Title: Progress in overcoming barriers to influenza immunization of pregnant women
Abstract: We are pleased to bring you this special issue of the American Journal of Obstetrics and Gynecology entitled “Progress in Overcoming Barriers to Influenza Immunization of Pregnant Women.” All of the manuscripts included in this special issue of the American Journal of Obstetrics and Gynecology are based on presentations made and discussions held at a 2-day meeting on October 27-28, 2011, in Rockville, MD. The conference was sponsored by the National Vaccine Program Office, and cosponsored by the American College of Obstetricians and Gynecologists, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institute of Allergy and Infectious Diseases. Representation at the conference is shown in the Table. The objectives of the meeting were to assess progress in overcoming barriers to pregnant women receiving influenza immunization, and to prioritize the next research and programmatic steps toward the goal of all pregnant women in the United States receiving influenza vaccine annually, as been recommended by the Advisory Committee on Immunization Practices and other groups for years.1Burney L.E. Influenza immunization: statement.Public Health Rep. 1960; 75: 944Crossref PubMed Google Scholar, 2Centers for Disease Control and PreventionPrevention and control of influenza, part 1, vaccines: recommendations of the Advisory Committee on Immunization Practices.MMWR Morb Mortal Wkly Rep. 1994; 43: 1-13Google Scholar, 3Centers for Disease Control and PreventionPrevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices.MMWR Morb Mortal Wkly Rep. 1995; 44: 1-22PubMed Google Scholar, 4Centers for Disease Control and PreventionPrevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR Morb Mortal Wkly Rep. 1997; 46: 1-25PubMed Google Scholar, 5Centers for Disease Control and PreventionPrevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR Morb Mortal Wkly Rep. 2004; 53: 1-40PubMed Google Scholar, 6American College of Obstetricians and GynecologistsCommittee opinion: influenza vaccination during pregnancy.Obstet Gynecol. 2010; 116: 1006-1007Crossref PubMed Scopus (99) Google Scholar, 7Centers for Disease Control and PreventionPrevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices.MMWR Morb Mortal Wkly Rep. 2010; 59: 1-62PubMed Google Scholar, 8Centers for Disease Control and PreventionPrevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011.MMWR Morb Mortal Wkly Rep. 2011; 60: 1128-1132PubMed Google ScholarTABLERepresentation at the Conference on Progress in Overcoming Barriers to Influenza Immunization for Pregnant WomenA. Universities and other research centers ○ Baylor College of Medicine ○ Boston University ○ Dalhousie University ○ Duke University ○ Emory University ○ Health Partners Research Foundation ○ Kaiser Permanente Northwest–Center for Health Research ○ Massachusetts General Hospital ○ Mount Sinai School of Medicine ○ University of Alabama at Birmingham ○ University of Cincinnati ○ University of Colorado ○ University of Pittsburgh ○ University of Washington ○ Vanderbilt University ○ Wake Forest University ○ Wayne State UniversityB. Organizations ○ Advisory Committee on Immunization Practices ○ American Academy of Family Practice ○ American Academy of Pediatrics ○ American College of Obstetricians and Gynecologists ○ American Medical Association ○ American Nurses Association ○ American Pharmacists Association ○ Association of Maternal and Child Health Programs ○ Association of State and Territorial Health Officials ○ Association of Women's Health, Obstetric, and Neonatal Nurses ○ Gates Foundation ○ National Hispanic Medical Association ○ National Medical Association ○ Society for Maternal-Fetal MedicineC. Federal government agencies and offices ○ Centers for Disease Control and Prevention ○ Food and Drug Administration ○ Health Resources Services Administration ○ Indian Health Service ○ National Institutes of Health ○ National Vaccine Program Office ○ Office of the General Counsel/Department of Health and Human ServicesD. Vaccine manufacturers ○ CSL Biotherapies ○ GlaxoSmithKline ○ Merck ○ Novartis ○ Sanofi PasteurRead. Progress in overcoming influenza immunization barriers. Am J Obstet Gynecol 2012. Open table in a new tab Read. Progress in overcoming influenza immunization barriers. Am J Obstet Gynecol 2012. As reviewed by Rasmussen and colleagues,9Rasmussen S.A. Jamieson D.J. Uyeki T.M. Effects of influenza on pregnant women and infants.Am J Obstet Gynecol. 2012; 207: S3-S8Abstract Full Text Full Text PDF PubMed Scopus (251) Google Scholar both pregnant women and young infants are at increased risk for morbidity and mortality with influenza illness. Influenza immunization rates among pregnant women in the United States have increased substantially over the past decade, yet the most recent data indicate half of all pregnant women in the United States remain unvaccinated.10Kennedy E.D. Ahluwalia I.B. Ding H. Lu P.-J. Singleton J.A. Bridges C.B. Monitoring seasonal influenza vaccination coverage among pregnant women in the United States.Am J Obstet Gynecol. 2012; 207: S9-S16Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar Current data support the immunogenicity and effectiveness of inactivated influenza vaccine among pregnant women.11Jamieson D.J. Kissen D.M. Bridges C.B. Rasmussen S.A. Benefits of influenza vaccination during pregnancy for pregnant women.Am J Obstet Gynecol. 2012; 207: S17-S20Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar In addition, the available evidence indicates influenza immunization during pregnancy conveys fetal and infant protection.12Steinhoff M.C. Omer S.B. A review of fetal and infant protection associated with antenatal influenza immunization.Am J Obstet Gynecol. 2012; 207: S21-S27Abstract Full Text Full Text PDF PubMed Scopus (53) Google Scholar Additional immunogenicity and efficacy studies of influenza immunization during pregnancy are underway, both in the United States and in other countries.13Adegbola R. Nesin M. Wairagkar N. Immunogenicity and efficacy of influenza immunization during pregnancy: recent and ongoing studies.Am J Obstet Gynecol. 2012; 207: S28-S32Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar The long history of research regarding the safety (for the pregnant woman14Munoz F.M. Safety of influenza vaccines in pregnant women.Am J Obstet Gynecol. 2012; 207: S33-S37Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar and for the fetus or neonate15Bednarcyzk R.A. Adjaye-Gbewonyo D. Omer S.B. Safety of influenza immunization during pregnancy for the fetus and the neonate.Am J Obstet Gynecol. 2012; 207: S38-S46Abstract Full Text Full Text PDF PubMed Scopus (68) Google Scholar) is reviewed in this special issue, and Kharbanda and colleagues16Kharbanda E.O. Vazquez-Benitez G. Shi W.X. et al.Assessing the safety of influenza immunization during pregnancy: the Vaccine Safety Datalink.Am J Obstet Gynecol. 2012; 207: S47-S51Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar describe ongoing efforts to assess the safety of such immunization within the Vaccine Safety Datalink. Postlicensure efforts to monitor the safety of US-licensed vaccines administered to pregnant women also are described.17Khromava A. Cohen C.J. Mazur M. Kanesa-thasan N. Crucitti A. Seifert H. Manufacturers' postmarketing safety surveillance of influenza vaccine exposure in pregnancy.Am J Obstet Gynecol. 2012; 207: S52-S56Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar The US regulatory environment with regard to immunization during pregnancy is addressed,18Marshall V. Gruber M. Influenza immunization during pregnancy: US regulatory perspective.Am J Obstet Gynecol. 2012; 207: S57-S62Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar as are liability issues related to immunization of pregnant women.19Jacobs A.L. Liability and maternal immunization: in utero injury claims in the VICP.Am J Obstet Gynecol. 2012; 207: S63-S66Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar Patient and health care provider barriers to influenza immunization during pregnancy, and possible ways to overcome these barriers, are addressed by Shavell and colleagues.20Shavell V.I. Moniz M.H. Gonik B. Beigi R.H. Influenza immunization in pregnancy: overcoming patient and health care provider barriers.Am J Obstet Gynecol. 2012; 207: S67-S74Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar While progress has been made in overcoming barriers to influenza immunization of pregnant women, such immunization is far from universal. Finally, Ault and colleagues21Ault K.A. Heine R.P. Riley L.E. Programmatic and research priorities for improving influenza immunization of pregnant women.Am J Obstet Gynecol. 2012; 207: S75-S77Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar outline programmatic and research priorities for improving influenza immunization of pregnant women. Programmatic and research priorities for improving influenza immunization of pregnant womenAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewDespite evidence regarding the benefits of influenza immunization during pregnancy for both the pregnant woman and her infant, as well as reassuring safety data, influenza vaccination rates in pregnancy have lagged. The 2009 influenza pandemic was accompanied by increased maternal vaccination rates. In this article, we review programmatic and research priorities with regard to overcoming barriers to influenza immunization of pregnant women. Full-Text PDF Effects of influenza on pregnant women and infantsAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewInfluenza vaccination during pregnancy has been shown to decrease the risk of influenza and its complications among pregnant women and their infants up to 6 months old. To adequately assess the benefits and potential risks that are associated with the use of influenza vaccine during pregnancy, it is necessary to examine the influenza-associated complications that occur among pregnant women and their children. Pregnant women have been shown to be at increased risk for morbidity and death with influenza illness during seasonal epidemics and pandemics. Full-Text PDF Benefits of influenza vaccination during pregnancy for pregnant womenAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewInfluenza vaccination is a cornerstone of influenza prevention efforts among pregnant women. Prior to 2005, data from studies conducted on pregnant women were limited, with much of the supporting evidence coming from influenza vaccine studies conducted among nonpregnant, age-matched populations. Since 2005, however, an increasing number of studies have demonstrated the safety and immunogenicity of influenza vaccine for pregnant women, including evidence of maternal transfer of antibody. In addition, the clinical benefit of influenza vaccination, both for the mother and infant, was demonstrated in a landmark randomized clinical trial conducted in Bangladesh. Full-Text PDF A review of fetal and infant protection associated with antenatal influenza immunizationAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewThe well-described burden of influenza morbidity in the pregnant woman and her young infant have led to increasing interest in the use of antenatal immunization to protect both the mother and the infant. In this review, we summarize the recent data on the effect of antenatal influenza infection, and influenza immunization, on mothers and infants. Antenatal influenza immunization can improve intrauterine growth in Asia and North America and reduce preterm deliveries. Studies of the pathogenetic process of influenza infection in the mother and fetus are needed. Full-Text PDF Immunogenicity and efficacy of influenza immunization during pregnancy: recent and ongoing studiesAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewPregnant women and young infants are at increased risk from influenza. The World Health Organization and public health guidelines from Australia, Canada, and the United States recommend immunizing pregnant women with trivalent inactivated influenza vaccine. However, there are multiple barriers to the uptake of this recommendation. Additionally, current vaccines are not licensed for infants <6 months of age. Immunizing pregnant women would provide protection to both mothers and infants. The Bill & Melinda Gates Foundation (BMGF) and the National Institute of Allergy and Infectious Diseases (NIAID) are trying to address some of the issues associated with maternal immunization, which could be an effective intervention in both high- and low-resource settings to combat the significant maternal and infant morbidity and mortality due to influenza. Full-Text PDF Monitoring seasonal influenza vaccination coverage among pregnant women in the United StatesAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewThis report describes surveillance systems used for assessing influenza vaccination coverage among pregnant women in the United States. Coverage estimates and factors associated with maternal vaccination are reviewed for internet panel surveys of pregnant women and the Pregnancy Risk Assessment Monitoring System (PRAMS); new estimates are reported from the Behavioral Risk Factor Surveillance System (BRFSS) and Internet panel surveys. Influenza vaccination coverage among pregnant women improved from 11% during the 2001-2002 influenza season to approximately 38% measured by BRFSS and 50% measured by Internet panel surveys during the 2010-2011 influenza season. Full-Text PDF Safety of influenza immunization during pregnancy for the fetus and the neonateAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewSince the 1960s, pregnant women in the United States have been recommended to receive influenza vaccine. A maternal concern about the possibility of adverse fetal and neonatal outcomes after the vaccination of pregnant women has been cited as a reason for low maternal influenza vaccination coverage. Recent research has identified benefits to the fetus and neonate after maternal influenza vaccination that have prompted efforts to increase coverage in pregnant women. There is a long history of research findings that highlight the safety of vaccinating pregnant women. Full-Text PDF Assessing the safety of influenza immunization during pregnancy: the Vaccine Safety DatalinkAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewThe influenza vaccine can reduce maternal and neonatal morbidity and mortality and thus is recommended for all pregnant women. However, concerns regarding safety of influenza vaccine remain a barrier to vaccination. We describe ongoing analyses of influenza vaccine safety during pregnancy within the Vaccine Safety Datalink that includes the evaluation of acute events, adverse pregnancy and birth outcomes, and congenital anomalies. In addition, we highlight unique challenges and strategies for the study of vaccine safety among pregnant women with the use of large linked databases. Full-Text PDF Influenza immunization in pregnancy: overcoming patient and health care provider barriersAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewSeasonal influenza imparts disproportionate morbidity and death to pregnant women. Immunization against influenza is the most effective intervention to mitigate the burden of influenza disease during pregnancy; nevertheless, immunization rates remain suboptimal in this patient population. Therefore, there is a clear need for strategies to optimize influenza vaccination among pregnant women. We reviewed potential patient and health care provider barriers to influenza immunization and propose effective strategies for overcoming them. Full-Text PDF Safety of influenza vaccines in pregnant womenAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewPrevention of influenza in pregnant women and their newborns through maternal immunization is a safe and effective intervention during seasonal epidemics and a priority during a pandemic. While influenza vaccination of pregnant women has been routine in the United States since the 1950s, coverage rates increased significantly only after the 2009 H1N1 influenza pandemic. Epidemiologic and clinical studies support the safety of inactivated influenza vaccines in pregnant women and their infants. Safety barriers to the use of vaccines during pregnancy can be addressed through research, active surveillance, and education. Full-Text PDF Liability and maternal immunization: in utero injury claims in the VICPAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewGenerally, under the National Childhood Vaccine Injury Act of 1986 (Vaccine Act), vaccine administrators and manufacturers are shielded from medical malpractice or products liability actions stemming from vaccine-related injuries and deaths. That said, as generous as these protections may be, they have boundaries, some of which are clear and others of which are unsettled. This is particularly so for in utero injuries stemming from immunization of pregnant women. The issue of whether in utero injuries are afforded such protections, vis á vis compensation by the National Vaccine Injury Compensation Program (VICP) under the Vaccine Act, has not definitively been resolved by the courts. Full-Text PDF Manufacturers' postmarketing safety surveillance of influenza vaccine exposure in pregnancyAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewPregnant women are at increased risk for hospitalization and death with influenza infection. The limited data on safety and effectiveness of influenza immunization in pregnancy emphasizes the importance of developing new and well-designed studies and of enhancing safety surveillance in pregnant women who are vaccinated with licensed influenza vaccines. Pregnancy exposure registries aim to collect and maintain data on the effects of marketed drugs and vaccines, when prescribed in pregnancy or during breastfeeding, on the women themselves and their children. Full-Text PDF Influenza immunization during pregnancy: US regulatory perspectiveAmerican Journal of Obstetrics & GynecologyVol. 207Issue 3PreviewMaternal immunization with inactivated influenza vaccines is an important public health strategy to protect mothers and young infants from the serious complications of influenza. Although not contraindicated in pregnant women, currently US-licensed influenza vaccines are not specifically labeled for use during pregnancy. Several postmarketing initiatives are ongoing to obtain maternal and infant safety and immunogenicity data on US-licensed inactivated influenza vaccines used in pregnant women. The Food and Drug Administration is revising its pregnancy labeling regulations to improve the characterization and communication of risks of drugs and biologics used during pregnancy. Full-Text PDF