For more information view the SAGE Journals Article Sharing page. Benefits of immunization outweigh the risk of vaccination-associated narcolepsy, which remains a rare disease. And while it was also one of the earliest places to start vaccinating, by the time the vaccine had been made many people there had already been infected. (2015) proposed “a mechanism for influenza infection/pandemic vaccine-associated narcolepsy”: In subjects with genetic susceptibility to narcolepsy, the presentation of NP [nucleoprotein] antigen during infection or after immunization with adjuvanted influenza vaccines containing increased amounts of NP may generate high titers of NP antibodies that can persist in the systemic circulation for months. Nearly a decade on from the 2009 influenza pandemic, scientists are still trying to solve what is proving to be an intractable medical mystery: Did some of the vaccines used to protect against the new flu virus trigger an increase in narcolepsy cases? At the same time, processes inside the body became increasingly seen as active participants in disease causation rather than passive objects of an external threat (a toxic vaccine). NIH Members of _ can log in with their society credentials below, Health: An Interdisciplinary Journal for the Social Study of Health, Illness and Medicine, https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution 4.0 License (. The organization emphasized that Sweden should follow the Finnish and Norwegian guidelines of seeing narcolepsy as similar to brain injuries, thereby highlighting that narcolepsy affected everything the patient did (Narkolepsiföreningen, 2017). However, these portrayals of children and futures are also shaped more generally by the history of vaccine safety debates, in which children have epitomized questions of state and parental responsibility as the ones who do not make vaccination decisions but need protection (Conis, 2015). The unexpected outbreak raised concerns (MacPhail, 2014). Finally, the patient organizations’ websites highlighted the high toll of vaccine-associated narcolepsy among children. As to why Pandemrix triggered narcolepsy, initial reports pointed tentatively to the adjuvant, AS03, which was not included in the other pandemic vaccines used in Europe, such as Celvapan and Focetria. For more information view the SAGE Journals Sharing page. Theories of the causative mechanisms of vaccine injury have changed over time. The email address and/or password entered does not match our records, please check and try again. Because of the general narcolepsy framework, vaccine-associated narcolepsy appears closely aligned with non-vaccine-related narcolepsy. Dauvilliers, Y, Arnulf, I, Lecendreux, M, European Centre for Disease Prevention and Control (ECDC) (. The condition is rare — about one person in 100,000 develops narcolepsy in a given year. This is especially the case with future pandemic vaccines, which are likely to be developed without time for extensive, long-term population-level studies. In such rhetoric, the futures at stake appear embedded in the moment of vaccination, when the injected substance interrupts not only the bodily functions of the vaccinated child, but also the very possibility of a carefree, exciting, effortlessly unfolding future (e.g. As Sharon Kaufman (2010) writes in the context of claims made by vaccine critics about the measles–mumps–rubella (MMR) vaccine and autism in the late 1990s and early 2000s, a condition like autism “represents a labeling process and a category of knowledge in which the boundaries of symptom inclusion and exclusion are fluid” (p. 11). “If you see it with wild-type virus, why wouldn’t you believe it could occur with vaccine?” Black said. But the publicity surrounding the problem — the tree shaking — may have brought forward narcolepsy diagnoses that might otherwise only have come to light later. “The only problem is: Will we find the answer?”, Aavitsland uses another word to describe this story. Simply select your manager software from the list below and click on download. A third rationale is to ensure that compensations required from pharmaceutical companies remain moderate in order to guarantee vaccine production. Under that scenario, countries that rolled out vaccine while the H1N1 virus was actively circulating would have vaccinated some people who were actually infected at the time. The second section turns to the rich biomedical literature on the causative mechanisms of vaccine-associated narcolepsy, highlighting the evasiveness of intricate material processes inside the body. The story begins in spring 2009, when a new influenza outbreak was reported in Mexico and California at the end of the usual influenza season. While narcolepsy is an understudied phenomenon, a set of risk factors have been established. View or download all the content the society has access to. For example, in the debate about hepatitis B as a required childhood vaccine in the United States in the 1980s and 1990s, vaccine proponents portrayed children as vulnerable to hepatitis B through daycare and school, while vaccine critics saw it as an illness of homosexuals and intravenous drug users (Conis, 2015: 179–202). It is also renegotiated within each legal system, as has happened, for example, in the history of the US vaccine court and important cases such as the Autism Omnibus Proceeding concluded in 2009 (Decoteau and Underman, 2015; Haertlein, 2012). A central question concerned whether vaccine-associated narcolepsy was part of general, non-vaccine-related narcolepsy, or whether it constituted a distinct condition. People sit in the waiting room at a Mexico City hospital to be checked for flu-like symptoms during the 2009 flu pandemic. These may include establishing sameness with other conditions while also claiming uniqueness; they may also include questioning the very terms of “rareness” (e.g. Furthermore, vaccine injuries are temporally and spatially situated. This reflected the fact that the underlying mechanisms of narcolepsy in general were blurry. Instead of answers, they came up with more theories, including one that argues that the timing of vaccination efforts may have played a role in the narcolepsy story. Even if vaccines containing the boosting compounds led to or contributed to a spike in narcolepsy cases, people here were not at risk. COVID-19: dealing with a potential risk factor for chronic neurological disorders. Epub 2012 Dec 16. Dauvilliers Y, Arnulf I, Lecendreux M, Monaca Charley C, Franco P, Drouot X, d'Ortho MP, Launois S, Lignot S, Bourgin P, Nogues B, Rey M, Bayard S, Scholz S, Lavault S, Tubert-Bitter P, Saussier C, Pariente A; Narcoflu-VF study group. But he has no funding for the research and only a single member of his team is working on it. In the case of patient organization websites and linked materials, I also pay attention to how cultural narratives are mobilized to establish or reframe vaccine injury. This line of research pointed to molecular mimicry. “But I think the real upshot is we need to figure this out because there will be another pandemic.”, Black was the principal investigator on SOMNIA; the acronym stands for Systematic Observational Method for Narcolepsy and Influenza Immunization Assessment. In Sweden, the Medical Products Agency published a registry study comprising 57 percent of the Swedish population in March 2011 (Medical Products Agency/Läkemedelsverket (MPA), 2011a), followed by a case inventory study of vaccinated and non-vaccinated children and adolescents with narcolepsy in June 2011 (MPA, 2011b). Furthermore, children with Pandemrix-associated narcolepsy had higher levels of antibodies to the nucleoprotein than vaccinated children without narcolepsy, and the presence of antibodies correlated with the presence of the DQB1*06:02 risk allele (Vaarala et al., 2014). Declaring a pandemic operated as a trigger within the international structures of pandemic preparedness. It’s not clear why the vaccines would have raised a recipient’s risk of developing narcolepsy. suggested that, despite having the same components as Arepanrix, Pandemrix had considerably higher amounts of structurally altered viral nucleoprotein. Epub 2019 May 6. The article maintains that what vaccine-associated narcolepsy is not only a biomedical but also a social and political question: it sets the parameters for what kinds of legal claims can be made about vaccine injury, what kind of patient activism appears as legitimate, and how future immunization campaigns conceptualize risk and benefit. COVID-19 is an emerging, rapidly evolving situation. The section explores the steps through which a new vaccine injury comes into being as a hazy possibility and then gradually as epidemiological reality. HHS Vaccine manufacture in pandemic times involved an expedited licensing process in order to make vaccines available during the pandemic peak. Living with Narcolepsy: Current Management Strategies, Future Prospects, and Overlooked Real-Life Concerns. 2020 Aug 27:1-8. doi: 10.1007/s00415-020-10131-y. Clipboard, Search History, and several other advanced features are temporarily unavailable. The long-standing tension between individual cases and population-level risk of vaccine injury, outlined in the previous section, runs through these studies. In the normal course of events, apples ripen and fall in their own time, but if you shake the tree, more apples fall at once. Her research interests include evolutionary narratives, population genetics, vaccine controversies, and affect and intersectionality. | The article begins with a discussion of the social, legal, and historical study of vaccine injuries in order to contextualize the Pandemrix debate. Adjuvants are agents that boost the immune reaction, thereby enabling a longer lasting immunity and the use of smaller amounts of viral material in a single shot, an important advantage in vaccine production within the pressing pandemic timeline. Ilta-Sanomat, 2010; Kelland, 2013; YLE—The Finnish National Broadcasting Company, 2011; see also Hall and Wolf, 2019). It has approached vaccine injury as a process that takes place through epidemiological and biomedical studies and the public engagements of patient organizations. Narcolepsy UK actively monitored and protested the state decision to base the level of disability on the moment when the claim was made rather than the likely effects of the injury in the future. 2020 Jul 16;12:453-466. doi: 10.2147/NSS.S162762. Reflecting the border-crossing nature of the pharmaceutical industry as well as the pandemic itself, numbers of vaccine-associated narcolepsy operated at the intersection of national and international public health. Some further studies found an increase in narcolepsy also among adults, but the incidence was less pronounced (e.g. As vaccine-associated narcolepsy emerged as a materially complex phenomenon, questions of risk and responsibility were also rendered increasingly multifaceted. The article traces the emergence of a new type of vaccine injury—vaccine-associated narcolepsy—following immunization with Pandemrix vaccine during the 2009 H1N1 pandemic in Europe. Yet, mortality from H1N1 appeared considerably lower than in visions of pandemic threat constructed around highly pathogenic avian influenza or SARS (Abeysinghe, 2015). While national studies arrived at different solutions, the VAESCO report sought to establish points of comparison. The article shows how these underlying tensions enable a range of mutually incompatible framings and mobilizations through which risk, harm, responsibility, and justice are claimed and negotiated. Lean Library can solve it. The following three analytical sections utilize different types of data. They are never completely normal, but they are close to normal and they can usually do most jobs,” said Dr. Emmanuel Mignot, a leading sleep disorder expert who has been working on the possible link between the H1N1 pandemic and narcolepsy. While the H1N1 pandemic waned in spring 2010, a new concern arose: in Finland and Sweden, where vaccination rates were particularly high, doctors noticed an unusual number of new cases of narcolepsy among children vaccinated with Pandemrix; there were suspected cases also in Iceland (ECDC, 2011). Following epidemiological studies, researchers turned to the material processes inside bodies. Narcolepsy UK is a general narcolepsy organization founded in the 1980s with well-established structures. Sharing links are not available for this article. Vaccine-associated narcolepsy is a novel type of vaccine injury associated with the H1N1 vaccine Pandemrix used during the 2009 pandemic in Europe. Please read and accept the terms and conditions and check the box to generate a sharing link. Narcolepsy Associated with Pandemrix Vaccine. Through these comparisons, vaccine-associated narcolepsy emerged gradually as a scientifically established, transnational phenomenon. Abeysinghe, 2015: 102–132). This product could help you, Accessing resources off campus can be a challenge. The increase in narcolepsy cases there put influenza infection on the table as a possible trigger. the site you are agreeing to our use of cookies. He also noted that most people who were vaccinated during the H1N1 pandemic didn’t go on to develop narcolepsy. Justin Sullivan/Getty Images. If you have access to a journal via a society or association membership, please browse to your society journal, select an article to view, and follow the instructions in this box. Wijnans L, Lecomte C, de Vries C, Weibel D, Sammon C, Hviid A, Svanström H, Mølgaard-Nielsen D, Heijbel H, Dahlström LA, Hallgren J, Sparen P, Jennum P, Mosseveld M, Schuemie M, van der Maas N, Partinen M, Romio S, Trotta F, Santuccio C, Menna A, Plazzi G, Moghadam KK, Ferro S, Lammers GJ, Overeem S, Johansen K, Kramarz P, Bonhoeffer J, Sturkenboom MC. CDC Vaccine Safety Efforts and Research. 2013 Feb 6;31(8):1246-54. doi: 10.1016/j.vaccine.2012.12.015. Conversely, the long lag between onset of narcolepsy symptoms and diagnosis could make it harder for scientists to detect a genuine phenomenon. But after the pandemic H1N1 virus made its way around China, authorities there reported an increase in narcolepsy diagnoses. The fact that vaccination efforts started at different times in different countries. View or download all content the institution has subscribed to. At the same time, vaccine-associated narcolepsy has become an object of political and societal debates, shaping pandemic preparedness plans, public attitudes toward vaccination programs, as well as patient activism around narcolepsy and medical injuries (e.g. Narcolepsy UK, 2016). Syringes with Pandemrix flu vaccine in Dresden, Germany. As Feltelius et al. Narcolepsy is divided into two categories: type 1 comes with cataplexy, a sudden loss of muscle control when experiencing emotions, and type 2 without cataplexy. Gottlieb, 2016; Reich, 2016). The emergence of new vaccine injuries takes place in relation to these histories of suspected, proven, and unsubstantiated claims of vaccine injury. The reports were met with initial caution by public health actors (e.g. Social scientists working on rare diseases have argued that establishing new conditions in need of care requires complex acts of converging and distancing. Narcolepsy UK, 2016; SOUND, 2017). It had been thought streptococcal infections — the cause of strep throat — might be a trigger for some people who are genetically vulnerable to developing narcolepsy. Exclusive analysis of biotech, pharma, and the life sciences. And since we don’t know what the mechanism is, if this association was real, that was one issue,” Black said. Vaccine injury is also a legal object. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. In the 1990s, these concerns focused on thimerosal, a mercury-based substance used as a preservative, reflecting the growing public awareness of mercury as dangerous to humans (Conis, 2015: 150). One central question was whether all cases filled the diagnostic criteria of narcolepsy. Briggs, 2011; Connolly, 2011; ECDC, 2011), which is not surprising considering the heated public debates in the history of vaccine injury claims. Both China and Taiwan have a short interval — weeks — between onset of excessive daytime sleepiness and the diagnosis of narcolepsy. 2019 Aug;38(8):873-876. doi: 10.1097/INF.0000000000002398. This was important, as vaccine injury claims rely on the temporal proximity between immunization and adverse events. While the contracts exempted GSK from financial responsibility, several governments have paid compensations to affected families. The effect of awareness bias. Narkolepsiföreningen states poignantly in one of the rotating images on top of the home page: “We vaccinated ourselves against the swine flu. As the following sections demonstrate, these past incidents and debates set the imaginative parameters within which the connection between Pandemrix and narcolepsy was conceptualized and negotiated. Brain. Exclusive analysis of biopharma, health policy, and the life sciences. The case provides a viewpoint into what happens to a novel vaccine injury after its public recognition. This was a concern both in the media and in the biomedical literature during the immediate post-pandemic period. The article has traced the emergence of a novel vaccine injury at the intersection of biomedical, material, social and political worlds. Such questions were beyond the reach of epidemiology and statistics, requiring a different set of biomedical approaches. “It’s probably [an] apples to apples [comparison], but it’s McIntosh to Golden Delicious or something. In type 1 narcolepsy, hypocretin levels are very low or undetectable. We searched all articles from PubMed, Web of Science and Scopus, and other relevant sources reporting the incidence and risk of post-vaccine narcolepsy. With the rise of environmentalism in the 1960s and 1970s, risk was located in the potentially toxic vaccine ingredients (Conis, 2015: 132). On the websites and in linked materials, vaccine-associated narcolepsy emerges as structured on currently likely and previously possible futures: life-before-Pandemrix, life-after-Pandemrix, and, most poignantly, life-that-would-have-been-without-Pandemrix. Black uses the metaphor of a food poisoning incident in a restaurant. In particular, risk, harm, and justice are negotiated in relation to the conceptual frameworks of past vaccine injury debates, and non-vaccine-related narcolepsy. For example, in the case of the MMR vaccine, the connection between MMR and autism claimed by vaccine critics was debated fervently in epidemiological terms, focusing on whether the increase in autism diagnoses was connected to the wide use of the MMR vaccine (vaccine critics’ view), or to some other factor such as changes in diagnostic categories (a prominent medical view; Conis, 2015; Kaufman, 2010; Reich, 2016). Although the epidemiological realness of vaccine-associated narcolepsy relied on national databases and the idea of national populations as biomedically meaningful entities, the existence of injury was ultimately verified through comparisons between countries. (Pandemrix is no longer sold; after the pandemic GSK and other manufacturers reverted to making seasonal vaccines that protect against several types of flu. These tensions and multiplicities in epidemiological and biomedical knowledge were negotiated and mobilized when families formed patient organizations and networks. In some countries, however, the time from onset of the condition to a diagnosis can be years. Finnish researchers already explored this idea, however, Aavitsland said. Narcolepsy, a neurological disorder that affects the body’s ability to maintain normal sleep-wake patterns, would certainly be among them. I have argued that the ambiguities around vaccine-associated narcolepsy become a site of political and cultural negotiations over responsibility. Not surprisingly, pro- and anti-vaccination campaigns portray vaccine-preventable diseases differently. Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France. What counts as injury differs between countries and legal systems (Holland, 2018). This provides an illustrative contrast: while the organizations share concerns, they also tackle with unique issues arising from national public health frameworks, which set the parameters within which vaccine injuries are negotiated. It is also known that narcolepsy typically appears in adolescence, suggesting that it involves the maturing neurological and immunological systems. The fact that infection rather than vaccination was linked to an increase in narcolepsy in China and Taiwan both complicates the vaccine-narcolepsy story and makes Black even more convinced the effect was real. Second, narcolepsy had not been previously linked to vaccines, and thus there was little literature that researchers could build on to identify a potential biological mechanism of vaccine injury. Like epidemiological studies, biomedical research designs engaged in tinkering. As reports of the possible association started to emerge, researchers in other countries looked to see if there had been an increase in narcolepsy cases after their H1N1 vaccination campaigns were rolled out. “It’s apples and oranges. Patients with type 1 narcolepsy also tend to have a particular genetic marker, human leukocyte antigen (HLA) DQB1*06:02. Crucial evidence came from GSK’s other AS03 adjuvanted pandemic vaccine, Arepanrix, used in Canada, which had not been linked to narcolepsy. New H1N1 viruses started circulating in 2009, and the first hints that vaccinations might have been linked to a rise in cases of narcolepsy came from Scandinavia. As a biomedical process, vaccine injury is typically evasive. In the summer of 2010, sleep experts in Finland, and later in Sweden, realized they were seeing more cases of the disorder than they normally would. Vaccine. Mignot, too, believes there was a true rise in narcolepsy cases during the pandemic, both among vaccinated and unvaccinated people. In the case of Pandemrix, patient organizations highlighted that, rather than a sleep disorder, narcolepsy was a neurological condition affecting the brain, and thus it impacted all aspects of life: sleep was a mentally exhausting, nearly always-present state in which hallucinations and sleep paralysis took place (e.g. Lundgren, 2017; Lundgren and Holmberg, 2017). This demonstrates that genetic knowledge is deployed in multiple ways in struggles for recognition and justice. Contact us if you experience any difficulty logging in. But the pandemic wave struck Sweden later. These concerns are reflected in narcolepsy patient organizations. People can develop narcolepsy at any stage of life, but onset most commonly occurs in childhood, adolescence, and young adulthood. Specific forms of critique emerged within each organization. Access to society journal content varies across our titles. Some society journals require you to create a personal profile, then activate your society account, You are adding the following journals to your email alerts, Did you struggle to get access to this article? Granath F, Gedeborg R, Smedje H, Feltelius N. Pharmacoepidemiol Drug Saf. We behaved responsibly” (Narkolepsiföreningen, n.d.b). Vaccine injuries reflect these complexities. It is an autoimmune disorder, caused when cells in the brain that produce a chemical called hypocretin are destroyed. These phenomena are echoed and mobilized in multiple and sometimes contradictory ways in the epidemiological and biomedical studies and on patient organization websites. Sarkanen T, Alakuijala A, Julkunen I, Partinen M. Curr Neurol Neurosci Rep. 2018 Jun 1;18(7):43. doi: 10.1007/s11910-018-0851-5. A variety of brands of vaccines were used. At the same time, different ways of framing vaccine-associated narcolepsy do not automatically translate into political positions. “There were 10 people there and one got diagnosed a month later and one six months and one a year later and one two years later — you’re not going to be able to figure out what happened,” he said. Change in risk for narcolepsy over time and impact of definition of onset date following vaccination with AS03 adjuvanted pandemic A/H1N1 influenza vaccine (Pandemrix) during the 2009 H1N1 influenza pandemic. In the United Kingdom, the government’s initial dismissal of mad cow disease in the 1990s formed a fertile ground for public claims about the government covering up an MMR-autism connection a few years later (Stöckl and Smajdor, 2017). The research was funded by the Centers for Disease Control and Prevention. Pediatr Infect Dis J. Your daily dose of news in health and medicine, Reporting from the frontiers of health and medicine, Spread of mutated coronavirus in Danish mink ‘hits all…, Spread of mutated coronavirus in Danish mink ‘hits all the scary buttons,’ but fears may be…, The hidden public health hazard of rapid Covid-19 tests, FDA scientists appear to offer major endorsement of Biogen’s…, FDA scientists appear to offer major endorsement of Biogen’s controversial Alzheimer’s treatment, Far more transparency is needed for Covid-19 vaccine trials. In this, narcolepsy resembled conditions such as developmental delays, immune deficiencies, metabolic disorders, and autism spectrum symptoms invoked in vaccine critical discourse (e.g. Focusing on antibodies to a protein present in the H1N1 virus but left out from the vaccine, the authors showed that most of the vaccine-associated narcolepsy patients lacked these antibodies and had thus not contracted the pandemic virus. Vaccine-associated narcolepsy differed in this respect, as genetic factors were perceived as potentially moving responsibility away from the state and the pharmaceutical industry. 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