An Education Intervention to Increase Human Papillomavirus Vaccination Confidence and Acceptability: A Randomized Controlled Trial.

OBJECTIVES: To explore the effect of an intervention to improve human papillomavirus (HPV) vaccination confidence, attitudes, and beliefs among non-Hispanic Black mothers. SAMPLE & SETTING: Participants were 63 non-Hispanic Black mothers of children aged 9-17 years who resided in the United States and whose children had not received HPV vaccination. Interventions and data collection were conducted via a videoconferencing platform. METHODS & VARIABLES: A randomized controlled trial was performed using two groups. The experimental group received two HPV vaccination education sessions and the control group received two healthy nutrition education sessions. Data were collected after the last intervention and four weeks later. Variables included HPV vaccination confidence, attitudes, and beliefs. RESULTS: The experimental group reported more positive attitudes and beliefs about HPV vaccination (p = 0.002) and greater vaccination confidence than the control group (p = 0.049). IMPLICATIONS FOR NURSING: Nurses can improve HPV vaccination confidence, attitudes, and beliefs among non-Hispanic Black mothers through HPV vaccination education.

Evidence-Based Cardiovascular Disease Medicines' Availability in Low-Cost Generic Drug Programs in the United States : A Cross-Sectional Study.

BACKGROUND: Low-cost generic programs (LCGPs) that expand access to affordable cardiovascular disease (CVD) medicines can assist patients in achieving desired cardiovascular outcomes. It is important that LCGPs offer CVD medicines that promote evidence-based prescribing. OBJECTIVE: To evaluate LCGPs' coverage of evidence-based CVD medications using a clinical framework that examines coverage of core treatments, coverage of options with the highest-quality evidence, and the variety of medication options and strengths that create choices and allow dosing titration. DESIGN: Cross-sectional study. SETTING: Publicly available LCGPs in March and April 2023 in the United States. PARTICIPANTS: 19 LCGPs. MEASUREMENTS: Proportion of LCGPs that offered evidence-based CVD medicines within a clinical framework for 6 CVDs (atrial fibrillation, heart failure, hyperlipidemia, hypertension, post-acute coronary syndrome secondary prevention, and stable angina) according to 4 availability metrics (breadth, choice, high-quality evidence, and titratability). RESULTS: The availability of CVD medication varied by program, drug, and CVD condition. Some programs had more breadth and choice of coverage for most CVDs (H-E-B, Kroger, Mark Cuban Cost Plus Drug Company, and Walmart), whereas many had more focused coverage and others markedly limited offerings. Nearly all LCGPs offered angiotensin-converting enzyme inhibitors, ß-blockers, thiazides, and moderate-intensity statins, but availability was low for higher-cost or lower-use generics (antiplatelets and antiarrhythmics). Core pharmacotherapy coverage and choices were limited for atrial fibrillation and heart failure but widely available for hypertension and hyperlipidemia. LIMITATION: In-depth cost analysis was not investigated. CONCLUSION: Coverage of evidence-based medications for the 6 CVDs investigated varied by LCGP and condition. Because high availability of core CVD pharmacotherapy can enhance optimal disease state management, LCGPs should identify existing limitations in their coverage and continuously revise their formularies to improve the comprehensiveness of CVD medication coverage. PRIMARY FUNDING SOURCE: None.

Antimalarial procurement in private-sector pharmaceutical outlets: decision-making complexities and implications for medicine quality in Tanzania.

Poor-quality medicines are a major threat to healthcare provision in low-income countries. The problem exacerbates disease vulnerabilities of already disadvantaged populations including children, women, and the elderly. However, while the higher-level structural drivers of this problem are well established, little is known about decision-making lower down pharmaceutical supply chains, and whether this might produce vulnerabilities for medicine quality. We conducted a mixed-methods study to explore retailer-supplier interactions and decision-making dynamics for antimalarial medicines in three regions of Tanzania: Tabora, Dodoma and Mbeya. A survey questionnaire was administered to 118 small scale-and mid-range retailers in urban and rural districts of the regions. We then conducted 12 in-depth interviews with staff and owners of medicine outlets in 2 districts of Tabora region to explore further the decision-making dynamics. Results show that private-sector retailers are driven first and foremost by business and economic practicalities when choosing a medicine supplier, prioritising low purchase price, free delivery, and availability of credit. Many also rely on suppliers with whom they have personal connections, developed either within or outside the business context. Medicine quality comes far lower down the list of priorities. These findings are perhaps not surprising in a context where businesses serving low-income customers are operating on very small margins. However, when price and personal connection eclipse any other considerations, there is a risk that poor-quality medicines may find their way into supply chains, especially in countries where regulatory capacity is limited, and pharmaceutical supply chains are complex and opaque.

Spending on and Use of Clinician-Administered Drugs in Medicare.

Importance: Medicare Part B drug expenditures have increased in recent years. This trend is likely to persist given the increased use and availability of biologics. Objectives: To assess the extent to which Medicare Part B spending growth was associated with changes in price vs quantity, and how these trends interacted with entry of new drugs into the marketplace. Design, Setting, and Participants: This cross-sectional study quantified the degree of spending concentration and the association between price and use of Part B drugs among fee-for-service Medicare beneficiaries. Data on use and spending for separately payable Part B drugs were included. Source data were aggregated to the drug-year level and reported from 2016 to 2020. Descriptive decomposition and index analyses quantified the relative association of price and use changes separately for existing single-source drugs, existing drugs that faced competition, and new drugs that entered the market. Data analysis was performed from June to December 2022. Main Outcomes and Measures: Part B drug spending by the fee-for-service Medicare program and beneficiaries, as well as use, defined as dosage units and beneficiaries using the drugs. Results: The study included 535 unique Part B drug products. From 2016 to 2020, 15 or fewer products comprised half of all Part B drug expenditures. The set of 7 drugs that comprised the top 25% of spending was very consistent over time, and all were biologics. Part B drug products that cost $1.85 or less per administration accounted for more than half of the doses administered in 2020. Spending on Part B drugs increased by $15 billion from 2016 to 2020. The entry of new, nonbiosimilar drugs during this period accounted for $12 billion of this increased spending (80%), while shifts in use and price increases among existing single-source brand drugs accounted for the remaining increase in spending. Part B spending decreased among the subset of existing drugs facing generic or biosimilar competition. Among single-source drugs on the market in 2016, the index that varied dosage units exceeded the index that varied price in all years, confirming that changes in use were associated more with spending growth for those drugs. Conclusions and Relevance: In this cross-sectional study of Medicare Part B drug expenditures, spending was found to be concentrated among a small number of drugs. The entry of new products was a key factor associated with recent increases in Part B drug spending. These findings suggest that policies targeting top-selling drugs may have greater potential to curb Part B drug spending than those targeting price growth.

Contextual factors affecting the implementation of drug checking for harm reduction: a scoping literature review from a North American perspective.

BACKGROUND: The opioid epidemic continues to be a significant cause of morbidity and mortality in the US. In 2020, 83% of opioid-related overdose deaths were due to synthetic opioids, such as fentanyl. Drug checking services have been widely implemented as a harm reduction intervention to facilitate the identification of substances in a drug sample. There is a need to inform decision-making on drug checking technologies and service implementation. This research aims to outline contextual considerations for the implementation of a drug checking service. METHODS: A scoping review was conducted using a structured search strategy in PubMed and EMBASE. Articles were independently screened by two reviewers, and included if they were primary literature and reported on an actionable consideration(s) for drug checking services. Data elements were extracted using a standardized form, and included study design, study population, drug checking technology utilized or discussed, and main findings. RESULTS: Twenty-nine articles were selected for inclusion, and four primary areas of consideration were identified: drug checking technologies, venue of a drug checking service, legality, and privacy. Technological considerations include the need for highly accurate, quantitative results which appeal to both populations of people with drug use disorder and recreational users. Accessibility of services was identified as an important factor that may be impacted by the location, integration with other services, how the service is provided (mobile vs. fixed), and the hours of operation. Maintaining plausible deniability and building trust were seen as important facilitators to service use and engagement. Issues surrounding legality were the most frequently cited barrier by patrons, including fear of criminalization, policing, and surveillance. Patrons and stakeholders identified a need for supportive policies that offer protections. Maintaining anonymity for patrons is crucial to addressing privacy-related barriers. CONCLUSION: This review highlights the need to understand the local population and climate for drug checking to implement a drug checking service successfully. Common themes identified in the literature included considerations related to the choice of technology, the type of venue, and the impact of legality and privacy. We intend to utilize these considerations in future research to help guide discussions with US-based stakeholders.

The impact of the COVID-19 pandemic on vaccination uptake in the United States and strategies to recover and improve vaccination rates: A review.

The COVID-19 pandemic disrupted routine healthcare delivery, causing declines in CDC-recommended vaccination rates across the life-course in the United States (US). Ensuring protection against disease outbreaks and associated morbidity and mortality depends on improving vaccine coverage rates (VCRs) and uptake. The authors conducted a targeted literature review to assess the pandemic's effects on routine vaccination rates across different populations, evaluating VCR recovery and improvement efforts. The review highlights articles published with data measuring or evaluating VCR decline across the US during the COVID-19 pandemic from January 2020 to April 2022, associated health impacts, and policy and programmatic strategies to recover routine VCRs. While vaccination rates stagnated or declined across some populations pre-pandemic, the review indicated there were further VCR declines in 2020 and 2021 compared to 2019 across numerous CDC-recommended vaccines, ages, and geographies, with some vaccines and sub-populations disproportionally impacted. The review additionally identified declines in patient healthcare visit frequency and increases in morbidity and mortality associated with vaccine-preventable disease (VPD) complications. Reviewed publications highlighted multifaceted strategies that could aid in recovering VCRs. Overall, findings demonstrate a significant reduction in VCRs across all age groups and highlight promising solutions to inform vaccine uptake efforts and ensure broader protection against VPDs.

Dynamic Trends and Underlying Factors of COVID-19 Vaccine Booster Hesitancy in Adults: Cross-Sectional Observational Study.

BACKGROUND: COVID-19 vaccine hesitancy reduces vaccination rates, which is detrimental to building herd immunity and halting the spread of COVID-19 and its variations. Most researches have simply identified the reasons affecting COVID-19 vaccination reluctance without delving into its dynamics, which makes forecasting future trends difficult. OBJECTIVE: This study aimed to examine the current COVID-19 vaccine booster hesitancy rate in Chinese adults as well as the dynamics of vaccine hesitancy and its influencing factors. The results of this study will have practical implications for policy responses in mainland China, and effective COVID-19 booster vaccination in specific populations. METHODS: The web-based survey was completed by creating questionnaires and using a stratified random sampling method to collect information from adults (≥18 years old) among 2556 households in 4 geographical regions of China. We collected sociodemographic information, health status, awareness of COVID-19 and its vaccine, self-perceptions, trust in medical staff and vaccine developers, and so on. The odds ratios and 95% CI for the statistical associations were estimated using logistic regression models. RESULTS: Overall, 6659 participants (females: n=3540, 53.2%; males: n=3119, 46.8%) responded. In total, 533 (8%; 95% CI 7.4%-8.7%) participants presented a clear hesitancy in receiving the COVID-19 booster vaccination, while 736 (11.1%; 95% CI 10.3%-11.8%) expressed hesitancy in regular booster vaccination. A higher prevalence of vaccine hesitancy in both booster vaccination and regular booster vaccination was observed among participants with a history of allergies, experiencing chronic disease, lower levels of public health prevention measures or susceptibility or benefits or self-efficiency, higher levels of severity or barriers, and lower trust in both medical staff and vaccine developers (P<.05). The females and participants with higher education levels, higher levels of barriers, lower levels of susceptibility, and lower trust in vaccine developers preferred to have attitudinal changes from acceptance to hesitancy, while people with higher education levels, lower self-report health conditions, experiencing chronic disease, history of allergies, and lower trust in medical staff and developers were all positively associated with constant COVID-19 booster hesitancy. CONCLUSIONS: The prevalence of COVID-19 vaccine booster hesitancy is not high in mainland China. However, there is a slight increment in hesitancy on regular booster vaccination. Conducting targeted information guidance for people with higher education levels and chronic diseases, as well as improving accessibility to booster vaccination and increasing trust in medical staff and vaccine producers may be highly effective in reducing vaccine hesitancy.

Assessment of childhood immunization services at private healthcare facilities in Indonesia: a case study in a highly-populated city.

Introduction: The need to enhance the utilization of the private sector for immunization programs in Indonesia while maintaining the high quality of services provided is evident. This study aimed to rapidly assess immunization services at private healthcare facilities in Indonesia by using Bandung, the most densely populated city, as the reference case. Methods: Initially, a situation analysis was conducted by collecting data from selected healthcare facilities (n = 9). Furthermore, a qualitative study was taken into account by developing framework approaches and conducting interviews with different layers, such as mid-level managers at healthcare facilities (n = 9), professional organizations (n = 4), and public stakeholders (n = 7). Results: The situation analysis showed that private healthcare facilities had provided sufficient time for essential childhood immunization services with adequate staff. Nevertheless, the number of limited staff the Ministry of Health (MoH) has trained remains a programmatic problem. Furthermore, private healthcare facilities have used the MoH guidelines and additional internal guidelines for immunization services as the primary reference, including in the efforts to provide complete and reliable equipment. Vaccine availability at private healthcare facilities is manageable with an acceptable out-of-stock level. The results of our interviews highlighted three key findings: the lack of coordination across public and private sectors, the need for immunization service delivery improvement at private healthcare facilities, and the urgency to strengthen institutional capacity for advocacy and immunization systems support. Conclusion: Even though private healthcare facilities have been shown to make a modest contribution to childhood immunization services in Indonesia, efforts should be made to expand the role of private healthcare facilities in improving the performance of routine immunization programs.

Assessment of availability and challenges of WHO recommended priority life-saving medicines for under five-year children in primary public health facilities of Amhara region.

BACKGROUND: The world health organization (WHO) priority lifesaving medicines are medicines recommended for the prevention and treatment of leading causes of under-five morbidity and mortality. They should be available in all health systems and at all times. However, the availability of these medicines and its determinants is not well studied in Ethiopia in general and in primary public health facilities Amhara region in particular. OBJECTIVE: The study aimed to assess the availability and challenges of the WHO-recommended priority lifesaving medicines for under-five children in primary public health facilities of the Amhara region. METHODS: A cross-sectional study design was conducted from February to December 2020 in 98 health centers and 22 primary hospitals in the Amhara region, Ethiopia. Facilities were selected with a simple random sampling technique. The data were collected through a pretested and structured questionnaire. Binary logistic regression was used to identify predictors associated with availability of WHO-recommended priority lifesaving medicines for under-five children. RESULTS: The availability of oral rehydration salt was high (82.5%) and the availability of vitamin A (47.5%), morphine tablet (13.3%), and artesunate rectal suppository (7.5%) were within low and very low WHO range respectively. Budget adequacy (AOR = 12.9 CI= (2.1-78.2)), periodic review of stock level ((AOR = 13.4,CI=(1.9-92.0)), training on integrated pharmaceutical logistic system ((AOR = 4.5,CI=(1.0-20.5)), inclusion of WHO priority under five children facility specific medicine list (AOR = 12.4,CI=(2.3-66.4)), lead time for EPSA(Ethiopia Pharmaceutical Supply Agency) procurement (AOR = 7.9,CI=(1.3-44.8)) were significantly associated with availability of all WHO priority lifesaving medicines for under- five children. CONCLUSION: The average availability of WHO-recommended priority lifesaving medicines for under-five children was low. The habit of updating bincard and adoption of the life-saving medicine list were the independent predictors of medication availability.

Correspondence to: Estimating the full health and economic benefits of current and future influenza vaccines.

We recently published an article in BMC Medicine looking at the potential health and economic impact of paediatric vaccination using next-generation influenza vaccines in Kenya: a modelling study. In their commentary on our article, Lafond et al. highlight the potential importance of the wider benefits of vaccination on cost-effectiveness. Whilst we agree with many points raised in the commentary, we think it raises further interesting discussion points, specifically around model complexity, model assumptions and data availability. These points are both relevant to this manuscript but have wider implications for vaccine cost-effectiveness studies.

Autoimmune diabetes mellitus after COVID-19 vaccination in adult population: a systematic review of case reports.

BACKGROUND: Autoimmune/type 1 diabetes mellitus (T1DM) is a recently described rare occurrence following the administration of adjuvants such as coronavirus disease 2019 (COVID-19) vaccines. This systematic review aimed to review all available literature on the potential association between COVID-19 vaccines and T1DM. METHODS: The Directory of Open Access Journals, MEDLINE, Google Scholar, and Scopus were systematically searched for all published studies from inception to July 2022. Articles reporting T1DM development within 8 weeks of administration of COVID-19 vaccine were included. Two reviewers independently performed the risk of bias assessment following the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Case Reports. RESULTS: Eight eligible studies were retrieved, comprising 12 patients diagnosed with T1DM after being vaccinated with a COVID-19 vaccine. Six patients (50%) reported T1DM after receiving the second dose. Five patients (41.7%) presented with diabetic ketoacidosis, of which four presented within the first eight days after vaccination. Five patients (41.7%) had genetic susceptibility, with RNA binding motif protein 45 (RBM45/DRB1) and major histocompatibility complex, class II, DQ beta 1 (HLA-DQB1) mutations being prominent. INTERPRETATION: In this review, we have shown a small number of new-onset diabetes cases coincidently occurring soon after the COVID-19 vaccine, especially in those with genetic susceptibility. Despite being older, these patients had a similar phenotype to T1DM. While there might be a causal relationship between COVID-19 vaccines and T1DM development, this should not influence decisions regarding vaccination since the overall benefit outweighs the risk. Further larger prospective trials are needed to assess causal relationship and to clarify the potential roles of COVID-19 vaccine-derived antigens in autoimmune disease development. PROTOCOL REGISTRATION: PROSPERO-CRD42022342093.

Investigation of non-National Immunization Program vaccination intentions in rural areas of China.

BACKGROUND: China's current immunization program was revised in 2007. Some common childhood vaccines such as those for influenza, pediatric pneumonia, Haemophilus influenzae, varicella, and rotavirus have not been included in the National Immunization Program (NIP) and need to be purchased by children's guardians at their own expense. Rural areas, constrained by economic development and vaccine awareness, have a low non-NIP vaccination rate and more family medical expenses and social burden. This study aims to examine the awareness and attitude of rural parents about non-NIP vaccines and relevant factors influencing their vaccination intention to provide strategic suggestions for expanding and improving the Chinese government's NIP policy. METHODS: A qualitative method of in-depth interviews were conducted for this study. We interviewed 30 rural parents in a central Chinese village to investigate their awareness of non-NIP vaccines and their vaccination intention and behavior. All the interview data were analyzed through the Colaizzi seven-step data analysis method. RESULTS: This study summarized the individual and social level factors influencing the non-NIP vaccination intention of rural parents. The individual level factors include four themes: perceived severity with physical harm, treatment consumption (cost of the treatment of the subject diseases), psychological burden, and social consequences being subthemes; perceived vulnerability with age vulnerability, medical history, immune quality (children's underlying immune status), and environmental vulnerability (sanitary condition of the rural environment) as subthemes; perceived efficacy with effect perception, psychological comfort, protective strength, and functional compensation (functions of non-NIP vaccines unreplaceable by NIP vaccines) being subthemes; and perceived cost consisting of two subthemes cost burden and adverse reaction. The social level influencing factors include the vaccination opinions in rural social networks, the accessibility of health services and vaccine products, and the guidance and promotion of vaccination policies. These factors act outside of individuals' subjective awareness and influence decisions regarding non-NIP vaccination in rural areas. CONCLUSION: Based on these influencing factors, this study constructs a structural model for non-NIP vaccination decision-making process in rural areas of China. The results play a guiding role in directing attention to children's health, promoting non-NIP vaccination, facilitating the dissemination of vaccine knowledge in rural areas, and improving NIP policies and practices in China.

Treatment of fever and associated symptoms in the emergency department: which drug to choose?

OBJECTIVE: Fever is a frequent cause of admission to the Emergency Department (ED) worldwide. Although it can be caused by a wide range of conditions, the most effective treatment based on its etiology is still undetermined. PATIENTS AND METHODS: This prospective, single-center, observational study enrolled adult patients who accessed the ED for fever. Physicians were free to administer paracetamol 1,000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I). The primary endpoint was both 1-degree and 1-point reduction in body temperature for all associated symptoms on the Numerical Rating Scale (NRS) after 1 hour (T1). The secondary endpoint was the reduction of at least 2 points on the NRS after two hours (T2). Adverse events, the need for rescue therapy, and the response based on the underlying etiology (bacterial, viral, or immune/neoplastic) were also evaluated. RESULTS: 324 patients (170 males, mean age 71±6 years) were enrolled: 187 had bacterial, 80 viral, and 57 neoplastic/inflammatory fever. Fever was treated with Paracetamol 1,000 mg (P) in 189 patients and with Paracetamol/Ibuprofen 500/150 mg (PI) in 135 subjects, while none of the patients were primarily treated with I. Based on the fever etiology P was administered to 113 patients with bacterial fever (59.8%), 48 patients with viral fever (25.4%), and 28 subjects with neoplastic/inflammatory fever (14.8%). PI was administered to 74 patients with bacterial fever (54.8%), 32 patients with viral fever (23.7%), and 29 subjects with neoplastic/inflammatory fever (21.5%). The primary endpoint was achieved by 126 patients, 70 of them (37.0%) were treated with P and 56 (41.5%) with PI (p=0.418). The secondary endpoint was achieved by 295 patients, 171 (90.5%) of them treated with P and 124 (91.9%) treated with PI (p=0.669). No significant differences were found between groups treated with P and PI concerning rescue therapy (15 vs. 6 patients; p=0.893). Interestingly, PI was more effective than P in patients with bacterial fever at T1 (P 33.6% vs. PI 48.6%; p=0.040), while efficacy of P and PI was similar at T2 for all kind of fever. CONCLUSIONS: Paracetamol 1,000 mg represents the first choice for the treatment of fever in the ED, followed by Paracetamol/Ibuprofen 500/150 mg. Interestingly, Paracetamol/Ibuprofen combination resulted in being more effective in patients with bacterial fever one hour after its administration.

Bayesian multitask learning for medicine recommendation based on online patient reviews.

MOTIVATION: We propose a drug recommendation model that integrates information from both structured data (patient demographic information) and unstructured texts (patient reviews). It is based on multitask learning to predict review ratings of several satisfaction-related measures for a given medicine, where related tasks can learn from each other for prediction. The learned models can then be applied to new patients for drug recommendation. This is fundamentally different from most recommender systems in e-commerce, which do not work well for new customers (referred to as the cold-start problem). To extract information from review texts, we employ both topic modeling and sentiment analysis. We further incorporate variable selection into the model via Bayesian LASSO, which aims to filter out irrelevant features. To our best knowledge, this is the first Bayesian multitask learning method for ordinal responses. We are also the first to apply multitask learning to medicine recommendation. The sample code and data are made available at GitHub: https://github.com/thrushcyc-github/BMull. RESULTS: We evaluate the proposed method on two sets of drug reviews involving 17 depression/high blood pressure-related drugs. Overall, our method performs better than existing benchmark methods in terms of accuracy and AUC (area under the receiver operating characteristic curve). It is effective even with a small sample size and only a few available features, and more robust to possible noninformative covariates. Due to our model explainability, insights generated from our model may work as a useful reference for doctors. In practice, however, a final decision should be carefully made by combining the information from the proposed recommender with doctors' domain knowledge and past experience. AVAILABILITY AND IMPLEMENTATION: The sample code and data are publicly available at GitHub: https://github.com/thrushcyc-github/BMull.

Sustained and Boosted Antibody Responses in Breast Milk After Maternal SARS-CoV-2 Vaccination.

Background: Pregnant and lactating women were not included in the initial large vaccine clinical trials for SARS-CoV-2 (COVID) infection. Delineating the antibody titers in serum and breast milk of lactating women is important to determine the safety and benefits of vaccination in this special population. Objective: To investigate COVID vaccinations in breastfeeding dyads and effects on lactation, the Antibody Detection of Vaccine-Induced Secretory Effects trial (ADVISE) prospectively evaluated anti-COVID antibodies in serum and breast milk after initial paired and booster vaccines. Methods: This is a prospective longitudinal surveillance cohort study of lactating women. Eligibility criteria included ≥18 years of age, currently lactating, and at enrollment either received COVID vaccination within the past 60 days or planning vaccination within 60 days. Results: Among 63 lactating mothers, COVID vaccination led to breast milk secretory IgA (sIgA) and IgG antibodies with consistent viral neutralizing activity. Milk sIgA titers increased further after second vaccination and were prolonged after a third booster dose, including women with extended breastfeeding beyond 12 months. Milk IgG antibody titers were higher and more sustained than sIgA. Antibody titers were not associated with individual dyad characteristics or vaccine manufacturer. Vaccine-induced antibodies from milk were not detected in infant circulation. Conclusions and Relevance: Maternal COVID vaccination during lactation is well tolerated and generates sustained and boosted antibody responses in breast milk. COVID-specific sIgA and IgG antibodies with neutralizing activity are found in breast milk, including boosted mothers who continue breastfeeding beyond 12 months. These data support universal COVID vaccinations for all lactating mothers, including booster immunizations during extended breastfeeding (NCT04895475).

Mental health and governmental response policy evaluation on COVID-19 based on vaccination status in Republic of Korea.

BACKGROUND: The coronavirus disease (COVID-19) pandemic has continued since the outbreak in December 2019. People experience depression and anxiety due to government policies and restrictions on physical activity due to the COVID-19 pandemic. This study aimed to compare and analyze people's experiences of COVID-19 blues, sports policy awareness, and participation intention according to their vaccination status. METHODS: This quantitative study used an online survey to collect demographic information, vaccination status, and variables. Data validity and reliability were verified through confirmatory factor analysis, and Cronbach's alpha coefficients were calculated using SPSS/AMOS 23.0. Finally, this comparative study was conducted using multivariate analysis of variance to investigate the differences in the dependent variables between the groups. RESULTS: The vaccinated group had higher scores for all factors related to COVID-19 blues (F = 19.147; p < .05; partial η2 = .046) and government policy (market responsiveness: F = 5.669, p < .05, partial η2 = .014; policy performance: F = 6.997, p < .05, partial η2 = .017; policy satisfaction: F = 7.647, p < .05, partial η2 = .019), apart from the intention to participate in sports (F = .014, p > .05, partial η2 = .000); these results demonstrate that people with COVID-19 blues and relatively high confidence in government quarantine policies were more likely to be vaccinated. In addition, all participants gave sports-participation intention the highest rating, regardless of their vaccination status; this reflects the current situation, in which individual activities are limited. CONCLUSIONS: This study analyzed the mental health of vaccinated and unvaccinated groups in Korean adult men, their perceptions of government policies, and their willingness to engage in physical activity. The findings are meaningful and highlight useful directions for future research. This study provides evidence which can help alleviate the mental damage caused by government quarantine policies and enable a better understanding of the COVID-19 pandemic. The results of this study provide important data for understanding the COVID-19 pandemic.

Vaccine cold chain management practices in primary health centers providing an expanded immunization program in Northwest Ethiopia: self-reported and actual practice observational study.

Background: Vaccines are vital health commodities that need an appropriate supply chain system. They could be transported, stored, and used at appropriate temperatures. The purpose of this study was to assess vaccine cold chain management practices in primary health centers offering an expanded program of immunization (EPI) in Bahir Dar, Northwest Ethiopia. Methods: A self-reported and actual practice observational cross-sectional study was conducted at primary public health centers in the Bahir Dar city administration from August 15 to 30, 2021. A simple random sampling method was used to select study participants. An interview-administered questionnaire and direct actual practice observation were used to collect data. The data was entered into the Epi-data 4.6 program and analyzed using SPSS version 25. Participants' knowledge, storage and transport conditions, IPLS management, and vaccine cold chain management practices were examined using independent samples t-tests and one-way ANOVA tests. Findings: A total of 50 respondents from ten health centers were enrolled in the study. Most of the EPI service providers had good knowledge (60%) and good practice in vaccine storage and transport (74%). However, more than two-thirds (68%) of EPI service providers had poor integrated pharmaceutical logistics system (IPLS) management. Only half (50%) of the health centers had good actual vaccine cold chain management practices. Higher educational background, longer work experience, and receiving training and supervision in EPI services, IPLS management, and vaccine inventory management resulted in higher knowledge, storage and transport management, IPLS management, and vaccine cold chain management practices. Conclusion: Although most EPI service providers in an interview assessment reported having good knowledge and good vaccine storage and transport management, only half of the health facilities followed the standard. Stakeholders are recommended to play a vital role in improving practices related to EPI services.

Immunisation status of children receiving care and support in Wales: a national data linkage study.

Background: In the UK, a robust childhood immunisation programme ensures children are offered protection against serious infections; identifying inequalities in vaccination coverage is essential. This is one of the first data linkage studies to examine coverage of primary, as well as pre-school booster and second dose of MMR vaccines, in children receiving support from social care services across Wales. Methods: By accessing records held within the Secure Anonymised Information Linkage (SAIL) Databank, vaccination status of children receiving social care and support between April 2016 and March 2021 (n = 24,540) was ascertained. This was achieved through linkage of the Children Receiving Care and Support (CRCS) Census and National Community Child Health Database which holds vaccination records for all children in Wales registered for NHS care. This sample was split into three groups - those children who had never been recorded on the Child Protection Register (CPR) or as 'Looked After' but in CRCS (n = 12,480), children ever on the CPR (n = 6,225) and those ever recorded as 'Looked After' but who were never on the CPR (n = 5,840). The comparison group of children and young people (CYP) never receiving welfare support consisted of 624,905 children. Results: Children receiving care or support were more likely to be up-to-date with all six vaccines (no recorded vaccines: 0.6-6.3%) compared to children in the comparison group (no recorded vaccines: 3-10.3%). However, of those who were vaccinated, they were less likely to be vaccinated in a timely manner; both early (5.2% vs. 22.2%; margin of error [ME] = 0.52, 95% CI [confidence interval] = -0.18 - -0.17, p < 0.001) and delayed vaccinations were more common (62.7% vs. 71.3%; ME = 0.58, 95% CI = 0.08-0.09, p < 0.001). Validation of the CRCS immunisation flag showed moderate levels of accuracy. Around 70% of immunisation flags were correct across all three groups. Discussion: Findings suggest a positive association between receiving services under a care and support plan and being up-to-date with immunisations; children receiving support under a care and support plan were more likely to have experienced early or late vaccinations, demonstrating that there is still more inter-disciplinary co-ordination and planning needed to improve these outcomes. Thus, identifying inequalities in vaccination coverage is essential to target interventions and to prioritise geographic areas for catch-up.

Vaccination Coverage Among Adolescents Aged 13-17 Years - National Immunization Survey-Teen, United States, 2022.

Three vaccines are routinely recommended for adolescents to prevent pertussis, meningococcal disease, and cancers caused by human papillomavirus (HPV). CDC analyzed data from the 2022 National Immunization Survey-Teen for 16,043 adolescents aged 13-17 years to assess vaccination coverage. Birth cohort analyses were conducted to assess trends in vaccination coverage by age 13 years (i.e., before the 13th birthday) and by age 14 years (i.e., before the 14th birthday) among adolescents who were due for routine vaccination before and during the COVID-19 pandemic. Cross-sectional analysis was used to assess coverage estimates among adolescents aged 13-17 years. In 2022, vaccination coverage by age 14 years among adolescents born in 2008 continued to lag that of earlier birth cohorts and varied by sociodemographic factors and access to health care compared with coverage among earlier birth cohorts. Vaccination coverage by age 13 years among adolescents born in 2009 was similar to coverage estimates obtained before the COVID-19 pandemic. Among all adolescents aged 13-17 years, 2022 vaccination coverage levels did not differ from 2021 levels; however, initiation of the HPV vaccination series decreased among those who were insured by Medicaid. Coverage with ≥1 dose of tetanus, diphtheria, and acellular pertussis vaccine and ≥1 dose meningococcal conjugate vaccine was high and stable (around 90%). Providers should review adolescent vaccination records, especially among those born in 2008 and those in populations eligible for the Vaccines for Children program, to ensure adolescents are up to date with all recommended vaccines.

Access to Vaccination for Newly Arrived Migrants: Developing a General Conceptual Framework for Understanding How to Improve Vaccination Coverage in European Countries.

Objectives: Access to vaccination for newly arrived migrants (NAMs) is a relevant concern that requires urgent attention in EU/EEA countries. This study aimed to develop a General Conceptual Framework (GCF) for understanding how to improve vaccination coverage for NAMs, by characterizing and critically analyzing system barriers and possible strategies to increase vaccination. Methods: A theoretical conceptualization of the GCF was hypothesized based on conceptual hubs in the immunization process. Barriers and solutions were identified through a non-systematic desktop literature review and qualitative research. The GCF guided the activities and facilitated the integration of results, thereby enriching the GCF with content. Results: The study explores the vaccination of NAMs and proposes strategies to overcome barriers in their vaccination process. It introduces a framework called GCF, which consists of five interconnected steps: entitlement, reachability, adherence, achievement, and evaluation of vaccination. The study also presents barriers and solutions identified through literature review and qualitative research, along with strategies to enhance professionals' knowledge, improve reachability, promote adherence, achieve vaccination coverage, and evaluate interventions. The study concludes by recommending strategies such as proximity, provider training, a migrant-sensitive approach, and data collection to improve vaccination outcomes for NAMs. Conclusion: Ensuring equitable access to healthcare services, including vaccination, is crucial not only from a humanitarian perspective but also for the overall public health of these countries.