Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants ≥ 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study.

OBJECTIVE: This study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator. METHODS: This study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 µg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization. RESULTS: In 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 µg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified. CONCLUSION: A single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).

Pneumococcal conjugate vaccination schedules in infants-acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study: statistical analysis plan.

RATIONALE: The effectiveness of immunisation with pneumococcal conjugate vaccine (PCV) has been demonstrated in many countries. However, the global impact of PCV is limited by its cost, which has prevented its introduction in some countries. Reducing the cost of PCV programmes will facilitate further vaccine introductions and improve the sustainability of PCV in low-income countries when they transition from subsidised vaccine supply. We are conducting a large, population-level, cluster-randomised field trial (PVS) of an alternative reduced-dose schedule of PCV compared to the standard schedule. We are also conducting a nested sub-study at the individual level to investigate the immunogenicity of the two schedules and their effects on pneumococcal carriage acquisition (PVS-AcqImm). METHODS AND DESIGN: PVS-AcqImm is a prospective, cluster-randomised trial of an alternative schedule of one dose of PCV scheduled at age 6 weeks with a booster dose at age 9 months compared to the standard of three primary doses scheduled at 6, 10, and 14 weeks of age. Sub-groups within the alternative schedule group receive yellow fever vaccine separately or co-administered with PCV at 9 months of age. The primary endpoints are (a) concentrations of vaccine-type anti-pneumococcal IgG at 18 months of age, (b) proportions with yellow fever neutralising antibody titre ≥ 1:8 4 weeks after separate or co-administration of PCV and yellow fever vaccines, and (c) rate of nasopharyngeal vaccine-type pneumococcal acquisition from 10-14 months of age. Participants and field staff are not masked to group allocation while measurement of the laboratory endpoints is masked. Approximately equal numbers of participants are resident in each of 28 randomly allocated geographic clusters (14 clusters in each group); 784 enrolled for acquisition measurements and 336 for immunogenicity measurements. PURPOSE: This statistical analysis plan (SAP) describes the PVS-AcqImm cohort and follow-up criteria to be used in different analyses. The SAP defines the endpoints and describes how adherence to the interventions will be presented. We describe the approach to analyses and how we will account for the effect of clustering. Defining the SAP prior to the conduct of analysis will avoid bias in analyses that may arise from prior knowledge of trial findings. TRIAL REGISTRATION: ISRCTN, ISRCTN7282161328. Registered on 28 November 2019. https://www.isrctn.com/ISRCTN72821613 . PROTOCOL: MRCG SCC number 1670, LSHTM Ref 17683. Current protocol version: 6.0, 24 May 2021. Version: 1.0 (5 April 2023); SAP revisions-none.

Migration and infant immunization timeliness in New Zealand: Evidence from the Growing Up in New Zealand study.

BACKGROUND: Migration has been recognized as an important determinant of child health outcomes including childhood vaccination status. This paper aims to examine the association between parental migration status and a less studied aspect of child immunization outcomes, namely timeliness, within the context of New Zealand (NZ), a country characterized by a substantial proportion of its resident population born overseas. Additionally, the study explored the impact of residential duration on children's immunization timeliness. METHODS: The data was taken from a large, representative population-based cohort study in NZ (Growing Up in NZ study). A total of 6156 children and their parents, comprising 2241 foreign-born and 3915 NZ-born mothers and a sub-group of their partners were included in the analysis. The survey data was linked with the National Immunization Register dataset. Timely immunization was defined as receiving two vaccines at each scheduled vaccination point (at six-week, three-month, and five-month, totaling six doses of vaccines) within 30 days of their due date. We examined the associations between parental migration status, maternal residential duration, and child immunization timeliness while controlling for socio-economic variations. The results were presented as adjusted odds ratios (AORs) with 95 % confidence intervals (CIs). RESULTS: The findings revealed that after adjustment for socioeconomic differences, children of foreign-born mothers exhibited higher odds of receiving all six studied vaccine doses on time compared to children of native-born mothers (AOR 1.51, 95 %CI:1.27-1.78). Similarly, having a foreign-born father was also significantly associated with timely completion of all six vaccine doses. Children of recent immigrants who had resided in the country for less than five years demonstrated higher odds of timely vaccination of all six vaccine doses compared to children of settled immigrants who had lived in the country for five or more years (AOR 1.65, 95 %CI: 1.25-2.19). CONCLUSION: This study revealed a significant pattern in NZ where immigrants exhibited higher rates of timely immunization for their children compared to native-born parents. However, the findings also underscore the importance of providing support to settled immigrants, as their children experienced declines in timely vaccination rates compared to children of recent immigrants and even those born to NZ-born parents.

Completion of multidose vaccine series in early childhood: current challenges and opportunities.

PURPOSE OF REVIEW: Completion of all doses in multidose vaccine series provides optimal protection against preventable infectious diseases. In this review, we describe clinical and public health implications of multidose vaccine series noncompletion, including current challenges to ensuring children receive all recommended vaccinations. We then highlight actionable steps toward achieving early childhood immunization goals. RECENT FINDINGS: Although coverage levels are high for most early childhood vaccinations, rates of completion are lower for vaccinations that require multiple doses. Recent research has shown that lower family socioeconomic status, a lack of health insurance coverage, having multiple children in the household, and moving across state lines are associated with children failing to complete multidose vaccine series. These findings provide contextual evidence to support that practical challenges to accessing immunization services are impediments to completion of multidose series. Strategies, including reminder/recall, use of centralized immunization information systems, and clinician prompts, have been shown to increase immunization rates. Re-investing in these effective interventions and modernizing the public health infrastructure can facilitate multidose vaccine series completion. SUMMARY: Completion of multidose vaccine series is a challenge for immunization service delivery. Increased efforts are needed to address remaining barriers and improve vaccination coverage in the United States.

Ranking de los programas de vacunación en América Latina, 2020. Rev Panam Salud Publica / Ranking of immunization programs in Latin America, 2020 / Ranking dos programas de vacinação na América Latina, 2020

[RESUMEN]. Objetivo. Construir y comparar el ranking de los programas nacionales de inmunizaciones (PNI) de América Latina del año 2020 con el año anterior. Métodos. Se evaluaron 18 PNI con base en la información pública obtenida de sitios oficiales de los ministerios de salud de los países, la Organización Mundial de la Salud, la Organización Panamericana de la Salud, el Fondo de las Naciones Unidas para la Infancia y referentes locales. El ranking se elaboró con base en el calendario de vacunación del año 2020 en distintas etapas de la vida, situaciones especiales, vacunación antigripal, coberturas vacunales (CV) del 2019 y aspectos programáticos. Resultados. Las CV disminuyeron en la mayoría de los países. El puntaje promedio regional y de la mayoría de los países también bajó en el 2020 excepto en Chile y Colombia. Chile lidera el ranking, seguido por Uruguay, Panamá y Costa Rica, y se destaca por su calendario completo, mayores CV y logros programáticos. Conclusiones. El menor puntaje global del 2020 resalta que es necesario recuperar la CV en la Región. Este análisis busca motivar a los países a abordar los desafíos pendientes.

[ABSTRACT]. Objective. Construct a ranking of national immunization programs in Latin America in 2020 and compare it with the previous year. Methods. Eighteen national immunization programs were evaluated on the basis of public information obtained from official sites of the countries' ministries of health, the World Health Organization, the Pan American Health Organization, the United Nations Children's Fund, and local sources. The ranking was based on the 2020 vaccination schedule for different life stages, special situations, vaccination against influenza, 2019 vac- cination coverage, and programmatic aspects. Results. Vaccination coverage decreased in most countries. The average regional declined in 2020, as did the scores for most countries, except Chile and Colombia. Chile leads the ranking, followed by Uruguay, Panama, and Costa Rica. Chile stands out for its full calendar, higher vaccination coverage rates, and programmatic achievements. Conclusions. The lower overall score in 2020 highlights the need to recover the Region's vaccination cove- rage rates. This analysis seeks to motivate countries to address pending challenges.

[RESUMO]. Objetivo. Construir e comparar o ranking dos programas nacionais de imunização (PNIs) na América Latina em 2020 com o ano anterior. Métodos. Foram avaliados 18 PNIs com base em informações públicas obtidas de sites oficiais dos ministérios da Saúde dos países, da Organização Mundial da Saúde, da Organização Pan-Americana da Saúde, do Fundo das Nações Unidas para a Infância e de fontes locais. O ranking foi compilado com base no calendário de vacinação de 2020 para diferentes fases da vida, situações especiais, vacinação contra a gripe, cobertura vacinal (CV) de 2019 e aspectos programáticos. Resultados. As CVs diminuíram na maioria dos países. A pontuação média regional e a pontuação da maioria dos países também caíram em 2020, exceto no Chile e na Colômbia. O Chile lidera o ranking, seguido do Uruguai, do Panamá e da Costa Rica, e se destaca por ter um calendário completo, maiores CVs e êxitos programáticos. Conclusões. A pontuação global mais baixa em 2020 destaca a necessidade de recuperar a CV da região. Esta análise busca motivar os países a enfrentar os desafios pendentes.

Observational analysis of the immunogenicity and safety of various types of spinal muscular atrophy vaccines.

BACKGROUND: This study aimed to evaluate the immunogenicity and safety of different types of poliovirus vaccines. METHODS: A randomized, blinded, single-center, parallel-controlled design was employed, and 360 infants aged ≥ 2 months were selected as study subjects. They were randomly assigned to bOPV group (oral Sabin vaccine) and sIPV group (Sabin strain inactivated polio vaccine), with 180 infants in each group. Adverse reaction events in the vaccinated subjects were recorded. The micro-neutralization test using cell culture was conducted to determine the geometric mean titer (GMT) of neutralizing antibodies against poliovirus types I, II, and III in different groups, and the seroconversion rates were calculated. RESULTS: Both groups exhibited a 100% seropositivity rate after booster immunization. The titers of neutralizing antibodies for the three types were predominantly distributed within the range of 1:128 to 1:512. The fold increase of type I antibodies differed markedly between the two groups (P < 0.05). Moreover, the fold increase of type II and type III antibodies for poliovirus differed slightly between the two groups (P > 0.05). The fourfold increase rate in sIPV group was drastically superior to that in bOPV group (P < 0.05). When comparing the post-immunization GMT levels of type I antibodies in individuals who completed the full course of spinal muscular atrophy vaccination, bOPV group showed greatly inferior levels to sIPV group (P < 0.05). For type II and type III antibodies, individuals in bOPV group demonstrated drastically superior post-immunization GMT levels to those in sIPV group (P < 0.05). The incidence of adverse reactions between the bOPV and sIPV groups differed slightly (P > 0.05). CONCLUSION: These findings indicated that both the oral vaccine and inactivated vaccine had good safety and immunogenicity in infants aged ≥ 2 months. The sIPV group generated higher levels of neutralizing antibodies in serum, particularly evident in the post-immunization GMT levels for types II and III.

Vaccination status among COVID-19 patients and duration of Polymerase Chain Reaction test positivity: evaluation of immunization schedule and type of vaccine.

Background: The introduction of the vaccine against SARS-CoV-2 has represented a cornerstone in the containment of the pandemic. Our aim was to assess the vaccination schedules in relation to the infection free interval and to the duration of positivity in case of infection. Study design: This study involves the SARS-CoV-2 infected people managed by the Local Health Authority ASL 1 Abruzzo. The data collected included: vaccine administration date, vaccine type, information on the Polymerase Chain Reaction test positivity, and demographic variables, such as age and sex. Methods: The duration of Polymerase Chain Reaction test positivity was assessed in relation to the vaccination status, the vaccine type and the time interval between the last vaccination dose and the first nasopharyngeal positive swab over the considered period. Results: The infection duration (DAYS) was significantly shorter in subjects vaccinated with a booster dose than unvaccinated subjects (12.8 vs 14.6; p<0.0001) and subjects vaccinated with the primary series only (12.8 vs 14.1; p<0.0001). Duration of PCR positivity was shorter with heterologous immunisation than with other vaccination schedules (p=0.0317). Conclusions: This study highlights, in a large cohort of patients, the association between vaccination schedule and the response to infection.

Safety of the novel oral poliovirus vaccine type 2 (nOPV2) in infants and young children aged 1 to <5 years and lot-to-lot consistency of the immune response to nOPV2 in infants in The Gambia: a phase 3, double-blind, randomised controlled trial.

BACKGROUND: Novel oral poliovirus vaccine type 2 (nOPV2) has been engineered to improve the genetic stability of Sabin oral poliovirus vaccine (OPV) and reduce the emergence of circulating vaccine-derived polioviruses. This trial aimed to provide key safety and immunogenicity data required for nOPV2 licensure and WHO prequalification. METHODS: This phase 3 trial recruited infants aged 18 to <52 weeks and young children aged 1 to <5 years in The Gambia. Infants randomly assigned to receive one or two doses of one of three lots of nOPV2 or one lot of bivalent OPV (bOPV). Young children were randomised to receive two doses of nOPV2 lot 1 or bOPV. The primary immunogenicity objective was to assess lot-to-lot equivalence of the three nOPV2 lots based on one-dose type 2 poliovirus neutralising antibody seroconversion rates in infants. Equivalence was declared if the 95% CI for the three pairwise rate differences was within the -10% to 10% equivalence margin. Tolerability and safety were assessed based on the rates of solicited adverse events to 7 days, unsolicited adverse events to 28 days, and serious adverse events to 3 months post-dose. Stool poliovirus excretion was examined. The trial was registered as PACTR202010705577776 and is completed. FINDINGS: Between February and October, 2021, 2345 infants and 600 young children were vaccinated. 2272 (96·9%) were eligible for inclusion in the post-dose one per-protocol population. Seroconversion rates ranged from 48·9% to 49·2% across the three lots. The minimum lower bound of the 95% CIs for the pairwise differences in seroconversion rates between lots was -5·8%. The maximum upper bound was 5·4%. Equivalence was therefore shown. Of those seronegative at baseline, 143 (85·6%) of 167 (95% CI 79·4-90·6) infants and 54 (83·1%) of 65 (71·7-91·2) young children seroconverted over the two-dose nOPV2 schedule. The post-two-dose seroprotection rates, including participants who were both seronegative and seropositive at baseline, were 604 (92·9%) of 650 (95% CI 90·7-94·8) in infants and 276 (95·5%) of 289 (92·4-97·6) in young children. No safety concerns were identified. 7 days post-dose one, 78 (41·7%) of 187 (95% CI 34·6-49·1) infants were excreting the type 2 poliovirus. INTERPRETATION: nOPV2 was immunogenic and safe in infants and young children in The Gambia. The data support the licensure and WHO prequalification of nOPV2. FUNDING: Bill & Melinda Gates Foundation.

Progress Toward Measles Elimination - World Health Organization Eastern Mediterranean Region, 2019-2022.

In 2015, all 22 World Health Organization Eastern Mediterranean Region (EMR) countries and areas (countries) pledged to achieve measles elimination by 2020. Despite success in several countries, most countries in the region still have not eliminated measles. This report updates a previous report and describes progress toward measles elimination in EMR during 2019-2022. During that period, estimated regional coverage with the first and second doses of a measles-containing vaccine (MCV) was 82%-83% and 76%-78%, respectively. During 2019-2022, approximately 160 million children were vaccinated during national or subnational supplementary immunization activities. Reported confirmed regional measles incidence decreased from 29.8 cases per 1 million population in 2019 to 7.4 in 2020, but then increased 68%, to 50.0 in 2022 because of challenges providing immunization services and conducting surveillance during the COVID-19 pandemic. Surveillance indicators deteriorated in 11 (50%) of the 22 EMR countries. During 2019-2022, four countries in the region were verified as having achieved measles elimination, but other countries reported immunity gaps and increased measles incidence in 2022. To achieve measles elimination in EMR, national immunization programs, especially in those countries with high measles incidence, will need to continue to recover from the COVID-19 pandemic, increase overall vaccination coverage to close immunity gaps, and maintain high-quality disease surveillance.

Vaccination patterns and up-to-date status of children 19-35 months, 2011-2021.

INTRODUCTION: Being up-to-date with all recommended vaccines is needed to protect children from vaccine preventable diseases. Understanding vaccination patterns is needed to develop messaging and strategies to increase vaccination uptake and confidence. METHODS: Data from the 2011 to 2021 National Immunization Surveys was used to assess trends and disparities in vaccination patterns, zero vaccination status, and up-to-date status of U.S. children by 19-35 months. RESULTS: From 2011 to 2021, adherence to the recommended schedule using the stringent definition increased from 35.7 % to 52.2 % (p < 0.01), adherence to the alternate schedule decreased from 28.2 % to 15.1 % (p < 0.01), and proportion of children who were not up-to-date decreased from 49.0 % to 33.3 % (p < 0.01). However, the proportion of children who had zero vaccinations did not change from 2011 (0.9 %) to 2021 (0.9 %; p = 0.08). In 2021, children 19-23 months were less likely to follow the recommended schedule than children 24-29 months (49.2 % compared to 56.4 %, p < 0.01). Adherence to the recommended schedule among children 19-23 months decreased in 2021 compared to 2020 overall and for some subpopulations (e.g. those with non-Hispanic (NH) Black parents (33.2 % compared to 44.9 %, p < 0.01). Furthermore, it was lowest among children of NH Black parents living at or below the federal poverty level (31.2 %) compared to their respective NH White counterparts (43.6 %, p < 0.01). CONCLUSIONS: While there were overall increases in adherence to the recommended schedule from 2011 to 2021, a sustained catch-up program is needed to prevent missed vaccinations and achieve equitable vaccination coverage for all children.

Exploring the reasons for defaulting from childhood immunization: a qualitative study in Pakistan.

BACKGROUND: Childhood vaccination is widely recognized as the most effective means to prevent various diseases. However, a considerable amount of children still miss out on their vaccination schedules. Therefore, this study explores the reasons for defaulting from the expanded program on immunization in district Swat, Pakistan. METHODS: A qualitative phenomenological approach was used. Data collection took place from March to September 2022. Thirty-six in-depth interviews were conducted with participants who had defaulter children. The collected qualitative data were analysed thematically to identify key patterns and themes related to the reasons for defaulting from childhood vaccination schedules. RESULTS: Six themes emerged, i.e., illness of the defaulter child at the scheduled time, perceived side effects of the vaccination, factors related to caregivers, myths and misconceptions, vaccinators attitudes and crowed vaccination centres, as well as poor immunization service arrangements. Four subthemes arose related to caregivers, such as lack of clear understanding about completion of vaccination, least priority for child's vaccination, cultural restriction on mothers, and the loss of vaccination card. CONCLUSION: According to the study's findings, caregivers have their own perceptions regarding the non-completion of their children's vaccination schedule. The childhood immunization defaulting arises from various factors including child illness, Adverse Events Following Immunization (AEFIs) concerns, misconceptions, improper injection techniques, and negative vaccinator attitudes. The vaccination completion rate may be increased if the concerns of the caregivers are appropriately addressed.

Ongoing Measles in the Developed and Developing World.

Measles is a vaccine-preventable illness. Nevertheless, in recent years, measles is still endemic and epidemic in both the developed world and the developing world. The public perception of measles in the past was that it was not a big deal. However, measles is associated with a number of complications which can be places in three categories which are: acute(diarrhea, otitis media, pneumonia, encephalitis, seizures, and death) and delayed-subacute sclerosing panencephalitis (SSPE) and post-measles immune amnesia. Contrary to the beliefs of the anti-vaccine lobby, measles is bad. In acute measles, the death rate is 1-3 per 1000 and the risk of encephalitis is 1 per 1000. Relatively recent investigations indicate that SSPE is considerably more common than previously believed. The worldwide contribution of post-measles immune amnesia to morbidity and mortality is likely to be huge. In exposure situations, two doses of measles vaccine will prevent 99% of cases. Presently in the United States, the first dose is given at 12 through 15 months of age. The second dose is most often administered at 4 through 6 years of age. In my opinion, the second dose of measles vaccine should be given 4-6 weeks after the first dose rather than at 4-6 years of age. Children who don't have antibody to measles should not travel to risk areas.

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016).

DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV) indicated in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Switching between HVs during the childhood vaccination series is sometimes necessary due to, for example, vaccine availability, health-care provider preference, and/or tender awards. The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. Healthy participants approximately 11-13 months of age who previously received a two-dose primary series of Hexyon® (HHV group) or Vaxelis® (VVV group) all received a Vaxelis® booster dose. Immunogenicity was evaluated by measuring antibody levels to individual vaccine antigens approximately 30 days following booster vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). The proportions of participants with antibody-specific responses for antigens contained in both Vaxelis® and Hexyon® at 30 days post-toddler-booster vaccination with Vaxelis® were comparable between groups, and higher in the VVV group for Vaxelis® antigens PRN and FIM2/3. The overall proportions of participants with AEs were generally comparable between groups. Following a booster dose of Vaxelis®, immune responses were comparable between groups for all shared antigens, and higher in the VVV group for antigens found only in Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens.

Vacinação contra a meningite na capital

Como funciona o esquema vacinal contra a meningite?

Birth characteristics as predictors of respiratory syncytial virus hospitalisation in newborns to optimise immunisation schedule.

AIM: To examine birth characteristics that influence infant respiratory syncytial virus (RSV) hospitalisation risk in order to identify risk factors for severe RSV infections. METHODS: Retrospective cohort study of 460 771 Sicilian children under 6 months old from January 2007 to December 2017. Hospital discharge records were consulted to identify cases and hospitalisations with International Classification of Diseases, Ninth Revision, Clinical Modification codes 466.11 (RSV bronchiolitis), 480.1 (RSV pneumonia) and 079.6 (RSV). RSV hospitalisation risk was estimated using adjusted odds ratios (aOR) and 95% confidence intervals (95% CI). RESULTS: Overall, 2420 (5.25 per 1000 infants) RSV-related hospitalisations were identified during the study, with girls accounting for 52.8%. RSV hospitalisation risk increased for full-term, transferred, extreme immature, and preterm neonates with serious issues (aOR 3.25, 95% CI 2.90-3.64; aOR 1.86, 95% CI 1.47-2.32; aOR 1.54, 95% CI 1.11-2.07; and aOR 1.48, 95% CI 1.14-1.90). Compared to children born in June, the risk of RSV hospitalisation was significantly higher in children born in January (aOR 28.09, 95% CI 17.68-48.24) and December (aOR 27.36, 95% CI 17.21-46.99). CONCLUSION: This study identified birth month and diagnosis-related groups as key predictors of RSV hospitalisations. This could help manage monoclonal antibody appropriateness criteria.

Tolerability, safety, and immunogenicity of the novel oral polio vaccine type 2 in children aged 6 weeks to 59 months in an outbreak response campaign in The Gambia: an observational cohort study.

BACKGROUND: Novel oral polio vaccine type 2 (nOPV2) has been used to interrupt circulating vaccine-derived poliovirus type 2 outbreaks following its WHO emergency use listing. This study reports data on the safety and immunogenicity of nOPV2 over two rounds of a campaign in The Gambia. METHODS: This observational cohort study collected baseline symptoms (vomiting, diarrhoea, irritability, reduced feeding, and reduced activity) and axillary temperature from children aged 6 weeks to 59 months in The Gambia before a series of two rounds of a nOPV2 campaign that took place on Nov 20-26, 2021, and March 19-22, 2022. Serum and stool samples were collected from a subset of the participants. The same symptoms were re-assessed during the week following each dose of nOPV2. Stool samples were collected on days 7 and 28, and serum was collected on day 28 following each dose. Adverse events, including adverse events of special interest, were documented for 28 days after each campaign round. Serum neutralising antibodies were measured by microneutralisation assay, and stool poliovirus excretion was measured by real-time RT-PCR. FINDINGS: Of the 5635 children eligible for the study, 5504 (97·7%) received at least one dose of nOPV2. There was no increase in axillary temperature or in any of the baseline symptoms following either rounds of the campaigns. There were no adverse events of special interest and no other safety signals of concern. Poliovirus type 2 seroconversion rates were 70% (95% CI 62 to 78; 87 of 124 children) following one dose of nOPV2 and 91% (85 to 95; 113 of 124 children) following two doses. Poliovirus excretion on day 7 was lower after the second round (162 of 459 samples; 35·3%, 95% CI 31·1 to 39·8) than after the first round (292 of 658 samples; 44·4%, 40·6 to 48·2) of the campaign (difference -9·1%; 95% CI -14·8 to -3·3), showing the induction of mucosal immunity. INTERPRETATION: In a campaign in west Africa, nOPV2 was well tolerated and safe. High rates of seroconversion and evidence of mucosal immunity support the licensure and WHO prequalification of this vaccine. FUNDING: Bill & Melinda Gates Foundation.

Issues with infectious disease vaccine introduction into routine vaccination in Japan, and considerations for accelerating the process.

Routine vaccinations help prevent the outbreak and spread of infectious diseases; however, it can take up to ten years from vaccine approval to introduction into routine vaccination schedules in Japan. Here, we investigate the information required to introduce an approved vaccine into routine vaccination schedules and the reasons why it takes so long. Based on the published data of the Immunization and Vaccine Committee of the Health Science Council, we set out to explore ways to facilitate discussion on this topic. The following issues were identified as discussion points: disease burden, efficacy and safety, and cost-effectiveness. Until now, epidemiological information has been used to evaluate the efficacy of vaccines, and also to evaluate the safety in the presence of notable adverse reactions. However, in some cases, it took a long time to obtain epidemiological information regarding the frequency of rare but serious adverse reactions and the need for a booster dose. Given the risk of spreading infectious diseases due to delays in decision-making, vaccines may have to be introduced into routine vaccination schedules based on the results of clinical trials that can be obtained in a relatively short period. In contrast, epidemiological information is necessary to evaluate the disease burden, frequency of adverse reactions, and the necessity of booster doses. Therefore, developing an epidemiological information collection system is urgently required.