Review of prescribing information for influenza vaccines for pregnant and lactating women (original) (raw)
Related papers
Delivering influenza vaccine to pregnant women
Epidemiologic reviews, 2006
Pregnant women have an increased risk of influenza infection and complications. The Advisory Committee on Immunization Practices currently recommends vaccination for women who are pregnant during influenza season. The authors review the literature concerning influenza vaccine safety, effectiveness, and coverage rates during pregnancy, as well as opportunities to improve vaccination rates during pregnancy. No study has demonstrated an increased risk of maternal complications or adverse fetal outcomes associated with inactivated influenza vaccine. Few studies have examined the effectiveness of vaccination during pregnancy, and the results from these studies are inconsistent, with some showing a protective effect and others showing no effect. Despite the proven safety of vaccination and the possible benefits to women and their infants, reported vaccination rates during pregnancy are generally less than 10%. Mothers frequently cite concerns about vaccine safety as a barrier to vaccination. Lack of adequate information about the risks and benefits of vaccination is reported by both patients and obstetric care providers. Organizational factors such as lack of vaccine storage facilities may also limit vaccination during pregnancy. Effective interventions should target factors pertaining to patients or providers, or they should address organizational or logistic barriers. The Advisory Committee on Immunization Practices currently recommends standing orders programs or reminders for patients and providers as strategies to improve vaccination rates.
Influenza immunization during pregnancy: US regulatory perspective
American Journal of Obstetrics and Gynecology, 2012
Maternal 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. To obtain a specifically labeled indication for use of an influenza vaccine during pregnancy, adequate and wellcontrolled prelicensure studies are needed to obtain data on the product's safety and effectiveness and to demonstrate protection of the mother and/or infant against influenza illness.
Safety of influenza vaccines in pregnant women
American Journal of Obstetrics and Gynecology, 2012
Prevention 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.
Journal of obstetrics and gynaecology Canada, 2009
Introduction: We wished to assess pregnant women's knowledge of influenza, vaccine safety during pregnancy and breast feeding, and the recommendations for use of the influenza vaccine in pregnancy. Methods: We performed a cross-sectional survey of postpartum women during influenza season in 2006. Results: Pregnant women's overall knowledge of these subjects was poor. Most women (95%) knew that influenza is highly contagious, but almost 90% incorrectly believed that pregnant women have the same risk of complications as non-pregnant women. Only one half of the women were aware of national recommendations for vaccination during pregnancy and that the vaccine is safe during pregnancy and breast feeding, and 80% incorrectly believed that the vaccine can cause birth defects. Only 20% of women had been offered the vaccine during the current pregnancy or a prior pregnancy. Conclusions: Pregnant women's knowledge about influenza vaccine recommendations and safety during pregnancy is poor. There is substantial room for improvement among prenatal care providers in both patient education and offering the vaccine.
Influenza vaccination in pregnancy: current evidence and selected national policies
The Lancet Infectious Diseases, 2008
In several countries, pregnant women are recommended seasonal infl uenza vaccination and identifi ed as a priority group for vaccination in the event of a pandemic. We review the evidence for the risks of infl uenza and the risks and benefi ts of seasonal infl uenza vaccination in pregnancy. Data on infl uenza vaccine safety in pregnancy are inadequate, but the few published studies report no serious side-eff ects in women or their infants, including no indication of harm from vaccination in the fi rst trimester. National policies diff er widely, mainly because of the limited data available, particularly on vaccination in the fi rst trimester. The evidence of excess morbidity during seasonal infl uenza supports vaccinating healthy pregnant women in the second or third trimester and those with comorbidities in any trimester. The evidence of excess mortality in two previous infl uenza pandemics supports vaccinating in any trimester during a pandemic. Figure: 3D electron tomography of the infl uenza virus (120 nm) Haemagglutinin spikes are in green; neuraminidase spikes are in yellow. Reproduced with permission from Alasdair Steven.
Assessing the safety of influenza immunization during pregnancy: the Vaccine Safety Datalink
American Journal of Obstetrics and Gynecology, 2012
The 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.
Vaccine, 2014
Pregnant women and their infants are vulnerable to severe disease and secondary complications from influenza infection. For this reason, annual influenza vaccination is recommended for all pregnant women in the United States. Women frequently cite concerns about vaccine safety as a barrier to vaccination. This review describes the safety of inactivated influenza vaccination during pregnancy with a focus on maternal obstetric events, including hypertensive disorders, gestational diabetes, and chorioamnionitis. Included in the review are new findings from two studies which examined the safety of seasonal inactivated influenza vaccination during pregnancy. The first study enrolled 641 pregnant women during the 2010-2011 season and prospectively followed them until delivery or pregnancy termination. The second study enrolled 1616 pregnant women during the 2010-2011 influenza season, and followed the women and their infants for six months after delivery. No associations between inactivated influenza vaccination and gestational diabetes, gestational hypertension, preeclampsia/eclampsia, or chorioamnionitis were observed in either cohort. When considered as a whole, these studies should further reassure women and clinicians that influenza vaccination during pregnancy is safe for mothers.
BMC Pregnancy and Childbirth, 2015
Background: Influenza vaccination during pregnancy can prevent serious illness in expectant mothers and provide protection to newborns; however, historically uptake has been limited due to a number of factors, including safety concerns. Symptomatic complaints are common during pregnancy and may be mistakenly associated with reactions to trivalent influenza vaccine (TIV). To investigate this, we compared post-vaccination events self-reported by pregnant women to events reported by non-pregnant women receiving TIV. Methods: A prospective cohort of 1,086 pregnant women and 314 non-pregnant female healthcare workers (HCWs) who received TIV between March-May 2014 were followed-up seven days post-vaccination to assess local and systemic adverse events following immunisation (AEFIs). Women were surveyed by text message regarding perceived reactions to TIV. Those reporting an AEFI completed an interview by telephone or mobile phone to ascertain details. Logistic regression models adjusting for age and residence were used to compare reactions reported by pregnant women and non-pregnant HCWs. Results: Similar proportions of pregnant women and non-pregnant, female HCWs reported ≥1 reaction following vaccination with TIV (13.0% and 17.3%, respectively; OR = 1.2 [95% CI: 0.8-1.8]). Non-pregnant, female HCWs were more likely to report fever or headache compared to pregnant women (OR: 4.6 [95% CI 2.1-10.3] and OR: 2.2 [95% CI 1.0-4.6], respectively). No other significant differences in reported symptoms were observed. No serious vaccine-associated adverse events were reported, and less than 2% of each group sought medical advice for a reaction.
International Journal of Infectious Diseases
Background: In 2012, the World Health Organization recommended influenza vaccination for all pregnant womenworldwide and the prioritisation of pregnant women in national influenzavaccination programmes. Nevertheless, vaccination rates in pregnant women often remain much lower than national targets. Objectives: To assess the benefits and risks associated with influenza infection and vaccination during pregnancy, and to consider obstacles that work against influenza vaccine uptake during pregnancy. Results: There is strong evidence that maternal and foetal outcomes can be compromised if women develop influenza infections during pregnancy. Influenza vaccines have been administered to millions of pregnant women and have demonstrated benefits in terms of disease prevention in mothers and their infants. There is a consensus amongst several recommending authorities that influenza vaccines may be safely administered during all stages of pregnancy. Healthcare professionals are recognised as the most important influencers of vaccine uptake, being well placed to recommend vaccination and directly address safety concerns. Conclusions: Despite data supporting the value of influenza vaccination during pregnancy, vaccine uptake remains low globally. Low uptake appears to be largely due to ineffective communication with pregnant women about the risks and benefits of influenza vaccination. A graphical abstract is available online.