Central Demyelinating Diseases After Vaccination Against Hepatitis B Virus: A Disproportionality Analysis Within the VAERS Database

Overview

Journal Drug Saf

Specialties Pharmacology
Toxicology

Date 2018 Mar 22

PMID 29560597

Citations 3

Authors

Julie Mouchet

Bernard Begaud

Affiliations

Soon will be listed here.

Abstract

Introduction: Hepatitis B (HB) vaccination programs were set up worldwide in the early 1990s. Despite their major focus on reducing the burden of HB infection, they have seldom achieved the targeted population coverage in most countries, including the USA, with around 24.5% of adults being vaccinated against HB. Among proposed reasons for this is the persisting doubt about a possible link between HB vaccination and the occurrence of cases of multiple sclerosis (MS).

Objective: Our objective was to evaluate a potential safety signal between MS and HB vaccination. We conducted a disproportionality analysis (DPA) using the cases reported to the Vaccine Adverse Event Reporting System (VAERS).

Methods: We calculated the proportional reporting rate (PRR) and reporting odds ratio (ROR) of MS having occurred within the 120 days following HB immunization in adults aged 19-49 years when compared with other vaccines using the reports recorded in the VAERS database. Both ratios were estimated globally and then according to the origin of reports (USA vs. non-USA). We then performed a sensitivity analysis using a broader category of demyelinating events.

Findings: MS cases following HB vaccination were more likely to originate from outside the USA and to be reported before 2000 than those associated with other immunizations. All computed ratios were found to be statistically significant, with PRRs ranging from 3.48 to 5.56 and RORs ranging from 3.48 to 5.62. When considering the geographical origin, similar RORs were obtained for both US and non-US cases.

Conclusion: In VAERS, MS cases were up to five times more likely to be reported after an HB vaccination than after any other vaccination. Since DPA is mainly suited for hypothesis generation, further studies evaluating the nature of the link between MS and HB vaccination would be of considerable importance.

Citing Articles

Real-world evidence of autoimmune hepatitis following COVID-19 vaccination: A population-based pharmacovigilance analysis.

Chen C, Xie D, Xiao J Front Pharmacol. 2023; 14:1100617.

PMID: 37124218 PMC: 10133579. DOI: 10.3389/fphar.2023.1100617.

Booster dose of COVID-19 mRNA vaccine does not increase risks of myocarditis and pericarditis compared with primary vaccination: New insights from the vaccine adverse event reporting system.

Chen C, Fu F, Ding L, Fang J, Xiao J Front Immunol. 2022; 13:938322.

PMID: 36172346 PMC: 9510366. DOI: 10.3389/fimmu.2022.938322.

Comment on "Central Demyelinating Diseases After Vaccination Against Hepatitis B Virus: A Disproportionality Analysis Within the VAERS Database".

Cohen C, Houdeau A, Khromava A Drug Saf. 2018; 41(12):1425-1427.

PMID: 30269242 PMC: 6223705. DOI: 10.1007/s40264-018-0733-4.

References

. Intussusception among recipients of rotavirus vaccine--United States, 1998-1999. MMWR Morb Mortal Wkly Rep. 1999; 48(27):577-81. View

Belbasis L, Bellou V, Evangelou E, Ioannidis J, Tzoulaki I . Environmental risk factors and multiple sclerosis: an umbrella review of systematic reviews and meta-analyses. Lancet Neurol. 2015; 14(3):263-73. DOI: 10.1016/S1474-4422(14)70267-4. View

Heekin R, Gandhy C, Robertson D . Seronegative Neuromyelitis Optica Spectrum Disorder following Exposure to Hepatitis B Vaccination. Case Rep Neurol. 2015; 7(1):78-83. PMC: 4427138. DOI: 10.1159/000381826. View

. Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine--United States, June 2005-September 2006. MMWR Morb Mortal Wkly Rep. 2006; 55(41):1120-4. View

Hernan M, Jick S, Olek M, Jick H . Recombinant hepatitis B vaccine and the risk of multiple sclerosis: a prospective study. Neurology. 2004; 63(5):838-42. DOI: 10.1212/01.wnl.0000138433.61870.82. View

Touze E, Gout O, Lyon-Caen O, Alperovitch A . [The first episode of central nervous system demyelinization and hepatitis B virus vaccination]. Rev Neurol (Paris). 2000; 156(3):242-6. View

Khamaisi M, Shoenfeld Y, Orbach H . Guillain-Barré syndrome following hepatitis B vaccination. Clin Exp Rheumatol. 2005; 22(6):767-70. View

Touze E, Fourrier A, Jeantaud I, Begaud B, Alperovitch A . Hepatitis B vaccination and first central nervous system demyelinating event: a case-control study. Neuroepidemiology. 2002; 21(4):180-6. DOI: 10.1159/000059520. View

Ball R, Halsey N, Braun M, Moulton L, Gale A, Rammohan K . Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the vaccine: Adverse Event Reporting System. J Clin Epidemiol. 2002; 55(8):819-24. DOI: 10.1016/s0895-4356(01)00500-5. View

10.

Fourrier A, Begaud B, Alperovitch A, Touze E, Decker N, IMBS J . Hepatitis B vaccine and first episodes of central nervous system demyelinating disorders: a comparison between reported and expected number of cases. Br J Clin Pharmacol. 2001; 51(5):489-90. PMC: 2014467. DOI: 10.1046/j.1365-2125.2001.01364.x. View

11.

Herroelen L, De Keyser J, Ebinger G . Central-nervous-system demyelination after immunisation with recombinant hepatitis B vaccine. Lancet. 1991; 338(8776):1174-5. DOI: 10.1016/0140-6736(91)92034-y. View

12.

Ascherio A, Zhang S, Hernan M, Olek M, Coplan P, Brodovicz K . Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001; 344(5):327-32. DOI: 10.1056/NEJM200102013440502. View

13.

Waller P, van Puijenbroek E, Egberts A, Evans S . The reporting odds ratio versus the proportional reporting ratio: 'deuce'. Pharmacoepidemiol Drug Saf. 2004; 13(8):525-6. DOI: 10.1002/pds.1002. View

14.

Tourbah A, Gout O, Liblau R, Lyon-Caen O, Bougniot C, Iba-Zizen M . Encephalitis after hepatitis B vaccination: recurrent disseminated encephalitis or MS?. Neurology. 1999; 53(2):396-401. DOI: 10.1212/wnl.53.2.396. View

15.

Velentgas P, Amato A, Bohn R, Chan K, Cochrane T, Funch D . Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination. Pharmacoepidemiol Drug Saf. 2012; 21(12):1350-8. DOI: 10.1002/pds.3321. View

16.

Karussis D . The diagnosis of multiple sclerosis and the various related demyelinating syndromes: a critical review. J Autoimmun. 2014; 48-49:134-42. DOI: 10.1016/j.jaut.2014.01.022. View

17.

DeStefano F, Verstraeten T, Jackson L, Okoro C, Benson P, Black S . Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol. 2003; 60(4):504-9. DOI: 10.1001/archneur.60.4.504. View

18.

Konstantinou D, Paschalis C, Maraziotis T, Dimopoulos P, Bassaris H, Skoutelis A . Two episodes of leukoencephalitis associated with recombinant hepatitis B vaccination in a single patient. Clin Infect Dis. 2001; 33(10):1772-3. DOI: 10.1086/322617. View

19.

Zipp F, Weil J, Einhaupl K . No increase in demyelinating diseases after hepatitis B vaccination. Nat Med. 1999; 5(9):964-5. DOI: 10.1038/12376. View

20.

Zorych I, Madigan D, Ryan P, Bate A . Disproportionality methods for pharmacovigilance in longitudinal observational databases. Stat Methods Med Res. 2011; 22(1):39-56. DOI: 10.1177/0962280211403602. View