 - including the Janssen vaccine. Therefore, the Danish Health Authority is closely monitoring the risk assessments initiated by, among others, U.S. and European pharmaceutical authorities and will continue to cooperate with Danish experts on research into the efficacy and side effects of all COVID-19 vaccines, including the new Janssen vaccine.

Updated 15 APR 2021