Swine flu vaccine and narcolepsy: questions and answers

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The National Institute for Health and Welfare (THL) said on Tuesday that the vaccination campaign against the H1N1, or swine flu virus last winter increased the risk of people between the ages of 4 and 19 to get narcolepsy, a disease which can cause the victim to fall asleep without warning. The cause of the disease is not known. One possibility is that the vaccine may have triggered the disease among people with a genetic or acquired disposition toward narcolepsy. Helsingin Sanomat answers 14 frequently-asked questions on the matter.
     
1. Why was the whole population offered a vaccination against swine flu?
      Most countries did the same. There had been long experiences with flu shots. Children were known to be especially prone to the disease, as well as those suffering from serious diseases, and pregnant women.
     
2. Who decided on the vaccination programme?
      The decision was made by the Ministry of social Affairs and Health at the recommendation of the National Institute for Health and Welfare (THL). This came after the World Health Organisation had declared that swine flu had reached pandemic proportions. The WHO recommended a number of measures, including vaccination.
     
3. What would have happened if no vaccination programme had been implemented?
      The epidemic caused a number of deaths at first, and eased later. It was expected to kill 100 people in Finland, and to fill intensive care wards at hospitals. Ultimately hundreds of thousands came down with the disease and 44 died.
     
4. Why was Pandemrix chosen as the vaccine?
      Of the three vaccines on the market, Pandemrix was chosen because it was thought that it would give the most effective level of immunity.
     
5. Where serious side effects expected?
      Before the vaccination programme was launched, the European Medicines Agency (EMA) gave a list of diseases to be monitored, and their rate of recurrence in Finland was ascertained. It would have been possible to recognise any changes immediately. Narcolepsy was not on the list, and nobody could suspect it.
     
6. Do vaccines usually have side-effects?
      When millions of people are vaccinated, side effects emerge that cannot be detected in advance even in the most far-reaching studies. Some people may have fallen ill even without the vaccination.
     
7. How are side-effects monitored?
      THL keeps a register of side-effects. Because of differences in data systems, the information does not flow very well from clinics which administer the vaccinations.
     
8. How much has narcolepsy increased after the vaccination programme?
      Normally, about 60 people a year come down with the disease in Finland. Last year there were 102. Soon after the vaccinations, 54 people aged 4 to 19 came down with the disease, and three were in the 30 to 39 age group.
     
9. Finland was the country where narcolepsy spread the most. Did Finland get a different vaccine or a different lot of vaccines than other countries?
      No, vaccines from the same lots went to other countries as well. Finland’s post-vaccine narcolepsy outbreak was smaller than it was in Iceland, where narcolepsy had not been seen in decades.
     
10. Was narcolepsy actually caused by the vaccine?
      It appears that the vaccination programme increased the narcolepsy risk of those aged 4 to 19 nine fold. The cause of narcolepsy is not known, but factors that increase susceptibility are hereditary factors as well as certain environmental factors. The hereditary factors apply to 28 per cent of Finns.
     
11. How can a person recognise the disease?
      The first symptoms are very strong fatigue and a tendency to fall asleep. Many also suffer from cataplexy, which is the loss of muscle tension.
     
12. Will there be more cases?
      Narcolepsy was diagnosed at an average 50 days after the vaccine was administered. The most serious cases have probably been dealt with.
     
13. Are families now being paid compensation?
      Fifteen applications have been submitted to the Finnish Pharmaceutical Insurance Pool concerning narcolepsy that emerged after a Pandemrix vaccination. The pool says that it will process the applications on a case-by-case basis when sufficient national and international studies are complete.
     
14. Is it safe to take the regular seasonal flu shot?
      Yes. Hundreds of people die of influenza each winter. The vaccinations can cause brief muscle pain and rising body temperature. This winter’s seasonal flu shot also provides protection against swine flu.
     
Helsingin Sanomat consulted a number of medical experts for this article.
     


Previously in HS International Edition:
  H1N1 vaccinations suspended over narcolepsy scare (25.8.2010)
  Children suffering from narcolepsy exhibit severe symptoms (8.11.2010)
  Narcolepsy diagnosed in 41 children vaccinated for H1N1 last year (14.12.2010)

Helsingin Sanomat