International collaborative safety monitoring for pandemic 2009 H1N1 vaccines: Estimation of the risk of Guillain-Barre syndrome-Singapore experience. Umapathi, T. Journal of the Peripheral Nervous System, 16(SUPPL. 3):S137–S138, 2011. ![International collaborative safety monitoring for pandemic 2009 H1N1 vaccines: Estimation of the risk of Guillain-Barre syndrome-Singapore experience [link]](https://bibbase.org/img/filetypes/link.svg "link")
Paper doi abstract bibtex To investigate the relationship between H1N1 vaccines and Guillain-Barre syndrome (GBS), an international collaborative consortium was set up in late 2009. It employed a self-controlled case series methodology, based on identifying all cases of GBS in a defined population and period, and then enquiring their vaccination status. This allows for calculation of the relative incidence of GBS with seasonality of influenza and seasonal influenza vaccination as time-varying confounders. Singapore is a collaborating center. All GBS patients admitted to two major public hospitals, covering a third of Singapore's population, were enrolled. Information on H1N1 vaccine exposure, vaccine-type and other vaccinations received was gathered. This was verified independently with the Singapore National Immunization Registry. Risk period was defined as days 1-42 post vaccination. All cases were diagnosed by neurologists using standard criteria and the Brighton case definitions. Vaccination with a monovalent H1N1 pandemic influenza strain started in October 2009, peaked in November 2009 to January 2010. In August 2010, WHO declared an end to the 2009 H1N1 influenza pandemic. With the availability of the trivalent seasonal influenza vaccines that contain the H1N1 pandemic strain, the take-up rate of the monovalent H1N1 pandemic influenza vaccine dropped significantly in the last quarter of 2010. GBS data collection in Singapore started in February 2010 after the study protocol was finalized and IRB approval was obtained. From February to October 2010, 22 GBS cases were identified (20 cases Brighton 4A, one Brighton 4 and one Brighton 2). Five patients were exposed to H1N1 vaccine but only two within six weeks following vaccination. One was a 77-year-old female who also received meningococcal vaccine at the same visit. She developed GBS one day after vaccination. The other was a 19-year-old army recruit who received H1N1, tetanus, typhoid and oral polio vaccines ten days prior to developing acute motor sensory axonal neuropathy. IgG anti-GD1b and -GT1a antibodies were detected in his serum. This data was submitted to the international collaboration for analysis. Simulation models used to calculate the risk of GBS after H1N1 vaccination will be discussed.
@article{umapathi_international_2011,
title = {International collaborative safety monitoring for pandemic 2009 {H1N1} vaccines: {Estimation} of the risk of {Guillain}-{Barre} syndrome-{Singapore} experience},
volume = {16},
issn = {1085-9489},
url = {http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed12&NEWS=N&AN=70506396},
doi = {10.1111/j.1529-8027.2011.00335.x},
abstract = {To investigate the relationship between H1N1 vaccines and Guillain-Barre syndrome (GBS), an international collaborative consortium was set up in late 2009. It employed a self-controlled case series methodology, based on identifying all cases of GBS in a defined population and period, and then enquiring their vaccination status. This allows for calculation of the relative incidence of GBS with seasonality of influenza and seasonal influenza vaccination as time-varying confounders. Singapore is a collaborating center. All GBS patients admitted to two major public hospitals, covering a third of Singapore's population, were enrolled. Information on H1N1 vaccine exposure, vaccine-type and other vaccinations received was gathered. This was verified independently with the Singapore National Immunization Registry. Risk period was defined as days 1-42 post vaccination. All cases were diagnosed by neurologists using standard criteria and the Brighton case definitions. Vaccination with a monovalent H1N1 pandemic influenza strain started in October 2009, peaked in November 2009 to January 2010. In August 2010, WHO declared an end to the 2009 H1N1 influenza pandemic. With the availability of the trivalent seasonal influenza vaccines that contain the H1N1 pandemic strain, the take-up rate of the monovalent H1N1 pandemic influenza vaccine dropped significantly in the last quarter of 2010. GBS data collection in Singapore started in February 2010 after the study protocol was finalized and IRB approval was obtained. From February to October 2010, 22 GBS cases were identified (20 cases Brighton 4A, one Brighton 4 and one Brighton 2). Five patients were exposed to H1N1 vaccine but only two within six weeks following vaccination. One was a 77-year-old female who also received meningococcal vaccine at the same visit. She developed GBS one day after vaccination. The other was a 19-year-old army recruit who received H1N1, tetanus, typhoid and oral polio vaccines ten days prior to developing acute motor sensory axonal neuropathy. IgG anti-GD1b and -GT1a antibodies were detected in his serum. This data was submitted to the international collaboration for analysis. Simulation models used to calculate the risk of GBS after H1N1 vaccination will be discussed.},
language = {English},
number = {SUPPL. 3},
journal = {Journal of the Peripheral Nervous System},
author = {Umapathi, T.},
year = {2011},
keywords = {*Guillain Barre syndrome, *Singapore, *monitoring, *pandemic, *peripheral nerve, *risk, *safety, *society, *vaccine, Meningococcus vaccine, World Health Organization, antibody, army, case study, exposure, female, human, immunization, immunoglobulin G, influenza, influenza vaccination, influenza vaccine, information processing, methodology, neuropathy, oral poliomyelitis vaccine, pandemic influenza, patient, population, public hospital, register, seasonal influenza, seasonal variation, serum, simulation, tetanus, typhoid fever, vaccination},
pages = {S137--S138},
}
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This allows for calculation of the relative incidence of GBS with seasonality of influenza and seasonal influenza vaccination as time-varying confounders. Singapore is a collaborating center. All GBS patients admitted to two major public hospitals, covering a third of Singapore's population, were enrolled. Information on H1N1 vaccine exposure, vaccine-type and other vaccinations received was gathered. This was verified independently with the Singapore National Immunization Registry. Risk period was defined as days 1-42 post vaccination. All cases were diagnosed by neurologists using standard criteria and the Brighton case definitions. Vaccination with a monovalent H1N1 pandemic influenza strain started in October 2009, peaked in November 2009 to January 2010. In August 2010, WHO declared an end to the 2009 H1N1 influenza pandemic. 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