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By NewsDesk @ bactiman63
The Norwegian Institute of Public Health has decided to extend the pause in the use of the AstraZeneca vaccine because more research is needed.
On March 11, 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 serious clinical cases internationally and a death in Denmark after vaccination. Since then, reports 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 that more research is needed on these cases in order to give the best possible advice on 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. .
“Therefore, we have decided to extend the temporary pause for the AstraZeneca vaccine until April 15,” he continues.
On March 18, the European Medicines Agency (EMA) decided to maintain approval of the AstraZeneca vaccine. The EMA considers the benefits to be high and the reported side effects rare, but notes that severe cases of rare side effects cannot be excluded.
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All patients in Norway and Europe with the severe clinical picture of blood clots, bleeding, and low platelet counts developed symptoms within a period of approximately two weeks after vaccination.
A delay in the immunization program has a direct effect on the protection of risk groups and on the possibility of making infection control measures more flexible.
“The AstraZeneca vaccine is a good vaccine that protects risk groups against COVID-19. However, it’s 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 would like more information on the following questions:
- Is there a higher incidence of the combination of blood clots, bleeding, 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 research is complex and time consuming, but it is necessary in order to make a final decision regarding the further use of the AstraZeneca vaccine.
- The Norwegian Medicines Agency and the Norwegian Institute of Public Health are reviewing all reports of suspected side effects reported after vaccination. Relevant notifications are sent to the European Medicines Agency.
- A national group of experts has been established to advise the Norwegian Institute of Public Health on the assessment of a possible causal relationship between severe cases and vaccination with the AstraZeneca vaccine, and how it should be followed up.
- The national reference group for the immunization program is analyzing the situation regarding the use / non-use of the vaccine, the confidence in the vaccines and the immunization program, and the communication of decisions.
- The Norwegian Institute of Public Health is collaborating with other Nordic health authorities on record analysis and maintains a continuous exchange of experience and information with national and international networks.
- The EMA will bring together clinical experts and further evaluations from the EMA are expected in early April.
The Norwegian Institute of Public Health stopped sending the AstraZeneca vaccine to the health service on March 11 and the vaccines that have been received are in storage. The doses of vaccine received by the health service before the suspension of the vaccine must be stored correctly at the place of vaccination.
The break delays the vaccination program by approximately one to two weeks. Under the current delivery plan, there will be around 200,000 doses of AstraZeneca vaccines in storage during the break.
People who have received the first dose of AstraZeneca vaccine will not be offered the second dose until the situation regarding the use of the AstraZeneca vaccine is clarified. We will return with more information on how more can be vaccinated. Data from clinical trials and follow-up studies in the UK show that there is already good protection a few weeks after the first dose, especially against a severe course of the disease.
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