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• W1964996893 abstract "This commentary is on the original article by Winstone et al. on pages 1117–1123 of this issue. On 11 June 2009, Director-General of the World Health Organization (WHO) Dr Margaret Chan declared in a press statement: ‘I have conferred with leading influenza experts, virologists, and public health officials. In line with procedures set out in the International Health Regulations, I have sought guidance and advice from an Emergency Committee established for this purpose. On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met. I have therefore decided to raise the level of influenza pandemic alert from phase 5 to phase 6. The world is now at the start of the 2009 influenza pandemic.’1 Subsequently, eight influenza A(H1N1)pdm09 vaccines were licensed within the EU/EEA in the latter part of 2009: Cantgrip by Cantacuzino, Celvapan by Baxter, Celltura by Novartis, Fluval P by Omnivest, Focetria by Novartis, Pandemrix by GlaxoSmithKline (GSK), Panenza by Sanofi Pasteur, and PanvaxH1N1 by CSL.2 International recommendations on which groups should be offered vaccination and in what order, came from the Strategic Advisory Group of Experts of the WHO and the EU Health Security Committee, followed by national decisions on priority groups taking this guidance into account. Pandemrix was the most used vaccine in Europe. European Medicines Agency (EMA) has estimated that as of 8 August 2010, at least 38.6 million people in EU/EEA countries had been vaccinated: more than 30.5 million with Pandemrix, more than 560 000 with Celvapan, and more than 6.5 million with Focetria. The following EU/EEA countries are known to have administered Pandemrix to their population in vaccination campaigns conducted during 2009/2010: Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Iceland, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, and the United Kingdom. However, the amount of vaccine used per unit of population was highly variable and there were also important differences in the age-groups that received the vaccine. For example the highest rates of immunizing children and adolescents were in Finland, Ireland, Norway, and Sweden. Pandemrix contained the WHO-recommended flu strain called A/California/7/2009 (H1N1) v-like strain (X-179A), an immunostimulating substance AS03 known as adjuvant including α-tocopherol (vitamin E) and squalene – plus the often-used preservative thiomersal. Pandemrix was produced in Europe in the Dresden facility of GSK. A very similar vaccine Arepanrix was produced by GSK in the Quebec facility and used extensively in Canada. The manufacturing processes are similar but not identical. While the Quebec facility first inactivates the influenza viruses by UV-light and formaldehyde followed by purification and disruption by deoxycholate, the Dresden facility first concentrate and purify the influenza viruses using a linear sucrose-density gradient-solution containing detergent to split the virus, further purify by diafiltration, and then as a final step inactivation by consecutive effects of deoxychelate and formaldehyde (Source: GSK, 2014). Squalene-containing adjuvants have been used in seasonal influenza vaccines provided to older people since 1996. The addition of α-tocopherol was new for this particular vaccine. Adding adjuvants to pandemic vaccines, the global production capacity increased by 100% to 400%, compared with the production of seasonal influenza vaccine. Another advantage is that adjuvants broaden and perhaps lengthen the protective response in those being immunized. Following the first spontaneous adverse drug reaction (ADR) reports in August 2010 of narcolepsy in children and adolescents previously vaccinated with Pandemrix,3 formal epidemiological studies confirmed an association. The first study conducted and published in the scientific literature from Finland in a series of studies undertaken in Europe to investigate the impact of adjuvanted H1N1 pandemic vaccines was published in 2012 and a 12.7-fold increased risk in children and adolescents aged between 4 years and 19 years was observed within 8 months after vaccination when compared with people in the same age group that were not vaccinated.4 A retrospective cohort study is currently ongoing in Canada, where a nearly identical GSK-equivalent vaccine (Arepanrix) was used. Narcolepsy diagnosis rates were assessed in a retrospective cohort study during the period 2000 to 2010 using large linked health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden, and the United Kingdom. The pooled overall incidence rate was shown to be 0.93 (95% CI: 0.90–0.97) per 100 000 PY.5 Since narcolepsy is an unusual and difficult-to-diagnose condition, and has never before been linked to vaccination, initial substantial underreporting is expected. However, following the signal, narcolepsy case reports associated with pandemic vaccines started to be sent. As of spring 2014, more than 900 ADR reports of narcolepsy following Pandemrix vaccination are available in the EMA Eudravigilance database. Narcolepsy can have a gradual onset, which is why public and professional awareness may therefore increase reporting. Other time-related factors of importance are different study periods analyzed, including cases reported before and after regulatory and media attention, and the reduced time from suspected symptoms to laboratory investigations observed in cases over time (in particular in countries with many cases). The study by Winstone et al.6 (conducted in England) confirms the clinical findings earlier reported from Finland. However, of great importance is that in England with significantly less media attention there was no evidence for a quicker diagnosis in vaccinated cases suggesting a real association. Recently a possible biological mechanism for developing narcolepsy was proposed by De la Herrán-Arita et al.7 Their data indicate presence of CD4(+) T cells in narcole-psy patients but not in DQ0602-positive healthy control participants that are reactive to hypocretin in narcolepsy patients and possible molecular mimicry between hypocretin and a similar epitope in influenza pH1N1, pHA1275-287. These are important implications for clinical practice and future research. The sudden increase of narcolepsy cases in Europe following Pandemrix vaccination should stimulate further research in optimizing treatment of affected individuals. In addition, the first data suggesting that narcolepsy is an immune-mediated disease should be confirmed in further studies with the aim to establish the respective roles of the influenza virus antigens and the adjuvant included since recent clinical trials assessing H7N9 vaccine candidate suggest that adjuvants are needed to obtain protective immunity to several influenza viruses. Finally, the possibility of whether differences between the manufacturing processes could play a role should be thoroughly explored." @default.
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• W1964996893 date "2014-07-23" @default.
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• W1964996893 title "The roles of influenza virus antigens and the AS03 adjuvant in the 2009 pandemic vaccine associated with narcolepsy needs further investigation" @default.
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