Trivalent Inactivated Influenza Vaccine and Spontaneous Abortion
ABSTRACT OBJECTIVE:: To estimate the association between spontaneous abortion and influenza vaccine receipt with a case-control study utilizing data from six health care organizations in the Vaccine Safety Datalink. METHODS:: Women aged 18-44 years with spontaneous abortion during the autumn of 2005 or 2006 were identified using International Classification of Diseases, 9th Revision, Clinical Modification codes. Cases of spontaneous abortion at 5-16 weeks of gestation were confirmed by medical record review; date of fetal demise was based on ultrasound information when available. Control group individuals with a live birth were individually matched to case group individuals by health care organization and date of last menstrual period (LMP). The primary exposure of interest was influenza vaccination during the 28 days preceding the date of spontaneous abortion of the matched pair. Conditional logistic regression models adjusted for maternal age, health care utilization, maternal diabetes, and parity. RESULTS:: Our final analysis included 243 women with spontaneous abortion and 243 matched control group women; 82% of women with spontaneous abortion had ultrasound confirmation of fetal demise. Using clinical diagnosis and ultrasound data, the mean gestational age at fetal demise was 7.8 weeks. Mean ages at LMP of case group women and control group women were 31.7 and 29.3 years, respectively (P<.001). Sixteen women with spontaneous abortion (7%) and 15 (6%) matched control group women received influenza vaccine within the 28-day exposure window. There was no association between spontaneous abortion and influenza vaccination in the 28-day exposure window (adjusted matched odds ratio 1.23, 95% confidence interval 0.53-2.89; P=.63). CONCLUSION:: There was no statistically significant increase in the risk of pregnancy loss in the 4 weeks after seasonal inactivated influenza vaccination. LEVEL OF EVIDENCE:: II.
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ABSTRACT: Background. Obstetrician-gynecologists are increasingly called upon to be vaccinators as an essential part of a woman's primary and preventive health care. Despite the established safety of vaccines, vaccine adverse events may occur. A national Vaccine Adverse Event Reporting System (VAERS) is a well-established mechanism to track adverse events. However, we hypothesized that many obstetrician-gynecologists are naive to the role and use of VAERS. Methods. We devised a ten-question survey to a sample of ACOG fellows to assess their knowledge and understanding of VAERS. We performed descriptive and frequency analysis for each of the questions and used one-way analysis of variance for continuous and chi-squared for categorical variables. Results. Of the 1000 fellows who received the survey, 377 responded. Only one respondent answered all nine knowledge questions correctly, and 9.2% of physicians had used VAERS. Older physicians were less familiar with VAERS in general and with the specific objectives of VAERS in particular (χ (2) = 10.7, P = .005). Conclusions. Obstetrician-gynecologist familiarity with VAERS is lacking. Only when the obstetrician-gynecologist is completely knowledgeable regarding standard vaccine practices, including the availability and use of programs such as VAERS, will providers be functioning as competent and complete vaccinators.Infectious Diseases in Obstetrics and Gynecology 09/2013; 2013:285257. DOI:10.1155/2013/285257
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ABSTRACT: To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events. We identified Vaccine Adverse Event Reporting System reports, which described receipt of live H1N1 vaccine during pregnancy without an indication of an adverse event at the time of the report during October 2009 to June 2010. We reviewed the initial reports and obtained pregnancy outcome and infant data through 6 months of age from medical records. We reviewed the numbers and characteristics of pregnancy complications and infant outcomes including major birth defects and medically important infant conditions. Rates of spontaneous abortion, preterm birth, and major birth defects and their 95% confidence intervals were calculated. The Vaccine Adverse Event Reporting System received 113 reports stating receipt of live H1N1 vaccine during pregnancy with no adverse events reported. We obtained follow-up maternal records on 95 of the 113 (84%) live H1N1 reports (40.2% were vaccinated in the first trimester) and found: 87 live births (two twin pregnancies) and no maternal deaths occurred. Number and rates of pregnancy-specific adverse events included: 10 (10.5%, 5.8-18.3) spontaneous abortions; four (4.7%, 1.8-11.4) preterm deliveries at 35-36 weeks of gestation; three (3.4%, 1.2-9.7) infants had one or more major birth defects noted at birth: one cleft palate, one cleft lip, and one microtia (underdeveloped or absent external ear). Seven neonates and infants were hospitalized for medically important conditions. One infant death occurred in a 2.5-month-old boy as a result of pertussis. Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified. LEVEL OF EVIDENCE:: III.Obstetrics and Gynecology 11/2013; 122(6). DOI:10.1097/AOG.0000000000000010 · 4.37 Impact Factor
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ABSTRACT: As pregnant women are considered a high-risk group for severe influenza illness, current recommendations advise vaccination of all pregnant women with inactivated influenza vaccine. Nevertheless, rates of maternal influenza vaccination have historically been low, possibly reflecting ongoing concerns about vaccine safety. Until recently, the majority of evidence concerning safety of influenza vaccination during pregnancy was limited to post-marketing pharmacovigilance studies; however, in the past 5 years, one randomized clinical trial and a number of observational studies reflecting seasonal trivalent inactivated influenza vaccines and monovalent H1N1 influenza vaccines have been published. This review summarizes the evidence pertaining to fetal and neonatal outcomes following influenza vaccination during pregnancy for comparative analytic studies published between 2008 and August 2013. Since the majority of these studies are observational in nature, issues related to study quality are also addressed.Expert Review of Vaccines 12/2013; 12(12):1417-30. DOI:10.1586/14760584.2013.851607 · 4.22 Impact Factor