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    You are here : Home » MS Research News » Vaccinations & MS

    Vaccinations & MS

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    Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1)

    VaccinationAbstract

    Objective To examine the risk of neurological and autoimmune disorders of special interest in people vaccinated against pandemic influenza A (H1N1) with Pandemrix (GlaxoSmithKline, Middlesex, UK) compared with unvaccinated people over 8-10 months.

    Design Retrospective cohort study linking individualised data on pandemic vaccinations to an inpatient and specialist database on healthcare utilisation in Stockholm county for follow-up during and after the pandemic period.

    Setting Stockholm county, Sweden.

    Population All people registered in Stockholm county on 1 October 2009 and who had lived in this region since 1 January 1998; 1 024 019 were vaccinated against H1N1 and 921 005 remained unvaccinated.

    Main outcome measures Neurological and autoimmune diagnoses according to the European Medicines Agency strategy for monitoring of adverse events of special interest defined using ICD-10 codes for Guillain-Barré syndrome, Bell’s palsy, multiple sclerosis, polyneuropathy, anaesthesia or hypoaesthesia, paraesthesia, narcolepsy (added), and autoimmune conditions such as rheumatoid arthritis, inflammatory bowel disease, and type 1 diabetes; and short term mortality according to vaccination status.

    Results Excess risks among vaccinated compared with unvaccinated people were of low magnitude for Bell’s palsy (hazard ratio 1.25, 95% confidence interval 1.06 to 1.48) and paraesthesia (1.11, 1.00 to 1.23) after adjustment for age, sex, socioeconomic status, and healthcare utilisation. Risks for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, and rheumatoid arthritis remained unchanged. The risks of paraesthesia and inflammatory bowel disease among those vaccinated in the early phase (within 45 days from 1 October 2009) of the vaccination campaign were significantly increased; the risk being increased within the first six weeks after vaccination. Those vaccinated in the early phase were at a slightly reduced risk of death than those who were unvaccinated (0.94, 0.91 to 0.98), whereas those vaccinated in the late phase had an overall reduced mortality (0.68, 0.64 to 0.71). These associations could be real or explained, partly or entirely, by residual confounding.

    Conclusions Results for the safety of Pandemrix over 8-10 months of follow-up were reassuring —notably, no change in the risk for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, or rheumatoid arthritis. Relative risks were significantly increased for Bell’s palsy, paraesthesia, and inflammatory bowel disease after vaccination, predominantly in the early phase of the vaccination campaign. Small numbers of children and adolescents with narcolepsy precluded any meaningful conclusions.

    Source: BMJ (19/10/11)

    Yellow fever vaccine risky for MS patients

    Yellow Fever VaccinePatients with multiple sclerosis who plan to travel to areas where yellow fever is endemic need to think carefully about whether to be vaccinated against the disease, researchers warned in a report on their small study.

    During a five-week at-risk period after vaccination, the annual rate of MS exacerbation was 8.57, compared with a rate of 0.67 after the end of the risk period, according to Mauricio F. Farez, MD, MPH, and Jorge Correale, MD, of Fundación para la Lucha contra las Enfermedades Neurológias de la Infancia in Buenos Aires, Argentina.

    This gave an exacerbation rate ratio for the risk period of 12.778 (95% CI 4.28 to 38.13, P<0.001), the researchers reported online in the Archives of Neurology.

    "A causal relationship between [yellow fever] vaccination and MS relapses can be indirectly inferred by the temporal relationship between events, and the biological plausibility of such a link," they wrote.

    They recommended that clinicians carefully discuss the risks and benefits with any MS patients contemplating travel to areas where exposure to yellow fever could occur.

    Yellow fever is a potentially lethal viral hemorrhagic fever transmitted by mosquitoes. The disease has re-emerged in recent years because of decreased vector control efforts in the areas of Africa and South America where the disease is endemic.

    Infections are thought to play a role in MS disease exacerbations, but the potential contribution of immunization is uncertain.

    To explore this concern, Farez and Correale followed seven patients with relapsing-remitting MS who received the 17D-204 yellow fever vaccine, matching them with seven unvaccinated MS patients, seven MS patients receiving influenza vaccine, and seven healthy controls.

    Most patients were in their 30s, and five of the seven were women.

    All the MS patients who were vaccinated were being treated with interferon beta-1a or glatiramer acetate (Copaxone).

    The at-risk period began one week after the immunization, when the immune response develops.

    Patients were followed for two years, during which time five patients experienced exacerbations. The overall annual exacerbation rate was 0.99.

    Among the clinical manifestations were myelitis, optic neuritis, and internuclear ophthalmoplegia.

    "It is important to note that four of these five patients had a significant and persistent Expanded Disability Status Scale score increase (≥2 points) on neurological evaluations conducted 12 months following the exacerbation," Farez and Correale observed.

    Immunization against influenza had no effect on MS relapse rate (P>0.05).

    Changes also were seen on MRI scans three months after the yellow fever immunization.

    At that time point, a mean of 2.6 new or enlarging T2 lesions and 2.14 gadolinium-enhanced lesions were detected.

    In contrast, MRI performed later during follow-up identified a mean of only 0.1 new or enlarging T2 lesions and no gadolinium-enhanced lesions.

    In addition, various immunological changes were observed after immunization, including increases in numbers of cells secreting proinflammatory cytokines and chemokines such as interleukin-1α; interferon-γ; and tumor necrosis factor.

    The increase in these autoreactive cells "may account for the clinical and radiological changes observed in these patients," the researchers wrote.

    They also noted that, in nonepidemic areas of Africa, the risk of acquiring yellow fever in the unvaccinated is about one in 2,000, and of these, one in seven will become ill. One in 10,000 will die.

    The numbers are much smaller in South America, they noted.

    The precise mechanisms by which MS exacerbations and other autoimmune responses can be induced by vaccination are uncertain, but probably differ according to genetic susceptibility and specific vaccine.

    Limitations of the study included the small number of patients and the lack of blinding.

    The research was funded by a grant from the Institute for Neurological Research Dr. Raúl Carrea, Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia.

    Correale is a board member and has received reimbursement for developing educational presentations for Merck Serono Argentina, Biogen Idec LATAM, and Merck Serono LATAM.

    Full Article

    Source: MedPage Today © 2011 Everyday Health, Inc. (15/06/11)

    Cervical cancer vaccine Gardasil possibly linked to MS episodes
    Gardasil VaccinationTHE cervical cancer vaccine Gardasil has triggered multiple sclerosis (MS)symptoms in some girls after being inoculated.

    Doctors said the victims were either teenagers or women in their early 20s who may have been predisposed to MS or who had a prior history of symptoms.

    St Vincent's Hospital neurologist Dr Ian Sutton reported five cases in a journal article in January. Another five have since emerged.

    "Gardasil vaccination is not the cause of MS; whether or not it was a trigger for episodes of inflammation in the brain in these rare cases is unclear," Dr Sutton said.

    All cases were in women aged under 26, the target group of a vaccination program that began in 2007.

    Symptoms began within three weeks of vaccination and lasted from weeks to months.

    "We have raised the question: has the vaccine modified what may have occurred anyway or just been an additional trigger?" Dr Sutton said.

    The Therapeutic Goods Administration (TGA) last week said six million doses of Gardasil – created by scientist and former Australian of the Year Ian Frazer – had been distributed in Australia, and 1476 suspected adverse reactions had been reported to the regulator.

    "The TGA is also aware of a small number of cases in which neurological symptoms, similar to those experienced in patients with a dedemyelinating disorder such as multiple sclerosis, have been reported shortly after HPV (human papillomavirus vaccination)," the regulator said.

    The cases involving neurological symptoms have been investigated by an independent panel.

    The vaccine has been tested on more than 30,000 women worldwide, its manufacturer CSL said.

    "In spite of reports of some neurological symptoms occurring after vaccination, when those have been investigated no causative relationship with the vaccine has been determined," company spokeswoman Rachel David said.

    Source: Couriermail.com.au © 2009 Queensland Newspapers. (13/12/09)

    A population-based case-control study on viral infections and vaccinations and subsequent multiple sclerosis risk

    Vaccinations and MS?

    The cause of MS is not known but many factors, including viruses, could play a role. The authors investigated whether infections such as measles, mumps, rubella, varicella and infectious mononucleosis, or vaccinations for these infections, were involved in the development of MS. They found that infectious mononucleosis was associated with higher MS risk.

    Viral infections are probably involved in the pathogenesis of multiple sclerosis (MS).

    A recent cohort study in the Gothenburg population revealed no change in MS incidence associated with the introduction of the Swedish measles, mumps and rubella vaccination programmes.

    The aim of the present study was to clarify whether these infections or vaccinations, and two other infections, varicella and infectious mononucleosis, influence MS risk.

    We performed a population-based case-control study in Gothenburg that included 509 MS cases and 2,067 controls, born 1959-1986.

    Data on infections and vaccinations were obtained from questionnaires and from child health and school health records.

    We found no significant associations between measles, mumps, rubella or varicella and MS risk. These results were consistent between the two source materials.

    Infectious mononucleosis was associated with significantly higher MS risk (odds ratio 2.03, 95% CI 1.52-2.73).

    Overall, there was no significant association between measles-mumps-rubella (MMR) vaccination and MS risk, while those MMR vaccinated before age ten only were at significantly higher MS risk (odds ratio 4.92, 95% CI 1.97-12.20).

    Those MMR vaccinated both before and after age ten had intermediate MS risk.

    Infection with measles, mumps, rubella and varicella did not influence MS risk in contrast to infectious mononucleosis which conferred doubled MS risk.

    The association with 'early' MMR vaccination only was an isolated finding, limited by a small number of subjects and multiple testing. Most likely this was a chance finding.

    Future studies could investigate it on an a priori basis.

    Ahlgren C, Torén K, Odén A, Andersen O.

    Institute of Clinical Neuroscience, Sahlgrenska University Hospital, 413 45, Gothenburg, Sweden.

    Source: Pubmed PMID: 19633994 (05/08/09)

    Possible vaccine against Multiple Sclerosis discovered

    MS Brain Scan

    Researchers at the Heidelberg University Hospital and the German Cancer Research Center in Heidelberg have succeeded in vaccinating mice with specially treated, autologous immune cells and preventing them from developing encephalitis, which is similar to multiple sclerosis in humans. A protein of the nervous system, that is the target of the harmful immune reaction in multiple sclerosis, was placed on the surface of the cells; the cells were treated with an agent that suppresses immune defense.

    The Heidelberg researchers have published their results – initially online – in the prestigious journal "Proceedings of the National Academy of Sciences USA".

    The team around Professor Dr. Peter Terness is working in the Department of Transplantation Immunology (Director: Professor Dr. Gerhard Opelz) of the Institute of Immunology at the Heidelberg University Hospital. Professor Terness and his colleagues work primarily on developing methods to prevent rejection of donor organs without impairing the immune system.

    "The vaccine against multiple sclerosis works on the same principle," explains Professor Terness. "We have to teach the immune system not to fight the donor organ, or in this case its own nerve cells, as a foreign body."

    In the course of their research on organ rejection, the scientists successfully treated immune cells (known as dendritic cells) of a donor animal with the chemotherapeutic agent mitomycin and injected them into the organ recipient before transplantation – the modified cells were not attacked. The immune system of the transplant recipient subsequently accepted the tissue of the donor animal as well. The results were published in "Transplantation" in 2007.

    Subsequently, Professor Terness's team used this procedure to suppress the harmful immune response in multiple sclerosis – in cooperation with Dr. Thilo Oelert from the Department of Molecular Immunology at the German Cancer Research Center they loaded immune cells from mice with a self protein from the nervous system, treated them with mitomycin, and reinjected them into the animals. Afterwards, experimental autoimmune encephalitis – the equivalent of multiple sclerosis in humans – could no longer be induced in these mice; they were resistant. "The treated cells express the target protein and simultaneously suppress the immune response. In this manner, the immune cells become accustomed to the protein and do not attack it later, even without the inhibitor," explains Professor Terness.

    The researchers now want to study whether this method is also effective for treating already-existing multiple sclerosis. They will use animal experiments to study whether the vaccine with treated autologous cells has not only a preventive effect, but a therapeutic effect as well.

    Source: University Hospital Heidelberg (02/12/08)

    Glaxo, Sanofi Pasteur MSD Under Investigation Over Vaccine and Multiple Sclerosis
    French authorities have launched an investigation into two managers from drugmakers GlaxoSmithKline (GSK) and Sanofi Pasteur MSD over an anti-hepatitis B drug vaccination campaign in the 1990's, a judicial source said.

    GlaxoSmithkline and Sanofi-Pasteur MSD, a joint venture between Sanofi Aventis (SNY) and Merck & Co. (MRK), have allegedly failed to fully disclose side effects from the vaccine.

    Sanofi Pasteur MSD is also accused of manslaughter after a young woman died from complications of multiple sclerosis in 1998 after being vaccined, the same source said.

    Dr Benot Soubeyrand, a Sanofi Pasteur MSD executive, said the company was cooperating with the authorities, although he added that the charges were " unjustified."

    Commenting on the manslaughter charge, Soubeyrand said the company "has neither committed a fault nor has been negligent."

    "Eleven studies, including three in France, have been conducted on the subject and none has shown the link between multiple sclerosis and the hepatitis B vaccine," he added.

    Some 30 plaintiffs have launched a civil action in the case.

    Source: CNN Money.com © 2008 BigCharts.com Inc. (01/02/08)

    Hepatitis B Vaccine Appears Not To Be Associated With Childhood Multiple Sclerosis
    Vaccinating against the hepatitis B virus does not appear to be associated with the risk of developing multiple sclerosis in childhood, according to a new article.

    Several studies have evaluated a possible association between the hepatitis B vaccine and the autoimmune neurological disease multiple sclerosis (MS) in adults, according to background information in the article. Most have found no significant increase in the risk of MS in the short or long term, although one identified a potentially increased risk within three years of vaccination. "Some of these epidemiologic studies have been criticized for methodological limitations," including how vaccination status was confirmed, the authors write.

    "This controversy created public misgivings about hepatitis B vaccination. Hepatitis B vaccination in children remained low in several countries despite vaccination campaigns supporting early vaccination against hepatitis B in children as a means of inducing strong and long-lasting immunity and despite high levels of hepatitis B--related morbidity and mortality worldwide."

    Yann Mikaeloff, M.D., Ph.D., of Hôpital Bicêtre, Le Kremlin Bicêtre, France, and colleagues studied 143 children who developed MS before age 16, with a first episode of the disease occurring between 1994 and 2003. Each patient was matched to an average of eight control participants from the general French population who were the same age and sex and lived in the same location but did not have MS. Telephone interviews and questionnaires were used to collect vaccination records and information about family history of MS or other autoimmune diseases.

    In the three years before the first episode of MS, approximately 32 percent of both the 143 patients and the 1,122 controls were vaccinated against hepatitis B. "Vaccination against hepatitis B within the three-year study period was not associated with an increased rate of a first episode of MS," the authors write. "The rate was also not increased for hepatitis B vaccination within six months of the index date or at any time since birth or as a function of the number of injections or the brand of hepatitis B vaccine."

    "Vaccination against hepatitis B does not seem to increase the risk of a first episode of MS in childhood," they conclude.

    Journal reference: Arch Pediatr Adolesc Med. 2007;161(12):1176-1182. 

    Source: Science Daily Copyright © 1995-2007 ScienceDaily LLC(04/12/07)

    Hepatitis B vaccine and risk of relapse after a first childhood episode of CNS inflammatory demyelination.
    Public concern about possible increases in the risk of multiple sclerosis associated with hepatitis B vaccination has led to low vaccination coverage.

    We investigated whether this vaccination after a first episode of acute CNS inflammatory demyelination in childhood increased the risk of conversion to multiple sclerosis.

    We studied the French Kid Sclérose en Plaques (KIDSEP) neuropaediatric cohort of patients enrolled between 1994 and 2003 from their first episode of acute CNS inflammatory demyelination (inclusion in the cohort) until the occurrence of a second episode, up to 2005.

    A Cox proportional hazards model of time-dependent vaccine exposure was used to evaluate the effect of vaccination (hepatitis B, tetanus) during follow-up on the risk of second episode occurrence (conversion to multiple sclerosis).

    The cohort included 356 subjects with a mean follow-up of 5.8 years (SD 2.7). Relapse occurred in 146 (41%) subjects during follow-up; 33 subjects were exposed to hepatitis B vaccine and 28 to tetanus vaccine at some time during follow-up. The adjusted hazard ratio (HR) for relapse occurring within 3 years of hepatitis B vaccination was 0.78 (0.32-1.89) and during any time period was 1.09 (0.53-2.24). The adjusted HR for relapse occurring within 3 years of tetanus vaccination was 0.99 (0.58-1.67) and during any time period was 1.08 (0.63-1.83).

    We conclude that vaccination against hepatitis B or tetanus after a first episode of CNS inflammatory demyelination in childhood does not appear to increase the risk of conversion to multiple sclerosis, although the possibility of a small increase in risk cannot be excluded.

    Mikaeloff Y, Caridade G, Assi S, Tardieu M, Suissa S; KIDSEP study group of the French Neuropaediatric Society. Assistance publique-Hôpitaux de Paris, Service de Neurologie Pédiatrique.

    Pubmed (15/06/07)

    Tetanus jab may curb multiple sclerosis risk
    Vaccination against tetanus may offer protection against the development of multiple sclerosis (MS), according to a new study from Boston-based researchers.

    Dr. Miguel A. Hernan and colleagues from Harvard School of Public Health pooled data from nine studies published between 1966 and 2005 that looked at the association between tetanus vaccination and MS risk. Analyses centered on a total of 963 MS cases and 3126 controls.

    They found that a history of having been immunised against tetanus was associated with a 33 percent decrease in risk of MS.

    The results of the current meta-analysis suggest that tetanus vaccination may prevent or delay the development of MS. The investigators call for further epidemiologic research to assess the role of timing of immunisation and the number of doses associated with this protective effect.

    The hypothesis that tetanus immunity may protect against MS is supported by the findings of two recent prospective studies, Hernan and colleagues note in a report in the journal Neurology.

    The biologic mechanism by which the tetanus vaccination may protect against MS is unclear, according to the authors. They note, however, that vaccination with tetanus toxoid may shift the T helper cell immune response from a proinflammatory Th1 response to an anti-inflammatory Th2 response.

    Immunising with the tetanus toxoid "could be a promising approach for the treatment and prevention of MS and other Th1 cell mediated autoimmune disorders," the clinicians charge.

    SOURCE: Neurology July 25, 2006.

    Hepatitis B vaccine and risk of multiple sclerosis

    The US Institute of Medicine has rejected a possible causal link between the Hepatitis B vaccine and MS. The possibility that hepatitis B vaccine causes or exacerbates Multiple Sclerosis stems from several case reports of onset or recurrence of MS symptoms shortly after vaccination.

    The Institute says: "It is difficult, however, to infer causation from individual case reports since they may simply represent coincidental temporal associations with vaccination. There is only weak, non-specific evidence to support the biological plausibility of an association between hepatitis B vaccine and Multiple Sclerosis.

    Epidemiological studies have found that hepatitis B vaccine does not increase the risk of developing Multiple Sclerosis or cause exacerbations."

    Ref: Expert Rev Vaccines, 2002 Dec,-1(4):461-6 DeStefano F, Verstraeten T, Chen RT. Centers for Disease Control and Prevention, Atla Georgia 30341-3724, USA.

    For further information, find this article at PubMed.

    Flu Vaccination

    "Flu Vaccination OK for MS", say US Doctors.

    Vaccinations do not appear to increase the short-term risk of causing relapses in MS. These are the findings of two major studies prompted by concerns that vaccination might lead to relapse.

    The first study was for the International Multi-Centre Vaccines in Multiple Sclerosis  (VACCIMUS) in the US. The results showed no increase in specific risk of relapse linked with tetanus, hepatitis B or influenza vaccination. The second case-controlled study of two nurses in the United States was done by Harvard University School of Public Health and followed 116,671 women since 1989.

    Ref: From the MS Information Source Book provided by the Information Resource Center and Library of the US National Multiple Sclerosis Society.

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