GrippeCanadaV3, Main, Exploration, bibRecord, 000126

Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS.

Identifieur interne : 000126 ( Main/Exploration ); précédent : 000125; suivant : 000127

Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS.

Auteurs : Christina D. Chambers [États-Unis] ; Diana L. Johnson [États-Unis] ; Ronghui Xu [États-Unis] ; Yunjun J. Luo [États-Unis] ; Carol Louik [États-Unis] ; Allen A. Mitchell [États-Unis] ; Michael Schatz [États-Unis] ; Kenneth L. Jones [États-Unis]

Source :

Vaccine [ 1873-2518 ] ; 2016.

RBID : pubmed:27449682

Descripteurs français

KwdFr :
- Avortement spontané (épidémiologie), Canada, Femelle, Grippe humaine (), Grossesse, Humains, Issue de la grossesse, Malformations (épidémiologie), Modèles de hasards proportionnels, Naissance prématurée (épidémiologie), Nourrisson petit pour son âge gestationnel, Risque, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), États-Unis d'Amérique, Études cas-témoins, Études prospectives.
MESH :
- administration et posologie : Vaccins antigrippaux.
- effets indésirables : Vaccins antigrippaux.
- épidémiologie : Avortement spontané, Malformations, Naissance prématurée.
- Canada, Femelle, Grippe humaine, Grossesse, Humains, Issue de la grossesse, Modèles de hasards proportionnels, Nourrisson petit pour son âge gestationnel, Risque, États-Unis d'Amérique, Études cas-témoins, Études prospectives.

English descriptors

KwdEn :
- Abortion, Spontaneous (epidemiology), Canada, Case-Control Studies, Congenital Abnormalities (epidemiology), Female, Humans, Infant, Small for Gestational Age, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (prevention & control), Pregnancy, Pregnancy Outcome, Premature Birth (epidemiology), Proportional Hazards Models, Prospective Studies, Risk, United States.
MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- epidemiology : Abortion, Spontaneous, Congenital Abnormalities, Premature Birth.
- prevention & control : Influenza, Human.
- Canada, Case-Control Studies, Female, Humans, Infant, Small for Gestational Age, Pregnancy, Pregnancy Outcome, Proportional Hazards Models, Prospective Studies, Risk, United States.

Abstract

INTRODUCTION

There is a need for pregnancy safety information overall and for each seasonal formulation of the influenza vaccine.

METHODS

As part of the cohort arm of the Vaccines and Medications in Pregnancy Surveillance System, vaccine-exposed and unexposed women in the U.S. or Canada were recruited during pregnancy in the 2010-2014 vaccine seasons and followed to pregnancy outcome. For the four seasons combined, crude and adjusted relative risks (RRs) were estimated with 95% confidence intervals (CIs) for major birth defects overall and infants small for gestational age. Crude and adjusted hazard ratios (HRs) were estimated with 95% CIs for spontaneous abortion and preterm delivery. Specific influenza season subanalyses were also conducted.

RESULTS

Of 1730 women, 1263 were exposed to an influenza vaccine and 467 were unexposed to any influenza vaccine. Among pregnancies with first-trimester exposure excluding lost-to-follow-up, 26/457 (5.7%) resulted in an infant with a major birth defect compared to 13/427 (3.0%) in the unexposed (RR 1.87, 95% CI 0.97, 3.59). No specific pattern of defects was evident in the vaccine-exposed cohort. The overall risk of spontaneous abortion was not elevated (HR 1.09, 95% CI 0.49, 2.40). Adjusted HRs for preterm delivery approximated 1.0 (adjusted HR 1.23, 95% CI 0.75, 2.02). RRs for small for gestational age infants on weight, length and head circumference ranged from 1.19 to 1.49 with all CIs including 1. Season-by-season analyses resulted in variation by season; however, estimates were based on small numbers.

CONCLUSIONS

Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine.

DOI: 10.1016/j.vaccine.2016.06.054
PubMed: 27449682

Affiliations:

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<term>Canada</term>
<term>Case-Control Studies</term>
<term>Congenital Abnormalities (epidemiology)</term>
<term>Female</term>
<term>Humans</term>
<term>Infant, Small for Gestational Age</term>
<term>Influenza Vaccines (administration & dosage)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza, Human (prevention & control)</term>
<term>Pregnancy</term>
<term>Pregnancy Outcome</term>
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<term>Prospective Studies</term>
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<term>Canada</term>
<term>Femelle</term>
<term>Grippe humaine ()</term>
<term>Grossesse</term>
<term>Humains</term>
<term>Issue de la grossesse</term>
<term>Malformations (épidémiologie)</term>
<term>Modèles de hasards proportionnels</term>
<term>Naissance prématurée (épidémiologie)</term>
<term>Nourrisson petit pour son âge gestationnel</term>
<term>Risque</term>
<term>Vaccins antigrippaux (administration et posologie)</term>
<term>Vaccins antigrippaux (effets indésirables)</term>
<term>États-Unis d'Amérique</term>
<term>Études cas-témoins</term>
<term>Études prospectives</term>
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<term>Premature Birth</term>
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<term>Naissance prématurée</term>
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<term>Grossesse</term>
<term>Humains</term>
<term>Issue de la grossesse</term>
<term>Modèles de hasards proportionnels</term>
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<front><div type="abstract" xml:lang="en"><p><b>INTRODUCTION</b>
</p>
<p>There is a need for pregnancy safety information overall and for each seasonal formulation of the influenza vaccine.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>As part of the cohort arm of the Vaccines and Medications in Pregnancy Surveillance System, vaccine-exposed and unexposed women in the U.S. or Canada were recruited during pregnancy in the 2010-2014 vaccine seasons and followed to pregnancy outcome. For the four seasons combined, crude and adjusted relative risks (RRs) were estimated with 95% confidence intervals (CIs) for major birth defects overall and infants small for gestational age. Crude and adjusted hazard ratios (HRs) were estimated with 95% CIs for spontaneous abortion and preterm delivery. Specific influenza season subanalyses were also conducted.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Of 1730 women, 1263 were exposed to an influenza vaccine and 467 were unexposed to any influenza vaccine. Among pregnancies with first-trimester exposure excluding lost-to-follow-up, 26/457 (5.7%) resulted in an infant with a major birth defect compared to 13/427 (3.0%) in the unexposed (RR 1.87, 95% CI 0.97, 3.59). No specific pattern of defects was evident in the vaccine-exposed cohort. The overall risk of spontaneous abortion was not elevated (HR 1.09, 95% CI 0.49, 2.40). Adjusted HRs for preterm delivery approximated 1.0 (adjusted HR 1.23, 95% CI 0.75, 2.02). RRs for small for gestational age infants on weight, length and head circumference ranged from 1.19 to 1.49 with all CIs including 1. Season-by-season analyses resulted in variation by season; however, estimates were based on small numbers.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27449682</PMID>
<DateCompleted><Year>2017</Year>
<Month>11</Month>
<Day>06</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>12</Month>
<Day>05</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>34</Volume>
<Issue>37</Issue>
<PubDate><Year>2016</Year>
<Month>08</Month>
<Day>17</Day>
</PubDate>
</JournalIssue>
<Title>Vaccine</Title>
<ISOAbbreviation>Vaccine</ISOAbbreviation>
</Journal>
<ArticleTitle>Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS.</ArticleTitle>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2016.06.054</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0264-410X(16)30478-9</ELocationID>
<Abstract><AbstractText Label="INTRODUCTION">There is a need for pregnancy safety information overall and for each seasonal formulation of the influenza vaccine.</AbstractText>
<AbstractText Label="METHODS">As part of the cohort arm of the Vaccines and Medications in Pregnancy Surveillance System, vaccine-exposed and unexposed women in the U.S. or Canada were recruited during pregnancy in the 2010-2014 vaccine seasons and followed to pregnancy outcome. For the four seasons combined, crude and adjusted relative risks (RRs) were estimated with 95% confidence intervals (CIs) for major birth defects overall and infants small for gestational age. Crude and adjusted hazard ratios (HRs) were estimated with 95% CIs for spontaneous abortion and preterm delivery. Specific influenza season subanalyses were also conducted.</AbstractText>
<AbstractText Label="RESULTS">Of 1730 women, 1263 were exposed to an influenza vaccine and 467 were unexposed to any influenza vaccine. Among pregnancies with first-trimester exposure excluding lost-to-follow-up, 26/457 (5.7%) resulted in an infant with a major birth defect compared to 13/427 (3.0%) in the unexposed (RR 1.87, 95% CI 0.97, 3.59). No specific pattern of defects was evident in the vaccine-exposed cohort. The overall risk of spontaneous abortion was not elevated (HR 1.09, 95% CI 0.49, 2.40). Adjusted HRs for preterm delivery approximated 1.0 (adjusted HR 1.23, 95% CI 0.75, 2.02). RRs for small for gestational age infants on weight, length and head circumference ranged from 1.19 to 1.49 with all CIs including 1. Season-by-season analyses resulted in variation by season; however, estimates were based on small numbers.</AbstractText>
<AbstractText Label="CONCLUSIONS">Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine.</AbstractText>
<CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Chambers</LastName>
<ForeName>Christina D</ForeName>
<Initials>CD</Initials>
<AffiliationInfo><Affiliation>Department of Pediatrics, University of California San Diego, La Jolla, CA, United States; Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States. Electronic address: chchambers@ucsd.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Johnson</LastName>
<ForeName>Diana L</ForeName>
<Initials>DL</Initials>
<AffiliationInfo><Affiliation>Department of Pediatrics, University of California San Diego, La Jolla, CA, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Xu</LastName>
<ForeName>Ronghui</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, United States; Department of Mathematics, University of California San Diego, La Jolla, CA, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Luo</LastName>
<ForeName>Yunjun J</ForeName>
<Initials>YJ</Initials>
<AffiliationInfo><Affiliation>Department of Pediatrics, University of California San Diego, La Jolla, CA, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Louik</LastName>
<ForeName>Carol</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Slone Epidemiology Center at Boston University, Boston, MA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mitchell</LastName>
<ForeName>Allen A</ForeName>
<Initials>AA</Initials>
<AffiliationInfo><Affiliation>Slone Epidemiology Center at Boston University, Boston, MA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Schatz</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>American Academy of Asthma, Allergy & Immunology, Milwaukee, WI, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jones</LastName>
<ForeName>Kenneth L</ForeName>
<Initials>KL</Initials>
<AffiliationInfo><Affiliation>Department of Pediatrics, University of California San Diego, La Jolla, CA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><CollectiveName>OTIS Collaborative Research Group</CollectiveName>
</Author>
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<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>07</Month>
<Day>20</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>Netherlands</Country>
<MedlineTA>Vaccine</MedlineTA>
<NlmUniqueID>8406899</NlmUniqueID>
<ISSNLinking>0264-410X</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000022" MajorTopicYN="N">Abortion, Spontaneous</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002170" MajorTopicYN="N">Canada</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000013" MajorTopicYN="N">Congenital Abnormalities</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007236" MajorTopicYN="Y">Infant, Small for Gestational Age</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011247" MajorTopicYN="N">Pregnancy</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011256" MajorTopicYN="N">Pregnancy Outcome</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D047928" MajorTopicYN="N">Premature Birth</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012306" MajorTopicYN="N">Risk</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N">United States</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Birth defects</Keyword>
<Keyword MajorTopicYN="Y">Influenza vaccine</Keyword>
<Keyword MajorTopicYN="Y">Pregnancy</Keyword>
<Keyword MajorTopicYN="Y">Preterm delivery</Keyword>
<Keyword MajorTopicYN="Y">Safety</Keyword>
<Keyword MajorTopicYN="Y">Small for gestational age</Keyword>
<Keyword MajorTopicYN="Y">Spontaneous abortion</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year>
<Month>03</Month>
<Day>01</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2016</Year>
<Month>06</Month>
<Day>13</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2016</Year>
<Month>06</Month>
<Day>16</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>7</Month>
<Day>25</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2016</Year>
<Month>7</Month>
<Day>28</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>11</Month>
<Day>7</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">27449682</ArticleId>
<ArticleId IdType="pii">S0264-410X(16)30478-9</ArticleId>
<ArticleId IdType="doi">10.1016/j.vaccine.2016.06.054</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Californie</li>
</region>
</list>
<tree><country name="États-Unis"><noRegion><name sortKey="Chambers, Christina D" sort="Chambers, Christina D" uniqKey="Chambers C" first="Christina D" last="Chambers">Christina D. Chambers</name>
</noRegion>
<name sortKey="Johnson, Diana L" sort="Johnson, Diana L" uniqKey="Johnson D" first="Diana L" last="Johnson">Diana L. Johnson</name>
<name sortKey="Jones, Kenneth L" sort="Jones, Kenneth L" uniqKey="Jones K" first="Kenneth L" last="Jones">Kenneth L. Jones</name>
<name sortKey="Louik, Carol" sort="Louik, Carol" uniqKey="Louik C" first="Carol" last="Louik">Carol Louik</name>
<name sortKey="Luo, Yunjun J" sort="Luo, Yunjun J" uniqKey="Luo Y" first="Yunjun J" last="Luo">Yunjun J. Luo</name>
<name sortKey="Mitchell, Allen A" sort="Mitchell, Allen A" uniqKey="Mitchell A" first="Allen A" last="Mitchell">Allen A. Mitchell</name>
<name sortKey="Schatz, Michael" sort="Schatz, Michael" uniqKey="Schatz M" first="Michael" last="Schatz">Michael Schatz</name>
<name sortKey="Xu, Ronghui" sort="Xu, Ronghui" uniqKey="Xu R" first="Ronghui" last="Xu">Ronghui Xu</name>
</country>
</tree>
</affiliations>
</record>

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Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS.

Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS.

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