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Extended pause for AstraZeneca vaccine
On 11th March 2021, the Norwegian Institute of Public Health decided to temporarily pause vaccination with the AstraZeneca vaccine in Norway. The decision was made after reports of severe clinical cases internationally and a death in Denmark after vaccination. Since then, notifications of similar clinical cases and four deaths have also been received in Norway.
“It is a difficult but correct decision to extend the pause for the AstraZeneca vaccine. We believe it is necessary to carry out more investigations into these cases so we can give the best possible advice about vaccination to the population in Norway, says Geir Bukholm, Director of the Division of Infection Control and Environmental Health at the Norwegian Institute of Public Health.
“We have therefore decided to extend the temporary pause for the AstraZeneca vaccine until 15 April,” he continues.
On 18th March, the European Medicines Agency (EMA) decided to maintain the approval of the AstraZeneca vaccine. EMA considers that the benefits are high and that the reported side effects are rare, but they point out that severe cases of rare side effects cannot be excluded.
All the patients in Norway and Europe with the severe clinical picture of blood clots, haemorrhages and low platelet counts developed symptoms within a period of approximately two weeks after vaccination.
A delay in the immunisation programme has a direct effect on protecting those in the risk groups and on the possibility of easing infection control measures.
"The AstraZeneca vaccine is a good vaccine that protects risk groups against COVID-19. However, it is important to weigh the benefits of vaccination against the risk of rare but serious side effects from continued use of the AstraZeneca vaccine, says Bukholm. “We need more time to consider this balance.”
The Norwegian Institute of Public Health wants more information about the following questions:
Is there an increased incidence of the combination of blood clots, haemorrhages and low platelet counts among those who have received the AstraZeneca vaccine compared to those who have not been vaccinated?
If so, what is the reason?
Are there any factors among the patients that may have contributed to the condition such as age, gender or other underlying diseases / conditions?
Bukholm explains that the Norwegian Institute of Public Health is working with clinical experts both in Norway and abroad to identify whether there is a causal relationship through several parallel studies. The investigation is complex and time-consuming but is necessary to be able to make a final decision regarding further use of the AstraZeneca vaccine.
The Norwegian Medicines Agency and the Norwegian Institute of Public Health are reviewing all notifications of suspected side effects reported after vaccination. Relevant notifications are forwarded to the European Medicines Agency.
A national expert group has been established to advise the Norwegian Institute of Public Health about assessing a possible causal relationship between the severe cases and vaccination with the AstraZeneca vaccine, and how this should be followed up.
The national reference group for the immunisation programme is looking at the situation concerning the use / non-use of the vaccine, confidence in vaccines and the immunisation programme, and the communication of decisions.
The Norwegian Institute of Public Health is collaborating with other Nordic health authorities about register analyses, and has a continuous exchange of experience and information with both national and international networks.
The EMA will gather clinical experts and new assessments are expected from EMA in early April.
Consequences for vaccination progress
The Norwegian Institute of Public Health stopped despatching the AstraZeneca vaccine to the healthcare service on 11th March and vaccines that have been received are in storage. Vaccine doses received by the healthcare service prior to the vaccine being put on hold must be stored correctly at the vaccination site.
The pause delays the immunisation programme by approximately one to two weeks. According to the current delivery plan, there will be around 200,000 doses of AstraZeneca vaccines in storage during the pause.
People who have received the first dose of the AstraZeneca vaccine will not be offered the second dose until the situation about the use of the AstraZeneca vaccine has been clarified. We will return with more information on how they can be vaccinated further. Data from clinical trials and follow-up studies in the UK show there is good protection already a few weeks after the first dose, especially against a severe disease course.