DARM DA study exercise group 4

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Background

The spreading of the H1N1 influenza virus, also referred to as the swine flu, originated from Mexico in the spring of 2009. From Mexico the virus spread first to North America and soon it was discovered also in Europe. The first case of swine flu in Finland was detected in may of 2009 and the first death associated with the virus in october 2009. The H1N1 virus caused typical influenza symptoms, but it was a completely new subtype with gene segments from bird, pig and human viruses and it was observed to be dangerous and even lethal to healthy population as well as risk groups.

The swine flu was declared a pandemic in june 2009 by the World Health Organization. In many countries, including Finland, this declaration lead to a swift resolution of purchasing vaccines for protection of the population against the virus. Finland chose the Pandemrix-vaccine which is manufactured by GlaxoSmithKline and was one of the first countries in Europe to receive the vaccine. Pandemrix was patented in the year 2006 and it was approved for use by the European Comission, based on recommendations from the European Medicals Agency. Vaccinations for health care personnel and risk groups began in autumn 2009, later when enough vaccines arrived in the country the vaccinations were offered and recommended for the whole population. The vaccine was expected to be efficient and cause mostly only mild adverse effects, similar to those associated with seasonal flu vaccines.

WHO announced in august 2010 that the swine flu pandemic had ended. In july 2010 it was estimated that globally over 18 000 people had died due to swine flu, which is only a small portion of victims caused by the annual influenza virus. Among the Finnish population it is estimated that thousands of people were infected with the virus and it caused 8 confirmed deaths in 2009-2010.

In the summer of 2010 the health care officials of Sweden and Finland received reports from health care professionals concerning narcolepsia being a suspected side effect of the Pandemrix-vaccine. The Finnish National Institute for Health and Welfare stated in february 2011 that there is a clear link between narcolepsy epidemic in Finnish children and the swine flu vaccinations. There are still ongoing investigations by the authorities in Finland and European Union concerning this matter.

Scope

Purpose

The purpose of this decision analysis study is to examine the effects of possibly postponing the decision of vaccinating the population of Finland. The objective would have been to control the epidemic with a massive hygiene campaign until the swine flu vaccine would have been properly tested and researched with the same criteria that apply to other vaccines so that potential adverse effects would have been detected. After proper testing and research have been made a new decision about vaccination can be made based on new data about Pandemrix and the current threat of the disease.

Question to be answered: Would the consequences of the swine flu epidemic be less harmful if the vaccination of the population would be postponed and reconcidered after proper testing and extensive hygiene campaign, than if the whole population would be vaccinated immediately?

Boundaries

This decision analysis is restricted to deal with decision making in Finland concerning which measures to take to prevent the pandemic from spreading in Finland. The group we are concentrating on is the whole Finnish population.

This decision making took place in spring 2009 when it became apparent that the swine flu would eventually reach also Finland. At this time governments worldwide began investigating possible approaches to prevent and restrict the spreading of the disease and to minimize the number of deaths.

Scenarios

Vaccination

• Prevention of increase in the prevalence of the swine flu is probable.
• Possible side effects of the vaccination.

Vaccination decision postponed

• Prevention of increase in the prevalence of the swine flu is probable.
• Slight increase in the prevalence of swine flu is possible. The prevalence of swine flu is expected to be significantly lower with hygiene campaign than without any actions.

Intended users

This study is directed to the Finnish Ministry of Social Affairs and Health.

Participants

This study is initiated by Sallamari Tynkkynen and Kati Iso-Markku, first year students of Master’s Degree Program in General Toxicology and Environmental Health Risk Assessment in the University of Eastern Finland. All the users of Opasnet are free to participate in this open assessment.

Definition

Vaccination

• Vaccination program of the whole population by Public Health Care system (requirements: money, time, personnel)
• Basic hygiene campaign
• Prevention of increase in the prevalence of the swine flu is probable
• Possible side effects of the vaccination

Vaccination decision postponed

• Development and launching of a more extensive national hygiene program, special focus on places where diseases often first appear and start to spread from; hospitals, military bases, schools, kindergartens, work places (requirements: money, time, personnel)
• Prevention of increase in the prevalence of the swine flu is probable.
• Slight increase in the prevalence of swine flu is possible. The prevalence of swine flu is expected to be significantly lower with extensive hygiene campaign than with basic hygiene campaign and no other actions.
• New decision point after receiving study results made according to protocol about Pandemrix.
  • Examine the effects of the performed hygiene campaign on the occurrence of swine flu
  • Is there still need for vaccinations or was the hygiene campaign efficient enough on its own?
  • If there is a need for vaccinations, is Pandemrix safe enough based on the new knowledge of adverse effects?

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Decision variables

Vaccination

• decision to vaccinate the whole population with Pandemrix as soon as possible, starting from risk groups.

Vaccination decision postponed

• implementation of more extensive hygiene protocols

Indicators

• Regarding swine flu, Disability-adjusted life years (DALY) will be considered as deaths caused by swine flu attested by medical professionals.
• Regarding adverse effects of vaccination, DALY will be considered as deaths and adverse effects that last for a time period of one month or more caused by complications due to vaccination.

Vaccination

• DALY from swine flu
• DALY from adverse effects of vaccination

Vaccination decision postponed

• DALY from swine flu

Other variables

• Related to DALYs from swine flu
  • Transmission speed of swine flu among the Finnish population
  • Rapidity and willingness of seeking medical attention after appearance of flu symptoms
  • Accessability of medical care (e.g. distance to health center)
  • Readiness of public health centers to manage increased flow of patients (e.g. number of personnel)

• Related to DALYs from adverse effects of vaccination
  • Age
  • Current health status
  • Quality of monitoring after vaccination
  • Time period of monitoring after vaccination
  • Professional skills of health care workers (pharmacists, doctors, nurses and people responsible of injection)

Calculation

• For us to be able to calculate DALYs from swine flu, we need the number of death certificates indicating swine flu as the cause of death from public health registry. Other variables related to DALYs from swine flu will also be taken into account during calculations if possible.

• For us to be able to calculate DALYs from side effects of vaccination we need the number of death certificates indicating side effect from the vaccination as cause of death. In addtion we need reports from doctors concerning adverse effects of vaccination. If the symptoms last for less than one month, the reports are excluded from calculations. Other variables related to DALYs from side effects of the vaccination will also be taken into account during calculations if possible.

Result

According to this study we would expect that postponing the vaccination decision would result in a better outcome than if the whole population would be vaccinated immediately. We believe that in the desicion variable of "vaccination" the number of DALYs would be greater than the number of DALYs in the decision variable of "vaccination decision postponed". This answers thoroughly the research question that was set in the beginning of this decision analysis and takes into account the different variables affecting the analysis. This study analysis could have been very useful to the Finnish Ministry of Social Affairs and Health in 2009 when the vaccination decision was made.