Background

The coronavirus vaccine from Janssen-Cilag is a so-called viral vector vaccine. It was conditionally approved by the medicines authorities on 11 March 2021, but has not been used in the coronavirus immunisation programme in Norway. This is due to the risk of rare but serious vaccine side effects in the form of low platelets, blood clots and bleeding.

The Government decided that anyone who wished to take the vaccine could be assessed by a doctor in order to get the Janssen vaccine. It was only available from a doctor after a thorough risk-benefit assessment. For most people, the risk of serious side effects from the Janssen vaccine outweighed the benefits in the situation at the time. This also applied to most people who were going to travel abroad.

This arrangement was not part of the coronavirus immunisation programme and was not recommended by the Norwegian Institute of Public Health. The Norwegian Institute of Public Health recommended that people should follow the coronavirus immunisation programme and have mRNA vaccines

• Read more about the NIPH’s assessment about use of the Janssen vaccine in the programme (in Norwegian): Vurderinger rundt bruk av COVID-19 VaccineJanssen i koronavaksinasjonsprogrammet (pdf)

More about the serious side effects after the Janssen vaccine

On 20^th April 2021, the European Medicines Agency (EMA) concluded that there is a probable link between the Janssen vaccine and serious cases of blood clots, low platelet counts and bleeding. These are now referred to as a very serious but rare side effect in the product information. The EMA still considers the vaccine to have a positive benefit-risk ratio, but the authorities of each country must assess the benefit-risk based on their infection situation. Based on the situation in Norway at the time, the Norwegian Institute of Public Health considered that the risk of the rare but serious side effects could outweigh the benefits for those groups who had not yet been vaccinated through the coronavirus immunisation programme.

News articles

• 20.04.2021 EMA ser mulig sammenheng mellom Janssen-vaksinen og sjeldne tilfeller med blodpropp (Legemiddelverket) 
  The European Medicines Agency (EMA) has concluded that rare cases of severe thrombosis with low platelet counts and bleeding are described as a very serious and rare side effect in the product information.
• 10.05.2021 FHI anbefaler ikke bruk av Janssen-vaksinen i Norge
  The Norwegian Institute of Public Health recommends that the Janssen vaccine not be used in the active coronavirus immunisation programme as the situation is now.
• 09.06.2021 Bestilling av COVID-19 Vaccine Janssen
  Due to the risk of serious side effects, the Janssen vaccine is not used in the Norwegian coronavirus immunisation programme. The government has decided that it will be possible to take the vaccine outside the programme.
• 09.06.2021 Janssen-vaksinen som tilvalg (Regjeringen) 
  The government has decided that the Janssen vaccine will be offered outside the coronavirus immunisation programme.
• 05.10.2021 Persons vaccinated with Janssen will be offered an additional dose of mRNA vaccine 
  The Ministry of Health and Care Services has decided to follow the Norwegian Institute of Public Health's recommendation to offer an extra dose of mRNA vaccine to those who have received one dose of the Janssen vaccine