A Broader Basis for Making Decisions concerning Viral Vector Vaccines

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The final decision concerning the use of the AstraZeneca and Janssen COVID-19 vaccines will be taken by the Norwegian Government. A committee of experts, both foreign and national, will be appointed to examine the consequences of using or not using these vaccines in the vaccination programme.

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The Norwegian Institute of Public Health recommends removing the AstraZeneca vaccine from the vaccination programme permanently due to the risk of rare but severe side effects. The Norwegian Institute of Public Health has assessed this in relation to the COVID-19 situation in Norway.

The assessment made by the experts at the Norwegian Institute of Public Health is solid and thorough. Working with colleagues in Denmark, the Norwegian Institute of Public Health and the community of experts in Norway were quick to discover these side effects and assess the causal connection to the vaccine.

The fact that the authorities take such rare but severe side effects seriously and that Norway has systems in place to discover them inspires trust. The rare side effects that made the Norwegian Institute of Public Health temporarily discontinue the use of the AstraZeneca vaccine can, with high probability, be linked to the vaccine. This is now internationally accepted, says Minister of Health and Care Services Bent Høie.

The use of the Janssen vaccine has been temporarily paused by the manufacturer following reports of the same type of rare severe side effects as those linked to the AstraZeneca vaccine.

Considerable consequences
Like the Norwegian Institute of Public Health, I am concerned about the severe side effects. However, I am also concerned about the ramifications of delaying the vaccination process and the reopening process for the population of Norway and Norwegian society.

Yesterday, the Coronavirus Commission concluded that children and adolescents have been shouldering a great burden during the pandemic. They should not have to carry this burden any longer than necessary. If we say a permanent ‘no’ to these vaccines, we risk not meeting our target of vaccinating everyone over 18 years of age by the end of the summer. This could mean we will have to live longer with the measures and a risk of new outbreaks, Mr Høie points out.

All over the world, experts are working to find out what causes the issues with this type of vaccine – viral vector vaccines.

The Norwegian Government does not believe that we have adequate grounds for drawing a final conclusion concerning whether or not to permanently remove the AstraZeneca vaccine from the Norwegian vaccination programme.

Saying a final ‘no’ to the vaccines from AstraZeneca could affect our opportunity to assess whether the Janssen vaccines, which are based on the same technology, can be used. We must remain open and wait for international knowledge and we must be open to the potential conclusion that the vaccines can be used.

The Norwegian Government is also preparing for a situation in which the vaccination programme must continue without the AstraZeneca and Janssen vaccines.

The Norwegian Institute of Public Health is currently assessing whether increasing the interval between the first and second doses of the Moderna and Pfizer vaccines from six to twelve weeks is an option. People who have received the first dose are well protected from COVID-19. If the interval can be increased before giving the second dose, more people can be vaccinated faster, says Mr Høie.

A broader assessment
The risk assessments made by the Norwegian Institute of Public Health of use of the AstraZeneca vaccine in Norway refer to Norwegian COVID-19 fatality numbers and deaths in Norway that may have been caused by severe side effects of the vaccine. Much work is currently being done internationally to increase knowledge of the risk of severe side effects.

The Norwegian Government therefore wants a broader assessment which concerns experiences with these vaccines in other countries and what delaying the vaccination process may mean in terms of strain on the population and on society as a whole.

The committee’s mandate
The committee of experts will perform a holistic risk assessment of continuing the use of viral vector vaccines, both on the individual level and the societal level. The committee will assess relevant international data concerning side effects and risks.

The committee will assess their use in different age groups and examine the possibility for compensating measures to prevent side effects and ensure a rapid medical response if they occur.

Furthermore, it will assess trust in the vaccination programme and the population’s desire to receive the different vaccines. It will consider voluntary use of these vaccines for those who wish for a speedier vaccination, subject to the vaccines being approved for use by the European Medicines Agency.

The committee is also asked to assess the societal consequences of discontinuing the use of these vaccines and what impact this would have on the prevalence of illness and mortality caused by COVID-19, especially among the younger age groups. This includes data on the consequences of long-term effects of COVID-19.

Based on its findings, the committee will make a recommendation to the Norwegian Government on how EMA-approved viral vector vaccines recommended for use in other European countries should be used in Norway. The deadline is 10 May.

The members of the committee of experts
The committee of experts will be chaired by Lars Vorland. Dr Vorland is a medical doctor and has a PhD in Medical Microbiology.

He has, among others, been Director of the Infection Control Division of the Norwegian Institute of Public Health, the Director of the Northern Norway Regional Health Authority and head of the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway.

Other members of the committee:

  • Gunnveig Grødeland, Scientist, University of Oslo
  • Gunnar Bovim , medical doctor, Adviser, Norwegian University of Science and Technology NTNU
  • Anne Kjersti Befring, Lawyer, Associate Professor, University of Oslo
  • Baard-Christian Schem, Senior Adviser, Western Norway Regional Health Authority
  • Steinar Krokstad, HUNT, Professor, Norwegian University of Science and Technology NTNU
  • Ingrid Hjort, Postdoctoral Fellow, Norwegian Business School BI
  • Jon Michael Gran, statistician, Associate Professor, University of Oslo
  • Ingvild Sørvoll, Senior Consultant, University Hospital of North Norway
  • Kathrine Kristoffersen, Chief Municipal Medical Officer, Tromsø
  • Linda Nøstbakken, Research Director, Statistics Norway
  • Marie-Paule Kieny, Research Director, INSERM, France
  • John Edmunds, Professor, London School of Hygiene and Tropical Medicine