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.
"Based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the COVID-19 vaccine from AstraZeneca. We have, therefore, decided to remove the vaccine from our vaccination programme," says Director General Søren Brostrøm. EMA concluded that the benefits of using the COVID-19 vaccine from AstraZeneca continue to outweigh the risks for people who receive it. The Danish Health Authority agrees with general findings of EMA that possible benefits of AZ in combatting the COVID-19 pandemic continue to outweigh the risk of serious adverse events. 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.
"In the midst of an epidemic, it has been a difficult decision to continue our vaccination programme without an effective and readily available vaccine against COVID-19. However, we have other vaccines at our disposal, and the epidemic is currently 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. The upcoming target groups for vaccination are less likely to become severely ill from COVID-19. We must weigh this against the fact that we now have a known risk of severe adverse effects from vaccination with AstraZeneca, even if the risk in absolute terms is slight," says Søren Brostrøm.
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.
"We are basically in agreement with EMA's assessment regarding the AstraZeneca vaccine. That is why it is important to emphasise that it is still an approved vaccine. And I understand if other countries in a different situation than us choose to continue using the vaccine. If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a healthcare system under pressure – and if we had not reached such an advanced point in our rollout of the vaccines – then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it," says Søren Brostrøm.
Regarding the Janssen vaccine from Johnson & Johnson, the manufacturer has quarantined deliveries, so we cannot currently use it in Denmark. 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.
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