Infant Vaccination Research Articles

Side Effect Profile of Meningococcal B Vaccine in Children

Objective: Invasive meningococcal infections have a clinical picture with a rapid onset and can lead to serious sequelae and death even in individuals who are treated early. The most common causes of related epidemics are serogroups A, B, C, W, Y, and X, and two different vaccines have been developed against serogroups A, C, W, and Y and serogroup B. The serogroup B-containing MenB-4C vaccine (Bexsero®) was licensed in Turkey in 2018 and is still being administered. In this study, the side effects of this vaccine in infants and children followed up in a tertiary pediatric clinic were questioned. Materials and Methods: In our study, the local and systemic side effects of the MenB-4C vaccine doses, which were administered between March 1, 2019, and March 1, 2022, at the Child Health Follow-up Outpatient Clinic of Gazi University Faculty of Medicine, were evaluated retrospectively. All infants and children aged 0-18 years who were vaccinated at this clinic on the specified dates (n = 102) were recruited, and a questionnaire was completed by calling their parents by telephone and questioning the side effects of the vaccine. Results: It was determined that a total of 224 doses of the MenB-4C vaccine were administered to 102 children over the three-year study period, Of these vaccines, 21.6% were administered during the year before the pandemic and 78.4% during the two years after the pandemic. According to the total number of doses, the rate of local and systemic side effects was 30.8% (n= 69). It was found that among the 69 doses with side effects, 42 (60.8%) were systemic (fever), and 27 (39.1%) were local (stiffness, redness, and pain at the injection site). Side effects were observed in 41.3% of the patients after the first dose of the vaccine, 23.3% after the second dose, and 25.9% after the third dose. Conclusion: In our study, no serious post-vaccine reactions, such as anaphylaxis and encephalopathy, were observed following vaccination with MenB-4C, and the most common side effects of this vaccine were fever and local pain, which were only transient and self-limiting, lasting only two to three days at most. Since the MenB-4C vaccine, which has been included in the vaccination schedule of most countries, is a strong tool to help prevent meningococcal infections, every parent presenting to a health institution should be informed by the physician about the necessity of this vaccine, and if possible, conjugated meningococcal vaccines containing not only serogroups A, C, W, and Y but also serogroup B should be added to the national vaccine scheme.

Immune Persistence following Primary Immunization and the Immunogenicity and Safety of a Booster Dose of a Multidose Sabin Strain-Based Inactivated Polio Vaccine in Infants Aged 18 Months.

The multidose Sabin-strain inactivated poliovirus vaccine (sIPV) has the potential to significantly aid in the eradication of poliomyelitis, particularly in low- and middle-income countries. As part of a phase III clinical trial in which infants were given three doses of primary immunization at 2, 3, and 4 months of age, this study aimed to evaluate immune persistence following primary immunization, as well as the safety and immunogenicity of a booster of the 5-dose sIPV in infants aged 18 months. Infants aged 18 months were given one booster dose of 5-dose sIPV in stage one, which was open-label. Unblinding was performed for stage two after completing primary immunization, which was randomized, blinded, and controlled; infants aged 18 months in the test group I-III, IPV group, and single-dose sIPV group were given one booster dose of 5-dose sIPV, conventional IPV, and single-dose sIPV, respectively, in stage two. This study included 1438 infants in the immune persistence and safety set and 1387 infants in the booster per-protocol set. Fourteen months after primary immunization, the seropositivity rates (≥1:8) for types 1-3 were 100%, 99.88%, and 99.53% in the 5-dose sIPV groups; 100%, 98.97%, and 97.23% in the IPV group; and 99.66%, 100%, and 99.66% in the single-dose sIPV group. A total of 30 days after booster immunization, the seropositivity rates (≥1:8) of 3 serotypes in all the groups reached 100%. The geometric mean titers of neutralizing antibodies for types 1-3 in the 5-dose sIPV group were 9962.89, 10273, and 7870.21, with geometric mean increases of 15.76, 33.15, and 24.5, compared to the pre-booster level. The overall incidence of adverse reactions was 8.97%, with fever being the most common, observed at rates of 7.1%, 5.52%, and 7.96% in the 5-dose sIPV, IPV, and single-dose groups, respectively (p = 0.4845). The 5-dose sIPV has shown promising immune persistence and robust immune response following a booster immunization, coupled with an acceptable safety profile.

Clinical research on RSV prevention in children and pregnant women: progress and perspectives.

Respiratory syncytial virus (RSV) is a significant causative agent of bronchitis and pneumonia in infants and children. The identification and structural analysis of the surface fusion glycoprotein of RSV represents a pivotal advancement in the development of RSV prevention. This review provides a comprehensive summary of RSV monoclonal antibody (mAb) and vaccine clinical trials registered on ClinicalTrials.gov, emphasizing on the classification, name, target, phase, clinical outcomes, and safety data of RSV vaccination in newborns, infants and children. We also discuss the characteristics of the types of RSV vaccines for maternal immunity and summarize the current clinical research progress of RSV vaccination in pregnant women and their protective efficacy in infants. This review will provide new ideas for the development of RSV prevention for children in the future.

Maternal singing reduced pain indexes in 2-month-old infants and increased proximity during vaccinations.

Immunisation is a global health priority, but methods of non-pharmacological pain relief are not widely used in routine clinical practice. In this study, we set out to investigate the effects of maternal singing during the routine vaccination of infants. We recruited 67 mother-infant pairs at Health Centres in the Aosta Region of Italy. Infants aged 2-4 months were randomly allocated to a singing intervention group or to a control group whose injections were administered following standard practice. Pre- and post-immunisation pain was blindly assessed using the Modified Behavioural Pain Scale, and mother-infant proximity indexes were assigned based on muted video-tracks. When assessed for pain, the infants in the maternal singing group were assigned significantly lower movement indexes (p = 0.032) and marginally significantly lower cry indexes (p = 0.076). A higher frequency of mother-to-infant gaze (p < 0.005) was observed in the singing group dyads. Finally, the intervention group mothers' self-perceived ease in singing was correlated with their previous singing experience and with lower anxiety following the vaccination procedure (p < 0.05). Maternal singing during immunisation procedures benefits both mothers and babies. The practice of singing is a biologically rooted and adaptive form of intuitive parental communication that should be encouraged, especially in at-risk populations.

A phase 3 randomized study to evaluate safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in healthy Japanese infants

ObjectivesSafety and immunogenicity evaluation of a 4-dose series with 20-valent pneumococcal conjugate vaccine (PCV20). MethodsThis phase 3, double-blind study randomized healthy Japanese infants to receive 4 doses (3 infant doses, 1 toddler dose) of PCV20 by subcutaneous (SC) or intramuscular (IM) injection or 13-valent PCV (PCV13) SC. A primary immunogenicity objective was to demonstrate noninferiority of PCV20 SC to PCV13 SC for percentages of participants meeting predefined serotype-specific immunoglobulin G concentrations 1 month after Dose 3. The 7 additional PCV20 serotypes were compared with the lowest vaccine serotype result in the PCV13 group. Safety and tolerability were assessed as the primary safety objective. ResultsOverall, 668 participants were randomized (PCV20 SC, n = 226; PCV13 SC, n = 224; PCV20 IM, n = 218). The primary noninferiority objective for PCV20 SC to PCV13 SC was met for 11/13 matched and 5/7 additional serotypes. Additional data showed PCV20 SC and IM elicited robust functional opsonophagocytic activity and boosting responses to all 20 vaccine serotypes. PCV20 had a similar safety/tolerability profile to PCV13, although local reactions were less frequent with PCV20 IM. ConclusionsA 4-dose series of PCV20 SC or IM elicited immune responses expected to be protective against all 20 serotypes in Japanese infants. NCT04530838

Risk and rates of hospitalisation in young children: A prospective study of a South African birth cohort.

Children in sub-Saharan Africa (SSA) are disproportionately affected by morbidity and mortality. There is also a growing vulnerable population of children who are HIV-exposed uninfected (HEU). Understanding reasons and risk factors for early-life child hospitalisation will help optimise interventions to improve health outcomes. We investigated hospitalisations from birth to two years in a South African birth cohort study. Mother-child pairs in the Drakenstein Child Health Study were followed from birth to two years with active surveillance for hospital admission and investigation of aetiology and outcome. Incidence, duration, cause, and factors associated with child hospitalisation were investigated, and compared between HEU and HIV-unexposed uninfected (HUU) children. Of 1136 children (247 HEU; 889 HUU), 314 (28%) children were hospitalised in 430 episodes despite >98% childhood vaccination coverage. The highest hospitalisation rate was from 0-6 months, decreasing thereafter; 20% (84/430) of hospitalisations occurred in neonates at birth. Amongst hospitalisations subsequent to discharge after birth, 83% (288/346) had an infectious cause; lower respiratory tract infection (LRTI) was the most common cause (49%;169/346) with respiratory syncytial virus (RSV) responsible for 31% of LRTIs; from 0-6 months, RSV-LRTI accounted for 22% (36/164) of all-cause hospitalisations. HIV exposure was associated with increased incidence rates of hospitalisation in infants (IRR 1.63 [95% CI 1.29-2.05]) and longer hospital admission (p = 0.004). Prematurity (HR 2.82 [95% CI 2.28-3.49]), delayed infant vaccinations (HR 1.43 [95% CI 1.12-1.82]), or raised maternal HIV viral load in HEU infants were risk factors for hospitalisation; breastfeeding was protective (HR 0.69 [95% CI 0.53-0.90]). In conclusion, children in SSA experience high rates of hospitalisation in early life. Infectious causes, especially RSV-LRTI, underly most hospital admissions. HEU children are at greater risk of hospitalisation in infancy compared to HUU children. Available strategies such as promoting breastfeeding, timely vaccination, and optimising antenatal maternal HIV care should be strengthened. New interventions to prevent RSV may have additional impact in reducing hospitalisation.

Infant Whole-Cell Versus Acellular Pertussis Vaccination in 1997 to 1999 and Risk of Childhood Hospitalization for Food-Induced Anaphylaxis: Linked Administrative Databases Cohort Study

Evidence suggests that children who had received an initial priming dose of whole-cell pertussis (wP) vaccine, rather than acellular pertussis (aP) vaccine, had a lower risk of developing IgE-mediated food allergy, the most common cause of anaphylaxis-related hospital presentations ofchildhood. To assess the association between wP versus aP vaccination in infancy and subsequent hospital presentations for anaphylaxis. This study was preregistered under PMID 34874968. Perinatal records for a cohort of New South Wales-born children (1997-1999) receiving their first dose of pertussis-containing vaccine before age 4 months were probabilistically linked to hospital and immunization records. We used adjusted Cox models to estimate hazard ratios (aHRs) and 95% CIs for anaphylaxis-coded hospitalizations. There were 218,093 New South Wales-born children who received a first dose of wP or aP before age 4 months. Among these children, 86 experienced at least one hospitalization for food-induced anaphylaxis at age 5-15 years (range of events per patient, one to three). The person-time of follow-up was 1,476,969 years, and 665,519 years for children vaccinated with wP as a first dose (wP-1 children) and aP as a first dose (aP-1 children), respectively. The incidence rates for first hospitalization for food anaphylaxis were 3.5 (95% CI, 2.6-4.6) and 5.1 (95% CI, 3.5-7.1) per 100,000 child-years among wP-1 children and aP-1 children, respectively (aHR for wP vs aP= 0.47; 95% CI, 0.26-0.83). For first admission for venom anaphylaxis, the incidence rate was 4.9 (95% CI, 3.9-6.2) per 100,000 child-years among wP-1 children and 5.1 (95% CI, 3.5-7.1) per 100,000 child-years among aP-1 children (aHR for wP vs aP= 0.92; 95% CI, 0.53-1.60), and for all-cause anaphylaxis, the incidence rate was 10.6 (95% CI, 9.0-12.4) per 100,000 child-years among wP-1 children and 12.8 (95% CI, 10.2-15.8) per 100,000 child-years among aP-1 children (aHR for wP vs aP= 0.92; 95% CI, 0.53-1.60). Vaccination with wP in infancy was associated with a lower risk of hospitalizations for food-induced anaphylaxis (and therefore severe IgE-mediated food allergy) occurring in childhood.

The effect of breastfeeding on reducing pain induced by pentavalent vaccine in infants: a randomized clinical trial

RESUMO Objetivo: Analisar o efeito da amamentação na redução da dor induzida pela vacina Pentavalente em lactentes e identificar o intervalo de tempo da amamentação necessário para sua ação antinocicepção. Método: Ensaio clínico randomizado paralelo aberto. Participaram 90 binômios mãe-lactente, distribuídos em grupo intervenção 1 (n = 30), que realizou a amamentação cinco minutos antes da vacinação; grupo intervenção 2 (n = 30), realizou a amamentação cinco minutos antes e durante a vacinação; e grupo controle (n = 30), que não realizou a amamentação. A variável desfecho foi o nível de dor mensurado pela Escala FLACC. A análise dos dados foi realizada por meio de estatística descritiva e inferencial, com aplicação dos testes Exato de Fisher, Kolmogorov-Smirnov, Kruskal-Wallis e de comparações múltiplas de Dunn, adotando nível de significância de 0,05. Resultados: A dor induzida pela vacina Pentavalente se reduziu nos grupos intervenção 1 e 2 (média de dor de 6,06 versus 3,83, respectivamente) em comparação ao grupo controle (média de dor de 7,43), o que foi significativo para o grupo intervenção 2 (p &lt; 0,001), indicando que, para alcançar menores níveis de dor, a amamentação deve ocorrer antes e durante a vacinação. Conclusão: A amamentação mais prolongada, realizada cinco minutos antes e durante todo o processo de vacinação, reduz a dor induzida pela vacina Pentavalente. Em sua aplicação não foram identificados riscos capazes de superar os benefícios de tal prática. Esses resultados endossam a importância de os profissionais de saúde incentivarem essa prática no tempo mínimo de cinco minutos antes e durante a aplicação de vacinas injetáveis para obtenção do efeito antinocicepção. Registro Brasileiro de Ensaios Clínicos: RBR-9vh37wr.

The effect of breastfeeding on reducing pain induced by pentavalent vaccine in infants: a randomized clinical trial.

To analyze the effect of breastfeeding on reducing Pentavalent vaccination pain in infants and to identify the necessary breastfeeding interval for antinociceptive action. Open parallel randomized clinical trial. Ninety mother-infant dyads participated, distributed into intervention group 1 (n = 30), which breastfed five minutes before vaccination; intervention group 2 (n = 30), which breastfed five minutes before and during vaccination; and control group (n = 30), which did not breastfeed. The outcome variable was the pain level measured by the FLACC Scale. Data analysis was conducted using descriptive and inferential statistics, applying Fisher's Exact, Kolmogorov-Smirnov, Kruskal-Wallis and Dunn's multiple comparison tests, with 0.05 significance level. Pain induced by the Pentavalent vaccine was reduced in intervention groups 1 and 2 (mean pain of 6.06 versus 3.83, respectively) compared to the control group (mean of pain of 7.43), which was significant for intervention group 2 (p < 0.001), indicating that, to achieve lower levels of pain, breastfeeding should be carried out before and during vaccination. Longer breastfeeding, conducted five minutes before and during vaccination, reduces the pain induced by the Pentavalent vaccine. No vaccination risks were identified to outweigh the benefits. These results endorse that health professionals should encourage breastfeeding at least five minutes before and during vaccine injection for an antinociception effect. Brazilian Clinical Trials Registry: RBR-9vh37wr.

Vaccination coverage and delay in vaccination of infants born in 2017 and 2018 in municipalities in the Southern region of Brazil: National Vaccination Coverage Survey 2020.

To evaluate vaccination coverage and delay in vaccine dose administration in infants in six municipalities in the Southern region of Brazil. National Vaccination Coverage Survey 2020, with infants born alive in 2017 and 2018, carried out from September 2020 to March 2022. Coverage of doses administered, doses administered on time and delay in dose administration were evaluated. For 4681 infants analyzed, coverage for vaccines recommended up to 24 months was 68.0% (95%CI 63.9;71.8%) for doses administered and 3.9% (95%CI 2.7%;5.7%) for doses administered on time. Delay time for the majority of late vaccinations was ≤ 3 months. For some boosters, 25% of vaccine administration was delayed by ≥ 6 months. In addition to tracking vaccine defaulters, strategies are needed to encourage compliance with the vaccination schedule at the recommended ages. Vaccination coverage for the set of vaccines recommended up to 24 months was 68.0% and 3.9% for on-time doses. Delay time for some doses exceeded six months in up to 25% of infants with delayed vaccination. Monitoring vaccine administration at the recommended ages is necessary, with the adoption of strategies that reinforce routine vaccination to prevent vaccination delays and abandonment. Primary care in surveillance and care for infants needs to reinforce actions to ensure timely vaccination. Studies to deepen knowledge of vaccination delay, determinants and strategies for their reduction are necessary.

Vaccination coverage and delay in vaccination of infants born in 2017 and 2018 in municipalities in the Southern region of Brazil: National Vaccination Coverage Survey 2020

RESUMO Objetivo Avaliar as coberturas vacinais e o atraso nas doses de vacinas em lactentes em seis municípios da região Sul do Brasil. Metodologia Inquérito Nacional de Cobertura Vacinal 2020, com lactentes nascidos vivos em 2017 e 2018, realizado entre setembro de 2020 e março de 2022. Foram avaliadas as coberturas de doses aplicadas, doses em dia e o tempo de atraso da aplicação. Resultados Para 4.681 lactentes analisados, as coberturas para vacinas indicadas até os 24 meses foram de 68,0% (IC95% 63,9;71,8) para doses aplicadas e 3,9% (IC95% 2,7;5,7) para doses em dia. A maioria das aplicações em atraso foi ≤ 3 meses. Para alguns reforços, 25% das aplicações atrasaram ≥ 6 meses. Conclusão Além da busca de faltosos às vacinas, são necessárias estratégias para estímulo ao cumprimento do esquema de vacinação nas idades preconizadas.

An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants

ABSTRACT Objectives Immunogenicity between 15-valent V114 (PCV15) and 20-valent PCV20 pneumococcal conjugate vaccines in healthy infants is compared in an indirect treatment comparison and matching-adjusted indirect comparison. Hypotheses: immunogenicity of V114 is non-inferior to PCV20 for all PCV13 serotypes, and superior to PCV20 for serotype 3 based on lower bound margins. Methods Two phase 3 pivotal studies on 3 + 1 pediatric vaccination schedule at age 2, 4, 6, and 12–15 months compared V114 (N = 858) to PCV13 (N = 856) and PCV20 (N = 1001) to PCV13 (N = 987). Infant’s age and race in V114 study were matched to those in PCV20 study. Primary endpoints were serotype-specific Immunoglobulin G (IgG) response rate difference (RRD) 30 days post-dose (PD)3; IgG geometric mean concentration (GMC) ratios 30 days PD3 and PD4. Results V114 was non-inferior ( >-10%-point; >0.5) to PCV20 (p-value <0.001) for all endpoints. V114 was superior ( >0%-point; >1.2) to PCV20 (p-value <0.001) for serotype 3: RRD was 34.5% (95%CI 27.9%-41.1%) PD3, and IgG GMC ratios were 2.39 (95%CI 2.12–2.68) PD3 and 2.15 (95%CI 1.90–2.41) PD4. Conclusion Immune response to V114 administered in a 3 + 1 schedule in healthy infants was considered non-inferior to PCV20 for all 13 PCV13 serotypes and superior for serotype 3 PD3 and PD4. Clinical trial registration www.clinicaltrials.gov identifiers NCT03893448, NCT04382326

Vaccination against pertussis in Latin American preterm and low-birth weight infants: experts opinion position for a neglected childhood age group

ABSTRACTBackgroundPertussis remains as one of the oldest leading vaccine-preventable diseases of childhood, despite many decades of primary vaccine doses’ and boosters’ implementation. Although the epidemiology is well understood in infants and children, premature babies and low-birth weight infants remain a special group where the disease incidence is unknown, severity of the disease is considerable, and specific vaccination recommendations are scarce.Research design and methodsA retrospective review of the available evidence of pertussis vaccination in premature and low birth weight infants was analyzed from January 2000 to December 2022 in six selected countries: Argentina, Mexico, Colombia, Panamá, Costa Rica, and Chile.ResultsChile had reports of adverse effects associated with vaccination of premature infants with the pentavalent vaccine, and their rationale to switching to the hexavalent vaccine. Colombia had reports of the justification for the use of hexavalent vaccine in prematures in the Neonatal Units and Kangaroo Mother Programs throughout the country. Mexico had selected publications of the vaccination status in prematures and low-birth weight infants.ConclusionDespite its importance, increased morbidity, and highest risk of complications in premature babies, there is a paucity of information of vaccine recommendations and coverage rates among selected Latin American infants.

Routine pediatric vaccinations during the COVID-19 pandemic: A review of the global impact.

The coronavirus disease 2019 (COVID-19) pandemic has put standard, routine childhood vaccinations at risk worldwide. The disruption in vaccine coverage has resulted in a negative impact on the health of children, with some races, ethnicities, age groups, areas of settlement, and parts of the world affected more than others. This literature review studied and examined the impact of COVID-19 on infant, child, and adolescent vaccinations. Retrospectively, the analysis showed a decline, delays, or interruptions in the coverage of vaccines during the pan-demic and a decline in some countries' pre-pandemic and post-pandemic eras. Necessary attempts and efforts should be made for these delayed and missed vaccinations, as failure to do so could put children's health at risk. Thus, priority should be directed at instituting catch-up programs to support vaccine uptake and decrease the probability of acquiring vaccine-preventable diseases.

Along came COVID-19: The changing landscape of serious childhood infections

The landscape of acute childhood infections changed dramatically across Europe in the immediate post-COVID-19 period. It was initially characterised by an unprecedented reduction of children with acute infections and reduced circulation of infectious pathogens in the community. With the lifting of non-pharmaceutical interventions (NPI) and return of circulating organisms, we witnessed re-emergence of infectious pathogens. We learned about the impact of NPIs on childhood infections and should learn from this for future outbreaks, balancing immediate need for interrupting population transmission with longer term rebound effects. Outbreaks of monkeypox, severe childhood hepatitis of unclear aetiology, and invasive Group A Streptococcus each presented with unique clinical dilemmas requiring urgent scientific evidence and public health messaging. Implementation of maternal and infant RSV vaccines, as well as other promising vaccine developments, will further impact the landscape of acute childhood infections.

Epidemiology of COVID-19 in Infants in the United States: Incidence, Severity, Fatality, and Variants of Concern.

The clinical spectrum of infant COVID-19 ranges from asymptomatic infection to life-threatening illness, yet epidemiologic surveillance has been limited for infants. Using COVID-19 case data (restricted to reporting states) and national mortality data, we calculated incidence, hospitalization, mortality and case fatality rates through March 2022. Reported incidence of COVID-19 was 64.1 new cases per 1000 infant years (95% CI: 63.3-64.9). We estimated that 594,012 infants tested positive for COVID-19 nationwide by March 31, 2022. Viral variant comparisons revealed that incidence was 7× higher during the Omicron (January-March 2022) versus the pre-Delta period (June 2020-May 2021). The cumulative case hospitalization rate was 4.1% (95% CI: 4.0%-4.3%). For every 74 hospitalized infants, one infant death occurred, but overall COVID-19-related infant case fatality was low, with 7.0 deaths per 10,000 cases (95% CI: 5.6-8.7). Nationwide, 333 COVID-19 infant deaths were reported. Only 13 infant deaths (3.9%) were the result of usually lethal congenital anomalies. The majority of infant decedents were non-White (28.2% Black, 26.1% Hispanic, 8.1% Asian, Indigenous or multiracial). More than half a million US infants contracted COVID-19 by March 2022. Longitudinal assessment of long-term infant SARS-CoV-2 infection sequelae remains a critical research gap. Extremely low infant vaccination rates (<5%), waning adult immunity and continued viral exposure risks suggest that infant COVID-19 will remain a persistent public health problem. Our study underscores the need to increase vaccination rates for mothers and infants, decrease viral exposure risks and improve health equity.

Non-pharmacological interventions to reduce vaccination-related pain in infants: an integrative review

Objective: To identify scientific evidence related to non-pharmacological interventions used to reduce vaccination-related pain in infants. Methods: This is an integrative review carried out using the PICo strategy, in the IBECS, MEDLINE and Scopus databases, from February to June 2022, which aimed to answer the following question: what is the scientific evidence regarding non-pharmacological interventions used to reduce pain associated with vaccination in infants? The descriptors combined with the OR and AND Booleans were infant, vaccination, pain. Articles from 2011 to 2021 and published in Portuguese, English or Spanish were included. Results: The final sample consisted of 32 studies. Non-pharmacological intervention measures proposed for pain relief in infants submitted to vaccination were: breastfeeding and oral sugar solutions; professional assistance in the vaccine room; and sensory stimulation measures. Conclusion: Using these strategies evidenced in the scientific literature is able to favor the most adequate management of pain related to vaccine administration and, therefore, increase infants’ comfort and well-being, in addition to favoring families’ compliance with vaccination.

Childhood immunization uptake determinants in Kinshasa, Democratic Republic of the Congo: ordered regressions to assess timely infant vaccines administered at birth and 6-weeks

BackgroundDespite global efforts to reduce preventable childhood illness by distributing infant vaccines, immunization coverage in sub-Saharan African settings remains low. Further, timely administration of vaccines at birth—tuberculosis (Bacille Calmette–Guérin [BCG]) and polio (OPV0)—remains inconsistent. As countries such as Democratic Republic of the Congo (DRC) prepare to add yet another birth-dose vaccine to their immunization schedule, this study aims to improve current and future birth-dose immunization coverage by understanding the determinants of infants receiving vaccinations within the national timeframe.MethodsThe study used two ordered regression models to assess barriers to timely BCG and first round of the hepatitis B (HepB3) immunization series across multiple time points using the Andersen Behavioral Model to conceptualize determinants at various levels. The assessment leveraged survey data collected during a continuous quality improvement study (NCT03048669) conducted in 105 maternity centers throughout Kinshasa Province, DRC. The final sample included 2398 (BCG analysis) and 2268 (HepB3 analysis) women-infant dyads living with HIV.ResultsBetween 2016 and 2020, 1981 infants (82.6%) received the BCG vaccine, and 1551 (68.4%) received the first dose of HepB3 vaccine. Of those who received the BCG vaccine, 26.3%, 43.5%, and 12.8% received BCG within 24 h, between one and seven days, and between one and 14 weeks, respectively. Of infants who received the HepB3 vaccine, 22.4% received it within six weeks, and 46% between six and 14 weeks of life. Many factors were positively associated with BCG uptake, including higher maternal education, household wealth, higher facility general readiness score, and religious-affiliated facility ownership. The factors influencing HepB3 uptake included older maternal age, higher education level, household wealth, transport by taxi to a facility, higher facility general and immunization readiness scores, and religious-affiliated facility ownership.ConclusionsThis study demonstrated that the study participants’ uptake of vaccines was consistent with the country average, but not in a timely manner. Various factors were associated with timely uptake of BCG and HepB3 vaccines. These findings suggest that investment to strengthen the vaccine delivery system might improve timely vaccine uptake and equity in vaccine coverage.

What Should We Know about Drug Levels and Therapeutic Drug Monitoring during Pregnancy and Breastfeeding in Inflammatory Bowel Disease under Biologic Therapy?

Data on the real long-term influences of in utero drug exposure in pregnant women on childhood development are scarce and remain not well determined and depend on the duration of in utero drug exposure and maternal drug levels. Therapeutic drug monitoring (TDM) during pregnancy may help limit fetal drug exposure while maintaining an effective dose for the treatment of the underlying inflammatory bowel disease (IBD) in women. Most antibody therapies used in patients with IBD are IgG molecules which are actively transported across the placenta, especially during the third trimester of the pregnancy. Here, we propose an up-to-date clinical review to summarize the available findings of serum drug levels in maternal blood during pregnancy, in the cord blood, infants at delivery and in breast milk of patients with IBD treated with biologics. Conversely, in comparison to adalimumab (ADA) levels, which are relatively stable during pregnancy, infliximab (IFX) drug clearance decreased significantly during the last two trimesters of the pregnancy, leading to increasing drug concentrations in the blood of the pregnant women. As most guidelines recommend using live vaccines in infants at the age of one or earlier in case of negative serum drug levels in newborns, statistical models could help clinicians in making a decision to adjust the last dose of the biologic during pregnancy and to determine the optimal date to vaccinate. Altogether, data from the literature offers strong reassurance in terms of safety for anti-TNFα therapies during pregnancy not only for IBD patients who intend to conceive, but also for pregnant women and for the physicians taking care of these patients. ADA and IFX levels in breast milk are detectable, but at very low levels, and therefore, it is recommended to pursue breast feeding under anti-TNFα therapy. Our knowledge on ustekinumab or vedolizumab levels in pregnant women remains unclear and scarce. These drugs are currently not recommended for patients with IBD in clinical practice. Therefore, TDM and proactive dose adjustment are not necessary during pregnancy since its impact on making a clinical decision have not yet been clearly demonstrated in routine practice. Overall, drug concentrations in the cord blood, an infant at birth and postpartum serum concentrations in infants, due to active placental drug transfer, may have a greater impact than the limited drug transfer in breast milk during lactation on the risk of infection and developmental outcomes. Ustekinumab and vedolizumab exposure during pregnancy and lactation are both considered low risk by the recent ECCO guidelines despite the limited data that are currently available.

1722. Impact of Universal Conjugate Pneumococcal Vaccination in Infants on the Incidence and Mortality of Pneumococcal Meningitis in the General Population in Uruguay, South America (2005 – 2022).

Abstract Background Universal vaccination of children with conjugate vaccines was introduced using the 7 – valent pneumococcal conjugate vaccine (PCV7), which was changed to PCV13 (2 + 1 schedule, years 2008 to 2010), with nationwide coverage of 95 %. The objective of this study is to analyze the impact of universal children vaccination with PCV7 and PCV13 on the incidence and mortality of pneumococcal meningitis (PM) in the general population in Uruguay. Methods This is a descriptive, retrospective study that includes all cases (children and adults) reported to the Department of Health Surveillance of the Ministry of Public Health with a diagnosis of PM between January 1, 2005, and December 31, 2022. Variables: cases per year, sex, age (≤ 15 years and &amp;gt; 15 years), identified serotype, and deaths by year. The average rates of cases per 100,000 inhabitants are described in two periods: Period 1 or pre – universal vaccination (P1) from 2005 to 2007 and Period 2 or post – universal vaccination (P2) from 2011 to 2022, with their respective confidence intervals. Statistical analysis were established based on frequency distribution and statistical significance tests as appropriate, considering a value of p equal to or less than 0.05 as statistically significant. The research was approved by the institutional Ethics Committee. Results The total number of cases (N) is 555, 56.5% are men. 102 cases from the vaccine introduction period (2008 to 2010) were excluded. The N for P1 is 149 (3 years), while for P2 it is 304 (12 years). The main results of incidence and mortality are shown in Table 1 and in the attached graphs. Lethality remains high (26.5% average for the total period). The vaccine serotypes (VS) decrease from 28.2% (95% CI: 20 to 35) in P1 to 12.2% (95% CI: 8.4 to 15) in P2, p: 0.00006. The non – VS increase from 18.1% (95% CI: 11 to 24) in P1 to 44.7% (95% CI: 39.1 to 50.3) in P2, p: 0.00000001. The predominant VS in P1 is 14 (26.2%, 95% CI: 13-39); in P2 there are 8.1%, 95% CI: 0.7-16.9), p: 0.071. The predominant VS in P2 is 3 (46%, 95% CI: 30-62); in P1 9.5% (95% CI: 0.6-18), p: 0.0003. The non – VS predominant in both periods is 12F. Evolution of incidence rates of PM in the general population and in people under and over 15 years of age as a function of time (in years). Mortality rates Conclusion The incidence and mortality of PM statistically decreased in children under 15 years old and in the general population, which can be attributed to herd immunity. Disclosures Marcos Delfino, Pediatrician, Pediatric Infectious Diseases, Pfizer: Finna María Catalina Pírez, Pediatrician, Pediatric infectologist, microbiologist Professor of pediatric, Degree V, Merck, Pfizer: Expert Testimony|Merck, Pfizer: Honoraria