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Vaccination with AstraZeneca vaccine against COVID-19 put on hold
“We will wait for information to see if there is an association between the vaccine and this case,” says Geir Bukholm, Director of the Division of Infection Control and Environmental Health at the Norwegian Institute of Public Health.
Due to reported suspected side effects in Denmark, the European Medicines Agency (EMA) has launched an investigation into the AstraZeneca vaccine.
“It has not been concluded that there is an association between vaccination and the incident in Denmark, but as a precaution we have chosen to put vaccination with the AstraZeneca vaccine on hold while the investigation is ongoing,” he adds.
Bukholm explains it is not an easy decision to suspend vaccination with the AstraZeneca vaccine. In Norway and Europe, suspected side effects are closely monitored. So far, the side effects reported after AstraZeneca vaccination reflect those expected and mentioned in the Summary of Product Characteristics: short-term headache, fever with chills, fatigue, and muscle and joint pain. In addition, many experience pain at the injection site.
“I would like to point out that this pause does not mean that we advise against vaccination with AstraZeneca in the future. The AstraZeneca vaccine has good documentation, and having sufficient doses to ensure protection for as many people as possible in the risk groups as early as possible is also important, says Bukholm. “We are in a situation of increasing transmission where protection against COVID-19 disease is increasingly important.”
Appointments arranged for vaccination with the AstraZeneca vaccine will now be cancelled, or replaced with offers of mRNA vaccines from BioNTech / Pfizer and Moderna.
There have been some reported cases of blood clots shortly after coronavirus vaccination in Norway. This is mainly among the elderly where there is often another underlying condition.
The Norwegian Medicines Agency is carefully reviewing all reported side effects after the AstraZeneca vaccine and other coronavirus vaccines. In addition, we will investigate whether there are cases of blood clots after vaccination that have not been reported, and ask healthcare professionals who suspect such an association to report this as soon as possible.
“We are also looking at whether we find indications that there is an increase of certain conditions in the health registries that could be side effects,” says Bukholm.
NIPH has established a preparedness register for COVID-19 - Beredt C19 - so that the NIPH can quickly obtain the necessary knowledge about the COVID-19 pandemic. The knowledge will help to enable the authorities to assess risk and implement measures to ensure the health of the entire population. These data are always updated and provide the opportunity for completely different analyses than we have been able to do before.
The NIPH is now conducting analyses that examine the connection between the AstraZeneca vaccine and various blood clotting conditions such as stroke and blood clots in the lungs. These are complicated analyses that will take some time. We have a good dialogue with the clinical professional communities to ensure the quality of our analyses.
We are in contact with European collaboration partners to investigate the possibility of joint Nordic analyses of rare incidents.
In Norway, 121,820 people have been vaccinated with the AstraZeneca vaccine. We ask those who have already been vaccinated not to worry unnecessarily. If there is an association between the vaccine and a blood clot, this would be an extremely rare side effect.
The pause means that we will stop despatching AstraZeneca vaccines from NIPH until further notice, and the doses that have been sent out must be stored in accordance with regulations at the vaccination site. We expect limited deliveries from AstraZeneca in the coming weeks. The pause will lead to some delay in the vaccination programme, i.e., how many will be vaccinated in the future. NIPH will prepare an updated vaccine scenario.
There is a difficult balance between the risk of serious, rare side effects of vaccination and the risk that people with a high risk of severe COVID-19 disease are not vaccinated and become infected with the coronavirus.