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Covid-19 vaccines in Denmark

You can read about the covid-19 vaccines from Pfizer-BioNTech and Moderna here.

The vaccines from Pfizer-BioNTech (Comirnaty®) and Moderna (Spikevax®) are mRNA vaccines, and both have been authorised for use in everyone aged 12 and older.  

Learn more about the recommended booster vaccination against covid-19

Film: Information on covid-19 vaccines

 

About the COVID-19 vaccines

1. How are the COVID-19 vaccines approved?

When vaccines are approved for use in Denmark, experts from the Danish Medicines Agency in Denmark work with colleagues from the other EU countries under the auspices of the European Medicines Agency (EMA). If the EMA experts then conclude there is sufficient scientific evidence of the vaccine's efficacy and safety from large-scale clinical trials involving thousands of participants, it is authorised for distribution throughout the EU countries. The EMA authorises vaccines if the benefits of the vaccine outweigh the risk of side effects. 

Although we all wish for vaccines to be quickly and readily available, in terms of quality, efficacy and safety, COVID-19 vaccines are subject to the same rigorous testing, scientific evaluation, approval and monitoring that applies to all medicines in the EU. 

Learn more about the development, evaluation, approval and monitoring of COVID-19 vaccines on EMA’s website

The Danish Health Authority is responsible for rolling out the national COVID-19 vaccination programme. The Authority is already in charge of other national vaccination schemes such as annual influenza vaccines and the Danish Childhood Vaccination Programme.  
Once the vaccines have been approved and transported to Denmark, they are distributed and administered to the public as soon as possible – a logistic exercise that requires extensive coordination among the parties involved. The Danish Health Authority's planning aims at ensuring that the process goes as smoothly as possible.

 

2. What are the differences between the COVID-19 vaccines from Pfizer-BioNTech and Moderna?

In Denmark, we currently use two different COVID-19 vaccines:

  • Comirnaty® from Pfizer-BioNTech
  • Spikevax® from Moderna

Although they are two vaccines, they are not so different as they are based on the same technology – messenger RNA (mRNA). Both vaccines have been tested in large-scale clinical studies with far more test subjects than are typically used when approving new medicines. 

Studies have shown that both vaccines are safe and effective.

All vaccines – including the COVID-19 vaccines from Moderna and Pfizer-BioNTech – can cause side effects. And while these side effects are not identica,l they are very similar. Mild and short-lasting side effects include soreness at the injection site, fatigue and headache. Learn more about the side effect under question 7 below. 

 

3. How have the vaccines been studied and tested?

The approved COVID-19 vaccines have been studied and tested in extensive clinical and randomised trials, in which half of the participants were given the vaccine, while the other half were given a placebo (saline injection).

Upwards of 40,000 volunteers participated in the extensive trials – more than eight times the usual number in vaccine trials.

The test subjects were – and continue to be – monitored to see whether they get COVID-19 and whether they experience any adverse side effects. Many of them did experience mild and transient side effects after they were vaccinated, which is quite normal and evidence that your body's immune system is reacting to the vaccine. No unacceptable side effects were recorded during the trials. 

We know from other vaccines that almost all side effects after vaccination occur within the first six weeks, and they very rarely occur later.

The Danish and European medicines authorities closely monitor the vaccines after they are approved – both in terms of how well they work and how many side effects they cause.
The European Medicines Agency impose exactly the same strict requirements on vaccines' efficacy and safety as they always do.

Learn more about vaccines against COVID-19 on the Danish Medicines Agency's website

 

4. What is in the vaccines?

mRNA-vaccines 

The vaccines from Pfizer-BioNTech and Moderna are both so-called RNA-based vaccines. They do not contain live virus, the active ingredients in the vaccine are broken down after they have done their job, and the vaccine's mRNA sequence (the molecule that tells cells what to build) does not affect the body's own DNA. 

RNA is a naturally occurring signalling agent in human body cells that encodes the formation of certain proteins. RNA-based vaccines work by containing a specific code that stimulates the body's cells to produce a protein (S-protein) that resembles the surface of novel coronavirus.

The messenger RNA vaccines (mRNA) work by encoding for spiked proteins that resemble the surface of the covid-19 virus. Therefore, they can stimulate the body's immune system to recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it and protect you against becoming infected and ill. 
 

Additives

The vaccines from Pfizer-BioNTech and Moderna contain additives that, among other things, are intended to stabilise RNA. RNA is wrapped in a small ball of fat that protects RNA from degradation and enables absorption into the body's cells. Some people (with so-called macrogol allergies) are allergic to one of the fat components, polyethylene glycol. The vaccines also contain minimal amounts of cholesterol, sugar and various salts. 
 

Watch the film

Information on covid-19 vaccines
 

5. Do the vaccines contain ethanol(alcohol) or pork gelatin?

The COVID-19 vaccines from Pfizer-BioNTech or Moderna do not contain ethanol(alcohol), pork gelatin, or any other animal products.   

 

6. What are the side effects of the covid-19 vaccines?

All vaccines have side effects, and this also applies to the covid-19 vaccines. In general, these are mild and transient, and we consider both vaccines to be very safe and highly documented. 

Mild and transient side effects

Most people will experience soreness at the injection site. Other common side effects include fatigue, headache, muscle and joint pain, chills, a slight rise in temperature, and redness and swelling at the injection site. These are generally signs that your body's immune system is reacting to the vaccine. You do not need to call your doctor if you experience these known and transient side effects. Please note that you should not worry if you are among those who do not experience any side effects - the vaccines will work regardless of whether you have any side effects or not. 

Experience with other vaccines tells us that almost all side effects occur within the first six weeks after vaccination, and they very rarely occur later. Danish and European medicines authorities monitor the vaccines closely after they have been approved – not only in terms of how well they work but also in terms of how many side effects they cause.

However, there is a difference in how well the immune system in older and younger people responds to vaccines. Older people usually have less effectively reacting immune systems and typically experience fewer side effects.  

Rare side effects

In rare cases, severe allergic reactions (anaphylaxis) may occur, which may be caused by, for example, allergies to the additives in the vaccines. 

If you have previously had a severe allergic reaction to a vaccine - or after injecting a medicine - please consult your doctor before being vaccinated against covid-19. If you are allergic to macrogol/PEG/polyethylen glycol, you should not get vaccinated with the vaccines from either Pfizer-BioNTech or Moderna. 

Learn more at the Danish Medicines Agency’s website about Vaccines against covid-19 and reported side effects:

Vaccines against covid-19 

Side effects

7. Can I go out and buy a covid-19 vaccine?

No, you cannot buy the covid-19 vaccines. All covid-19 vaccines delivered to Denmark is distributed through the free vaccination programme. 
Updated 21 DEC 2021