DARM DA Study Exercise group 2

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In 2009 Finland moved from the containment phase to the treatment phase of dealing with the swine flu pandemic which required massive vaccination of inhabitants of Finland. Swine flu is a self-limiting disease and resolves with rest and symptomatic care. However, there are some individuals in the risk group who may not be able to deal with the disease and thus will require vaccination as primary prevention and a more intense secondary prevention.

Background

A statement issued by the office of the Director General of the WHO in June of 2009 stated as follows, “As of today, nearly 30 000 confirmed cases have been reported in 74 countries .… Further spread is considered inevitable. I have therefore decided to raise the level of influenza pandemic alert from phase 5 to phase 6 .… Globally, we have good reason to believe that this pandemic, at least in its early days, will be of moderate severity.” The explosive cross-border transmission pattern bore the hallmark of a full blown pandemic that was actively evolving. As of 26th October 2009 Finland had 522 laboratory confirmed cases of influenza A(H1N1) virus in. First death in Finland confirmed to be associated with A(H1N1) influenza virus on 27th Oct. 2009. Prior to this, there was reported unabated spread of virus throughout Europe. Priority groups for vaccination were identified as health care professionals, pregnant women and persons aged from 6 months to 64 years who may belong to a risk group due to some other illness; and the broad objective of vaccination was to curtail further spread of the illness and prevent severe complications. The decision to vaccinate seemed well informed on the premise that 1) the explosive pattern of spread warranted urgent action to mitigate further transmission; 2) older persons in Finland, 65 years and above, who had experienced the Spanish flu of 1918 had cross-reacting antibodies with the swine flu virus; 3) there was available a low viral particle load vaccine coupled with an adjuvant boost believed to have minimal likelihood for adverse events. The vaccine was ‘pandemic specific’ and had received EMEA and WHO endorsement; 4) the danger of possible secondary transmission past the peak of the transmission curve of the virus. Within the narrow window of opportunity for health action a risk benefit scenario for vaccination was inevitable, bearing in mind that there was no previous experience with this vaccine in human populations. Probable effects were modeled from experience with other influenza vaccines and existing data on the chosen adjuvant. Consequently, marketing authorization was granted to the manufacturers, GlaxoSmithKline Biologicals, for the vaccine under ‘exceptional circumstances’. The approved vaccine was Pandemrix; an inactivated flu virus of the strain A/California/7/2009 (H1N1) v-like strain (X 179A). The vaccine was developed following the outbreak of the swine flu pandemic which was declared in 25th April, 2009(4). The adjuvant, called AS03, was composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). The vaccine preparation consisted of a 2.5 ml suspension that was to reconstituted with 2.5ml emulsion for intramuscular injection(5). Following recommendations by the Committee for Medicinal Products for Human Use (CHMP) and US Food and Drug Administration the vaccine was authorized for marketing by the European Commission on 30th September, 2009 after undergoing only phase 1 trials. The WHO had earlier declared Pandemrix approved for swine flu A8H1N1) interventions(6). The most common known side effects seen with Pandemrix at the time were headache, fever and fatigue, arthralgia, myalgia, injection site reactions such as induration, swelling, pain and redness(4). The World Health Organization has come under intense criticism for the stampeded response to the pandemic, with particular reference to the mass vaccination campaigns. An expert panel that was set up to audit the activities of the WHO purports that the danger posed by swine flu was blown out of proportion to expedite actions that may have undelying percuniary interests. Allegations of WHO expert committee members having ties to drug companies have fostered deep mistrust in different parts of the world that may impact on public response in the event of a future influenza pandemic(7). These allegations become more grave in the face of an ensuing side-effect that no one envisaged, namely narcolepsy. Available data emerging from Finland and Sweden showed a clear excess of risk of narcolepsy among persons vaccinated, though this was insufficient to infer direct causality(8). Concerns stemming from the narcolepsy episodes were however sufficient to warrant halting of vaccination campaigns. In view of the backdrop given above, this analysis aims to support the decision to vaccinate by weighting the rationale at various levels of the decision chain.

Scope

Purpose

The purpose is to evaluate how vaccination will impact on the swine pandemic in Finland. The study population all individuals who will be vaccinated individuals. Major outputs that will be considered are 1) new cases of swine flu before and after vaccination, 2) side effects likely to arise from the vaccination 3) cost of vaccination.

Boundaries

Spatial: Finland==

Temporal: From June 2009 to 2011==

Scenarios

Possible scenarios with respect to the swine flu pandemic in Finland and a decision to vaccinate include:

1) Implementation of a mass vaccination programme which may have the following implications:

• An interruption of further transmission within the population.
• Achievement of herd immunity which will diminish possibilities of secondary transmission.
• Greater likelihood of the emmergence of side effects from the vaccination of so many people.
• Higher cost outlay from the large scale of the project.
• Reduce loss from healthcare cost and sick-off days from work.

2) Implementation of a selective immunization programme targeting priority and risk groups. Implications may include:

• Protection of the most vulnerable population from contracting the disease.
• Reduced overall number of cases suffering possible side effects.
• Reduced cost for programme implementation.
• Reduced societal concerns about mass vaccination.
• Poorer prospects for achieving herd immunity

Intended users

• The Ministry of Welfare and Health of Finland.
• Policy makers and decision makers with jurisdiction in the Swine flu outbreak.

Participants

   * Participants are those who may participate in the making of the assessment. 
     The minimum group of people for a successful assessment is always described. 
     If some groups must be excluded, this must be explicitly motivated.

DARM exercise group 2

Definition

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Decision variables

   * Decision variables: decisions that are considered.

Indicators

   * Indicators: outcome variables of interest.

Value variables

   * Value variables: value judgements (usually about indicators).

Other variables

   * Other variables: any variables that link to the causal network and are within the boundaries of the assessment.

Analyses

   * Analyses: statistical and other analyses that contain two or more variables, e.g. optimizing.

Indices

   * Indices: lists of particular locations along spatial, temporal, or other dimensions. 

Result

   * Results of indicators and assessment-specific analyses. 

Conclusions

   * Conclusions are based on the results, given the scope. 

References

1. Suomen vanhimmalla väestöllä on suojaavia vasta-aineita sikainfluenssaa vastaan. 2010. http://www.ktl.fi/portal/suomi/osastot/vimo/ajankohtaista/?bid=3328

2. Ministry of Social Affairs and Health: Two cases of influenza A(H1N1) confirmed in Finland. 2009 http://www.thl.fi/en_US/web/en/pressrelease?id=13307

3. THL and MSAH: Influenza A(H1N1)v epidemic about to start, first death in Finland confirmed. 27 Oct 2009 http://www.thl.fi/en_US/web/en/pressrelease?id=21364

4. Pandemrix http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000832/human_med_000965.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125&jsenabled=true

5. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_All_Authorised_presentations/human/000832/WC500038123.pdf

6. Pandemrix - Adjuvanted H1N1 Influenza Vaccine http://www.drugdevelopment-technology.com/projects/pandemrix/

7. Laura Phillips , Swine Flu Response by WHO Criticized. March 12, 2011 http://www.thirdage.com/news/swine-flu-response-who-criticized_3-12-2011

8. European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/02/news_detail_001211.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1&jsenabled=true