Difference between revisions of "Talk:Assessment of the health impacts of H1N1 vaccination"

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m (Darm exercise 4: improvement, evaluation, further discussion info added)
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{{attack|B10 |All data compiled to date indicate that pandemic vaccines including Pandemrix match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}}
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{{attack|J5 |Pandemrix is a safe vaccine and narcolepsy risk is low. |--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
  
{{attack|B11 |Adjuvanted vaccines commonly provide a stronger immune response than unadjuvanted vaccines and also provide a broader immune response allowing for some potential drift of the influenza virus (Pandemrix is an adjuvanted vaccine).|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}}
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:{{defend|D5 |Compared to other vaccines, Pandemrix has a lower Hg content (2.5 vs 25 µg), which could cause neurological problems in children|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="rokotusinfoswineflu">[http://www.rokotusinfo.fi/rokotteet/sikainfluenssa_html Rokotusinfo: Swine flu]</ref>
  
{{attack|B12 |The number of cases of side effects of H1N1 vaccines (including Pandemrix) is in line with normal background rates on a population basis, as reported in a recent study European Medicines Agency |--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}}
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:{{defend|J4 | Pandemrix probably does not cause narcolepsy except in Finland and Sweden, where there may be genetic or other factors triggering the risk. Therefore, global conclusions cannot be made. |--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
  
{{attack|A1 |According to EMA, data received so far is still insufficient to establish a causal relationship between Pandemrix and narcolepsy. One possible explanation for the results is that Pandemrix could interact with unknown local environmental and/or genetic factor in contributing to the increased risk of narcolepsy among the vaccinated population aged 4 to 19 years in Finland|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}  
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::{{defend|A1 |According to EMA, data received so far is still insufficient to establish a causal relationship between Pandemrix and narcolepsy. One possible explanation for the results is that Pandemrix could interact with unknown local environmental and/or genetic factor in contributing to the increased risk of narcolepsy among the vaccinated population aged 4 to 19 years in Finland|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}  
  
{{attack|A2 |The overall annual incidence of narcolepsy remained consistent with prevaccination scenarios|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:22, 1 April 2011 (EEST)}}
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::{{defend|B2 |The European Medicines Agency says that no link between the Pandemrix swine flu vaccine and narcolepsy has been established|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:17, 4 April 2011 (EEST)}} <ref>[http://yle.fi/uutiset/news/2010/09/eu_agency_no_link_between_pandemrix_and_narcolepsy_2006172.html YLE: EU agency does not find link between Pandemrix and narcolepsy]</ref>
  
{{defend_invalid|A1 |Even though a nine fold increase in narcolepsy was found in vaccinated population, the occurrence of narcolepsy was still very rare with this apparent increase. A number of different reasons may account for the observed rise in the incidence of narcolepsy namely: A (H1N1) infection, vaccination, combined effect of infection and vaccination, or some other factor entirely. Infections have been documented as causing narcolepsy.|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
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::{{defend|A2 |The overall annual incidence of narcolepsy remained consistent with prevaccination scenarios.|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:22, 1 April 2011 (EEST)}}
:{{attack|A1 |No similar increase in incidence of narcolepsy is reported in other Nordic countries. Canada has extensively used this type of vaccine with no evidence of increased risk for narcolepsy|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
 
{{defend|A2 |as there is presently no swine flu epidemic in Finland, there  is no immediate need for swine flu vaccination|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
 
  
 +
::{{defend|A4 |No similar increase in incidence of narcolepsy is reported in other Nordic countries. Canada has extensively used this type of vaccine with no evidence of increased risk for narcolepsy|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
  
{{attack|1 |Despite risks, Pandemrix is an effective vaccine and has clearly net positive effects in countries where emergency treatment is poorly available for severe swine flu cases.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST)}}
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::{{comment|# |Is this a defence of argument A3b rather an attack?|--[[User:Jouni|Jouni]] 07:05, 2 April 2011 (EEST)}}
  
{{defend|2 |The reputation of Pandemrix is globally so poor that it is impossible to use it any more.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST)}}
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::{{defend|B3 |According to THL's (Finnish National Institute for Health and Welfare) Vaccine Department's head, Dr. Terhi Kilpi,`the Pandemrix vaccine alone did not cause narcolepsy in Finnish children`.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 09:51, 4 April 2011 (EEST)}} <ref name="rokotusinfo"/>
:{{defend_invalid|3 |In Finland, THL decided to stop the use of Pandemrix.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST), [http://www.thl.fi/fi_FI/web/fi/uutinen?id{{eq}}22930]}}
 
::{{attack|E6 |The vaccination used last year will most likely protect also against the possible swine flu epidemic of this year, although the virus has changed a bit.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:57, 1 April 2011 (EEST) [http://www.thl.fi/fi_FI/web/fi/uutinen?id{{eq}}23692]}}
 
:::{{defend|E7 |Vaccination is a very good method of preventing swine flu infections.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:59, 1 April 2011 (EEST) [http://www.thl.fi/fi_FI/web/fi/uutinen?id{{eq}}23692]}}
 
:::{{defend|E8 |WHO recommended that H1N1 virus strain be included in the seasonal flu vaccines for the 2009/2010 season, because H1N1 is still in circulation, but behaving like a seasonal flu virus. |--[[User:Anna Kokkonen|Anna Kokkonen]] 11:10, 1 April 2011 (EEST) [http://www.ema.europa.eu/ema/index.jsp?curl{{eq}}pages/special_topics/general/general_content_000461.jsp&murl{{eq}}menus/special_topics/special_topics.jsp&mid{{eq}}WC0b01ac05801d7bfe&jsenabled{{eq}}true]}}
 
:::{{defend|E9 |The information supplied on the safety and effectiveness of three of the pandemic-influenza vaccines was considered complete enough for the Agency's Committee for Medicinal Products for Human Use  to recommend their use outside a pandemic situation. |--[[User:Anna Kokkonen|Anna Kokkonen]] 11:10, 1 April 2011 (EEST) [http://www.ema.europa.eu/ema/index.jsp?curl{{eq}}pages/special_topics/general/general_content_000461.jsp&murl{{eq}}menus/special_topics/special_topics.jsp&mid{{eq}}WC0b01ac05801d7bfe&jsenabled{{eq}}true]}}
 
  
{{attack|E4 |The side effects of Pandemrix have been accentuated, although the benefits are much more significant.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:50, 1 April 2011 (EEST) [http://www.hs.fi/kotimaa/artikkeli/MTV3+Arkkiatri+moittii+sikainfluenssarokotteen+vastustajia/1135250236010]}}
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:{{defend|A3a |Even though a nine fold increase in narcolepsy was found in vaccinated population, the occurrence of narcolepsy was still very rare with this apparent increase.|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
  
{{attack|E5 |Nursing staff in hospitals should be vaccinated; it is their responsibility as medical professionals.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:54, 1 April 2011 (EEST) [http://www.hs.fi/kotimaa/artikkeli/MTV3+Arkkiatri+moittii+sikainfluenssarokotteen+vastustajia/1135250236010]}}
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::{{comment|# |This sounds like an attack, not defence, of the main statement. The same applies to A3b.|--[[User:Jouni|Jouni]] 07:05, 2 April 2011 (EEST)}}
  
{{comment|D1 |The decision to use Pandemrix was probably led by panic and other choices should be considered at this point|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
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:{{defend|A3b | A number of different reasons may account for the observed rise in the incidence of narcolepsy namely: (H1N1) infection, vaccination, combined effect of infection and vaccination, or some other factor entirely. Infections have been documented as causing narcolepsy.|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
::{{defend|D2 |Finland used a vaccination with additives, against the recommendation of WHO|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
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:::{{defend|D3 |Additives can cause flu-like symptoms, increasing the public's opinion against vaccination|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
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::{{comment|# |I divided your argument into two because the parts seem to be separate things.|--[[User:Jouni|Jouni]] 07:05, 2 April 2011 (EEST)}}
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:{{defend|B1 |All data compiled to date indicate that pandemic vaccines including Pandemrix match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.The number of cases of side effects of H1N1 vaccines (including Pandemrix) is in line with normal background rates on a population basis.(European Medicines Agency.) |--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}} <ref name="ecdc_qa">[http://ecdc.europa.eu/en/healthtopics/H1N1/vaccines/Pages/QA_health_professionals_vaccines.aspx European Centre for Disease Prevention and Control (ECDC): Questions and answers]</ref>
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{{attack|J5 |Pandemrix is an effective vaccine with strong benefits.|--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
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 +
:{{defend|B4 |Adjuvanted vaccines commonly provide a stronger immune response than unadjuvanted vaccines and also provide a broader immune response allowing for some potential drift of the influenza virus (Pandemrix is an adjuvanted vaccine).|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}} <ref name="ecdc_qa"/>
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:{{defend|B5 |A positive effect of the vaccine can be felt from pregnant women, it gives immunization to the mother-to-be and the new born that is not eligible for vaccination until the age of six months. The adverse events reported so far have mainly been symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the safety profile of the vaccine. The vaccine can even be given to breastfeeding mothers and this will reduce the chance that the infant will get influenza.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:20, 1 April 2011 (EEST)}} <ref name="ecdc_qa"/>
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:{{defend|E7 |Vaccination is a very good method of preventing swine flu infections.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:59, 1 April 2011 (EEST)}} <ref name="thl20101209"/>
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{{attack|D3b |The vaccine may still have been used where no other option was available and upon consideration in individual cases, for instance for people travelling to areas where an epidemic was in progress.|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="thl20100825">[http://www.thl.fi/en_US/web/en/pressrelease?id=22930 THL press release 25 Aug 2010]</ref>
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{{attack invalid|J1 |Despite risks, Pandemrix is an effective vaccine and has clearly net positive effects in countries where emergency treatment is poorly available for severe swine flu cases.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST)}}
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:{{attack|D2 |By September 2010 there was no conclusive prelimininary impact of the vaccine in other countries and research was ongoing in several countries to monitor the effect of the vaccine in preventing illness and death. Side effects are still there and will be treated poorly in these countries.|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="thl20100825"/>
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:{{defend|E4 |The side effects of Pandemrix have been accentuated, although the benefits are much more significant.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:50, 1 April 2011 (EEST)}} <ref name="hsarkkiatri">[http://www.hs.fi/kotimaa/artikkeli/MTV3+Arkkiatri+moittii+sikainfluenssarokotteen+vastustajia/1135250236010 Helsingin Sanomat]: Arkkiatri moittii sikainfluenssarokotteen vastustajia (in Finnish)</ref>
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:{{defend|D1 |This statement is true in the case of Finland that preliminary analyses of the impact of the swine flu epidemic in Finland in 2009 indicated that there were far fewer severe cases of influenza among pregnant women, who were among the first to be given the vaccine, than in countries where the first wave of influenza occurred before vaccinations were started. Also,in Europe alone, Pandemrix had been given to at least 30 million people and by end of August 2010 Sweden and Finland reported  a total of 26 cases of narcolepsy. I dont think this risk is too high as the statement suggests|--[[User:June|June]] 00:56, 3 April 2011 (EEST)}} <ref name="thl20100825"/>
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:{{defend|C2 |According to Gennady Onishchenko, Russian Federation's chief doctor, the mortality rate at June 2009 was 1,6% in Mexico and 0,1% in United States. This supports the view that vaccination would be more useful in countries where emergency treatment for severe flu is poorly available.|--[[User:Jpmannikko|Jpmannikko]] 19:28, 4 April 2011 (EEST)}}
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:{{defend|C3 |In a review by the U.S. National Institutes of Health, the 2009 flu pandemic vaccines appear both effective and safe, having a similar safety profile to the normal seasonal influenza vaccine.|--[[User:Jpmannikko|Jpmannikko]] 17:00, 4 April 2011 (EEST)}}
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::{{attack invalid|C4 |According to CDC Pandemrix is not licenced for use in the United States, which implies safety concerns.|--[[User:Jpmannikko|Jpmannikko]] 17:15, 4 April 2011 (EEST), --[[User:Jouni|Jouni]] 06:55, 6 April 2011 (EEST)}}
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:::{{comment|# |I added some clarification, because the mere fact about the lisence status is irrelevant.|--[[User:Jouni|Jouni]] 06:55, 6 April 2011 (EEST)}}
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:::{{attack|C5 |Arepanrix, a H1N1 influenza vaccine similar to Pandemrix and also made by GSK was used in Canada. There has been no increase in narcolepsy cases in Canada reported.|--[[User:Jpmannikko|Jpmannikko]] 17:15, 4 April 2011 (EEST)}}
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{{defend invalid|J2 |The reputation of Pandemrix is globally so poor that it is impossible to use it any more.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST)}}
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:{{attack|B7 |Pandemrix vaccine was used in 38 countries worldwide during the 2009/2010 season. Increased cases of narcolepsy have been observed only in Finland, Iceland and Sweden (W.H.O). This I think makes its global reputation intact.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:27, 4 April 2011 (EEST)}} <ref>[http://www.euro.who.int/en/what-we-do/health-topics/disease-prevention/vaccines-and-immunization/news/news/2011/02/pandemrix-vaccine-and-increased-risk-of-narcolepsy WHO Europe]: Pandemrix® vaccine and increased risk of narcolepsy</ref>
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:{{attack|C7 |Pandemrix has been approved by the European Medicines Agency. Increased narcolepsy rates have only been reported in Finland and Sweden, and not for example in Great Britain, where Pandemrix formed the bulk of governments mass vaccination programme.|--[[User:Jpmannikko|Jpmannikko]] 17:25, 4 April 2011 (EEST)}}
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:{{attack|D6 |The reputation may have been poor especially in Finland, Sweden and in informed people outside these two countries at the time Narcolepsy cases were reported to be associated with Pandemrix but at this stage, however according to WHO it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon as you have stated, therefore its not a global view and it may still be used where its reputation is good.|--[[User:June|June]] 02:45, 3 April 2011 (EEST)}} <ref>[http://www.who.int/vaccine_safety/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_february2011/en/index.html WHO Global Advisory Committee on Vaccine Safety]: Statement on narcolepsy and vaccination</ref>
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:{{attack|E9 |The information supplied on the safety and effectiveness of three of the pandemic-influenza vaccines was considered complete enough for the Agency's Committee for Medicinal Products for Human Use  to recommend their use outside a pandemic situation. |--[[User:Anna Kokkonen|Anna Kokkonen]] 11:10, 1 April 2011 (EEST)}} <ref name="emaswineflu">[http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000461.jsp&murl=menus/special_topics/special_topics.jsp&mid=WC0b01ac05801d7bfe&jsenabled=true European Medicines Agency (EMA)]: Information page on Swine flu</ref>
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::{{comment|# |I am not sure if this is a convincing argument about reputation. However, you may want to create a new argument about the safety of Pandemrix, and then it would be defended by this argument.|--[[User:Jouni|Jouni]] 08:15, 2 April 2011 (EEST)}}
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:{{defend|B6 |A total of 2300 Reports of Adverse Reactions From Pandemrix Vaccine have been reported in Sweden|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:10, 4 April 2011 (EEST)}} <ref>[http://preventdisease.com/news/09/113009_2300_reports_adverse_reactions_sweden.shtml PreventDisease.com]: Total of 2300 Reports of Adverse Reactions From Pandemrix Vaccine in Sweden</ref>
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:{{defend|J3 |In Finland, THL decided to stop the use of Pandemrix.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST) <ref name="thlstoppandemrix">[http://www.thl.fi/fi_FI/web/fi/uutinen?id=22930 THL recommends to stop the use of Pandemrix]</ref>}}
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::{{attack invalid|C9 |Kari Välimäki, Chief of staff at the Ministry of Social Affairs and Health, argues, that the suspension of Pandemrix is only a precautionary action, and that there is no doubt that in a similar situation, the same decisions would have been made.|--[[User:Jpmannikko|Jpmannikko]] 16:55, 4 April 2011 (EEST)}}
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:::{{attack|J4 | This is just a pseudo-objective way of saying that the bad reputation made THL stop the use.|--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
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::{{defend|D7 |Although the causal relationship between the Pandemrix vaccine and increased narcolepsy cases is not yet confirmed, THL stopped the vaccinations as a safety measure until the matter can be fully investigated. A potential link between the Pandemrix vaccine and narcolepsy will be investigated in Finland by paedriatic neurologists and THL experts.|--[[User:Minna Ruokolainen|Minna Ruokolainen]] 21:51, 3 April 2011 (EEST)}} <ref name="thl20100825"/>
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{{defend|J6 |Pandemrix should not be used due to precautionary reasons and because there are alternatives.|--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
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:{{defend|D8 |The most of the narcolepsy cases in Finland are observed among the children. THL´s decision is far too late and THL should not have used Pandemrix at all or at least for the vaccination of children, because the WHO recommendations for not using the Pandemrix-vaccine for chilred were available before THL launched the vaccination campaing.  |--[[User:Minna Ruokolainen|Minna Ruokolainen]] 21:33, 3 April 2011 (EEST)}} <ref name="rokotusinfoswineflu"/>
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:{{defend|A5 |As there is presently no swine flu epidemic in Finland, there  is no immediate need for swine flu vaccination|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
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:{{defend|D3a |The decision to use Pandemrix was probably led by panic and other choices should be considered at this point when narcolepsy cases were identified. |--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
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::{{comment|# |This is a valid comment. However, comments do not affect the outcome of a discussion. You might want to develop this into an attack or a defence.|--[[User:Jouni|Jouni]] 07:45, 2 April 2011 (EEST)}}
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::{{defend|D4 |Finland used a vaccine with adjuvants (Hg and squalene) for whole population, against the recommendation of WHO. WHO recommended that vaccine with adjuvant should not be be used for pregnant women and children because side-effects were not properly known|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="rokotusinfoswineflu"/>
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:::{{branch|D5 |The lack of scientific-based and reliable information of the effects of adjuvants (and vaccine) caused the public´s lose of confidence in authorities, fear in public and increased the public's opinion against vaccination overall.|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="rokotusinfoswineflu"/>
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::::{{comment|# |Good usage of branches! However, branches do not affect the outcome of a discussion. You could use this branch also to defend J2 and then it would have an impact on this discussion.|--[[User:Jouni|Jouni]] 07:45, 2 April 2011 (EEST)}}
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{{defend invalid|B8 |There maybe a conflict of interest in the approval of Pandemrix for swine flu vaccination in Finland|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:50, 4 April 2011 (EEST)}}
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:{{attack|B11 |According to Chancellor of Justice, Jaakko Jonkka, there's no direct [ evidence to support ] suspicion of bribery but there is a risky situation because the seller funds the buyer.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:57, 4 April 2011 (EEST) <ref name="rokotusinfo">[http://www.rokotusinfo.fi/english_html Rokotusinfo]</ref>}}
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:{{attack|C11 |The World Health Organization (WHO) examined the link between THL and GSK and found no evidence that research funding and the pharmaceutical company would have influenced the choise of vaccines|--[[User:Jpmannikko|Jpmannikko]] 16:51, 4 April 2011 (EEST)}}
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:{{defend|B9 |Vaccine Department's head at THL, Dr. Terhi Kilpi have a close relationship with GlaxoSmithKline, the manufactural of Pandemrix vaccine. |--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:50, 4 April 2011 (EEST)}} <ref name="rokotusinfo"/>
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:{{defend|B10 |GlaxoSmithKline has funded several THL's activities with millions of euros.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:57, 4 April 2011 (EEST)}}
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:{{defend|C10 |There have been claims that THL would have had a conflict of interest, as it had received financing worth EUR 6 million from the vaccine producer GalaxoSmithKline (GSK)|--[[User:Jpmannikko|Jpmannikko]] 16:51, 4 April 2011 (EEST)}}
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{{branch|C12 |The interesting question about Pandemrix is perhaps not if it should not be used because of narcolepsy threat, but whether if it was actually needed at all. Russian Federations chief doctor Gennady Onishchenko stated on June 2, 2009 that swine flu was not aggressive enough to cause worldwide pandemic. He noted that the mortality rate of confirmed cases was 1,6% in Mexico and only 0,1% in United States. He also noted that there was 16,000 cases so far when during any flu season some 10,000 people become ill in Moscow alone.|--[[User:Jpmannikko|Jpmannikko]] 19:25, 4 April 2011 (EEST)}}
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:{{comment|# |Good usage of branch functionalities! However, this is also an attack, because it changes the resolution of the statement away from "accepted".|--[[User:Jouni|Jouni]] 06:55, 6 April 2011 (EEST)}}
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{{attack invalid|E6 |The vaccination used last year will most likely protect also against the possible swine flu epidemic of this year, although the virus has changed a bit.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:57, 1 April 2011 (EEST)}} <ref name="thl20101209">[http://www.thl.fi/fi_FI/web/fi/uutinen?id=23692 THL press release 9 Dec 2010]</ref>
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:{{attack|J6 |This may be true but what is the connection to the statement? This is irrelevant.|--[[User:Jouni|Jouni]] 08:15, 2 April 2011 (EEST)}}
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:{{defend|E8 |WHO recommended that H1N1 virus strain be included in the seasonal flu vaccines for the 2009/2010 season, because H1N1 is still in circulation, but behaving like a seasonal flu virus. |--[[User:Anna Kokkonen|Anna Kokkonen]] 11:10, 1 April 2011 (EEST)}} <ref name="emaswineflu"/>
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{{attack|E5 |Nursing staff in hospitals should be vaccinated; it is their responsibility as medical professionals.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:54, 1 April 2011 (EEST)}} <ref name="hsarkkiatri"/>
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:{{comment|# |This may be true but what is the connection to the statement? Does this actually relate more to E4 than the main statement?|--[[User:Jouni|Jouni]] 08:15, 2 April 2011 (EEST)}}
  
{{attack|D4 |Pandemrix has a lower Hg content than other vaccines (2.5 vs 25 µg), which could cause other neurological problems in children|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
 
 
}}
 
}}
  
Line 66: Line 153:
 
* [[Talk:Assessment of the health impacts of H1N1 vaccination/Group E]] (Finnish material)
 
* [[Talk:Assessment of the health impacts of H1N1 vaccination/Group E]] (Finnish material)
  
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==See also==
  
 
'''Additional material:
 
'''Additional material:
 
* [[:File:Swine flu story.ppt]]
 
* [[:File:Swine flu story.ppt]]
 
* [[Decision analysis and risk management#See also]]
 
* [[Decision analysis and risk management#See also]]
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==References==
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<references/>

Revision as of 15:17, 6 April 2011

Darm exercise 4

Tasks:

  • Make pairs and select one group A-E (D and E have Finnish material).
  • Look at page Discussion for theoretical and practical advice. Also page op_fi:Keskustelun jälkijäsentäminen may be useful.
  • Look at the two or three links on your group's page.
  • Read the texts and try to identify arguments about the use of Pandemrix. Note that arguments can be (and most are) indirect arguments.
  • Rewrite the arguments in such a way that they can be understood outside the original context.
  • Place the arguments into a hierarchical tree of attacking and defending arguments pointing toward the main statement about Pandemrix use.
  • You can also make up your own arguments, or if you have extra time, read additional material (see end of the page).
  • When each group has done their own part, there will be a general discussion about all argumentations by the groups. All argumentations will be merged onto this page based on the discussion.
  • Think: How many readers do you need to make this extra effort of collecting, organising and synthesising information and opinions a worthwhile activity of social learning?


The group specific pages can be improved until Monday (4.4.) evening.
Evaluation of the exercise will be based on the contents of the group pages as of Monday evening.
The argumentation by different groups will be compiled on this page and discussed more on the lecture on Thursday 7.4.

Pandemrix should not be used because of narcolepsy risk

How to read discussions

Statements: Pandemrix should not be used any more anywhere because its narcolepsy risk is too high.

Resolution: Resolution not yet found.

(A stable resolution, when found, should be updated to the main page.)

Argumentation:

J5 : Pandemrix is a safe vaccine and narcolepsy risk is low. --Jouni 18:17, 6 April 2011 (EEST)

D5 : Compared to other vaccines, Pandemrix has a lower Hg content (2.5 vs 25 µg), which could cause neurological problems in children --Carmen Gil 11:25, 1 April 2011 (EEST) [1]
J4 : Pandemrix probably does not cause narcolepsy except in Finland and Sweden, where there may be genetic or other factors triggering the risk. Therefore, global conclusions cannot be made. --Jouni 18:17, 6 April 2011 (EEST)
A1 : According to EMA, data received so far is still insufficient to establish a causal relationship between Pandemrix and narcolepsy. One possible explanation for the results is that Pandemrix could interact with unknown local environmental and/or genetic factor in contributing to the increased risk of narcolepsy among the vaccinated population aged 4 to 19 years in Finland --Jacob Attipoe 11:18, 1 April 2011 (EEST)
B2 : The European Medicines Agency says that no link between the Pandemrix swine flu vaccine and narcolepsy has been established --Oluyemitoyinbo 12:17, 4 April 2011 (EEST) [2]
A2 : The overall annual incidence of narcolepsy remained consistent with prevaccination scenarios. --Jacob Attipoe 11:22, 1 April 2011 (EEST)
A4 : No similar increase in incidence of narcolepsy is reported in other Nordic countries. Canada has extensively used this type of vaccine with no evidence of increased risk for narcolepsy --Jacob Attipoe 11:18, 1 April 2011 (EEST)
--# : Is this a defence of argument A3b rather an attack? --Jouni 07:05, 2 April 2011 (EEST)
B3 : According to THL's (Finnish National Institute for Health and Welfare) Vaccine Department's head, Dr. Terhi Kilpi,`the Pandemrix vaccine alone did not cause narcolepsy in Finnish children`. --Oluyemitoyinbo 09:51, 4 April 2011 (EEST) [3]
A3a : Even though a nine fold increase in narcolepsy was found in vaccinated population, the occurrence of narcolepsy was still very rare with this apparent increase. --Jacob Attipoe 11:18, 1 April 2011 (EEST)
--# : This sounds like an attack, not defence, of the main statement. The same applies to A3b. --Jouni 07:05, 2 April 2011 (EEST)
A3b : A number of different reasons may account for the observed rise in the incidence of narcolepsy namely: (H1N1) infection, vaccination, combined effect of infection and vaccination, or some other factor entirely. Infections have been documented as causing narcolepsy. --Jacob Attipoe 11:18, 1 April 2011 (EEST)
--# : I divided your argument into two because the parts seem to be separate things. --Jouni 07:05, 2 April 2011 (EEST)
B1 : All data compiled to date indicate that pandemic vaccines including Pandemrix match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.The number of cases of side effects of H1N1 vaccines (including Pandemrix) is in line with normal background rates on a population basis.(European Medicines Agency.) --Oluyemitoyinbo 11:12, 1 April 2011 (EEST) [4]

J5 : Pandemrix is an effective vaccine with strong benefits. --Jouni 18:17, 6 April 2011 (EEST)

B4 : Adjuvanted vaccines commonly provide a stronger immune response than unadjuvanted vaccines and also provide a broader immune response allowing for some potential drift of the influenza virus (Pandemrix is an adjuvanted vaccine). --Oluyemitoyinbo 11:12, 1 April 2011 (EEST) [4]
B5 : A positive effect of the vaccine can be felt from pregnant women, it gives immunization to the mother-to-be and the new born that is not eligible for vaccination until the age of six months. The adverse events reported so far have mainly been symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the safety profile of the vaccine. The vaccine can even be given to breastfeeding mothers and this will reduce the chance that the infant will get influenza. --Oluyemitoyinbo 11:20, 1 April 2011 (EEST) [4]
E7 : Vaccination is a very good method of preventing swine flu infections. --Sallamari Tynkkynen 10:59, 1 April 2011 (EEST) [5]

D3b : The vaccine may still have been used where no other option was available and upon consideration in individual cases, for instance for people travelling to areas where an epidemic was in progress. --Carmen Gil 11:25, 1 April 2011 (EEST) [6]

J1 Despite risks, Pandemrix is an effective vaccine and has clearly net positive effects in countries where emergency treatment is poorly available for severe swine flu cases. --Jouni 23:05, 31 March 2011 (EEST)

D2 : By September 2010 there was no conclusive prelimininary impact of the vaccine in other countries and research was ongoing in several countries to monitor the effect of the vaccine in preventing illness and death. Side effects are still there and will be treated poorly in these countries. --Carmen Gil 11:25, 1 April 2011 (EEST) [6]
E4 : The side effects of Pandemrix have been accentuated, although the benefits are much more significant. --Sallamari Tynkkynen 10:50, 1 April 2011 (EEST) [7]
D1 : This statement is true in the case of Finland that preliminary analyses of the impact of the swine flu epidemic in Finland in 2009 indicated that there were far fewer severe cases of influenza among pregnant women, who were among the first to be given the vaccine, than in countries where the first wave of influenza occurred before vaccinations were started. Also,in Europe alone, Pandemrix had been given to at least 30 million people and by end of August 2010 Sweden and Finland reported a total of 26 cases of narcolepsy. I dont think this risk is too high as the statement suggests --June 00:56, 3 April 2011 (EEST) [6]
C2 : According to Gennady Onishchenko, Russian Federation's chief doctor, the mortality rate at June 2009 was 1,6% in Mexico and 0,1% in United States. This supports the view that vaccination would be more useful in countries where emergency treatment for severe flu is poorly available. --Jpmannikko 19:28, 4 April 2011 (EEST)
C3 : In a review by the U.S. National Institutes of Health, the 2009 flu pandemic vaccines appear both effective and safe, having a similar safety profile to the normal seasonal influenza vaccine. --Jpmannikko 17:00, 4 April 2011 (EEST)
C4 According to CDC Pandemrix is not licenced for use in the United States, which implies safety concerns. --Jpmannikko 17:15, 4 April 2011 (EEST), --Jouni 06:55, 6 April 2011 (EEST)
--# : I added some clarification, because the mere fact about the lisence status is irrelevant. --Jouni 06:55, 6 April 2011 (EEST)
C5 : Arepanrix, a H1N1 influenza vaccine similar to Pandemrix and also made by GSK was used in Canada. There has been no increase in narcolepsy cases in Canada reported. --Jpmannikko 17:15, 4 April 2011 (EEST)

J2 The reputation of Pandemrix is globally so poor that it is impossible to use it any more. --Jouni 23:05, 31 March 2011 (EEST)

B7 : Pandemrix vaccine was used in 38 countries worldwide during the 2009/2010 season. Increased cases of narcolepsy have been observed only in Finland, Iceland and Sweden (W.H.O). This I think makes its global reputation intact. --Oluyemitoyinbo 12:27, 4 April 2011 (EEST) [8]
C7 : Pandemrix has been approved by the European Medicines Agency. Increased narcolepsy rates have only been reported in Finland and Sweden, and not for example in Great Britain, where Pandemrix formed the bulk of governments mass vaccination programme. --Jpmannikko 17:25, 4 April 2011 (EEST)
D6 : The reputation may have been poor especially in Finland, Sweden and in informed people outside these two countries at the time Narcolepsy cases were reported to be associated with Pandemrix but at this stage, however according to WHO it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon as you have stated, therefore its not a global view and it may still be used where its reputation is good. --June 02:45, 3 April 2011 (EEST) [9]
E9 : The information supplied on the safety and effectiveness of three of the pandemic-influenza vaccines was considered complete enough for the Agency's Committee for Medicinal Products for Human Use to recommend their use outside a pandemic situation. --Anna Kokkonen 11:10, 1 April 2011 (EEST) [10]
--# : I am not sure if this is a convincing argument about reputation. However, you may want to create a new argument about the safety of Pandemrix, and then it would be defended by this argument. --Jouni 08:15, 2 April 2011 (EEST)
B6 : A total of 2300 Reports of Adverse Reactions From Pandemrix Vaccine have been reported in Sweden --Oluyemitoyinbo 12:10, 4 April 2011 (EEST) [11]
J3 : In Finland, THL decided to stop the use of Pandemrix. --Jouni 23:05, 31 March 2011 (EEST) [12]
C9 Kari Välimäki, Chief of staff at the Ministry of Social Affairs and Health, argues, that the suspension of Pandemrix is only a precautionary action, and that there is no doubt that in a similar situation, the same decisions would have been made. --Jpmannikko 16:55, 4 April 2011 (EEST)
J4 : This is just a pseudo-objective way of saying that the bad reputation made THL stop the use. --Jouni 18:17, 6 April 2011 (EEST)
D7 : Although the causal relationship between the Pandemrix vaccine and increased narcolepsy cases is not yet confirmed, THL stopped the vaccinations as a safety measure until the matter can be fully investigated. A potential link between the Pandemrix vaccine and narcolepsy will be investigated in Finland by paedriatic neurologists and THL experts. --Minna Ruokolainen 21:51, 3 April 2011 (EEST) [6]

J6 : Pandemrix should not be used due to precautionary reasons and because there are alternatives. --Jouni 18:17, 6 April 2011 (EEST)

D8 : The most of the narcolepsy cases in Finland are observed among the children. THL´s decision is far too late and THL should not have used Pandemrix at all or at least for the vaccination of children, because the WHO recommendations for not using the Pandemrix-vaccine for chilred were available before THL launched the vaccination campaing. --Minna Ruokolainen 21:33, 3 April 2011 (EEST) [1]
A5 : As there is presently no swine flu epidemic in Finland, there is no immediate need for swine flu vaccination --Jacob Attipoe 11:18, 1 April 2011 (EEST)
D3a : The decision to use Pandemrix was probably led by panic and other choices should be considered at this point when narcolepsy cases were identified. --Carmen Gil 11:25, 1 April 2011 (EEST)
--# : This is a valid comment. However, comments do not affect the outcome of a discussion. You might want to develop this into an attack or a defence. --Jouni 07:45, 2 April 2011 (EEST)
D4 : Finland used a vaccine with adjuvants (Hg and squalene) for whole population, against the recommendation of WHO. WHO recommended that vaccine with adjuvant should not be be used for pregnant women and children because side-effects were not properly known --Carmen Gil 11:25, 1 April 2011 (EEST) [1]
D5 : The lack of scientific-based and reliable information of the effects of adjuvants (and vaccine) caused the public´s lose of confidence in authorities, fear in public and increased the public's opinion against vaccination overall. --Carmen Gil 11:25, 1 April 2011 (EEST) [1]
--# : Good usage of branches! However, branches do not affect the outcome of a discussion. You could use this branch also to defend J2 and then it would have an impact on this discussion. --Jouni 07:45, 2 April 2011 (EEST)

B8 There maybe a conflict of interest in the approval of Pandemrix for swine flu vaccination in Finland --Oluyemitoyinbo 12:50, 4 April 2011 (EEST)

B11 : According to Chancellor of Justice, Jaakko Jonkka, there's no direct [ evidence to support ] suspicion of bribery but there is a risky situation because the seller funds the buyer. --Oluyemitoyinbo 12:57, 4 April 2011 (EEST) [3]
C11 : The World Health Organization (WHO) examined the link between THL and GSK and found no evidence that research funding and the pharmaceutical company would have influenced the choise of vaccines --Jpmannikko 16:51, 4 April 2011 (EEST)
B9 : Vaccine Department's head at THL, Dr. Terhi Kilpi have a close relationship with GlaxoSmithKline, the manufactural of Pandemrix vaccine. --Oluyemitoyinbo 12:50, 4 April 2011 (EEST) [3]
B10 : GlaxoSmithKline has funded several THL's activities with millions of euros. --Oluyemitoyinbo 12:57, 4 April 2011 (EEST)
C10 : There have been claims that THL would have had a conflict of interest, as it had received financing worth EUR 6 million from the vaccine producer GalaxoSmithKline (GSK) --Jpmannikko 16:51, 4 April 2011 (EEST)

C12 : The interesting question about Pandemrix is perhaps not if it should not be used because of narcolepsy threat, but whether if it was actually needed at all. Russian Federations chief doctor Gennady Onishchenko stated on June 2, 2009 that swine flu was not aggressive enough to cause worldwide pandemic. He noted that the mortality rate of confirmed cases was 1,6% in Mexico and only 0,1% in United States. He also noted that there was 16,000 cases so far when during any flu season some 10,000 people become ill in Moscow alone. --Jpmannikko 19:25, 4 April 2011 (EEST)

--# : Good usage of branch functionalities! However, this is also an attack, because it changes the resolution of the statement away from "accepted". --Jouni 06:55, 6 April 2011 (EEST)

E6 The vaccination used last year will most likely protect also against the possible swine flu epidemic of this year, although the virus has changed a bit. --Sallamari Tynkkynen 10:57, 1 April 2011 (EEST) [5]

J6 : This may be true but what is the connection to the statement? This is irrelevant. --Jouni 08:15, 2 April 2011 (EEST)
E8 : WHO recommended that H1N1 virus strain be included in the seasonal flu vaccines for the 2009/2010 season, because H1N1 is still in circulation, but behaving like a seasonal flu virus. --Anna Kokkonen 11:10, 1 April 2011 (EEST) [10]

E5 : Nursing staff in hospitals should be vaccinated; it is their responsibility as medical professionals. --Sallamari Tynkkynen 10:54, 1 April 2011 (EEST) [7]

--# : This may be true but what is the connection to the statement? Does this actually relate more to E4 than the main statement? --Jouni 08:15, 2 April 2011 (EEST)


Discussion groups:

See also

Additional material:

References

  1. 1.0 1.1 1.2 1.3 Rokotusinfo: Swine flu
  2. YLE: EU agency does not find link between Pandemrix and narcolepsy
  3. 3.0 3.1 3.2 Rokotusinfo
  4. 4.0 4.1 4.2 European Centre for Disease Prevention and Control (ECDC): Questions and answers
  5. 5.0 5.1 THL press release 9 Dec 2010
  6. 6.0 6.1 6.2 6.3 THL press release 25 Aug 2010
  7. 7.0 7.1 Helsingin Sanomat: Arkkiatri moittii sikainfluenssarokotteen vastustajia (in Finnish)
  8. WHO Europe: Pandemrix® vaccine and increased risk of narcolepsy
  9. WHO Global Advisory Committee on Vaccine Safety: Statement on narcolepsy and vaccination
  10. 10.0 10.1 European Medicines Agency (EMA): Information page on Swine flu
  11. PreventDisease.com: Total of 2300 Reports of Adverse Reactions From Pandemrix Vaccine in Sweden
  12. THL recommends to stop the use of Pandemrix