The decision to put vaccination with the COVID-19 vaccine from AstraZeneca on hold is extended for another three weeks
The Danish Health Authority’s decision to pause the COVID-19 vaccine from AstraZeneca remains in effect because the assessment of the use of the vaccine in the Danish vaccination programme against COVID-19 is still ongoing.
The Danish Health Authority put vaccination with the COVID-19 vaccine from AstraZeneca on hold on 11 March 2021 following reports of several severe cases of blood clots, decrease in platelet count and bleeding. Subsequently, the European Medicines Agency (EMA) has analysed 25 cases of these and similar types of severe and rare side effects.
On 18 March 2021, a preliminary review from the EMA concluded that the COVID-19 vaccine from AstraZeneca might be associated with the occurrence of rare but severe cases of blood clots.
"We have launched several independent studies and consulted relevant experts. We are confident that we will be able to uncover the extent and possible correlation between the side effects and the vaccine and, combined with reviews and conclusions from the EMA, we will have a solid foundation on which to make our final decision on using the vaccine from AstraZeneca", says Director General Søren Brostrøm.
The Danish Health Authority continuously receives feedback and results of the ongoing studies, but it is still too early to draw any definitive conclusions.
"At this time, we believe that our basis for making a final decision on any future use of the COVID-19 vaccine from AstraZeneca is too uncertain. Many studies have been initiated, but we do not yet have any conclusions. Therefore, the hold on using the vaccine remains in effect," says Director General Søren Brostrøm.
The consequence of the extended hold on the vaccine for another three weeks is that any bookings for the first or second injection with the AstraZeneca vaccine will be cancelled. Furthermore, those who have already been invited to vaccination with AstraZeneca – and who would otherwise have been given the first injection in the coming weeks – will have to wait a little longer.
"We are very conscious that a continued hold on vaccination with the COVID-19 vaccine from AstraZeneca delays the Danish vaccination programme against COVID-19. However, the vaccines are already in the refrigerator. If we decide to recommence vaccination with the COVID-19 vaccine from AstraZeneca, we can quickly distribute and use the vaccines," says Søren Brostrøm.
The Danish Health Authority will make its final decision on the COVID-19 vaccine from AstraZeneca in week 15.
The foundations of the Danish Health Authority's assessment
To strengthen the professional dialogue between health authorities and experts, the Danish Health Authority has assembled Danish experts in areas such as anticoagulant medicine, immunology, neurology, infectious medications, and pharmacoepidemiology.
The Danish Health Authority also has an ongoing dialogue with the Danish Medicines Agency and Staten Serum Institut about the monitoring of adverse reactions to the COVID-19 vaccines and the course of the COVID-19 epidemic in Denmark.
Danish experts have initiated both laboratory studies of the suspected cases in Denmark and so-called pharmacoepidemiological research, which analyses the effect of the vaccine in the Danish population based on registered data.
Document
The Danish Health and Medicines Authority's professional considerations behind continued discontinuation of COVID-19 Vaccine AstraZeneca® - in Danish:
Sundhedsstyrelsens faglige overvejelser bag fortsat pausering af COVID-19 Vaccine AstraZeneca®
Meetings about signal detection for vaccine adverse reaction
Informative meeting on adverse reaction signals for AstraZeneca vaccine (meeting held 17 March 2021) - in Danish:
Orienterende møde om bivirkningssignaler ved AstraZeneca-vaccine (møde afholdt 17. marts 2021)
2nd Informative meeting on adverse reaction signals for AstraZeneca vaccine (meeting held 22 March 2021) - in Danish:
2. orienterende møde om bivirkningssignaler ved AstraZeneca-vaccine (møde afholdt 22. marts 2021)