Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program

Daniel A. Salmon; Aysha Akhtar; Michelle J. Mergler; Kirsten S. Vannice; Hector Izurieta; Robert Ball; Grace M. Lee; Claudia Vellozzi; Patrick Garman; Francesca Cunningham; Bruce Gellin; Howard Koh; Nicole Lurie; Dale R. Burwen; Jay C. Butler; Vito Caserta; George Curlin; Frank DeStefano; Arthur Elliot; Amy V. Groom; Hayley Hughes; Rita Helfand; Wei Hua; Jeffrey Kelman; George Korch; Philip R. Krause; Sarah Landry; Karen Midthun; Yandong Qiang; John T. Redd; Elizabeth L. Skillen; Andrea Renee Sutherland; Cindy Weinbaum; Robert P. Wise

doi:10.1542/peds.2010-1722L

Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program

Daniel A. Salmon, Aysha Akhtar, Michelle J. Mergler, Kirsten S. Vannice, Hector Izurieta, Robert Ball, Grace M. Lee, Claudia Vellozzi, Patrick Garman, Francesca Cunningham, Bruce Gellin, Howard Koh, Nicole Lurie, Dale R. Burwen, Jay C. Butler, Vito Caserta, George Curlin, Frank DeStefano, Arthur Elliot, Amy V. GroomHayley Hughes, Rita Helfand, Wei Hua, Jeffrey Kelman, George Korch, Philip R. Krause, Sarah Landry, Karen Midthun, Yandong Qiang, John T. Redd, Elizabeth L. Skillen, Andrea Renee Sutherland, Cindy Weinbaum, Robert P. Wise

Bloomberg School of Public Health

Research output: Contribution to journal › Review article › peer-review

40 Scopus citations

Abstract

The effort to vaccinate the US population against the 2009 H1N1 influenza virus hinged, in part, on public confidence in vaccine safety. Early in the vaccine program, >20% of parents reported that they would not vaccinate their children. Concerns about the safety of the vaccines were reported by many parents as a factor that contributed to their intention to forgo vaccination (see www.hsph.harvard.edu/news/ press-releases/2009-releases/survey-40-adults- absolutely-certain-h1n1-vaccine.html and www.med.umich.edu/mott/npch/reports/ h1n1.htm). The safety profiles of 2009 H1N1 monovalent influenza vaccines were anticipated to be (and have been) similar to those of seasonal influenza vaccines, for which an excellent safety profile has been demonstrated. Here we describe steps taken by the US government to (1) assess the key federal systems in place before 2009 for monitoring the safety of vaccines and (2) integrate and upgrade those systems for optimal vaccine-safety monitoring during the 2009 H1N1 monovalent influenza vaccination program. These efforts improved monitoring of 2009 H1N1 vaccine safety, hold promise for enhancing future national monitoring of vaccine safety, and may ultimately help improve public confidence in vaccines.

Original language	English (US)
Pages (from-to)	S78-S86
Journal	Pediatrics
Volume	127
Issue number	SUPPL. 1
DOIs	https://doi.org/10.1542/peds.2010-1722L
State	Published - May 2011

Keywords

H1N1 influenza
Vaccine safety

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health

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10.1542/peds.2010-1722L

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Salmon, D. A., Akhtar, A., Mergler, M. J., Vannice, K. S., Izurieta, H., Ball, R., Lee, G. M., Vellozzi, C., Garman, P., Cunningham, F., Gellin, B., Koh, H., Lurie, N., Burwen, D. R., Butler, J. C., Caserta, V., Curlin, G., DeStefano, F., Elliot, A., ... Wise, R. P. (2011). Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program. Pediatrics, 127(SUPPL. 1), S78-S86. https://doi.org/10.1542/peds.2010-1722L

Salmon, DA, Akhtar, A, Mergler, MJ, Vannice, KS, Izurieta, H, Ball, R, Lee, GM, Vellozzi, C, Garman, P, Cunningham, F, Gellin, B, Koh, H, Lurie, N, Burwen, DR, Butler, JC, Caserta, V, Curlin, G, DeStefano, F, Elliot, A, Groom, AV, Hughes, H, Helfand, R, Hua, W, Kelman, J, Korch, G, Krause, PR, Landry, S, Midthun, K, Qiang, Y, Redd, JT, Skillen, EL, Sutherland, AR, Weinbaum, C & Wise, RP 2011, 'Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program', Pediatrics, vol. 127, no. SUPPL. 1, pp. S78-S86. https://doi.org/10.1542/peds.2010-1722L

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title = "Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program",

abstract = "The effort to vaccinate the US population against the 2009 H1N1 influenza virus hinged, in part, on public confidence in vaccine safety. Early in the vaccine program, >20% of parents reported that they would not vaccinate their children. Concerns about the safety of the vaccines were reported by many parents as a factor that contributed to their intention to forgo vaccination (see www.hsph.harvard.edu/news/ press-releases/2009-releases/survey-40-adults- absolutely-certain-h1n1-vaccine.html and www.med.umich.edu/mott/npch/reports/ h1n1.htm). The safety profiles of 2009 H1N1 monovalent influenza vaccines were anticipated to be (and have been) similar to those of seasonal influenza vaccines, for which an excellent safety profile has been demonstrated. Here we describe steps taken by the US government to (1) assess the key federal systems in place before 2009 for monitoring the safety of vaccines and (2) integrate and upgrade those systems for optimal vaccine-safety monitoring during the 2009 H1N1 monovalent influenza vaccination program. These efforts improved monitoring of 2009 H1N1 vaccine safety, hold promise for enhancing future national monitoring of vaccine safety, and may ultimately help improve public confidence in vaccines.",

keywords = "H1N1 influenza, Vaccine safety",

author = "Salmon, {Daniel A.} and Aysha Akhtar and Mergler, {Michelle J.} and Vannice, {Kirsten S.} and Hector Izurieta and Robert Ball and Lee, {Grace M.} and Claudia Vellozzi and Patrick Garman and Francesca Cunningham and Bruce Gellin and Howard Koh and Nicole Lurie and Burwen, {Dale R.} and Butler, {Jay C.} and Vito Caserta and George Curlin and Frank DeStefano and Arthur Elliot and Groom, {Amy V.} and Hayley Hughes and Rita Helfand and Wei Hua and Jeffrey Kelman and George Korch and Krause, {Philip R.} and Sarah Landry and Karen Midthun and Yandong Qiang and Redd, {John T.} and Skillen, {Elizabeth L.} and Sutherland, {Andrea Renee} and Cindy Weinbaum and Wise, {Robert P.}",

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AU - Salmon, Daniel A.

AU - Akhtar, Aysha

AU - Mergler, Michelle J.

AU - Vannice, Kirsten S.

AU - Izurieta, Hector

AU - Ball, Robert

AU - Lee, Grace M.

AU - Vellozzi, Claudia

AU - Garman, Patrick

AU - Cunningham, Francesca

AU - Gellin, Bruce

AU - Koh, Howard

AU - Lurie, Nicole

AU - Burwen, Dale R.

AU - Butler, Jay C.

AU - Caserta, Vito

AU - Curlin, George

AU - DeStefano, Frank

AU - Elliot, Arthur

AU - Groom, Amy V.

AU - Hughes, Hayley

AU - Helfand, Rita

AU - Hua, Wei

AU - Kelman, Jeffrey

AU - Korch, George

AU - Krause, Philip R.

AU - Landry, Sarah

AU - Midthun, Karen

AU - Qiang, Yandong

AU - Redd, John T.

AU - Skillen, Elizabeth L.

AU - Sutherland, Andrea Renee

AU - Weinbaum, Cindy

AU - Wise, Robert P.

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N2 - The effort to vaccinate the US population against the 2009 H1N1 influenza virus hinged, in part, on public confidence in vaccine safety. Early in the vaccine program, >20% of parents reported that they would not vaccinate their children. Concerns about the safety of the vaccines were reported by many parents as a factor that contributed to their intention to forgo vaccination (see www.hsph.harvard.edu/news/ press-releases/2009-releases/survey-40-adults- absolutely-certain-h1n1-vaccine.html and www.med.umich.edu/mott/npch/reports/ h1n1.htm). The safety profiles of 2009 H1N1 monovalent influenza vaccines were anticipated to be (and have been) similar to those of seasonal influenza vaccines, for which an excellent safety profile has been demonstrated. Here we describe steps taken by the US government to (1) assess the key federal systems in place before 2009 for monitoring the safety of vaccines and (2) integrate and upgrade those systems for optimal vaccine-safety monitoring during the 2009 H1N1 monovalent influenza vaccination program. These efforts improved monitoring of 2009 H1N1 vaccine safety, hold promise for enhancing future national monitoring of vaccine safety, and may ultimately help improve public confidence in vaccines.

AB - The effort to vaccinate the US population against the 2009 H1N1 influenza virus hinged, in part, on public confidence in vaccine safety. Early in the vaccine program, >20% of parents reported that they would not vaccinate their children. Concerns about the safety of the vaccines were reported by many parents as a factor that contributed to their intention to forgo vaccination (see www.hsph.harvard.edu/news/ press-releases/2009-releases/survey-40-adults- absolutely-certain-h1n1-vaccine.html and www.med.umich.edu/mott/npch/reports/ h1n1.htm). The safety profiles of 2009 H1N1 monovalent influenza vaccines were anticipated to be (and have been) similar to those of seasonal influenza vaccines, for which an excellent safety profile has been demonstrated. Here we describe steps taken by the US government to (1) assess the key federal systems in place before 2009 for monitoring the safety of vaccines and (2) integrate and upgrade those systems for optimal vaccine-safety monitoring during the 2009 H1N1 monovalent influenza vaccination program. These efforts improved monitoring of 2009 H1N1 vaccine safety, hold promise for enhancing future national monitoring of vaccine safety, and may ultimately help improve public confidence in vaccines.

KW - H1N1 influenza

KW - Vaccine safety

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Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program

Abstract

Keywords

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