Prenatal Vaccination Patterns among Birthing Individuals with History of Preterm Birth in the Pre- and Post-COVID Era.

OBJECTIVE: This study aims to explore vaccination acceptance among individuals with a history of preterm birth between March and June during the pre-COVID (2019), early-COVID (2020), and late-COVID (2021) periods. STUDY DESIGN: This is a cross-sectional, retrospective cohort study of pregnant individuals with a history of preterm birth (<37 weeks' gestation) who initiated care of a subsequent pregnancy during pre-COVID (March-June 2019), early-COVID (March-June 2020), or late-COVID (March-June 2021). The primary outcome of interest was vaccination status for influenza, Tdap, and COVID-19 vaccines. Fisher's exact and chi-square tests were used to investigate association between vaccination status and time periods, race/ethnicity, and insurance. RESULTS: Among 293 pregnancies, influenza vaccination rate was highest in early-COVID (p < 0.05). There was no statistically significant difference in Tdap or COVID-19 vaccination between time periods. COVID-19 vaccination was highest in individuals with private insurance (p < 0.05). There was no statistically significant difference in vaccination status by race/ethnicity. CONCLUSION: In this study on high-risk pregnant individuals, the majority of our cohort remained unvaccinated against COVID-19 into the late-COVID period. Additionally, their influenza vaccination rates were greater than the national average in early-COVID and substantially lower than the national average in late-COVID. This shift in influenza vaccination acceptance may have been sparked by COVID-19 vaccine distribution beginning in January 2021 leading to overall vaccination hesitancy. Standardized guidelines and counseling concerning prenatal safety in recommended immunizations may serve as important tools of reassurance and health promotion. KEY POINTS: · Maternal infections during pregnancy are a risk factor for preterm birth.. · High-risk cohort had low influenza vaccination post-COVID possibly due to COVID-19 vaccine hesitancy.. · Vaccination education may be a uniquely important tool among high-risk pregnant patients..

Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine.

BACKGROUND: Prevention of respiratory syncytial virus (RSV) disease in infants is an unmet vaccine need, and maternal immunization is a potential strategy to address this need. This study evaluated concomitant administration of RSV stabilized prefusion F subunit vaccine (RSVpreF) and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) in healthy, nonpregnant women 18‒49 years of age. METHODS: In this phase 2b, multicenter, placebo-controlled, observer-blind, noninferiority study, participants were randomized to receive RSVpreF in a range of doses and formulations with Tdap or alone, or Tdap alone. Safety and immunogenicity were assessed. RESULTS: Local reactions and systemic events were generally similar across vaccine groups. Noninferiority of anti-RSV-A and anti-RSV-B immune responses induced by RSVpreF with Tdap was demonstrated compared to RSVpreF alone. Noninferiority of anti-diphtheria toxoid and anti-tetanus toxoid immune responses after administration of RSVpreF with Tdap was demonstrated compared to Tdap alone; noninferiority was not met for anti-pertussis component responses. CONCLUSIONS: RSVpreF was safe and well tolerated when administered with Tdap or alone in nonpregnant women 18‒49 years of age. Immune responses induced by Tdap administered with RSVpreF were noninferior for the tetanus and diphtheria components of Tdap, but not for pertussis. CLINICAL TRIALS REGISTRATION: NCT04071158.

The optimal strategy for pertussis vaccination: a systematic review and meta-analysis of randomized control trials and real-world data.

OBJECTIVE: Severe pertussis infection has been reported in infants before receiving routine immunization series. This problem could be solved by vaccinating mothers during pregnancy or children at birth. This study aimed to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) and real-world evidence to evaluate the optimal strategy for pertussis vaccination. DATA SOURCES: PubMed, Embase, and the Cochrane Library databases were searched until December 2020. STUDY ELIGIBILITY CRITERIA: RCTs, cohort studies, case-control studies, and case series were included if they investigated the efficacy, immunogenicity, and safety of acellular pertussis vaccine during pregnancy and at birth. METHODS: Number of pertussis cases, severe adverse events (SAEs), and pertussis antibody concentration in infants before and after they receive routine vaccination series were extracted and random-effect model was used to pool the analyses. RESULTS: Overall, 29 studies were included. Our meta-analysis revealed that pertussis immunization during pregnancy significantly increased the concentrations of 3 pertussis antibodies and reduced the incidence rates of infected infants below 3 months of age (odds ratio, 0.22; 95% confidence interval, 0.14-0.33). Similarly, infants vaccinated at birth had higher levels of pertussis antibody than those who were not. No significant difference in rates of severe adverse events was seen in all vaccination groups (during pregnancy [risk ratio, 1.18; 95% confidence interval, 0.76-1.82] and at birth [risk ratio, 0.72; 95% confidence interval, 0.34-1.54]). CONCLUSION: Pertussis vaccination during pregnancy could protect infants against pertussis disease before the routine vaccination. Pertussis immunization at birth would be an alternative for infants whose mothers did not receive pertussis vaccines during pregnancy.

Mucosal Immunization with DTaP Confers Protection against Bordetella pertussis Infection and Cough in Sprague-Dawley Rats.

Pertussis is a respiratory disease caused by the Gram-negative pathogen, Bordetella pertussis. The transition from a whole-cell pertussis vaccine (wP and DTP) to an acellular pertussis vaccine (aP, DTaP, and Tdap) correlates with an increase in pertussis cases, despite widespread vaccine implementation and coverage, and it is now appreciated that the protection provided by aP rapidly wanes. To recapitulate the localized immunity observed from natural infection, mucosal vaccination with aP was explored using the coughing rat model of pertussis. Overall, our goal was to evaluate the route of vaccination in the coughing rat model of pertussis. Immunity induced by both oral gavage and intranasal vaccination of aP in B. pertussis challenged rats over a 9-day infection was compared to intramuscular wP (IM-wP)- and IM-aP-immunized rats that were used as positive controls. Our data demonstrate that mucosal immunization of aP resulted in the production of anti-B. pertussis IgG antibody titers similar to IM-wP- and IM-aP-vaccinated controls postchallenge. IN-aP also induced anti-B. pertussis IgA antibodies in the nasal cavity. Immunization with IM-wP, IM-aP, IN-aP, and OG-aP immunization protected against B. pertussis-induced cough, whereas OG-aP immunization did not protect against respiratory distress. Mucosal immunization by both intranasal and oral gavage administration protected against acute inflammation and decreased bacterial burden in the lung compared to mock-vaccinated challenge rats. The data presented in this study suggest that mucosal vaccination with aP can induce a mucosal immune response and provide protection against B. pertussis challenge. This study highlights the potential benefits and uses of the coughing rat model of pertussis; however, further questions regarding waning immunity still require additional investigation.

Adequate tetanus but poor diphtheria and pertussis response to a Tdap booster in adolescents with juvenile systemic lupus erythematosus.

BACKGROUND: Reports on vaccine responses in immunocompromised patients, such as juvenile systemic lupus erythematosus (jSLE), have shown highly variable results. OBJECTIVE: To compare the immune response and safety after a Tdap booster in 26 jSLE patients and 26 matched healthy adolescents.Methodology: Adverse events and disease activity were evaluated. Lymphocyte immunophenotyping was performed by flow cytometry. Tetanus, diphtheria and pertussis toxin antibodies were assessed by ELISA; whole blood was stimulated with whole cell pertussis and supernatants were assessed for cytokines by xMAP. RESULTS: Both groups showed a similar frequency of adverse events. There was no evidence of disease reactivation after Tdap booster in the jSLE cohort. Both groups showed a significant increase in antibody titers for all three antigens on D14 and D28 (p < 0.001). jSLE patients had a significantly lower increase in diphtheria titers than the control group (p = 0.007). jSLE patients had a distinct titer increase of tetanus and pertussis antibodies when compared to controls (p = 0.004 and p < 0.001, respectively). There was a lower frequency of pertussis seroconversion in the jSLE group on D14 (p = 0.009), D28 (p = 0.023), D12m (p = 0.015) and D24m (p = 0.004). Cellular immune response to Bordetella pertussis showed significantly lower levels of IFNγ (p < 0.001) and higher levels of IL10, IL12, IL21 and TNFα in jSLE patients than controls. CONCLUSIONS: jSLE patients had good response to Tdap booster dose for the tetanus antigen, but not for diphtheria and pertussis. This vaccine was safe in relation to adverse events and absence of disease reactivation.

National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years - United States, 2020.

The Advisory Committee on Immunization Practices (ACIP) recommends that adolescents aged 11-12 years routinely receive tetanus, diphtheria, and acellular pertussis (Tdap); meningococcal conjugate (MenACWY); and human papillomavirus (HPV) vaccines. Catch-up vaccination is recommended for hepatitis B (HepB); hepatitis A (HepA); measles, mumps, and rubella (MMR); and varicella (VAR) vaccines for adolescents whose childhood vaccinations are not current. Adolescents are also recommended to receive a booster dose of MenACWY vaccine at age 16 years, and shared clinical decision-making is recommended for the serogroup B meningococcal vaccine (MenB) for persons aged 16-23 years (1). To estimate coverage with recommended vaccines, CDC analyzed data from the 2020 National Immunization Survey-Teen (NIS-Teen) for 20,163 adolescents aged 13-17 years.* Coverage with ≥1 dose of HPV vaccine increased from 71.5% in 2019 to 75.1% in 2020. The percentage of adolescents who were up to date† with HPV vaccination (HPV UTD) increased from 54.2% in 2019 to 58.6% in 2020. Coverage with ≥1 dose of Tdap, ≥1 dose (and among adolescents aged 17 years, ≥2 doses) of MenACWY remained similar to coverage in 2019 (90.1%, 89.3%, and 54.4% respectively). Coverage increased for ≥2 doses of HepA among adolescents aged 13-17 years and ≥1 dose of MenB among adolescents aged 17 years. Adolescents living below the federal poverty level§ had higher HPV vaccination coverage than adolescents living at or above the poverty level. Adolescents living outside a metropolitan statistical area (MSA)¶ had lower coverage with ≥1 MenACWY and ≥1 HPV dose, and a lower proportion being HPV UTD than adolescents in MSA principal cities. In 2020, the COVID-19 pandemic disrupted routine immunization services. Results from the 2020 NIS-Teen reflect adolescent vaccination coverage before the COVID-19 pandemic. The 2020 NIS-Teen data could be used to assess the impact of the COVID-19 pandemic on catch-up vaccination but not on routine adolescent vaccination because adolescents included in the survey were aged ≥13 years, past the age when most routine adolescent vaccines are recommended, and most vaccinations occurred before March 2020. Continued efforts to reach adolescents whose routine medical care has been affected by the COVID-19 pandemic are necessary to protect persons and communities from vaccine-preventable diseases and outbreaks.

National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years - United States, 2019.

Three vaccines are recommended by the Advisory Committee on Immunization Practices (ACIP) for routine vaccination of adolescents aged 11-12 years to protect against 1) pertussis; 2) meningococcal disease caused by types A, C, W, and Y; and 3) human papillomavirus (HPV)-associated cancers (1). At age 16 years, a booster dose of quadrivalent meningococcal conjugate vaccine (MenACWY) is recommended. Persons aged 16-23 years can receive serogroup B meningococcal vaccine (MenB), if determined to be appropriate through shared clinical decision-making. CDC analyzed data from the 2019 National Immunization Survey-Teen (NIS-Teen) to estimate vaccination coverage among adolescents aged 13-17 years in the United States.* Coverage with ≥1 dose of HPV vaccine increased from 68.1% in 2018 to 71.5% in 2019, and the percentage of adolescents who were up to date† with the HPV vaccination series (HPV UTD) increased from 51.1% in 2018 to 54.2% in 2019. Both HPV vaccination coverage measures improved among females and males. An increase in adolescent coverage with ≥1 dose of MenACWY (from 86.6% in 2018 to 88.9% in 2019) also was observed. Among adolescents aged 17 years, 53.7% received the booster dose of MenACWY in 2019, not statistically different from 50.8% in 2018; 21.8% received ≥1 dose of MenB, a 4.6 percentage point increase from 17.2% in 2018. Among adolescents living at or above the poverty level,§ those living outside a metropolitan statistical area (MSA)¶ had lower coverage with ≥1 dose of MenACWY and with ≥1 HPV vaccine dose, and a lower percentage were HPV UTD, compared with those living in MSA principal cities. In early 2020, the coronavirus disease 2019 (COVID-19) pandemic changed the way health care providers operate and provide routine and essential services. An examination of Vaccines for Children (VFC) provider ordering data showed that vaccine orders for HPV vaccine; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap); and MenACWY decreased in mid-March when COVID-19 was declared a national emergency (Supplementary Figure 1, https://stacks.cdc.gov/view/cdc/91795). Ensuring that routine immunization services for adolescents are maintained or reinitiated is essential to continuing progress in protecting persons and communities from vaccine-preventable diseases and outbreaks.

Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B Vaccine, and Guidance for Use in Infants.

On December 21, 2018 the Food and Drug Administration (FDA) licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP) adsorbed, inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib) conjugate (meningococcal protein conjugate) and hepatitis B (HepB) (recombinant) vaccine, DTaP-IPV-Hib-HepB (Vaxelis; MCM Vaccine Company),* for use as a 3-dose series in infants at ages 2, 4, and 6 months (1). On June 26, 2019, after reviewing data on safety and immunogenicity, the Advisory Committee on Immunization Practices (ACIP)† voted to include DTaP-IPV-Hib-HepB in the federal Vaccines for Children (VFC) program.§ This report summarizes the indications for DTaP-IPV-Hib-HepB and provides guidance for its use.

Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccines: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2019.

Since 2005, a single dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine has been recommended by the Advisory Committee on Immunization Practices (ACIP) for adolescents and adults (1,2). After receipt of Tdap, booster doses of tetanus and diphtheria toxoids (Td) vaccine are recommended every 10 years or when indicated for wound management. During the October 2019 meeting of ACIP, the organization updated its recommendations to allow use of either Td or Tdap where previously only Td was recommended. These situations include decennial Td booster doses, tetanus prophylaxis when indicated for wound management in persons who had previously received Tdap, and for multiple doses in the catch-up immunization schedule for persons aged ≥7 years with incomplete or unknown vaccination history. Allowing either Tdap or Td to be used in situations where Td only was previously recommended increases provider point-of-care flexibility. This report updates ACIP recommendations and guidance regarding the use of Tdap vaccines (3).

Variation in Tdap and Influenza Vaccination Coverage Among Pregnant Women by Insurance Type - Florida, 2016-2018.

Infants are at increased risk for pertussis-associated morbidity and mortality, and pregnant women and their infants are more likely than other patient populations to experience severe influenza-related illness (1,2). The Advisory Committee on Immunization Practices (ACIP) recommends that all women receive the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine during each pregnancy, preferably during the early part of gestational weeks 27-36 (3). ACIP also recommends that women who are or might be pregnant during the influenza season receive the inactivated influenza vaccine at any time during pregnancy (4). Despite these recommendations, coverage with Tdap and influenza vaccines during pregnancy has been low, with approximately one half of women receiving each vaccine and only one third receiving both, based on a survey during March-April 2019 (5). Data obtained through a retrospective chart review of randomly selected pregnant women who delivered at the University of Florida Health Shands Hospital in Gainesville, Florida, from January 1, 2016, to December 31, 2018, were analyzed to assess vaccination coverage by insurance type. Because the Florida Medicaid policy at that time did not cover these vaccines during pregnancy, the hospital system offered Tdap and influenza vaccines at no additional cost to mothers during the immediate postpartum hospital stay. Among 341 women, 68.6% of privately insured and 13.4% with Medicaid received Tdap during pregnancy, and among 316 women, 70.4% of privately insured and 35.6% with Medicaid received influenza vaccine during pregnancy. Many women, especially those with Medicaid, were vaccinated in the immediate postpartum period, when vaccination was available at no cost, increasing Tdap vaccination rates to 79.3% for privately insured and 51.7% for women with Medicaid; influenza vaccination rates rose to 72.0% for privately insured and 43.5% for women with Medicaid. These data suggest that the state Medicaid policy to not cover these vaccines during pregnancy might have significantly reduced coverage among its enrollees.

Influenza and Tdap Vaccination Coverage Among Pregnant Women - United States, April 2020.

Vaccination of pregnant women with influenza vaccine and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) can decrease the risk for influenza and pertussis among pregnant women and their infants. The Advisory Committee on Immunization Practices (ACIP) recommends that all women who are or might be pregnant during the influenza season receive influenza vaccine, which can be administered at any time during pregnancy (1). ACIP also recommends that women receive Tdap during each pregnancy, preferably during the early part of gestational weeks 27-36 (2,3). Despite these recommendations, vaccination coverage among pregnant women has been found to be suboptimal with racial/ethnic disparities persisting (4-6). To assess influenza and Tdap vaccination coverage among women pregnant during the 2019-20 influenza season, CDC analyzed data from an Internet panel survey conducted during April 2020. Among 1,841 survey respondents who were pregnant anytime during October 2019-January 2020, 61.2% reported receiving influenza vaccine before or during their pregnancy, an increase of 7.5 percentage points compared with the rate during the 2018-19 season. Among 463 respondents who had a live birth by their survey date, 56.6% reported receiving Tdap during pregnancy, similar to the 2018-19 season (4). Vaccination coverage was highest among women who reported receiving a provider offer or referral for vaccination (influenza = 75.2%; Tdap = 72.7%). Compared with the 2018-19 season, increases in influenza vaccination coverage were observed during the 2019-20 season for non-Hispanic Black (Black) women (14.7 percentage points, to 52.7%), Hispanic women (9.9 percentage points, to 67.2%), and women of other non-Hispanic (other) races (7.9 percentage points, to 69.6%), and did not change for non-Hispanic White (White) women (60.6%). As in the 2018-19 season, Hispanic and Black women had the lowest Tdap vaccination coverage (35.8% and 38.8%, respectively), compared with White women (65.5%) and women of other races (54.0%); in addition, a decrease in Tdap vaccination coverage was observed among Hispanic women in 2019-20 compared with the previous season. Racial/ethnic disparities in influenza vaccination coverage decreased but persisted, even among women who received a provider offer or referral for vaccination. Consistent provider offers or referrals, in combination with conversations culturally and linguistically tailored for patients of all races/ethnicities, could increase vaccination coverage among pregnant women in all racial/ethnic groups and reduce disparities in coverage.

Tetanus, diphtheria and acellular pertussis (Tdap) vaccine for prevention of pertussis among adults aged 19 years and older in the United States: A cost-effectiveness analysis.

Currently, the Advisory Committee on Immunization Practices recommends one-time tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination for all adults 19 years and older. This study is designed to evaluate the cost-effectiveness of Tdap vaccination for Tdap-eligible adults aged 19 through 85 in the United States. A cost-effectiveness model was developed to compute costs and health outcomes associated with pertussis among 100,000 Tdap-eligible persons of each age cohort. From the societal perspective, the cost per quality-adjusted life-year (QALY) saved was evaluated under the vaccination scenarios. Sensitivity analyses were also conducted to evaluate the impacts of changes in key variables. All costs were adjusted to 2018 US$ with an annual discount rate of 3% applied to costs and outcomes. The incremental cost-effectiveness ratios (ICERs) for vaccinating US adults aged 19 to 85 with Tdap ranged from $248,000/QALY to $900,000/QALY. The lowest cost per QALY was found to be $248,000 for the age 65 cohort, followed by $332,000 for the cohort of age 19, and followed by $477,000 for the age 50 cohort. Sensitivity analysis showed the most dramatic changes in ICER occurred when changing the underreporting factor, vaccine effectiveness and vaccination costs. While Tdap vaccination may not be as cost effective as predicted earlier, it remains the best available preventive measure against pertussis. Further investigation of the true burden of pertussis disease among adults and the effectiveness of Tdap vaccination in this population is needed to better estimate the impact of Tdap vaccination.

Risk factors associated with death in infants <120 days old with severe pertussis: a case-control study.

BACKGROUND AND PURPOSE: Pertussis is a serious infectious disease in young infants, and severe cases frequently cause death. Our study explored risk factors for death from severe pertussis. METHOD: A case-control study of infants with severe pertussis admitted to the paediatric intensive care unit (PICU) in the Children's Hospital of Chongqing Medical University, China, from January 1, 2013, to June 30, 2019, was conducted. Pertussis was confirmed by clinical features and laboratory examinations. Severe pertussis was defined as patients with pertussis resulting in PICU admission or death. To understand the risk factors for death, we compared fatal and nonfatal cases of severe pertussis in infants aged < 120 days by collecting clinical and laboratory data. RESULTS: The participants included 63 infants < 120 days of age with severe pertussis. Fifteen fatal cases were confirmed and compared with 44 nonfatal severe pertussis cases, Four patients with termination of treatment were excluded. In the univariate analysis, the risk factors associated with death included apnoea (P = 0.001), leukocytosis (white blood cell (WBC) count≥30 × 109/L (P = 0.001) or ≥ 50 × 109/L (P = 0)), highest lymphocyte count (P = 0), pulmonary hypertension (P = 0.001), and length of PICU stay (P = 0.003). The multivariate analysis revealed that apnoea (OR 23.722, 95%CI 2.796-201.26, P = 0.004), leukocytosis (OR 63.708, 95%CI 3.574-1135.674, P = 0.005) and pulmonary hypertension (OR 26.109, 95%CI 1.800-378.809, P = 0.017) were significantly associated with death. CONCLUSION: Leukocytosis and pulmonary hypertension exhibited the greatest associations with death in infants with severe pertussis admitted to the PICU. Vaccination is still the most effective protection method against pertussis.

A patient with respiratory toxigenic diphtheria in Greece after more than 30 years.

The introduction of treatment and systematic vaccination has significantly reduced diphtheria mortality; however, toxigenic strains continue to circulate worldwide. The emergence of an indigenous diphtheria case with fatal outcome in Greece, after 30 years, raised challenges for laboratory confirmation, clinical and public health management. Toxigenic Corynebacterium diphtheriae was isolated from an incompletely vaccinated 8-year-old boy with underlying conditions. The child passed away due to respiratory distress syndrome, before the administration of diphtheria antitoxin (DAT). All close contacts in family, school and hospital settings were investigated. Pharyngeal swabs were obtained to determine asymptomatic carriage. Chemoprophylaxis was given for 7 days to all close contacts and a booster dose to those incompletely vaccinated. Testing revealed a classmate, belonging to a subpopulation group (Roma), and incompletely vaccinated, as an asymptomatic carrier with an indistinguishable toxigenic strain (same novel multilocus sequence type, designated ST698). This case highlights the role of asymptomatic carriage, as the entry of toxigenic strains into susceptible populations can put individuals and their environment at risk. Maintenance of high-level epidemiological and microbiological surveillance, implementation of systematic vaccination in children and adults with primary and booster doses, availability of a DAT stockpile, and allowing timely administration are the cornerstone to prevent similar incidents in the future.

Immunogenicity and safety of a DTaP-IPV/Hib pentavalent vaccine given as primary and booster vaccinations in healthy infants and toddlers in Japan.

BACKGROUND: Globally, the use of single DTaP-IPV/Hib vaccines that combine DTaP-IPV and Hib is widespread, but in Japan vaccination is usually concomitant at separate sites. The immunogenicity and safety of a primary vaccination series and booster of a combined pentavalent DTaP-IPV/Hib vaccine were evaluated and compared to separate administration of DTaP-IPV and Hib in Japanese infants. METHODS: Healthy Japanese infants were administered DTaP-IPV/Hib (Group A: N = 207) or DTaP-IPV + Hib (Group B: N = 207) by the subcutaneous (SC) or DTaP-IPV/Hib by the intramuscular (IM) route (Group C: N = 10). All subjects received a 3-dose primary vaccination series and a booster. Non-inferiority (Group A versus Group B) was tested post-primary series and subsequent post hoc analyses were performed for anti-Hib. Safety was assessed by parental reports. RESULTS: Non-inferiority for SC administration of Group A versus Group B for the primary series was demonstrated for antibody responses to all antigens except Hib using the threshold of 1.0 µg/mL. Post hoc analyses for anti-Hib demonstrated non-inferiority for the primary series response using 0.15 µg/mL, and for pre-booster antibody persistence and the booster response using 0.15 µg/mL and 1.0 µg/mL. The immune response was similar for each antigen following SC or IM administration. There were no safety concerns in any group, and a lower incidence of injection sites for the IM route was observed as expected. CONCLUSIONS: These data show the good immunogenicity and safety profile of the DTaP-IPV/Hib vaccine as a 3-dose infant primary series followed by a booster in the second year of life in Japan.

Factors associated with Tdap vaccination receipt during pregnancy: a cross-sectional study.

OBJECTIVE: Pertussis morbidity and mortality disproportionately affect infants younger than 1 year, who constitute 70% of deaths from pertussis. In 2017, 43% of infants younger than 6 months diagnosed with pertussis were hospitalized. In 2012, the Advisory Committee on Immunization Practices recommended that all pregnant women should receive Tdap (tetanus-diphtheria-acellular pertussis) vaccine between 27- and 36-weeks gestation in an effort to reduce infant pertussis morbidity and mortality. However, Tdap vaccination rates among pregnant women remain far from robust. The aim of this study was to assess factors associated with maternal Tdap uptake to help providers identify best practices that can improve Tdap receipt and identify women at risk for not receiving this important vaccine. STUDY DESIGN: A retrospective cross-sectional study. METHODS: A review of prenatal and delivery records was performed on all maternal-infant dyads with infants older than 36 weeks gestation admitted to the term nursery at Albany Medical Center from January 1, 2016 to April 16, 2016. A chi-squared analysis using STATA®, version 14.1, was performed to determine if any variables were associated with Tdap uptake, with statistical significance defined as P < 0.05. Multivariate analysis was performed to identify the variables which had the greatest effect on Tdap receipt. RESULTS: Tdap vaccine was received by 65.8% of pregnant women (n = 400) in the study; median gestational age of receipt was 30 weeks. Maternal influenza vaccine receipt, infant hepatitis B vaccine receipt, provider recommendation of Tdap vaccination, and on-site availability of Tdap vaccine were all positively associated with maternal Tdap receipt during pregnancy. CONCLUSION: Receipt of Tdap by pregnant women was highest in those who had received a provider recommendation about its benefits and who also received influenza vaccine during pregnancy. Because women who received the influenza vaccine themselves and also consented to have their infants receive the hepatitis B vaccine had significantly higher uptake rates, encouraging vaccines usage and combating vaccine hesitancy in general can improve Tdap uptake rates. A small, but statistically significant association with receipt of assisted reproductive technologies was also seen, meriting future research.

Overcoming barriers to adolescent vaccination: perspectives from vaccine providers in North Carolina.

To capture strategies for achieving high adolescent coverage of tetanus-diphtheria-acellular pertussis (Tdap), meningococcal conjugate (MenACWY), and human papillomavirus (HPV) vaccination, we surveyed employees of 20 North Carolina (N.C.) clinics that achieved adolescent vaccination coverage higher than the state average. One employee per clinic completed a surveysummarizing clinic practices regarding adolescent vaccination; perceived barriers and facilitators to Tdap/MenACWY/HPV vaccination; and the role of "champions" who made special efforts to promote adolescent vaccination. Common perceived barriers for all vaccinations were parental opposition and logistical barriers to receiving vaccination. For HPV vaccination, employees cited parental concerns about sexual behavior and injection site pain; no school vaccination requirement; and low-perceived benefit in boys. Most clinics (80%) implemented successful changes to increase adolescent vaccination: consistently offering vaccination, tracking vaccination status using existing data, providing appointment reminders, updating providers on vaccination recommendations, and expanding vaccination hours. Strategies to improve HPV vaccination included co-administration with Tdap and MenACWY, and providing reminders to complete the vaccination series. Vaccine champions strongly recommended vaccination to parents (55%) and educated parents on vaccination recommendations (36%). Clinics in N.C.and similar settings can implement these and other low-resource strategies to overcome adolescent vaccination barriers. ABBREVIATIONS: CDC=Centers for Disease Control and Prevention; EHR=Electronic health record; HPV=Human papillomavirus; Tdap=Tetanus-diphtheria-acellular pertussis vaccine; MenACWY=Meningococcal Conjugate Vaccine; NCIB=North Carolina Immunization Branch; NCIR=North Carolina Immunization Registry; ACIP=Advisory Committee on Immunization Practices.

Using the North Dakota IIS to Assess the Response of Health Care Providers to the ACIP Recommendation for Tdap Vaccination During Pregnancy.

OBJECTIVES: To evaluate the response of North Dakota health care providers to follow the recommendation set forth by the Advisory Committee on Immunization Practices (ACIP) to administer a dose of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine to women during each pregnancy using the North Dakota Immunization Information System (NDIIS). METHODS: Data from the NDIIS for North Dakota infants born during calendar years 2013-2018 were extracted. Mother's name was taken from the newborn records and matched to NDIIS female client records to identify the population of mothers of newborns who would have been recommended to receive Tdap during their pregnancy. Doses of Tdap vaccine administered after October 1, 2012, were extracted from the NDIIS, and the dose records were matched back to the mother's record. The time from baby's birthdate back to the doses of Tdap vaccine administered to the mother was measured to find any doses that would have been administered during pregnancy. RESULTS: The percentage of women receiving Tdap vaccine during pregnancy increased from 31.5% in 2013 to 60.6% in 2018. Of those women who received Tdap during pregnancy, 94% received the vaccine during the ACIP-recommended interval of 27 to 36 weeks' gestation, using the assumption that all babies were born at 40 weeks' gestation. CONCLUSIONS: North Dakota health care providers have responded positively to the recommendation of the ACIP to administer a dose of Tdap vaccine to women during each pregnancy and have increased their administration of the vaccine to their patients.

Increased Tdap and Influenza Vaccination Acquisition Among Patients Participating in Group Prenatal Care.

CenteringPregnancy, an alternative to traditional prenatal care, offers additional time between clinicians and patients with the goal of increasing knowledge, understanding, and autonomy in pregnant participants. We investigated whether these women would be more likely to receive recommended Tdap and influenza vaccinations relative to others who received one-on-one traditional prenatal care. Our study employed a retrospective chart review of all women who participated in CenteringPregnancy group care compared to a group of matched women who received only traditional prenatal care at a large, quaternary care referral academic center. We extracted demographic and clinical characteristics from charts that included maternal age during pregnancy care and parity. Outcome variables of interest were influenza and Tdap vaccination status. Compared with traditional obstetrical care patients, women who participated in CenteringPregnancy were 1.7-2.7 times more likely to obtain the Tdap and influenza vaccines. These findings may be attributable to the increased opportunity for patient education and social support offered by the CenteringPregnancy model.

At-birth vaccination timeliness: An analysis of inborns in the highlands of Jos, North-Central Nigeria.

INTRODUCTION: Immunisation and vaccination programmes are preventive and cost-effective child health interventions for reducing childhood mortality and disability from infectious diseases. Timely administration of these vaccines is important to ensure their effectiveness in disease prevention. AIM: The aim was to determine the timeliness, barriers and predictors of at-birth vaccinations. MATERIALS AND METHODS: This was a cross-sectional study of 355 mother-newborn pairs using simple random sampling technique by balloting. SPSS version 23.0 was used for data analysis. Crude and adjusted odds ratios (AORs) were used as point estimates in the binary logistic regression model, while 95% confidence interval (CI) was used as the interval estimate. A P < 0.05 was considered statistically significant for the study. RESULTS: The mean age of the mothers was 31.0 ± 6 years. The median age of newborns at vaccination was 18 h (IQR = 1 - 17) h. About 185 (52.1%) of the newborns studied were males. Only 191 (53.8%) newborns received at-birth vaccination within 24 h of life. Weekend delivery, birth outside vaccination days, delivery during public holidays and vaccine stock-outs were barriers to timely vaccinations. Private hospital delivery was an independent predictor of delayed at-birth vaccinations (AOR = 2.616; 95% CI = 1.382-4.951). CONCLUSIONS: Our study has identified weekend delivery, preterm birth, delivery outside vaccination days and vaccines stock-outs as barriers to timely at-birth vaccinations. Private hospital delivery is a significant predictor of delayed at-birth vaccinations.