On November 10, 2021, the Swedish parliament voted to approve state compensation for past and future injuries caused by COVID-19 vaccinations.
In accordance with the decision adopting the government bill, Prop. 2020/21:221, the Swedish state will compensate patients with vaccination-related injuries when the Swedish Pharmaceutical Insurance, which covers anyone in Sweden who suffers from the adverse effects of pharmaceutical treatment, does not apply. Such would be the case when the manufacturer is not part of the Swedish Pharmaceutical Insurance or when the insurance payout has reached the total monetary cap set for compensation through the Swedish Pharmaceutical Insurance. For injuries related to the COVID-19 vaccination, the cap is currently set at 20 million Swedish kronor (SEK) (about US$2.3 million).
To qualify for compensation, patients need only show that the probability the vaccine caused the injury outweighs (övervägande sannolikhet) other possible causes — they are not required to prove that the vaccination caused the injury. Moreover, the new law requires that the vaccine was administered in Sweden and among those approved for use in Sweden by the European Medicines Agency, which currently include Comirnaty from Pfizer/BioNTech, Spikevax from Moderna, Vaxzevria from AstraZeneca, and Covid-19 Vaccine Janssen from Janssen-Cilag. In addition, Comirnaty is approved for use in children age 12 and older. Presently, only Comirnaty and Spikevax are used in Sweden. Vaxzevria and Vaccine Janssen are no longer used as part of the Swedish vaccination program, but prior vaccination with these vaccines is covered by the provision. On October 6, 2021, the Public Health Agency of Sweden stopped all vaccinations with Spikevax in persons born 1991 or later. No vaccine is approved for use in children younger than 12 years old in Sweden.
Compensation is capped at SEK10 million (about US$1.1 million) per individual or 200 price index amounts (prisbasbelopp) and must be calculated using the provision in the Tort Act (Skadeståndslagen (SFS 1972:207)) concerning personal injuries (personskada). (Prop. 2020/21:221, new 12 §.) Claims for compensation payments may not be used to collect a debt. (Prop. 2020/21:221, new 22 §.)
The law is scheduled to enter into force on December 1, 2021, but will also apply to injuries sustained before this date. (Prop. 2020/21:221, add. 6, 117.)The state compensation rules for Covid-19 vaccination-related injuries are similar to those adopted in 2016 for injuries tied to the vaccination of children during the swine flu pandemic in Sweden. (Lag om statlig ersättning till personer som insjuknat i narkolepsi efter pandemivaccinering (SFS 2016:417).) During the 2009–2010 swine flu pandemic Sweden vaccinated about 60% of its population, resulting in about 700 claims for vaccination-related narcolepsy in children and teenagers. On November 1, 2021, the Swedish Pharmaceutical Insurer announced that the SEK150 million that had been allocated for these injuries has been spent and that all pending claims have been transferred to Kammarkollegiet, the Swedish state’s Legal, Financial and Administrative Services Agency.