359 narcolepsy-related notices of injury filed concerning the Pandemrix vaccine – 115 notices filed concerning other adverse effects

News, 8th. of December 2020, The Finnish Pharmaceutical Insurance Pool 

The Pharmaceutical Insurance Pool has by 30 November 2020 received 474 notices of injury related to adverse effects caused by the Pandemrix vaccine in the 2009 vaccination campaign. The majority of them, or 359 notices, are related to suspected narcolepsy. The number of notices filed concerning other adverse effects is 115.

Most narcolepsy-related notices have received favourable claims decisions

Thus far, the Pharmaceutical Insurance Pool has made 236 favourable claims decisions and rejected 123 claims related to suspected narcolepsy.

Of the notices of injury filed, 85 were rejected as the person’s symptoms started more than two years after the vaccination. Two years is the time window defined by the Pharmaceutical Insurance Pool for the existence of causality. This is based on studies conducted by the National Institute for Health and Welfare.

38 of the notices of injury were rejected as the persons have not been diagnosed with narcolepsy.

Other adverse effects are primarily transient

The Pharmaceutical Insurance Pool has issued 19 favourable decisions and rejected 96 notices of injury related to adverse effects of the Pandemrix vaccine not related to narcolepsy.

– The compensable cases have primarily been transient neurological syndromes and adverse effects. A small number of such transient syndromes occurs with nearly all vaccines; in other words, they are not specific to the Pandemrix vaccine, says Asko Nio, Director of the Pharmaceutical Insurance Pool.

Case-by-case decisions have been made when making the claims decisions, based on medical and legal assessment, on whether the adverse effects can be connected to the Pandemrix vaccine, in other words, whether there is causality between the vaccine and the symptoms.

– In most cases, there was no causality with the Pandemrix vaccine, which is why no compensation can be claimed under the pharmaceutical insurance, Nio says.

Compensation paid totals EUR 12.2 million – compensation liability will continue long into the future

The Pharmaceutical Insurance Pool has paid compensation in the total amount of approximately EUR 12.2 million for the adverse effects caused by the Pandemrix vaccine. EUR 11.6 million of the compensation have been paid for narcolepsy cases and EUR 530,000 for other adverse effects.

– Paying compensation on the adverse effects resulting from the Pandemrix vaccine will continue long into the future, particularly because many of those who fell ill due to the vaccine were adolescents and children, Nio points out.

Additional information:

Juha-Pekka Halmeenmäki, Managing Director
tel. +358 40 922 9000