Association of the COVID-19 Pandemic With Routine Childhood Vaccination Rates and Proportion Up to Date With Vaccinations Across 8 US Health Systems in the Vaccine Safety Datalink.

Importance: The COVID-19 pandemic has affected routine vaccine delivery in the US and globally. The magnitude of these disruptions and their association with childhood vaccination coverage are unclear.

Objectives: To compare trends in pediatric vaccination before and during the pandemic and to evaluate the proportion of children up to date (UTD) with vaccinations by age, race, and ethnicity.

Order of Live and Inactivated Vaccines and Risk of Non-vaccine-targeted Infections in US Children 11-23 Months of Age.

Background: Some findings from observational studies have suggested that recent receipt of live vaccines may be associated with decreased non-vaccine-targeted infection risk and mortality. Our objective was to estimate risk of non-vaccine-targeted infections based on most recent vaccine type (live vaccines only, inactivated vaccines only or both concurrently) received in US children 11-23 months of age.

Methods: We conducted a retrospective cohort study within the Vaccine Safety Datalink.

Clinical Decision Support for Recognizing and Managing Hypertensive Blood Pressure in Youth: No Significant Impact on Medical Costs.

Objective: To evaluate economic costs from the health system perspective of an electronic health record-based clinical decision support (CDS) tool, TeenBP, designed to assist in the recognition and management of hypertension in youth.

Methods: Twenty primary care clinics within an integrated health system were randomized to the TeenBP CDS or usual care (UC), with patient enrollment from 4/15/14 to 4/14/16. The 12-month change in standardized medical care costs for insured patients aged 10 to 17 years without prior hypertension were calculated for each study arm.

Birth and early developmental screening outcomes associated with cannabis exposure during pregnancy.

Objective: To compare birth and early developmental screening outcomes for infants with and without in utero cannabis exposures.

Study Design: Observational cohort of women receiving prenatal care within a large health system, live birth between October 1, 2015 and December 1, 2017, and at least one infant visit. Cannabis exposure was through routine urine toxicology screen.

Uptake and safety of hepatitis A vaccination during pregnancy: A Vaccine Safety Datalink study.

Introduction: Infection with hepatitis A virus (HAV) during pregnancy, although uncommon, is associated with gestational complications and pre-term labor. Hepatitis A vaccine (HepA) is recommended for anyone at increased risk for contracting hepatitis A, including women at risk who are also pregnant. Limited data are available on the safety of maternal HepA vaccination.

Safety of guidelines recommending live attenuated influenza vaccine for routine use in children and adolescents with asthma.

Objective: Evaluate whether a guideline recommending Live Attenuated Influenza Vaccine (LAIV) for children 2 years and older with asthma increased risks for lower respiratory events (LREs), within 21 or 42 days of vaccination, as compared to standard guidelines to administer Inactivated Influenza Vaccine (IIV) in children with asthma.

Methods: This was a pre/post guideline retrospective cohort study of children ages 2-17 years with asthma and receiving one or more influenza vaccines in two large medical groups from 2007 to 2016. Both groups recommended IIV in the pre-period; in 2010, one group implemented a guideline recommending LAIV for all children, including those with asthma.

Trends in Outpatient Antibiotic Use in 3 Health Plans.

Objectives: Previous analyses of data from 3 large health plans suggested that the substantial downward trend in antibiotic use among children appeared to have attenuated by 2010. Now, data through 2014 from these same plans allow us to assess whether antibiotic use has declined further or remained stable.

Methods: Population-based antibiotic-dispensing rates were calculated from the same health plans for each study year between 2000 and 2014.

Safety of repeated doses of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine in adults and adolescents.

In light of waning immunity to pertussis following receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine, maintaining protection may require repeated Tdap vaccination. We evaluated the safety of repeated doses of tetanus-containing vaccine in 68 915 nonpregnant adolescents and adults in the Vaccine Safety Datalink population who had received an initial dose of Tdap. Compared with 7521 subjects who received a subsequent dose of tetanus toxoid, reduced diphtheria (Td) vaccine, the 61 394 subjects who received a subsequent dose of Tdap did not have significantly elevated risk of medical visits for seizure, cranial nerve disorders, limb swelling, pain in limb, cellulitis, paralytic syndromes, or encephalopathy/encephalitis/meningitis.

Association Between Estimated Cumulative Vaccine Antigen Exposure Through the First 23 Months of Life and Non-Vaccine-Targeted Infections From 24 Through 47 Months of Age.

Importance: Some parents are concerned that multiple vaccines in early childhood could weaken their child's immune system. Biological data suggest that increased vaccine antigen exposure could increase the risk for infections not targeted by vaccines.

Objective: To examine estimated cumulative vaccine antigen exposure through the first 23 months of life in children with and without non-vaccine-targeted infections from 24 through 47 months of age.

Clinical Decision Support for Recognition and Management of Hypertension: A Randomized Trial.

Objectives: Although blood pressure (BP) is routinely measured in outpatient visits, elevated BP and hypertension are often not recognized. We evaluated whether an electronic health record-linked clinical decision support (CDS) tool could improve the recognition and management of hypertension in adolescents.

Methods: We randomly assigned 20 primary care clinics within an integrated care system to CDS or usual care.

Rates and risk factors associated with hospitalization for pneumonia with ICU admission among adults.

Background: Pneumonia poses a significant burden to the U.S. health-care system.

The safety of live attenuated influenza vaccine in children and adolescents 2 through 17 years of age: A Vaccine Safety Datalink study.

Purpose: To evaluate the safety of live attenuated influenza vaccine (LAIV) in children 2 through 17 years of age.

Methods: The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between September 1, 2003 and March 31, 2013.

Maternal and Infant Outcomes After Human Papillomavirus Vaccination in the Periconceptional Period or During Pregnancy.

Objective: To evaluate whether quadrivalent human papillomavirus vaccine (4vHPV) administered during the periconceptional period or during pregnancy was associated with increased risks for adverse obstetric events, adverse birth outcomes, or selected major structural birth defects.

Methods: We conducted a retrospective, observational cohort study using administrative and health care data from the Vaccine Safety Datalink. Insured women 13-27 years old with singleton pregnancies and a live birth from January 1, 2007, through September 1, 2013, who received 4vHPV during the periconceptional period (2 weeks before to 2 weeks after their last menstrual period), during pregnancy, or during both periods combined were compared with women who had a live birth during the same time period and received 4vHPV 4-18 months before their last menstrual period.

Evaluation of an Electronic Clinical Decision Support Tool for Incident Elevated BP in Adolescents.

Objective: To evaluate, among adolescents 10 to 17 years of age with an incident hypertensive blood pressure (BP; ≥95th percentile) at a primary care visit, whether TeenBP, a novel electronic health record-linked clinical decision support tool (CDS), improved recognition of elevated BP, and return for follow-up BP evaluation.

Methods: We conducted a pragmatic cluster randomized trial in 20 primary care clinics in a large Midwestern medical group. Ten clinics received the TeenBP CDS, including an alert to remeasure a hypertensive BP at that visit, an alert that a hypertensive BP should be repeated in 1 to 3 weeks, and patient-specific order sets.

Maternal Tdap vaccination and risk of infant morbidity.

Introduction: An increased risk of diagnosed chorioamnionitis in women vaccinated with Tdap during pregnancy was previously detected at two Vaccine Safety Datalink (VSD) sites. The clinical significance of this finding related to infant outcomes remains uncertain.

Methods: Retrospective cohort study of singleton live births born to women who were continuously insured from 6months prior to their last menstrual period through 6weeks postpartum, with ≥1 outpatient visit during pregnancy from January 1, 2010 to November 15, 2013 at seven integrated United States health care systems part of the VSD.

First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring.

Objective: To examine risks for major structural birth defects in infants after first trimester inactivated influenza vaccine (IIV) exposures.

Study Design: In this observational study, we used electronic health data from 7 Vaccine Safety Datalink sites to examine risks for selected major structural defects in infants after maternal IIV exposure. Vaccine exposures for women with continuous insurance enrollment through pregnancy who delivered singleton live births between 2004 and 2013 were identified from standardized files.

ACL Tears in School-Aged Children and Adolescents Over 20 Years.

Background: Anterior cruciate ligament (ACL) tears are thought to occur with increasing frequency in young patients. No study has shown increased incidence over time. We hypothesized the incidence of ACL tears in young patients has increased over the past 20 years.

Identifying birth defects in automated data sources in the Vaccine Safety Datalink.

Purpose: The Vaccine Safety Datalink (VSD), a collaboration between the Centers for Disease Control and Prevention and several large healthcare organizations, aims to monitor safety of vaccines administered in the USA. We present definitions and prevalence estimates for major structural birth defects to be used in studies of maternal vaccine safety.

Methods: In this observational study, we created and refined algorithms for identifying major structural birth defects from electronic healthcare data, conducted formal chart reviews for severe cardiac defects, and conducted limited chart validation for other defects.

Impact of Copayment Changes on Children's Albuterol Inhaler Use and Costs after the Clean Air Act Chlorofluorocarbon Ban.

Objective: To examine changes in children's albuterol use and out-of-pocket (OOP) costs in response to increased copayments after the Food and Drug Administration banned inhalers with chlorofluorocarbon (CFC) propellants.

Setting: Four health maintenance organizations (HMOs), two that increased copayments for albuterol inhalers that went from generic CFC-containing to branded CFC-free versions, and two that retained generic copayments for CFC-free inhalers (controls). We included children with asthma aged 4-17 years with commercial coverage from 2007 to 2010.

Risk of Preterm or Small-for-Gestational-Age Birth After Influenza Vaccination During Pregnancy: Caveats When Conducting Retrospective Observational Studies.

Vaccines are increasingly targeted toward women of reproductive age, and vaccines to prevent influenza and pertussis are recommended during pregnancy. Prelicensure clinical trials typically have not included pregnant women, and when they are included, trials cannot detect rare events. Thus, postmarketing vaccine safety assessments are necessary.