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Dansk

The vaccine from AstraZeneca

Following international reports on several severe cases of blot clots, bleeding, and low platelet counts, The Danish Health Authority has removed the COVID-19 vaccine from AstraZeneca from the Danish vaccination programme.

The primary basis for this assessment is that the risk of severe illness and death from adverse reactions from vaccination with the vaccine from AstraZeneca is expected to be unacceptably high in relation to the prevention of severe illness and death from COVID-19 at the current infection pressure.

Futhermore, in Denmark the epidemic is currently well under control and other vaccines are available to us.

The Danish Health Authority's decision means that anyone who has received their first injection with the vaccine from AstraZeneca will complete their course of vaccination with an injection of an mRNA vaccine. 

Those who have been invited to vaccination with the vaccine from AstraZeneca but have had the invitation cancelled will receive a new invitation. 

 

See when it is your turn to get vaccinated:

Vaccination calendar

 

FAQ - the COVID-19 vaccine from AstraZeneca

1. Why has the Danish Health Authority decided to continue the vaccination programme without the vaccine from AstraZeneca?

We have reached this decision because studies show a possible link between rare but severe blood clots, bleeding and low blood platelet counts and the vaccine from AstraZeneca.

Since we currently have good control of the epidemic in Denmark and have other vaccines available, we have decided to continue the rollout of the vaccination programme without the vaccine from AstraZeneca.

2. Will Denmark use the vaccine from AstraZeneca later on?

We cannot rule that out. If the situation changes dramatically, for example, we experience an aggressive third wave in Denmark that puts enormous pressure on our national health service. 

3. Why does Denmark choose to stop using the vaccine from AstraZeneca when the European Medicines Agency (EMA) upholds its approval of the vaccine?

The current situation in Denmark is favourable - we have good control over the epidemic, and we have other vaccines available. Our overall 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.

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. That is precisely what underlies our decision in Denmark.

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

Based on documentation and recommendations from other countries, we have decided to complete your vaccination with a so-called mRNA vaccine. Therefore, you will receive a new invitation to vaccination approximately 12 weeks after gettingyour first injection with the vaccine from AstraZeneca.

You will automatically receive a new invitation in your e-Boks when you can book a new vaccination appointment. If you are exempt from receiving Digital Post, you will get a letter through the mail.

We strive to make sure that this will happen after about 12 weeks, but it may take a little longer. However, you do not have to get your second injection precisely 12 weeks after the first injection. So please do not worry and rest assured that an invitation is on its way.

You are considered fully vaccinated 14 days after receiving the second injection.

5. What do we know about vaccinating people with two different vaccines?

The Danish Health Authority’s decision has been made based on medical and professional considerations. Other countries, for example Germany, will also give those who receive the first injection with the vaccine from AstraZeneca the second injection with an mRNA vaccine. The European Medicines Agency (EMA) is currently deliberating whether they will be able to offer a joint European recommendation on how to complete vaccination of these individuals. 

In Denmark and abroad, scientific studies are launched to gain more insight into the effects of mixing different vaccines. 

In Denmark, the so-called ENFORCE study examines blood samples from people who have been vaccinated with two different vaccines, and they monitor those people closely to assess the efficacy and possible side effects. The results are not yet in, but the Danish Health Authority closely monitors the Danish and international studies.

6. Can you expect worse or particular side effects if you combine the vaccines?

No. 

There is no indication that combining the vaccines will cause other, worse or particular side effects. You can expect the common side effect from any vaccine such as fever, muscle and joint pain,general malaise, headache, etc. These side effects are quite harmless and a sign that your body's immune system is responding to the vaccine.

7. Why are the recommended intervals between the two injections different?

The recommended interval between the first and second injections with the vaccine from AstraZeneca is 4-12 weeks.

We recommend that you wait about 12 weeks from the time you were injected with the vaccine from AstraZeneca until you get a dose of an mRNA vaccine. The recommendation  to get the second injection after 12 weeks is based on professional considerations about optimal efficacy and minimise the vaccines’ side effects.

8. Is it necessary to be injected with more than one vaccine dose?

We recommend that you accept the offer to receive an injection with an mRNA vaccine after you received your first injection with the COVID-19 vaccine from AstraZeneca.

Several studies, for example from England and Scotland, have shown that the risk of being hospitalised due to COVID-19 is drastically reduced after getting the first injection with the vaccine from AstraZeneca. 

However, it is undocumented to which extent you are protected from even becoming infected with COVID-19 after the first injection with the vaccine from AstraZeneca. On this basis, the Danish Health Authority recommends that you accept the offer of an injection with an mRNA vaccine about 12 weeks after you received the first injection with the vaccine from AstraZeneca. 

9. Why am I not offered an entirely new course of vaccination with two injections of the same mRNA vaccine instead of just one injection?

We would risk ‘over-vaccinating’ people if we offered a completely new course of vaccination with two doses of another vaccine, which could increase the likelihood of side effects. 

However, the Danish Health Authority monitors the situation in Denmark and abroad closely.  

10. My invitation to the first injection with the vaccine from AstraZeneca was cancelled. What happens next?

You will receive a new invitation in your e-Boks according to your age and the target group to which you belong. If you are exempt from receiving Digital Post, you will get a letter through the mail.

If you were offered vaccination by virtue of your work in the healthcare, elderly care or social care sector, you can now expect to be invited in accordance with your age. If your employer assesses that your duties require that you are placed in target group 4, you may still be referred earlier.

11. I was previously in Group 4. When will I be offered a new vaccination?

You will receive a new invitation in your e-Boks according to your age and target group. If you are exempt from receiving Digital Post, you will get a letter through the mail.

However, some healthcare, elderly care or social care sector employees may be vaccinated earlier, following a concrete assessment by his or her employer and based on the tightened criteria. 

You may, for example, be offered vaccination earlier if you care for or treat confirmed or suspected COVID-19 cases. To protect the most vulnerable citizens, caregivers in a nursing home, for example, if only a few residents are vaccinated. 

12. Do the severe side effects only occur after the first injection with the COVID-19 vaccine from AstraZeneca

Rare but severe cases of blood clots, bleeding, and low blood platelets (VITT) have occurred after the first as well as after the second injection with the vaccine from AstraZeneca.

13. Is Denmark not overreacting? After all, birth control pills can also cause blood clots

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. 

14. Can the severe and rare side effect VITT occur because the vaccine is inserted into a blood vessel

The European Medicines Agency (EMA) considers it highly unlikely that the wrong vaccination technique can trigger the occurrence of severe cases of blood clots that, in some cases, have been fatal. 

However, it cannot be completely ruled out, which is why the Danish Health Authority monitors the development closely. 

15. Are the other vaccines safe?

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-BioNTech and Moderna and have concluded that the vaccines are safe to use.

16. How will this affect the vaccination calendar?

The vaccination calendar is updated on an ongoing basis. The removal of the vaccine from Johnson & Johsom has pushed back the end date for when the everyone is vaccinated.

See when it is your turn to get vaccinated in:

Vaccination calendar

 

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

Once you have received your second injection with an mRNA vaccine, your corona passport will indicate that you have been fully vaccinated.
Updated 08 JUN 2021