Norway’s 2009 swine flu vaccines: “We are still receiving adverse drug reaction reports in 2020”
Vaccination is on many of our minds in the wake of the COVID-19 pandemic, with new treatments currently being created, approved, and distributed.
COVID-19 vaccine distribution has begun, and public reactions are diverse. Many are happy, seeing an end to the pandemic in sight. Some are worried about medical side effects. Others still are flat-out opposed to the vaccine.
But COVID-19 isn’t Norway’s first pandemic nor mass vaccination situation.
We explored the case of Norway’s last big vaccine distribution, which followed the 2009-2010 H1N1 (swine flu) pandemic.
Keep in mind, as you read, that H1N1 and COVID-19 are two totally different illnesses, with different vaccinations and outcomes.
A decade of medical innovation also divides the two.
The H1N1 vaccine in Norway
Norway’s vaccination system
Let’s start with an introduction to how the vaccination system works in Norway.
Residents of Norway can contact their health care providers to receive a vaccination.
All side effects of medicines are reported to the Norwegian Medicines Agency (Legemiddelverket, LMV), be they directly from patients or from medical health care personnel. LMV deals with all medicinal side effects, even those that do not give the patients a right to compensation.
The Norwegian System of Patient Injury Compensation (NPE) handles compensation claims from patients who think they may have gotten an injury from an error or omission in health care treatment.
The purpose of the compensation is to cover additional expenses incurred as a result of the patient’s injury. More information on NPE’s criteria to qualify for compensation for a patient injury can be found here.
Because Norway’s swine flu vaccinations cause side effects in some cases, we spoke to NPE and LMV to learn more.
How many people reported side effects of the swine flu vaccines, total?
“2001 adverse drug reaction reports have been filed in relation to the swine flu vaccines since 2009”, a Norwegian Medicines Agency LMV spokesperson tells us.
What were the reported side effects?
The LMV spokesperson explains:
“935 of the reports were classified as non-serious, while 1066 of the reports were classified as serious.
The most frequent system-organ classes affected were:
- 20,28% of the reported adverse drug reactions were of a general character, such as pain at the administration site, fever, and fatigue
- 26,73% of the reported adverse drug reactions were in the nervous system, such as headache, dizziness, and numbness
The less frequent organ-classes affected are listed below.
The Norwegian System of Patient Injury Compensation (NPE) spokesperson adds:
“We can only answer for the patients who have sent a claim for compensation to us. We have so far given compensation to 107 young patients (up to 19 years), due to the fact that they got narcolepsy from the vaccine. This is a serious and lifelong condition.”
How much was paid out in compensation in NOK, and to how many people?
“We have paid out NOK 374 million to 156 patients”, the (NPE) spokesperson says, continuing:
“The amount each patient gets as compensation depends on how serious the side effect is.”
What ages were people who experienced side effects?
The LMV spokesperson tells us:
- 30.1% was between 0-19 years old
- 24.8% was between 20-39 years old
- 27.7% was between 40-59 years old
- 11.1% was 60+ years old
- In 6.4% of the reports, the age is unknown.
Are you still receiving side effect reports from these vaccines? When was the most recent side effect reported?
“We are still receiving ADR reports related to these vaccines.
“The most recent were received in November this year”, the LMV spokesperson says.
What were the names of the swine flu vaccines and who produced them?
The LMV spokesperson explains:
- Pandemrix – Marketing authorization holder: GlaxoSmithKline Biologicals Services S.A
- Celvapan – Marketing authorization holder: Nanotherapeutics Bohumil, S.R.O.
Pandemrix was, by far, the most frequently used vaccine in Norway in 2009/2010.
Celvapan was only offered to a minor group of the vaccines, and only 4 adverse drug reaction reports are related to this vaccine.”
Source: Norway Today
