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Vaccination against COVID-19

Worldwide efforts are currently made to develop clinically safe and efficacious vaccines against COVID-19. The Danish Health Authority and the other health authorities are poised and ready for the arrival of one or more vaccines in Denmark.

A COVID-19 vaccination is an important tool and will be an essential supplement to other measures to reduce the spread of novel coronavirus in society. However, even at a time when a COVID-19 vaccination programme is in place, we must all continue to follow the general advice on good hand hygiene and distance.

Several promising candidate vaccines are currently in the pipeline. Still, so far, none of them has been approved by the relevant medicines agencies and given the go-ahead for mass production. 

 

COVID-19 vaccination programme

The purpose of the vaccine and the roles of the various health authorities

There are many reasons why we want to vaccinate the population:

  • Miminise the number of death, severe courses of the disease and long-term effects due to COVID-19.
  • Minimise the spread of infection in society.
  • Ensure the continued performance of vital societal functions.

Furthermore, while vaccination provides direct protection to those who are vaccinated, it also indirectly reduces the spread of infection in society, thus protecting other people, including those who are at higher risk of severe illness from COVID-19.

The Danish health authorities have various parts to play in the Danish COVID-19 vaccination programme. We cannot answer all your questions at present but will update this site as and when new information becomes available. 

The Danish Health Authority is responsible for planning the national vaccination programme. Limited initial vaccine supply will necessitate recommendations for which groups should be the first to get a safe and efficacious vaccine. Based on the science, we have set these priority groups based on e.g. age, occupation, vulnerability, outbreaks, geographical boundaries, vital societal functions, etc. We will also head up communication to the public as well as health professionals and, work with all relevant stakeholders to determine who will administer the vaccine. 

The Danish Medicines Agency plays a central role in the approval and monitoring of clinical trials. Along with experts from other medicines regulatory agencies in the EU, the Danish Medicines Agency works closely with the European Medicines Agency's (EMA) on granting authorisation to companies who apply for approval of vaccines for distribution within the whole of EU. After a vaccine has been authorised, the Danish Medicines Agency will be responsible for monitoring all Danish reports of possible side effects of the vaccine, and for monitoring the safety of the vaccines at European level in collaboration with medicines regulatory agencies from the other EU countries and the European Medicines Agency.

The Danish Medicines Agency is responsible for informing the public of the reasons behind the approval of the vaccines, their efficacy, and how safe they are. 

Statens Serum Institut is responsible for the procurement and distribution of the vaccines. The Institut will also monitor the number of vaccinations as well as the frequency of vaccine-preventable diseases in Denmark.

Statens Serum Institut will also be advising the country's doctors and other healthcare workers on vaccines and the prevention of infectious diseases.
The health authorities advise the Ministry of Health, which ultimately decides who will be eligible to receive free vaccinations under a publicly funded national vaccination scheme.

 

How is a COVID-19 vaccine approved?

When vaccines are evaluated for approval, experts from the Danish Medicines Agency work with colleagues from the other EU countries under the auspices of the European Medicines Agency (EMA). If the EMA then concludes there is sufficient scientific evidence of the vaccine's efficaciousness and safety from large-scale clinical trials, the vaccine will be approved for distribution throughout the EU countries.

The Danish Medicines Agency describes the evaluation and authorisation procedure on its website.  

The Danish Health Authority is responsible for rolling out the national COVID-19 vaccination scheme. The Authority is already in charge of other national vaccination schemes such as annual influenza vaccines and the Danish Childhood Vaccination Programme.  

 

Vaccines in the pipeline. When will they arrive, and how many doses will we get?

On the Danish Medicines Agency's website, you can see which vaccines are currently under development.

Several candidate vaccines show promising early interim results and are in the final stages. However, a vaccine is only approved when it is shown to be efficacious for a certain period of time and, as yet, no COVID-19 has been approved. 

We do not yet know when the first vaccine will be available in Denmark. 

The EU negotiates on behalf of all EU countries. Once vaccines against COVID-19 are available, their supply is likely to be limited, at least initially. Supply capacity, both initially and over time, will thus determine vaccine usage and delivery prioritisation. Access will probably be based on population size, but at this time, we do not know how many vaccines doses Denmark will be getting. 

 

How many times do I need to be vaccinated and how long will I be protected?

At this time, we do not know when and which COVID-19 vaccines we are going to get. We do not know the characteristics of future vaccines.

Therefore, we cannot say whether the new vaccine must be administered at regular interval to be efficacious – much like a flu vaccine – and for how long the vaccine will protect you.

 

Will the vaccine have any side effects?

There is a risk of side effects associated with all medicines – including vaccines. 

From the vaccines already in use, we know that you can get e.g. transient redness where you have been injected, as well as fever, malaise or muscle soreness following the vaccination.

Serious side effects can also occur after vaccination, but they are usually rare. Before a vaccine is authorised for use in the entire population, we require documentation of the vaccine's efficacy and safety from large clinical trials. Furthermore, vaccines are only approved if the beneficial effects – i.e. the protection against the disease against which one is vaccinated – outweighs any possible side effects. 

Like any other medicine, new vaccines are closely monitored, and any adverse reactions reported– at the national level by the Danish Medicines Agency, who will be working closely with the European Medicines Agency. 

 
Updated 16 NOV 2020