tetano
Editor, Senior Moderator
Vaccine. 2019 Sep 17. pii: S0264-410X(19)31244-7. doi: 10.1016/j.vaccine.2019.09.035. [Epub ahead of print]
[h=1]Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15.[/h] Donahue JG[SUP]1[/SUP], Kieke BA[SUP]2[/SUP], King JP[SUP]3[/SUP], Mascola MA[SUP]4[/SUP], Shimabukuro TT[SUP]5[/SUP], DeStefano F[SUP]6[/SUP], Hanson KE[SUP]7[/SUP], McClure DL[SUP]8[/SUP], Olaiya O[SUP]9[/SUP], Glanz JM[SUP]10[/SUP], Hechter RC[SUP]11[/SUP], Irving SA[SUP]12[/SUP], Jackson LA[SUP]13[/SUP], Klein NP[SUP]14[/SUP], Naleway AL[SUP]15[/SUP], Weintraub ES[SUP]16[/SUP], Belongia EA[SUP]17[/SUP].
[h=3]Author information[/h] 1 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: donahue.james@mcrf.mfldclin.edu. 2 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: kieke.burney@marshfieldresearch.org. 3 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: king.jennifer@marshfieldresearch.org. 4 Marshfield Clinic, Department of Obstetrics and Gynecology, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: mascola.maria@marshfieldclinic.org. 5 Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: ayv6@cdc.gov. 6 Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: fxd1@cdc.gov. 7 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: hanson.kayla@marshfieldresearch.org. 8 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: mcclure.david@marshfieldresearch.org. 9 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: olaiya.oluwatosin@marshfieldresearch.org. 10 Kaiser Permanente Colorado, 10065 E Harvard Ave, Suite 300, Denver, CO 80231, United States. Electronic address: jason.m.glanz@kp.org. 11 Kaiser Permanente Southern California, 100 S Los Robles Ave., 2nd Floor, Pasadena, CA 91101, United States. Electronic address: rulin.c.hechter@kp.org. 12 Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, United States. Electronic address: stephanie.a.irving@kpchr.org. 13 Kaiser Permanente Washington, 1730 Minor Ave, Suite 1600, Seattle, WA 98101, United States. Electronic address: lisa.a.jackson@kp.org. 14 Kaiser Permanente Northern California, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, United States. Electronic address: Nicola.Klein@kp.org. 15 Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, United States. Electronic address: Allison.Naleway@kpchr.org. 16 Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: eiw8@cdc.gov. 17 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: belongia.edward@marshfieldclinic.org.
[h=3]Abstract[/h] [h=4]INTRODUCTION:[/h] A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three recent influenza seasons and SAB among women who were and were not vaccinated in the previous influenza season.
[h=4]METHODS:[/h] We conducted a case-control study over three influenza seasons (2012-13, 2013-14, 2014-15) in the Vaccine Safety Datalink (VSD). Cases (women with SAB) and controls (women with live births) were matched on VSD site, date of last menstrual period, age group, and influenza vaccination status in the previous influenza season. Of 1908 presumptive cases identified from the electronic record, 1236 were included in the main analysis. Administration of IIV was documented in several risk windows, including 1-28, 29-56, and >56 days before the SAB date.
[h=4]RESULTS:[/h] Among 627 matched pairs vaccinated in the previous season, no association was found between vaccination in the 1-28 day risk window and SAB (adjusted odds ratio (aOR) 0.9; 95% confidence interval (CI) 0.6-1.5). The season-specific aOR ranged from 0.5 to 1.7 with all CIs including the null value of 1.0. Similarly, no association was found among women who were not vaccinated in the previous season; the season-specific aOR in the 1-28 day risk window ranged from 0.6 to 0.7 and the 95% CI included 1.0 in each season. There was no association found between SAB and influenza vaccination in the other risk windows, or when vaccine receipt was analyzed relative to date of conception.
[h=4]CONCLUSION:[/h] During these seasons we found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Influenza; Influenza vaccine; Pregnancy; Spontaneous abortion
PMID: 31540812 DOI: 10.1016/j.vaccine.2019.09.035
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[h=1]Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15.[/h] Donahue JG[SUP]1[/SUP], Kieke BA[SUP]2[/SUP], King JP[SUP]3[/SUP], Mascola MA[SUP]4[/SUP], Shimabukuro TT[SUP]5[/SUP], DeStefano F[SUP]6[/SUP], Hanson KE[SUP]7[/SUP], McClure DL[SUP]8[/SUP], Olaiya O[SUP]9[/SUP], Glanz JM[SUP]10[/SUP], Hechter RC[SUP]11[/SUP], Irving SA[SUP]12[/SUP], Jackson LA[SUP]13[/SUP], Klein NP[SUP]14[/SUP], Naleway AL[SUP]15[/SUP], Weintraub ES[SUP]16[/SUP], Belongia EA[SUP]17[/SUP].
[h=3]Author information[/h] 1 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: donahue.james@mcrf.mfldclin.edu. 2 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: kieke.burney@marshfieldresearch.org. 3 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: king.jennifer@marshfieldresearch.org. 4 Marshfield Clinic, Department of Obstetrics and Gynecology, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: mascola.maria@marshfieldclinic.org. 5 Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: ayv6@cdc.gov. 6 Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: fxd1@cdc.gov. 7 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: hanson.kayla@marshfieldresearch.org. 8 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: mcclure.david@marshfieldresearch.org. 9 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: olaiya.oluwatosin@marshfieldresearch.org. 10 Kaiser Permanente Colorado, 10065 E Harvard Ave, Suite 300, Denver, CO 80231, United States. Electronic address: jason.m.glanz@kp.org. 11 Kaiser Permanente Southern California, 100 S Los Robles Ave., 2nd Floor, Pasadena, CA 91101, United States. Electronic address: rulin.c.hechter@kp.org. 12 Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, United States. Electronic address: stephanie.a.irving@kpchr.org. 13 Kaiser Permanente Washington, 1730 Minor Ave, Suite 1600, Seattle, WA 98101, United States. Electronic address: lisa.a.jackson@kp.org. 14 Kaiser Permanente Northern California, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, United States. Electronic address: Nicola.Klein@kp.org. 15 Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, United States. Electronic address: Allison.Naleway@kpchr.org. 16 Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: eiw8@cdc.gov. 17 Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: belongia.edward@marshfieldclinic.org.
[h=3]Abstract[/h] [h=4]INTRODUCTION:[/h] A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three recent influenza seasons and SAB among women who were and were not vaccinated in the previous influenza season.
[h=4]METHODS:[/h] We conducted a case-control study over three influenza seasons (2012-13, 2013-14, 2014-15) in the Vaccine Safety Datalink (VSD). Cases (women with SAB) and controls (women with live births) were matched on VSD site, date of last menstrual period, age group, and influenza vaccination status in the previous influenza season. Of 1908 presumptive cases identified from the electronic record, 1236 were included in the main analysis. Administration of IIV was documented in several risk windows, including 1-28, 29-56, and >56 days before the SAB date.
[h=4]RESULTS:[/h] Among 627 matched pairs vaccinated in the previous season, no association was found between vaccination in the 1-28 day risk window and SAB (adjusted odds ratio (aOR) 0.9; 95% confidence interval (CI) 0.6-1.5). The season-specific aOR ranged from 0.5 to 1.7 with all CIs including the null value of 1.0. Similarly, no association was found among women who were not vaccinated in the previous season; the season-specific aOR in the 1-28 day risk window ranged from 0.6 to 0.7 and the 95% CI included 1.0 in each season. There was no association found between SAB and influenza vaccination in the other risk windows, or when vaccine receipt was analyzed relative to date of conception.
[h=4]CONCLUSION:[/h] During these seasons we found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Influenza; Influenza vaccine; Pregnancy; Spontaneous abortion
PMID: 31540812 DOI: 10.1016/j.vaccine.2019.09.035
Free full text