he Norwegian Medicines Agency has received a total of 11,014 reports of suspected adverse reactions. Of these, 6,293 reports have been assessed. A total of 724 are classified as serious and 5,569 as non-serious.
The reports of adverse reactions that we have received do not provide a basis for revising the current recommendations regarding vaccination with the Comirnaty (BioNTech/Pfizer) and Moderna COVID-19 vaccines.
After reports had been submitted in a number of countries concerning cases of rare and very severe blood clots with low blood platelet counts and bleeding, the European medicines authorities have concluded that there is a link to the vaccine. This is now being updated as a rare adverse reaction in the product information.
On 11 March 2021, the Norwegian Institute of Public Health suspended use of the vaccine, and no further cases of this rare blood clot combination have been reported in Norway since 18 March. Reports have been submitted concerning a total of six patients with this rare combination of symptoms, four of whom have died. Five of the incidents have been described in a recently published study by Oslo University Hospital (OUS) and the University Hospital of North Norway (UNN) in the New England Journal of Medicines.
The Norwegian Institute of Public Health recommends removing the AstraZeneca vaccine from the vaccination programme permanently. 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.
The Jansen vaccine was developed using the same technology as Vaxzevria (AstraZeneca). Following reports of similar cases of this severe and very rare combination of blood clots with a low blood platelet count following vaccination in the USA, the EMA is now also investigating this vaccine. Pharmaceutical firm Johnson & Johnson has announced that it is halting rollout of the vaccine in Europe while the investigation is ongoing.
Most of the reports submitted to date concern common adverse and expected reactions, such as pain at the injection site, headache, general malaise with fever, fatigue, nausea and pain in the body. These adverse reactions last around 2-3 days and are known from the studies which formed the basis for the vaccine authorisations.
Any suspicion that a COVID-19 vaccine has triggered an adverse reaction is sufficient to report the reaction. It is particularly important to report adverse reactions which are not referred to in the patient information leaflet or which are considered to be very serious. Health professionals are obliged to report suspected serious adverse reactions to vaccines. The causal relationship need not be known.
It is particularly important to report reactions where any of the following are suspected:
Health care professionals should report adverse reactions via melde.no.
The general population can report adverse reactions via helsenorge.no, but you should consult a doctor or other health professional in the case of suspected serious or unexpected adverse reactions following vaccination. You do not need to report a possible adverse reaction yourself if a health professional has already reported the reaction.
Reports of adverse reactions following vaccination are followed up by the Norwegian Medicines Agency in partnership with the Norwegian Institute of Public Health and the regional medicines information and pharmacovigilance centres (RELIS). The Norwegian Medicines Agency is responsible for the National ADR Register, and exchanges adverse reaction data with the European Medicines Agency (EMA) and the World Health Organization (WHO). This provides us with a better basis for assessing causation, identifying new adverse reactions and implementing measures to safeguard patient safety.
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