Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden
BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d5956 (Published 12 October 2011) Cite this as: BMJ 2011;343:d5956All rapid responses
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We take note with great interest and a sigh of relief that the paper written by Bardage C et al. (1) states the safety of the pandemic influenza vaccine, and especially their conclusion that noted no change in risk for Guillain-Barre syndrome, multiple sclerosis, type 1 diabetes, or rheumatoid arthritis in a large cohort in Stockholm county after an 8 to 10-month follow-up. Similar findings about Guillain-Barre syndrome are reported by Verity C et al. (2), that in 57 cases of Guillain-Barre syndrome or Fisher’s syndrome observed a 16-fold increased risk for the disease within 1 month of an influenza-like illness, but no association between Guillain-Barre syndrome and seasonal influenza vaccination. Moreover, Dieleman J et al. (3) could not find any increased risk of Guillain-Barre syndrome after adjuvanted pandemic influenza A (H1N1) 2009 vaccine in a population of 50 million people in Europe. Type 1 diabetes and HIV infection are recognized as associated medical conditions that confer greater vulnerability and risk of complications in the event of an influenza infection, and possibly suffer from higher rate of vaccination complication.
In 2009 we vaccinated 80 children with type 1 diabetes and 66 children with HIV-infection, with adjuvanted pandemic influenza A (H1N1) 2009 vaccine co-administered with the seasonal influenza vaccine, with a good seroconversion and seroprotection in both groups, as published elsewhere (4,5). The side effects of the vaccination after a 6-month follow-up were mild and mostly local (4,5). After a 2-year follow-up (November 2009-October 2011), none of them reported Guillain-Barre syndrome or other neurologic disease, nor autoimmune diseases. Moreover, no increased risk of type 1 diabetes due to influenza (pandemic or seasonal) has been observed during pandemic influenza (6), nor 2 years after.
As paediatricians we would like to underline the importance of correct information, especially about the vaccine issue, increasingly under attack even by physicians. During the last pandemic influenza a large number of doses of vaccine have remained unused, at least in Italy, just because the fear of hypothetical serious side effects has convinced many people not to vaccinate. Fortunately, this epidemic of influenza was less deadly than expected. However, it is certain that most of the time misinformation (more anecdotal than evidence-based) can be far more dangerous than the disease itself (e.g., influenza) or treatment to prevent it (e.g., vaccine). We hope that a paper like this one by Bardage C et al (1) will help further spread safe and effective care for our children.
References –
1. Bardage C, Persson I, Ortqvist A, Bergman U, Ludvigsson JF, Granath F. Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. BMJ 2011;343:bmj.d5956.
2. Verity C, Stellitano L, Winstone AM, Andrews N, Stowe J, Miller E. Guillain-Barré syndrome and H1N1 influenza vaccine in UK children. Lancet 2011; 378: 1545-1546.
3. Dieleman J, Romio S, Johansen K, Weibel D, Bonhoeffer J, Sturkenboom M; VAESCO-GBS Case-Control Study Group. Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ 2011 343:bmj.d3908.
4. Zuccotti GV, Pariani E, Scaramuzza A, Santoro L, Giani E, Macedoni M, Gazzarri A, Anselmi G, Amendola A, Zanetti A. Long-lasting immunogenicity and safety of a 2009 pandemic influenza A(H1N1) MF59-adjuvanted vaccine when co-administered with a 2009-2010 seasonal influenza vaccine in young patients with Type 1 diabetes mellitus. Diabet Med 2011 Sep 14. doi: 10.1111/j.1464-5491.2011.03449.x.
5. Viganò A, Giacomet V, Pariani E, Giani E, Manfredini V, Bedogni G, Erba P, Amendola A, Zanetti A, Zuccotti G. Long-term immunogenicity after one and two doses of a monovalent MF59-adjuvanted A/H1N1 Influenza virus vaccine coadministered with the seasonal 2009-2010 nonadjuvanted Influenza virus vaccine in HIV-infected children, adolescents, and young adults in a randomized controlled trial. Clin Vaccine Immunol 201; 18:1503-1509.
6. Rabbone I, Scaramuzza AE, Iafusco D, Bonfanti R, Lombardo F, Cherubini V, Toni S, Cerutti F, Zuccotti GV. Pandemic influenza vaccination coverage in children with type 1 diabetes: analysis from seven Italian centers. Hum Vaccine 2011 (in press).
Competing interests: No competing interests
Re: Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden
Dear Editor
We read with great interest the recent paper "Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden" by Bardage et al (1). In order to look at the risk of neurological and autoimmune disorders in people vaccinated against pandemic influenza A (H1N1) with Pandemrix (GlaxoSmithKline, Middlesex, UK) the authors looked at follow-up data among more than one million people vaccinated with Pandemrix and 900 000 unvaccinated people in the population of Stockholm county.
Even though the results were mostly reassuring, a small but significant excess risk was found for paresthesia and inflammatory bowel disease (OR 1.17; 95% confidence interval [1.12.-1.22]). This late result is actually reminiscent of what we observed in a pediatric population-based case-control study. A total of 222 incident cases of Crohn’s disease and 60 incident cases of ulcerative colitis occurring before 17 years of age were matched by sex, age and geographical location with one control subject. The most significant risk factor for Crohn’s disease was BCG (bacille Calmette-Guerin) vaccination (OR 3.6; [1.1-11.9]) with a dose effect, one shot being associated with an OR of 2.6 [1.0-6.5] and more than one shot with an OR of 3.6 [1.4-9.7]. Children with Crohn’s disease were also more often exposed to smallpox vaccination (OR=2.1 [1.01-4.3]) and poliomyelitis vaccination (OR=2.6 [1.1-6.2]).
At present, the link between various kinds of vaccination and inflammatory bowel disease is not established. However, based on this data and our previous experience, the potential impact of vaccines and adjuvants which are present in the Pandemrix vaccine as well as in BCG, polyomelitis and smallpox vaccines in triggering the occurrence of inflammatory bowel disease in a predisposed subject needs to be further investigated.
(1) Bardage C, Persson I, Örtqvist A, Bergman U, Ludvigsson JF, Granath F. Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. BMJ 2011;343:bmj.d5956.
(2) Baron S, Turck D, Leplat C, Merle V, Gower-Rousseau C, Marti R, et al. Environmental risk factors in paediatric inflammatory bowel diseases: a population based case control study. Gut 2005; 54: 357-63.
Francis Vasseur Epidemio-geneticist, Corinne Gower-Rousseau Gastroenterologist, Dominique Turck Professor of Pediatrics, Jean-Frédéric Colombel Professor of Gastroenterology, EPIMAD Registry, Public Health Clinic, University Hospital of Lille Parc Eurasanté CHRU 59037 Lille cedex.
Competing interests: No competing interests