School closures due to seasonal influenza: a prospective data collection-based study of eleven influenza seasons-United States, 2011-2022.

Background: While numerous studies explore pandemic-associated school closures, literature is scant regarding seasonal influenza-associated closures. We previously reported summaries on COVID-19 pandemic-related school closures in the United States (US), which affected virtually all schools in the nation. The current prospective study aims to address the knowledge gap for seasonal influenza-related closures in the United States. Methods: We conducted systematic daily online searches from August 1, 2011 to June 30, 2022, to identify public announcements of unplanned school closures in the US lasting ≥1 day, selecting those that mentioned influenza and influenza-like illness (ILI) as reason for school closure (ILI-SCs). We studied ILI-SC temporal patterns and compared them with reported outpatient ILI-related healthcare visits. Findings: We documented that ILI-SCs occurred annually, with yearly totals ranging from 11 ILI-SCs in both the 2013-2014 and 2020-2021 school years to 2886 ILI-SCs in the 2019-2020 school year among more than 100,000 kindergarten through twelfth grade schools in the US. ILI-SCs occurred concurrently with widespread illness and the strongest correlations were observed during influenza A (H3N2)-dominant seasons, most notably in the 2016-2017 (Spearman rank correlation (rs) = 0.83) and the 2017-2018 (rs = 0.84) school years. ILI-SCs were heavily centered in U.S. Department of Health and Human Services Region 4 (states of Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee) [60% (6040/9166, Region 4/Total school closures)] and disproportionately impacted rural and lower-income communities. Interpretation: Outside of a pandemic, disease-related school closures are extreme and generally rare events for US schools and communities. Timely compilation of publicly available ILI-SC announcements could enhance influenza surveillance, particularly in severe influenza seasons or pandemics when ILI-SCs are prevalent. Funding: This work was supported by the U.S. Centers for Disease Control and Prevention. Co-authors (NZ, YZ, HG, AU) were or are US CDC employees, and FJ was a contractor through Cherokee Nation Operational Solutions, LLC, which supported FJ's salary, but had no additional role in the study.

Call to action: Harmonization of pharmacovigilance regulations for post-marketing pregnancy and breastfeeding safety studies.

Globally, more than 200 million women become pregnant each year, most of whom receive medications despite limited information on their safe use during pregnancy. The paucity of drug safety data on pregnant and breastfeeding women stems from the routine exclusion of this population from clinical trials due to scientific, ethical, regulatory and legal concerns. Consequently, at the time of initial drug approval, there may be scant safety data to inform the drug benefit-risk balance to the mother, foetus or infant. Although momentum is growing to include this underrepresented population in clinical trials, most information on drug exposure outcomes comes from data collected in the postmarketing setting. Regulatory guidance and legislation on medication use in pregnancy and breastfeeding were reviewed globally by the TransCelerate IGR PV Pregnancy and Breastfeeding Team. The International Conference of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards and Council for International Organizations of Medical Sciences guidelines served as benchmarks for national safety regulations and guidance. The landscape assessment identified a lack of harmonization of global regulations on research in pregnant and breastfeeding women and a lack of specific regulations on this topic in the majority of the territories included in the assessment. This article focuses on the ambiguities and lack of harmonization in global regulations on postmarketing pregnancy and breastfeeding safety studies. There is currently no ICH standard to guide these types of safety studies and, in most regions reviewed, there are no clear regulations or guidance on when and how to conduct them. While a challenging undertaking, greater clarity and harmonization would facilitate more timely completion of postmarketing pregnancy safety studies that would ultimately generate the critical data needed to optimize benefit-risk decisions for women who may conceive, as well as pregnant and breastfeeding women.

Household Transmission Dynamics of Seasonal Human Coronaviruses.

BACKGROUND: Household transmission studies inform how viruses spread among close contacts, but few characterize household transmission of endemic coronaviruses. METHODS: We used data collected from 223 households with school-age children participating in weekly disease surveillance over 2 respiratory virus seasons (December 2015 to May 2017), to describe clinical characteristics of endemic human coronaviruses (HCoV-229E, HcoV-HKU1, HcoV-NL63, HcoV-OC43) infections, and community and household transmission probabilities using a chain-binomial model correcting for missing data from untested households. RESULTS: Among 947 participants in 223 households, we observed 121 infections during the study, most commonly subtype HCoV-OC43. Higher proportions of infected children (<19 years) displayed influenza-like illness symptoms than infected adults (relative risk, 3.0; 95% credible interval [CrI], 1.5-6.9). The estimated weekly household transmission probability was 9% (95% CrI, 6-13) and weekly community acquisition probability was 7% (95% CrI, 5-10). We found no evidence for differences in community or household transmission probabilities by age or symptom status. Simulations suggest that our study was underpowered to detect such differences. CONCLUSIONS: Our study highlights the need for large household studies to inform household transmission, the challenges in estimating household transmission probabilities from asymptomatic individuals, and implications for controlling endemic CoVs.

Predicting virologically confirmed influenza using school absences in Allegheny County, Pennsylvania, USA during the 2007-2015 influenza seasons.

BACKGROUND: Children are important in community-level influenza transmission. School-based monitoring may inform influenza surveillance. METHODS: We used reported weekly confirmed influenza in Allegheny County during the 2007 and 2010-2015 influenza seasons using Pennsylvania's Allegheny County Health Department all-age influenza cases from health facilities, and all-cause and influenza-like illness (ILI)-specific absences from nine county school districts. Negative binomial regression predicted influenza cases using all-cause and illness-specific absence rates, calendar week, average weekly temperature, and relative humidity, using four cross-validations. RESULTS: School districts reported 2 184 220 all-cause absences (2010-2015). Three one-season studies reported 19 577 all-cause and 3012 ILI-related absences (2007, 2012, 2015). Over seven seasons, 11 946 confirmed influenza cases were reported. Absences improved seasonal model fits and predictions. Multivariate models using elementary school absences outperformed middle and high school models (relative mean absolute error (relMAE) = 0.94, 0.98, 0.99). K-5 grade-specific absence models had lowest mean absolute errors (MAE) in cross-validations. ILI-specific absences performed marginally better than all-cause absences in two years, adjusting for other covariates, but markedly worse one year. CONCLUSIONS: Our findings suggest seasonal models including K-5th grade absences predict all-age-confirmed influenza and may serve as a useful surveillance tool.

Feasibility of Social Distancing Practices in US Schools to Reduce Influenza Transmission During a Pandemic.

BACKGROUND: Schools are socially dense environments, and school-based outbreaks often predate and fuel community-wide transmission of seasonal and pandemic influenza. While preemptive school closures can effectively reduce influenza transmission, they are disruptive and currently recommended only for pandemics. We assessed the feasibility of implementing other social distancing practices in K-12 schools as a first step in seeking an alternative to preemptive school closures. METHODS: We conducted 36 focus groups with education and public health officials across the United States. We identified and characterized themes and compared feasibility of practices by primary versus secondary school and region of the United States. RESULTS: Participants discussed 29 school practices (25 within-school practices implemented as part of the school day and 4 reduced-schedule practices that impact school hours). Participants reported that elementary schools commonly implement several within-school practices as part of routine operations such as homeroom stay, restriction of hall movement, and staggering of recess times. Because of routine implementation and limited use of individualized schedules within elementary schools, within-school practices were generally felt to be more feasible for elementary schools than secondary schools. Of reduced-schedule practices, shortening the school week and the school day was considered the most feasible; however, reduced-schedule practices were generally perceived to be less feasible than within-school practices for all grade levels. CONCLUSIONS: Our findings suggest that schools have many options to increase social distance other than closing. Future research should evaluate which of these seemingly feasible practices are effective in reducing influenza transmission in schools and surrounding communities.

School and preparedness officials' perspectives on social distancing practices to reduce influenza transmission during a pandemic: Considerations to guide future work.

The objective of this qualitative study was to explore the perspectives of school and preparedness officials on the feasibility of implementing a range of social distancing practices to reduce influenza transmission during a pandemic. In the summer of 2017, we conducted 36 focus groups by teleconference and webinar lasting 90 min with school and preparedness stakeholders from across the United States. We identified and characterized 11 themes arising from the focus group protocol's domains as well as unanticipated emergent themes. These themes were: the need for effective stakeholder communication, the importance of partnering for buy-in, the role of social distancing in heightening anxiety, ensuring student safety, how practices work in combination, challenges with enforcement, lack of funding for school nurses, differing views about schools' role in protecting public health, the need for education and community engagement to ensure consistent implementation, the need for collaborative decision-making, and tension between standardizing public health guidance and adapting to local contexts. Addressing several crosscutting considerations can increase the likelihood that social distancing practices will be feasible and acceptable to school stakeholders.

School practices to promote social distancing in K-12 schools: review of influenza pandemic policies and practices.

BACKGROUND: During an evolving influenza pandemic, community mitigation strategies, such as social distancing, can slow down virus transmission in schools and surrounding communities. To date, research on school practices to promote social distancing in primary and secondary schools has focused on prolonged school closure, with little attention paid to the identification and feasibility of other more sustainable interventions. To develop a list and typology of school practices that have been proposed and/or implemented in an influenza pandemic and to uncover any barriers identified, lessons learned from their use, and documented impacts. METHODS: We conducted a review of the peer-reviewed and grey literature on social distancing interventions in schools other than school closure. We also collected state government guidance documents directed to local education agencies or schools to assess state policies regarding social distancing. We collected standardized information from each document using an abstraction form and generated descriptive statistics on common plan elements. RESULTS: The document review revealed limited literature on school practices to promote social distancing, as well as limited incorporation of school practices to promote social distancing into state government guidance documents. Among the 38 states that had guidance documents that met inclusion criteria, fewer than half (42%) mentioned a single school practice to promote social distancing, and none provided any substantive detail about the policies or practices needed to enact them. The most frequently identified school practices were cancelling or postponing after-school activities, canceling classes or activities with a high rate of mixing/contact that occur within the school day, and reducing mixing during transport. CONCLUSION: Little information is available to schools to develop policies and procedures on social distancing. Additional research and guidance are needed to assess the feasibility and effectiveness of school practices to promote social distancing.

Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016.

BACKGROUND: The safety of hepatitis B vaccination during pregnancy has not been well studied. OBJECTIVE: We characterized adverse events (AEs) after hepatitis B vaccination of pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS: We searched VAERS for AEs reports involving pregnant women who received hepatitis B vaccine from January 1, 1990-June 30, 2016. All reports and available medical records were reviewed by physicians. Observed AEs were compared to expected AEs and known rates of pregnancy outcomes to assess for any unexpected safety concern. RESULTS: We found 192 reports involving pregnant women following hepatitis B vaccination of which 110 (57.3%) described AEs; 12 (6.3%) were classified as serious; one newborn death was identified in a severely premature delivery, and there were no maternal deaths. Eighty-two (42.7%) reports did not describe any AEs. Among pregnancies for which gestational age was reported, most women were vaccinated during the first trimester, 86/115 (74.7%). Among reports describing an AE, the most common pregnancy-specific outcomes included spontaneous abortion in 23 reports, preterm delivery in 7 reports, and elective termination in 5 reports. The most common non-pregnancy specific outcomes were general disorders and administration site conditions, such as injection site and systemic reactions, in 21 reports. Among 22 reports describing an AE among infants born to women vaccinated during pregnancy, 5 described major birth defects each affecting different organ systems. CONCLUSION: Our analysis of VAERS reports involving hepatitis B vaccination during pregnancy did not identify any new or unexpected safety concerns.

Unintended costs and consequences of school closures implemented in preparation for Hurricane Isaac in Harrison County School District, Mississippi, August-September 2012.

INTRODUCTION: School closures, while an effective measure against the spread of disease during a pandemic, may carry unintended social and economic consequences for students and families. We evaluated these costs and consequences following a 4-day school closure in Mississippi's Harrison County School District (HCSD). METHODS: In a survey of all households with students enrolled in HCSD, we collected information on difficulties related to the school closure, including interruption of employment and pay, loss of access to subsidized school meals, and arrangement of alternative childcare. We analyzed this information in the context of certain demographic characteristics of the survey respondents and households, such as race, level of education, and income. We also estimated the average number of lost work days and documented the childcare alternatives chosen by households affected by the school closure. RESULTS: We received 2,229 (28.4%) completed surveys from an estimated 7,851 households eligible to participate. About half (1,082 [48.5%]) of the households experienced at least some difficulty during the closure, primarily in three areas: uncertainty about duration of the closure, lost income, and the effort of arranging alternate childcare. Adults working outside the home, particularly the major wage earner in the household, were more likely to suffer lost income while schools were closed, an effect mitigated by paid leave benefits. Difficulty arranging childcare was reported most frequently by respondents with lower levels of education and households with younger children. Beyond the top three concerns expressed by households in HCSD, the survey also shed light on the issue of food insecurity when subsidized school meals are not available. Reported by 17.9% of households participating in the subsidized school lunch program, difficulty providing meals during the closure was associated with higher numbers of dependent children, selection of "other" as the race of the household respondent, and lower levels of education. CONCLUSION: To help prevent undue financial hardship in families of school children, public health authorities and school administrators should provide recommendations for childcare alternatives and paid leave or remote work options during prolonged school closures, particularly to households in which all adults work outside of the home.

Evaluation of Unintended Social and Economic Consequences of an Unplanned School Closure in Rural Illinois.

BACKGROUND: School closure is one of the primary measures considered during severe influenza pandemics and other emergencies. However, prolonged school closures may cause unintended adverse consequences to schools, students, and their families. A better understanding of these consequences will inform prepandemic planning, and help public health and education authorities in making informed decisions when considering school closures. METHODS: We conducted a household survey and interviewed school officials following an 8-day long closure of a school district in rural Illinois. We described household responses regarding difficulties of school closure, and summarized main themes from school official interviews. RESULTS: A total of 208 (27%) household surveys were completed and returned. This school closure caused difficulties to 36 (17%) households; uncertain duration of closure, childcare arrangements, and lost pay were the most often reported difficulties. Having 1 adult in the household losing pay and household income below $25,000 were significantly associated with overall difficulty during this school closure. Concern about student health and safety was the most frequent theme in school administrator interviews. CONCLUSIONS: Whereas the majority of responding households did not report difficulties during this school closure, households with 1 adult losing pay during the closure reported incurring additional expenses for childcare.

Reactive School Closure During Increased Influenza-Like Illness (ILI) Activity in Western Kentucky, 2013: A Field Evaluation of Effect on ILI Incidence and Economic and Social Consequences for Families.

Background. School closures are an important mitigation strategy during influenza pandemic: if implemented early in a local outbreak, they can slow the disease spread in the surrounding community. During seasonal influenza epidemics, school closures may occur reactively, after the disease is already widespread in the community. Such reactive closures are often too late to reduce influenza transmission. However, they can provide data to determine under which circumstances they might be effective in reducing influenza-like illness (ILI) transmission. Methods. We conducted a household survey in a school district in Kentucky. District A closed after high student absenteeism due to influenza-like illness (ILI), whereas adjacent Districts B and C remained open. We collected data on self-reported ILI among household members in these 3 districts 2 weeks before the District A closure, during closure, and 2 weeks after reopening, and we evaluated economic and social consequences of school closure on student households in District A. The difference-in-differences method was applied to compare changes in ILI rates from before to after closure between districts. Results. Estimated average daily ILI rate decreased less in District A than in District B or C for the entire sample and when stratified by age groups (0-5 years old, 6-18 years old, and above 18 years old). Twenty-five percent of District A households reported ≥1 closure-related economic or social difficulty. Conclusions. Closing schools after a widespread ILI activity in District A did not reduce ILI transmission but caused difficulties for some households.

Online Work Force Analyzes Social Media to Identify Consequences of an Unplanned School Closure - Using Technology to Prepare for the Next Pandemic.

BACKGROUND: During an influenza pandemic, the United States Centers for Disease Control and Prevention (CDC) may recommend school closures. These closures could have unintended consequences for students and their families. Publicly available social media could be analyzed to identify the consequences of an unplanned school closure. METHODS: As a proxy for an unplanned, pandemic-related school closure, we used the district-wide school closure due to the September 10-18, 2012 teachers' strike in Chicago, Illinois. We captured social media posts about the school closure using the Radian6 social media-monitoring platform. An online workforce from Amazon Mechanical Turk categorized each post into one of two groups. The first group included relevant posts that described the impact of the closure on students and their families. The second group included irrelevant posts that described the political aspects of the strike or topics unrelated to the school closure. All relevant posts were further categorized as expressing a positive, negative, or neutral sentiment. We analyzed patterns of relevant posts and sentiment over time and compared our findings to household surveys conducted after other unplanned school closures. RESULTS: We captured 4,546 social media posts about the district-wide school closure using our search criteria. Of these, 930 (20%) were categorized as relevant by the online workforce. Of the relevant posts, 619 (67%) expressed a negative sentiment, 51 (5%) expressed a positive sentiment, and 260 (28%) were neutral. The number of relevant posts, and especially those with a negative sentiment, peaked on day 1 of the strike. Negative sentiment expressed concerns about childcare, missed school lunches, and the lack of class time for students. This was consistent with findings from previously conducted household surveys. CONCLUSION: Social media are publicly available and can readily provide information on the impact of an unplanned school closure on students and their families. Using social media to assess the impact of an unplanned school closure due to a public health event would be informative. An online workforce can effectively assist with the review process.

Enhanced surveillance of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011-2015.

BACKGROUND: In October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine. OBJECTIVES: We characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011-2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005-2010). METHODS: We searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/01/2011-6/30/2015) and compared it to published data before the routine Tdap recommendation (01/01/2005-06/30/2010). We conducted clinical review of reports and available medical records. The clinical pattern of reports in the post-recommendation period was compared with the pattern before the routine Tdap recommendation. RESULTS: We found 392 reports of Tdap vaccination after the routine recommendation. One neonatal death but no maternal deaths were reported. No maternal or neonatal deaths were reported before the recommendation. We observed an increase in proportion of reports for stillbirths (1.5-2.8%) and injection site reactions/arm pain (4.5-11.9%) after the recommendation compared to the period before the routine recommendation for Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion (16.7-1%). After the 2011 Tdap recommendation, in most reports, vaccination (79%) occurred during the third trimester compared to 4% before the 2011 Tdap recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did not report an AE. One medical facility accounted for 27% of all submitted reports. CONCLUSIONS: No new or unexpected vaccine AEs were noted among pregnant women who received Tdap after routine recommendations for maternal Tdap vaccination. Changes in reporting patterns would be expected, given the broader use of Tdap in pregnant women in the third trimester.

Comparing Observed with Predicted Weekly Influenza-Like Illness Rates during the Winter Holiday Break, United States, 2004-2013.

In the United States, influenza season typically begins in October or November, peaks in February, and tapers off in April. During the winter holiday break, from the end of December to the beginning of January, changes in social mixing patterns, healthcare-seeking behaviors, and surveillance reporting could affect influenza-like illness (ILI) rates. We compared predicted with observed weekly ILI to examine trends around the winter break period. We examined weekly rates of ILI by region in the United States from influenza season 2003-2004 to 2012-2013. We compared observed and predicted ILI rates from week 44 to week 8 of each influenza season using the auto-regressive integrated moving average (ARIMA) method. Of 1,530 region, week, and year combinations, 64 observed ILI rates were significantly higher than predicted by the model. Of these, 21 occurred during the typical winter holiday break period (weeks 51-52); 12 occurred during influenza season 2012-2013. There were 46 observed ILI rates that were significantly lower than predicted. Of these, 16 occurred after the typical holiday break during week 1, eight of which occurred during season 2012-2013. Of 90 (10 HHS regions x 9 seasons) predictions during the peak week, 78 predicted ILI rates were lower than observed. Out of 73 predictions for the post-peak week, 62 ILI rates were higher than observed. There were 53 out of 73 models that had lower peak and higher post-peak predicted ILI rates than were actually observed. While most regions had ILI rates higher than predicted during winter holiday break and lower than predicted after the break during the 2012-2013 season, overall there was not a consistent relationship between observed and predicted ILI around the winter holiday break during the other influenza seasons.

Evaluation of an unplanned school closure in a Colorado school district: implications for pandemic influenza preparedness.

OBJECTIVE: From January 29 through February 5, 2013, a school district outside metropolitan Denver, Colorado, was closed because of absenteeism related to influenza-like illness (ILI) among students and staff. We evaluated the consequences and acceptability of the closure among affected households. METHODS: We conducted a household survey regarding parent or guardian employment and income interruptions, alternative child care arrangements, interruption of noneducational school services, ILI symptoms, student re-congregation, and communication preferences during the closure. RESULTS: Of the 35 (31%) of 113 households surveyed, the majority (28 [80%]) reported that the closure was not challenging. Seven (20%) households reported challenges: 5 (14%) reported that 1 or more adults missed work, 3 (9%) reported lost pay, and 1 (3%) reported challenges because of missed subsidized school meals. The majority (22 [63%]) of households reported that a hypothetical 1-month closure would not represent a problem; 6 of 8 households that did anticipate challenges reported that all adults worked outside the home. The majority (58%) of students visited at least 1 outside venue during the closure. CONCLUSIONS: A brief school closure did not pose a major problem for the majority of the affected households surveyed. School and public health officials should consider the needs of families in which all adults work outside the home when creating school closure contingency plans.

Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013.

BACKGROUND: In 2006, quadrivalent human papillomavirus (HPV4; Gardasil, Merck & Co., Inc.) vaccine was licensed in the US for use in females aged 9-26 years. HPV4 is not recommended during pregnancy; however, inadvertent administration during pregnancy may occur. OBJECTIVES: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received HPV4 vaccine and assess for potentially concerning adverse events among non-manufacturer reports. METHODS: We searched the VAERS database for non-manufacturer reports of adverse events (AEs) in pregnant women who received HPV4 vaccine from 6/1/2006 to 12/31/2013. We conducted clinical review of reports and available medical records. RESULTS: We found 147 reports after HPV4 vaccine administered to pregnant women. The most frequent pregnancy-specific AE was spontaneous abortion in 15 (10.2%) reports, followed by elective terminations in 6 (4.1%). Maternal fever was the most frequent non-pregnancy-specific AE in 3 reports. Two reports of major birth defects were received. No maternal deaths were noted. One hundred-three (70.1%) reports did not describe an AE. CONCLUSIONS: This review of VAERS non-manufacturer reports following vaccination with HPV4 in pregnancy did not find any unexpected patterns in maternal or fetal outcomes.

Why is school closed today? Unplanned K-12 school closures in the United States, 2011-2013.

INTRODUCTION: We describe characteristics of unplanned school closures (USCs) in the United States over two consecutive academic years during a non-pandemic period to provide context for implementation of school closures during a pandemic. METHODS: From August 1, 2011 through June 30, 2013, daily systematic internet searches were conducted for publicly announced USCs lasting ≥ 1 day. The reason for closure and the closure dates were recorded. Information on school characteristics was obtained from the National Center for Education Statistics. RESULTS: During the two-year study period, 20,723 USCs were identified affecting 27,066,426 students. Common causes of closure included weather (79%), natural disasters (14%), and problems with school buildings or utilities (4%). Only 771 (4%) USCs lasted ≥ 4 school days. Illness was the cause of 212 (1%) USCs; of these, 126 (59%) were related to respiratory illnesses and showed seasonal variation with peaks in February 2012 and January 2013. CONCLUSIONS: USCs are common events resulting in missed school days for millions of students. Illness causes few USCs compared with weather and natural disasters. Few communities have experience with prolonged closures for illness.

Hepatitis B outbreak associated with a home health care agency serving multiple assisted living facilities in Texas, 2008-2010.

We investigated a multifacility outbreak of acute hepatitis B virus infection involving 21 residents across 10 assisted living facilities in Texas during the period January 2008 through July 2010. Epidemiologic and laboratory data suggested that these infections belonged to a single outbreak. The only common exposure was receipt of assisted monitoring of blood glucose from the same home health care agency. Improved infection control oversight and training of assisted living facility and home health care agency personnel providing assisted monitoring of blood glucose is needed.

Safety of influenza A (H1N1) 2009 live attenuated monovalent vaccine in pregnant women.

OBJECTIVE: To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: a review of the Vaccine Adverse Event Reporting System.

OBJECTIVE: We characterized reports to the Vaccine Adverse Event (AE) Reporting System (VAERS) of pregnant women who received meningococcal polysaccharide-protein conjugate vaccine Menactra (MenACWY-D; Sanofi Pasteur Inc., Swiftwater, PA). STUDY DESIGN: We searched VAERS for reports of pregnant women who received MenACWY-D from Jan. 1, 2005 through Dec. 31, 2011. We conducted clinical review of reports and available medical records. RESULTS: Of 103 identified reports, 38 (36.7%) did not describe any AE. No maternal or infant deaths were reported. The most frequent pregnancy-specific AE was spontaneous abortion in 17 (16.5%) reports. Urinary tract infections and fever with vomiting were the most frequent nonpregnancy-specific AEs found in 4 (3.9%) and 3 (2.9%) reports, respectively. We identified 1 report with a major congenital anomaly (aqueductal stenosis and severe ventriculomegaly). CONCLUSION: Our comprehensive review of reports to VAERS in pregnant women after MenACWY-D did not identify any concerning patterns in maternal, infant, or fetal outcomes.