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The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group evaluates the safety and other key features of new platform technology vaccines, including nucleic acid (RNA and DNA) vaccines. This manuscript uses the BRAVATO template to report the key considerations for a benefit-risk assessment of the coronavirus disease 2019 (COVID-19) mRNA-based vaccine BNT162b2 (Comirnaty®, or Pfizer-BioNTech COVID-19 vaccine) including the subsequent Original/Omicron BA.1, Original/Omicron BA.4-5 and Omicron XBB.1.5 variant-adapted vaccines developed by BioNTech and Pfizer to protect against COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Initial Emergency Use Authorizations or conditional Marketing Authorizations for the original BNT162b2 vaccine were granted based upon a favorable benefit-risk assessment taking into account clinical safety, immunogenicity, and efficacy data, which was subsequently reconfirmed for younger age groups, and by real world evidence data. In addition, the favorable benefit-risk assessment was maintained for the bivalent vaccines, developed against newly arising SARS-CoV-2 variants, with accumulating clinical trial data., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The Brighton Collaboration BRAVATO authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. BioNTech authors are current employees of BioNTech, a for-profit organization, who may own stock or hold stock options. AM is an inventor on patents and/or patent applications related to RNA technology and COVID-19 vaccines., (Published by Elsevier Ltd.)

Objectives We evaluated the safety, immunogenicity and efficacy of Abdala, a protein subunit vaccine for 2019 coronavirus disease (COVID-19), in children and adolescents. Methods A phase 2, open-label, single-arm clinical trial was carried out. Subjects aged 3 to 18 years were eligible. Abdala vaccine was administered intramuscularly at 0-14-28 days. The main endpoints were safety and the immunobridging analysis with a non-inferiority design, to infer the efficacy of the vaccine in paediatric population based on the comparison of neutralizing antibodies (NAb) to SARS-CoV-2, with adults (19-21 years). The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000390. Results From September 13th to September 17th, 2021, 703 participants were included in the context of a predominantly SARS-CoV-2 Delta variant circulation. The number of individuals who experienced adverse reactions was 264/703 (37·6%). Adverse reactions were mostly mild and occurred at the injection site, which resolved within the first 24-48 h. There were no reports of severe adverse events. For the non-inferiority comparison of 297 children (3-11 years) with 297 adults, the geometric mean (GMT) ratio of SARS-CoV-2 NAb was 0·87 (95% CI 0·69-1·08) and 1·07 (0·82-1·39) in the same comparison for 203 adolescents (12-18 years) and 203 adults. For both age groups, the lower limit of GMT was higher than 0·67. The differences in seroresponse rates of Nab for children were 1% (-2%, 4%) and -3% (-7%, 1%) for adolescents, higher than -10% in both age groups. Conclusions The Abdala vaccine was safe and immunogenic in a paediatric population aged 3-18 years, with inferred efficacy based on non-inferior analysis. The vaccine is very suitable to fit into massive vaccination strategies, considering the advantages of using the same vaccine strength (RBD 50 μg) and schedule of administration for both adults and children, as well as the easy storage and handling conditions at 2-8 °C., Competing Interests: Declaration of competing interest Authors FHB, JQG, YMB, KaUP, KlUP, JLRR, MAV, ZCE, MLF, MAA and VLMG, are employees of the Centre for Genetic Engineering and Biotechnology, Havana Network, where Abdala vaccine active ingredient is produced and the formulation was developed. The remaining authors have no conflict of interest. No honoraria, consulting fees or payments for seminar presentations, speeches or appearances have been received by any of the authors., (Copyright © 2024 Centre for Genetic Engineering and Biotechnology, Havana, Cuba. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Vaccinations are important for informal caregivers and their care recipients. Mental health problems are common among care givers. The aim of this study was to investigate vaccination readiness in informal caregivers and associations with mental health issues. Associations between vaccination readiness in informal caregivers and the vaccination status of their aged care recipients were examined., Methods: Within the multicenter prospective registry study 'Bavarian ambulatory Covid-19 Monitor (BaCoM) ', informal caregivers were asked for symptoms of depression (PHQ-9), burden of caretaking (BSFC-s), psychological antecedents of vaccination readiness (5C model) and previous Covid-19 infections of their care recipients. The vaccination status against Covid-19, seasonal influenza and pneumococcal disease was determined via vaccination certificates. Data analysis was performed using ordinal regressions and Mann-Whitney-U tests., Results: Data of n = 91 informal caregivers, associated with n = 84 care recipients were collected. Symptoms of depression were associated with reduced vaccination readiness (Calculation: p = 0.026, OR = 1.18), as well as the perceived burden of caretaking (Confidence: p = 0.006, OR = 0.88). A previous Covid-19 infection of the care recipients was associated with decreased vaccination readiness of informal caregivers (Median (Q1-Q3) Confidence: 5.0 (4.5-6.0) vs. 4.0 (3.0-5.0); Calculation: 5.0 (3.0-6.0) vs. 4.0 (1.0-5.0)). The vaccination status of the care recipients interrelated significantly with vaccination readiness of their informal caregivers (Confidence: p < 0.001; Complacency: p < 0.01; Constraints p < 0.05). No significant interrelations between vaccination readiness and the vaccination status against seasonal influenza or pneumococcal disease occurred., Conclusion: Mental health issues of informal caregivers seem to be associated with the actual vaccination status against Covid-19 in their care recipients. Target group specific counselling as well as an active involvement of informal caregivers in shared decision-making processes can be of relevance, but even more attention should be paid to the protection of mental health for informal caregivers., Trial Registration Number: German Register of Clinical Studies DRKS 26039., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Influenza vaccination is critical for children with sickle cell disease (SCD) due to risks of severe influenza infections. Despite declining influenza vaccination among children since the COVID-19 pandemic, less is known about influenza vaccine coverage among youth with SCD during this same period. We compared influenza vaccine uptake among youth with SCD seen by a SCD provider in clinic during the 2019-2020 and 2022-2023 influenza seasons and described infection characteristics. Overall, 85% (n = 220) of children received their influenza vaccine during 2019-2020 compared to 75% (n = 245) in 2022-2023 (p = 0.059). Participants seen during both seasons were more likely to shift from vaccinated in 2019-2020 to unvaccinated in 2022-2023 than vice versa (McNemar's OR = 3.0; p = 0.008). Among 66 documented infections, 25.8% resulted in hospitalization. We found high influenza vaccine uptake but those seen during both seasons were more likely to become unvaccinated. More research is needed to understand influenza vaccine decision-making in this population., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Identifying immune correlates of risk following COVID-19 vaccine boosters has become paramount as a result of the challenges in generating additional efficacy data. The trial data described here was collected in the United States, with a large part of the study conduct coinciding with the emergence of the SARS-CoV-2 Omicron BA.1 variant. The vaccine trial involved the administration of a booster dose of Ad26.COV2·S at least 6 months after primary vaccination with either a single dose of Ad26.COV2·S or a 2-dose BNT162b2 vaccine regimen. Immunogenicity was assessed through Wuhan Spike binding antibodies (bAb), neutralizing antibodies (nAb), and Omicron BA.1 cross-neutralizing antibodies (nAb BA.1) at Day 1 (pre-boost), Day 15-, and 6-months post-boost. Immune correlates analyses demonstrate that, higher titers of bAb, nAb, and nAb BA.1 at Day 15 were consistently associated with a lower risk of symptomatic COVID-19 following a booster dose of Ad26.COV2·S, irrespective of the primary vaccine regimen. Similar results were obtained using multivariable analyses. Furthermore, Day 1 nAb levels against the Wuhan reference strain exhibited a statistically significant inverse relationship with the risk of symptomatic COVID-19. These findings highlight the value of assessing immune correlates for vaccine boosters, especially in the context of emerging SARS-CoV-2 variants. Clinical trials registration:NCT04999111., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Mathieu Le Gars reports was provided by Janssen Pharmaceuticals Inc. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Objective: This study examines the impact of the COVID-19 pandemic on both routine and non-routine vaccinations in infants during their initial 18 months of life, concurrently exploring the complex influence of sociodemographic factors., Methods: A cohort study was conducted, involving 2007 children in two distinct periods: pre-pandemic (January-June 2018) and pandemic (March 2020-May 2021). Participants were classified into two cohorts: 962 children in the 2018 group and 1045 children in the 2020-21 group. Utilizing unconditional logistic regression, the association between vaccination (complete or non-routine) and socioeconomic factors was examined, with adjustments for potential confounding variables such as age, breastfeeding, gestational age, and twins., Results: The study's analysis reveals that in the post-pandemic period, mothers were three times more likely to opt for non-routine vaccines (95% CI 2.25-4.23). However, no significant alterations were observed in routine vaccination rates. Protective factors for complete vaccination included having an employed mother, higher education, and a medium-to-high income. Conversely, a higher income was associated with a reduced likelihood of complete vaccination (OR 0.34, 95% CI 0.20-0.59)., Conclusion: Contrary to initial expectations, this study concludes that the COVID-19 pandemic did not have a substantial impact on childhood complete vaccination rates. Nevertheless, a noticeable increase in the choice of non-routine vaccination was observed. Sociodemographic factors, such as maternal education, income, and employment status, emerged as key influencers, particularly in the context of deciding on non-routine vaccinations., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

In recent years, India has seen significant improvements in childhood immunization, but rates among the urban poor remain stagnant. Disruptions during COVID-19 pandemic have created further challenges. This paper focuses on how social norms, vaccine confidence, and interpersonal communication independently and jointly affect vaccine intentions among caregivers of infants living in six slum areas in Varanasi, India. Data for this study come from the baseline assessments conducted before implementing the Happy Baby Program, an intervention to improve vaccination attitudes and intentions. In-person interviews (N = 2,058) were conducted with caretakers of children up to two years old. Analyses showed that interpersonal communication about vaccines, descriptive norms, injunctive norms, and vaccine confidence were each associated with intentions to vaccinate in both a bivariate and, except for injunctive norms, a multivariate model. In addition, we found significant interactions among these variables, suggesting that the roles of interpersonal communication and vaccine confidence attenuated the relationship between social norms and vaccination intention. Overall, our model explained 46.2 % of the variance in vaccine intention. Given the strengths of the relationships observed in this study, intervention strategies should focus on enhancing social norms and vaccine confidence to promote vaccination., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Rajiv N. Rimal reports financial support was provided by Global Alliance Fund. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Introduction: Argentina authorized COVID-19 vaccination for adolescents 12 years and older in August 2021, and then for children three years and older in October 2021. Children aged 6 months-2 years received a two-dose regimen beginning July 2022., Objective: This study aims to analyze the impact of COVID-19 vaccination among children aged 0-17, considering vaccination status and mortality for the 2020-2022 period., Methods: We conducted a population-level analysis examining all-cause mortality, COVID-19 cases, deaths, and vaccination records. We compared outcomes with child mortality for diseases for which vaccination is compulsory, before and after each vaccine rollout., Results: A decrease in COVID-19-related deaths was observed in 2022 for pediatric age groups (3-11 and 12-17) with relatively higher vaccination coverage. However, no decrease was observed for the 0-2 year old age group, which had the longest delay in access to immunization and lowest vaccination coverage. When compared to unvaccinated populations in 2022, we observe an 8-15-fold reduction in cumulative death rates for pediatric populations vaccinated with 1 or more doses, and a 16-18-fold reduction for those vaccinated with 2 or more doses. Historical analysis shows that for diseases for which vaccination is now compulsory in many countries, pre-vaccine-rollout mortality was lower than COVID-19 deaths during 2020-2022., Conclusions and Relevance: SARS-CoV-2 immunization was associated with reduced COVID-19 deaths for children and adolescents in Argentina. Our findings suggest that greater efforts should be undertaken to ensure wider COVID-19 vaccine coverage in children and adolescents, especially infants., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: COVID-19 vaccine hesitancy has been particularly high among immigrant populations, whose experience is shaped by a history of racism and discriminations, and distrust of the healthcare system. In this study we draw from the Theory of Planned Behavior to examine COVID-19 vaccine hesitancy among immigrants in Chicago., Methods: A mixed-methods approach comprising of both focus groups and a health survey was conducted from February to August 2022. Five focus groups were held (N = 35) among Black, Asian and Arab/Palestine participants to understand attitudes and beliefs around the COVID-19 vaccine. Focus groups were analyzed using a modified template approach to text analysis. Based on these findings and themes, we developed a survey that was conducted among 413 immigrants from the mentioned communities. We used hierarchical ordinal regression analyses to examine the relationship between COVID-19 vaccine hesitancy and vaccination status., Results: Qualitative analysis suggest that the major factors influencing COVID-19 vaccine hesitancy included fear of adverse reactions, misinformation around COVID-19 and the vaccine, negative social norms around vaccination, and external pressure to get vaccinated. From our quantitative analysis we found that 24% of participants were unvaccinated, 5% were partially vaccinated, 32.3% were vaccinated but not boosted, and 39% were vaccinated and boosted for COVID-19. Hierarchical regression models suggest that immigrants who hold negative attitudes and social norms around the COVID-19 vaccine are less likely to vaccinate., Conclusions: Understanding vaccine hesitancy among immigrants allows for the creation of culturally and linguistically tailored education that can be utilized to increase vaccine confidence and uptake., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Ltd.)

JN.1, the dominating SARS-CoV-2 variant, is antigenically distinct from ancestral BA.1, BA.5 and XBB.1.5 variants, raising concern about effectiveness of updated COVID-19 vaccines. Here, we compared the neutralizing antibody response against JN.1, 1-month after receipt of the three available Moderna mRNA vaccines. Sera obtained from 37, 30 and 30 XBB.1.5, BA.1 and BA.4-5 -vaccine recipients, respectively, were tested for anti-RBD IgG and for JN-1 specific neutralizing antibody levels. Geometric mean fold rise (GMFR) in JN.1 specific neutralizing titers was 27 (95 % CI: 17-43.1), 10.1 (95 % CI: 6.48-15.7) and 8.77 (95 % CI: 5.69-13.5) following XBB.1.5, BA.1 and BA.4-5 vaccines, respectively, translating into a 64 % lower adjusted response (geometric mean ratio [GMR] = 0.36, 95 % CI: 0.21-0.6) in the BA.1 arm, and a 75 % lower response (GMR = 0.25, 95 % CI: 0.15-0.43) in the BA.4-5 arm. This suggests that XBB.1.5 vaccination will most likely, result in improved effectiveness against JN.1 compared with other COVID-19 vaccines., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Spyros Chalkias, Rituparna Das and Gamal Elfatarany are employees of Moderna, Inc. and may hold stock/stock options in the company. Gili Regev-Yochay served as a consultant to Merck, GSK, Astrazenca, Pfizer and Moderna., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Objectives: To identify and synthesise evidence on cultural and social attitudes towards coronavirus disease 2019 (COVID-19) vaccination and factors associated with vaccine acceptance in the adult population., Design: Systematic review., Data Sources: Six electronic databases were searched (CINAHL, Coronavirus Research Database, Embase, MEDLINE, Nursing and Allied Health Database, and Web of Science Core Collection). Additional studies were identified through Google Scholar and hand searching the reference lists of all studies included in the review., Method: The searches were conducted to identify all relevant studies published in English, from December 2019 to December 2021. The Critical Appraisal Skills Programme (CASP) and Appraisal tool for Cross-Sectional Studies (AXIS tool) were used to critically appraise the quality of included studies. Data were extracted and synthesised narratively., Results: 1260 records were identified, of which 38 studies were included in the review. Low COVID-19 vaccination acceptance rates were found among young people, females, non-medical students, and even some healthcare workers, which were associated with misinformation obtained through social media platforms, unknown side effects, questionable conspiracy theories, and doubts about efficacy and safety. Higher COVID-19 vaccination acceptance rates were due to recommendations from healthcare professionals and government sources, and the perceived increased risk of contracting COVID-19., Conclusion: COVID-19 vaccine acceptance varies across the globe. To increase the acceptance rate of the COVID-19 vaccine, public health education programmes should be promoted effectively and target specifically the groups who are most hesitant to receive the vaccine such as young people, females, and non-medical students. Vaccine hesitancy among healthcare workers can affect vaccination rates as the majority of the population views them as a trustworthy source for vaccine-related knowledge. Staff training is important to enhance their confidence and communication skills in providing information about COVID-19 vaccination to combat the misunderstanding of the public and encourage vaccine uptake., Prospero Registration Number: CRD42021248016., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

The COVID-19 pandemic is having a profound impact on the health, social and economic well-being of people in Canada and around the world. To address vaccine disparity among vulnerable populations facing social-structural challenges, it is crucial to provide evidence-based information on the importance of completion of the recommended vaccination schedule. In this study, we investigated vaccination rates and variables as facilitators or barriers to COVID-19 vaccination among vulnerable populations living in Vancouver's inner-city residents. On a weekly basis, a team (including health care providers [HCPs] and support staff) conducts a Community Pop-up Clinic (CPC) event at single room occupancy dwellings in Vancouver's inner city to provide COVID-19 vaccine and/or related information. Participants also completed a survey about their COVID-19 vaccination status and COVID knowledge, including knowledge about COVID vaccination. We collected data from 892 CPC participants between January 2021-August 2023. The median age at baseline was 45 (IQR 36-55) years, with 317 (35.5 %) female and 285 (31.9 %) self-identified as Indigenous. Within the population, 512 (57.4 %) reported unstable housing and 441 (49.5 %) were active injection drug users. Regarding COVID-19 vaccinations, 235 (26.3 %) were unvaccinated, 119 (13.3 %) had received one dose of the COVID-19 vaccine, 432 (48.4 %) had received 2 doses, and 106 (11.8 %) had received at least 3 doses. Variables such as age (AOR 2.28, 95 % CI 1.37-3.80, p < 0.001) and HCV seropositivity (AOR 1.91, 95 % CI 1.20-3.04, p = 0.005) were significantly associated with higher odds of vaccination uptake. Conversely, unstable housing was significantly associated with a lower odds of vaccination uptake (AOR 0.53, 95 % CI 0.35-0.79, p = 0.002). Results from this study suggest that targeted community focused initiatives are crucial to address vaccine disparity among vulnerable populations living in Vancouver's inner city facing unstable housing and drug use injection., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: BC has received research grants, honoraria and/or acted as a remunerated advisor for AbbVie, Astra Zeneca, Gilead Sciences, GSK, Indivior Canada, Merck, Moderna, Sanofi Pasteur, Seqirus, and ViiV Healthcare. In particular, AbbVie and Gilead Sciences have funded the community pop-up clinic program in a direct way. SB, SY, SS, and RY has no conflict of interest to declare., (Copyright © 2024. Published by Elsevier Ltd.)

Background: We recently reported a near disappearance of B. pertussis and a decline in anti-B. pertussis antibodies during the peak implementation of Coronavirus disease 2019 (COVID-19) non-pharmaceutical interventions (NPI) in 2021 in British Columbia (BC), Canada. During 2021-2023, incidence of reported B. pertussis cases remained low in BC at < 1/100,000 population. This study determined how serological evidence of B. pertussis changed after the gradual relaxation of NPI between 2021-2023., Methods: Randomly selected blood samples from school staff 25-51 years old (n = 65) were collected yearly between 2021-2023 in the Vancouver metropolitan area, BC, Canada, and tested for anti-pertussis toxin (PT) IgG levels. Serological evidence of B. pertussis infection (thereafter "seroconversion") was defined as a quantifiable anti-PT IgG levels in subjects with anti-PT IgG levels below lower limit of quantification in the preceding year or a > 4-fold increase in anti-PT IgG levels between two subsequent years. Samples were also tested for anti-diphtheria toxoid (DT) IgG, and similar seroconversion criteria were applied to exclude seroconversion due to vaccination with tetanus-diphtheria-acellular-pertussis (Tdap)., Results: Three subjects met seroconversion criteria for anti-PT IgG between 2021 and 2022 and 9 between 2022 and 2023, yielding a seroconversion rate of 4.6 /100 person-years and 14.9/100 person-years, P = 0.127, respectively. None of the subjects met the criteria for vaccination with Tdap. The geometric mean concentration of anti-PT IgG showed a statistically significant decrease in 2022 compared with 2021, 4.8 IU/mL IU/ml (95 % confidence interval [CI], 3.8-5.9) vs. 6.4 IU/ml (95 % CI, 4.9-8.2; p = 0.001), followed by a statistically significant increase in 2023 compared with 2022 6.5 IU/ml (95 % CI, 4.9-8.5) vs. 4.8 IU/ml (95 % CI, 3.8-5.9; p = 0.0006), respectively., Discussion: Serological evidence of B. pertussis increased between 2022 and 2023 despite low reported cases, which suggests that B. pertussis circulation resumed after relaxing of COVID-19 NPI., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: BA received honoraria for participation in live meetings from Sanofi Pasteur France and Canada related to pertussis and RSV., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Heterologous COVID-19 vaccine boosters have not been evaluated for patients with hematological malignancies. A Novavax booster was administered for 56 individuals with hematological malignancies who had received a primary COVID-19 series and prior boosters with mRNA vaccines only. Blood specimens were obtained at baseline (pre-vaccine), 28 days, and 168 days after vaccination with the Novavax booster. The median fold change of anti-Spike IgG was 1.02 (IQR 0.79, 1.3) between baseline and Day 28. Circulating Spike protein-specific B cells increased 1.4-fold at Day 28 (p < 0.05). Increases in antibody and T cell responses were modest without significance, with a waning of humoral and cellular responses at 168 days after vaccination., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: The global effort to combat the COVID-19 pandemic highlights the pivotal role of vaccination in public health, particularly considering emerging severe acute respiratory syndrome-coronavirus-2 variants. While priority has been given to immunising vulnerable populations, children remain a significant unvaccinated group, prompting NHS England to include them in their new vaccination strategy. The role parents play in child healthcare decisions, specifically regarding COVID-19 vaccination, is crucial, and the Health Belief Model (HBM) provides a framework for understanding parental vaccination behaviour., Methods: To investigate the predictors influencing parental decision-making for COVID-19 vaccination in children aged 5-11, an online cross-sectional survey was conducted amongst parents (n = 206) living in the UK aged > 18, with one or more children aged 5-11. The present study measured HBM constructs, demographic factors, vaccine hesitancy and vaccine decision-making self-efficacy. Binomial logistic regression was used to analyse the responses of 206 participants using the child vaccination status (vaccinated vs. unvaccinated) as the outcome variable., Findings: The regression model significantly predicted child vaccination status, identifying perceived barriers, cues to action and parent age as significant predictors. Higher cues to action and older parent age increased the likelihood of child vaccination, while greater perceived barriers decreased it. The model achieved 80.8 % overall accuracy by correctly identifying 87.6 % of vaccinated cases and 69.4 % of unvaccinated cases, demonstrating high accuracy in predicting parental vaccination decisions., Conclusion: The present study contributes to our understanding of the factors shaping parental decision-making regarding COVID-19 child vaccination, highlighting the impact of perceived barriers, cues to action and parent age. Future public health campaigns should address the specific barriers faced by parents, emphasise external cues to action and tailor messaging to acknowledge age-related differences in parental vaccine decision-making. By addressing the aforementioned factors influencing parental behaviour regarding child vaccination, future interventions can increase the number of children vaccinated against COVID-19, preventing transmission, protecting from severe illness and contributing to the NHS vaccination strategy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Data on immunogenicity induced by SARS-CoV-2 infection and its sustainability are essential to inform COVID-19 vaccine schedule. A prospective cohort study was conducted among adults at-risk for COVID-19 during the Omicron variant-dominant epidemic. All were followed up for anti-spike RBD levels on days 0, 14, 90 and 180 after enrollment. Of the 871 individuals included, 264 (30.3 %) had COVID-19. Those with COVID-19 had significantly lower baseline geometric mean level of anti-spike RBD than those without COVID-19 (326 vs. 989; P < 0.001). Among the COVID-19 patients, anti-spike RBD level significantly increased the most at 14 days after infection and dropped significantly at day 90 and day 180. Giving a booster dose during 91-180 days after infection induced high level of anti-spike RBD through 180 days. These findings suggest high level but short-lived immunity induced by SARS-CoV-2 infection while sustained immunity required a booster dose administered from 90 days after the infection., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Importance: Routine vaccinations are key to prevent outbreaks of vaccine-preventable diseases. However, there have been documented declines in routine childhood vaccinations in the U.S. and worldwide during the COVID-19 pandemic., Objective: Assess how the COVID-19 pandemic impacted routine childhood vaccinations by evaluating vaccination coverage for routine childhood vaccinations for children born in 2016-2021., Methods: Data on routine childhood vaccinations reported to CDC by nine U.S. jurisdictions via the immunization information systems (IISs) by December 31, 2022, were available for analyses. Population size for each age group was obtained from the National Center for Health Statistics' Bridging Population Estimates., Main Outcomes and Measures: Vaccination coverage for routine childhood vaccinations at age three months, five months, seven months, one year, and two years was calculated by vaccine type and overall, for 4:3:1:3:3:1:4 series (≥4 doses DTaP, ≥3 doses Polio, ≥1 dose MMR, ≥3 doses Hib, ≥3 doses Hepatitis B, ≥1 dose Varicella, and ≥ 4 doses pneumococcal conjugate), for each birth cohort year and by jurisdiction., Results: Overall, there was a 10.4 percentage point decrease in the 4:3:1:3:3:1:4 series in those children born in 2020 compared to those children born in 2016. As of December 31, 2022, 71.0% and 71.3% of children born in 2016 and 2017, respectively, were up to date on their routine childhood vaccinations by two years of age compared to 69.1%, 64.7% and 60.6% for children born in 2018, 2019, and 2020, respectively., Conclusions and Relevance: The decline in vaccination coverage for routine childhood vaccines is concerning. In order to protect population health, strategic efforts are needed by health care providers, schools, parents, as well as state, local, and federal governments to work together to address these declines in vaccination coverage during the COVID-19 pandemic to prevent outbreaks of vaccine preventable diseases by maintaining high levels of population immunity., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)

The level of neutralizing antibodies required to confer protection against COVID-19 breakthrough infections (BIs) is unclear, and the ability to know the immune status of individuals against the rapidly changing endemic variants is limited. We assessed longitudinal serum anti-RBD antibody levels and neutralizing activities (NTs) against Omicron BA.5 and XBB.1.5 in healthcare workers following the fourth monovalent and fifth bivalent BA.4-5 vaccines. The occurrence of BIs was also followed, and pre-infection antibody levels were compared between patients who developed BI and those who did not. In addition, we collected whole blood samples on the same day as the sera and stored them on filter papers (nos. 545, 590, and 424) for up to two months, then measured their NTs using dried blood spots (DBS) eluates, and compared them with the NTs in paired sera. Pre-infection levels of NTs were lower in patients who developed BI than those who did not, but the anti-RBD antibody levels were not different between them. The NTs below 50 % using 200-fold diluted sera might be one of the indicators of high risk for COVID-19 BI. However, the NTs against XBB.1.5 at 6 months after the fifth dose of bivalent BA.4-5 vaccine were lower than this threshold in almost half of infection-naïve participants. NTs measured using DBS eluates were strongly correlated with those measured using paired sera, but the time and temperature stability varied with the type of filter paper; no. 545 filter paper was found to most suitable for NT evaluation., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ‘ADVANTEC provide filter papers for neutralizing antibody assays. We have no conflicts of interest to declare.’., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: During the COVID-19 pandemic, there was an unprecedented effort to engage people in clinical vaccine research. Most of the French volunteers registered in the first weeks after the launch in October 2020 of COVIREIVAC, an electronic platform dedicated to COVID-19 vaccine clinical trials (VCT). In the context of pandemic preparedness, identifying factors associated with eagerness or hesitancy to participate in VCT may help to increase recruitment of volunteers from diverse backgrounds., Methods: We used a mixed-method survey offered to the volunteers registered on the COVIREIVAC platform, and semi-directed interviews in participants to COVID-19 VCTs. Volunteers were divided into three categories: early volunteers (EV), registered before the launch of the COVID-19 vaccination campaign, middle volunteers (MV) registered between the first of January 2021 and the generalization of the COVID-19 vaccination to the entire population in May 2021, and late volunteers (LV) registered afterward., Results: Among the 56,101 COVIREIVAC registered volunteers, 2,741 (4.9 %) completed the survey, 1,915 (69.6%) were EV, 301 (11.0%) were MV and 525 (19.2 %) were LV. Sixteen were face-to-face interviewed. Age, educational level, attitudes toward vaccination evaluated with the 5C-model did not differ between EV and MV. Women gender and the possibility to choose the vaccine platform was associated with being a MV. LV were significantly younger, had a lower educational level and had less positive attitudes toward vaccines than EV and MV. The main motivations for participation in VCTs were altruistic notably in EV and MV. For LV, they registered in the hope to choice the vaccine technology. Among the respondents, 2,041 (74.5 %) would consider to participate in a non-COVID-19 VCT., Conclusion: LV on the COVIREIVAC platform had a distinct profile from EV and MV, and were less confident in vaccines. Restoring confidence in vaccines and clinical may help to engage more diverse populations in VCTs., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: Luxembourg experienced major consecutive SARS-CoV-2 infection waves due to Omicron variants during 2022 while having achieved a high vaccination coverage in 2021. We investigated the risk factors associated to severe outcomes (i.e., hospitalisation, deaths) and estimated vaccine effectiveness (VE) as well as the role of immunity conferred by prior infections against severe outcomes in adults., Methods: We linked reported SARS-CoV-2 cases among residents aged ≥ 20 years with vaccination data and SARS-CoV-2 related hospitalisations and deaths. Cases were followed-up until day 14 for COVID-19 related hospital admission and up to day 28 for mortality after a positive test. We analysed the association between the vaccination status and severe forms using proportional Cox regression, adjusting for previous infection, age, sex and nursing homes residency. VE was measured as 1-adjusted hazard ratio of vaccinated vs unvaccinated individuals. The population preventable fraction was computed using the adjusted hazard ratio and the proportion of cases within the vaccination category., Results: Between December 2021, and March 2023, we recorded 187143 SARS-CoV-2 cases, 1728 (0.93%) hospitalizations and 611 (0.33%) deaths. The risk of severe outcomes increased with age, was higher among men and nursing home residents. Compared to unvaccinated adults, VE against hospitalization was 38.8% (95%CI: 28.1%-47.8%) for a complete primary cycle of vaccination, 62.1% (95%CI: 57.0%-66.7%) for one booster, and 71.6% (95%CI: 66.7%-76.2%) for two booster doses. VE against death was respectively 49.5% (95%CI: 30.8%-63.3%), 69.0% (95%CI: 61.2%-75.3%) and 76.2% (95%CI: 68.4%-82.2%). Previous infection was not associated with lower risk of hospitalisation or mortality. The vaccination lowered mortality by 55.8 % (95%CI: 46.3%-62.8%) and reduced hospital admissions by 49.1% (95%CI: 43.4%-54.4%)., Conclusions: Complete vaccination and booster but not previous infection were protective against hospitalization and death. The vaccination program in Luxembourg led to substantial reductions in SARS-CoV-2-related mortality and hospitalizations at the population level., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Communities of color had higher rates of Coronavirus (COVID-19) infection and lower rates of COVID-19 vaccination during the pandemic. Parental concern about the safety and necessity of pediatric COVID-19 vaccines contribute to low childhood vaccination. Enlisting parents and caregivers as trusted messengers is an evidence-based approach to mitigate this challenge. VaxUpPhillyFamilies was formed to engage parents and caregivers as vaccine ambassadors to increase vaccination rates in children of color. This study aimed to understand the key benefits, challenges, and lessons learned from the VaxUpPhillyFamilies program., Methods: Three online debriefing sessions with ambassadors were conducted between September 7 and October 24, 2022, to share best practices, address challenges, receive emerging vaccine information, and provide support. Thematic analysis was utilized to develop broad themes and subthemes., Results: Four themes with corresponding subthemes were identified: 1) Motivations to Become an Ambassador: a) improving the health of the community and b) personal satisfaction; 2) Defining Success: a) community interactions and b) influencing opinions; 3) Best Approaches: a) being mentally prepared with facts, b) addressing community health needs beyond COVID-19, c) demonstrating empathy, d) "meeting them where they're at" by motivational interviewing, and e) building trust and connection; 4) Challenges: a) changes in vaccine guidelines, b) vaccine misinformation, c) varied perceptions of severity of COVID-19 illness and benefits of the vaccine, d) breakdown of communication from trusted sources, and e) structural barriers to engagement., Conclusion: Parents and caregivers were a resource for delivering evidence-based messaging about COVID-19 and other health challenges. To effectively equip parents and caregivers as public health ambassadors, it is critical to offer training in engagement strategies, to identify and combat misinformation, and to provide support in navigating challenges. VaxUpPhillyFamilies program is a model for future public health campaigns., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Multisystem inflammatory syndrome associated to Covid-19 (MIS-C) is one of the most severe outcomes of SARS-CoV-2 in children. Covid-19 vaccines were successfully implemented in Chile for the pediatric population since 2021, using both mRNA and inactivated platforms. Effectiveness against MIS-C has been reported for mRNA vaccines. The aim of this study was to describe the epidemiologic trend of MIS-C in Chile during Covid-19 pandemic, both before and after the availability of vaccination for children., Materials and Methods: Analytic study of MIS-C cases from April 2020 to December 2022. Epidemiological data, SARS-CoV-2 variants and vaccination uptake information were obtained from the Epidemiology Department-Ministry of Health, Institute of Public Health and the National Immunization Program, respectively., Results: 496 cases of MIS-C were reported, 58 % males. Median age was 5 years and most frequent age-cohorts were 6-11 and 0-2 years old with a 33 % each. After the introduction of the Covid-19 vaccine, most cases occurred in children aged 0-2 years. Incidence rates were 3.8, 5.4 and 1.7 per 100,000 inhabitants in 2020, 2021 and 2022, respectively. 97 % of cases (481) occurred in unvaccinated subjects. On those previously vaccinated (15), all but one case occurred in children receiving the inactivated vaccine. No association among circulating variants and incidence was observed. Incidence rate reduction (IRR) comparison between 2020 and 2021-2022 periods was 0.72 (CI 95 % 0.65-0.81, p < 0.05) overall; 0.86 for 0-2 years (CI 95 %:0.71-1; p = 0.12); 0.88 for 3-5 years (CI 95 %:0.69-1.11; p = 0.28); 0.61 for 6-11 years (CI 95 %: 0.50-0.75; p < 0.05); and 0.64 for 12-17 years (CI 95 %:0.47-0.89; p < 0.05), consistent with vaccination uptake during the studied period: 63 % for 3-5 years, 91 % for 6-11 years, and 99 % for 12-17 years., Conclusions: A decline of MIS-C incidence and a shift to younger, unvaccinated population overtime was observed. IRR decreased in age-cohorts which achieved high vaccination rates., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Rodolfo Villena reports a relationship with Sinovac Biotech Ltd that includes: funding grants. Rodolfo Villena reports a relationship with Pfizer that includes: speaking and lecture fees. Rodolfo Villena reports a relationship with Janssen Pharmaceuticals Inc that includes: funding grants. Giannina Izquierdo reports a relationship with Pfizer Inc that includes: speaking and lecture fees. Juan Pablo Torres reports a relationship with Pfizer that includes: speaking and lecture fees If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Face-to-face meetings on a conference table are a frequent form of communication. The short-range exposure risk of aerosol disease transmission is high in the scenario of susceptible facing the infectious person over the table. We propose a mitigation methodology using the air curtain to reduce direct exposure to virus-laden aerosols. A numerical model was validated with experimental data to simulate the dispersion of aerosols. A dynamic mesh was adopted to consider the head movement of a 3D thermal manikin model. Results show that nodding head increase the potential risk by 74 % compared to motionless. Subsequently, for a single air curtain, placing it in the middle of the table is more effective in preventing risks than on the sides. For double air curtains, increasing the distance between them has a greater risk reduction effect than a shorter distance. Increasing the air velocity or width is more effective than increasing the number of air curtains. A moderate velocity (1 m s -1 ) works well to reduce the risk of nasal breathing. A higher velocity (2 m s -1 ) is needed for the coughing scenario. For similar indoor environments, the air curtains on the table can offer active precautions without changing the current ventilation system., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

The COVID-19 pandemic was caused by the SARS-CoV-2 virus, marking one of the most catastrophic global health crises of the 21st century. Throughout this period, widespread use and improper disposal of personal protective equipment (PPE) emerged as a pressing environmental issue, significantly impacting various life forms. During the COVID-19 pandemic, there was a high rate of PEP disposal. An alarming 1.6 × 10 6 tons of plastic waste each day has been generated since the onset of the outbreak, predominantly from the inadequate disposal of PPE. The mismanagement and subsequent degradation of discarded PPE significantly contribute to increased non-biodegradable micro(nano)plastic (MNP) waste. This pollution has had profound adverse effects on terrestrial, marine, and aquatic ecosystems, which have been extensively of concern recently. Accumulated MNPs within aquatic organisms could serve as a potential route for human exposure when consuming seafood. This review presents a novel aspect concerning the pollution caused by MNPs, particularly remarking on their role during the pandemic and their detrimental effects on human health. These microplastic particles, through the process of fragmentation, transform into nanoparticles, persisting in the environment and posing potential hazards. The prevalence of MNP from PPE, notably masks, raises concerns about their plausible health risks, warranting global attention and comprehensive exploration. Conducting a comprehensive evaluation of the long-term effects of these processes and implementing effective management strategies is essential., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background and Objectives: People with multiple sclerosis (MS) have an increased risk of severe coronavirus infection due to their level of motor disability or exposure to certain immunosuppressive treatments. Thus, patients with MS have had priority access to coronavirus disease 2019 (COVID-19) vaccination. However, relapses after vaccination have been reported, leading some patients to not seek the recommended booster doses. The main objective was to estimate the risk of severe relapse after 1, 2, and 3 (booster) doses of COVID-19 vaccination in patients with MS. The secondary objectives were to assess the risk of relapse in clinically meaningful subgroups according to the type of vaccine, the characteristics of the patients, and the use of disease-modifying treatments (DMTs)., Methods: We conducted a nationwide study using data from the French National Health Data System. Patients with MS were identified according to ICD codes, specific treatments, and reimbursement data up to March 31, 2022. Relapses requiring treatment with high-dose corticosteroids were identified. A self-controlled case series method was used to evaluate the risk of relapse associated with COVID-19 vaccines in the 45 days after vaccination. The associated risk was evaluated after 1, 2, or 3 (booster) doses and is expressed as overall incidence rate ratios (IRRs) and in subgroups of interest., Results: Overall, 124,545 patients with MS were identified on January 1, 2021, and 82% received at least 1 dose of a COVID-19 vaccine (n = 102,524) until December 31, 2021, for a total of 259,880 doses. The combined IRR for MS relapse was 0.97 (0.91-1.03, p = 0.30). The same absence of risk was confirmed in various subgroups (age younger than 50 years, duration of MS < 10 years, use of DMT). A small increase in the relapse risk cannot be excluded after a booster dose (IRR 1.39 [1.08-1.80]) for patients with high MS activity, especially when not treated., Discussion: There is no increased risk of relapse requiring corticosteroid therapy after COVID-19 vaccination for almost all patients. We cannot exclude an increased risk after the booster dose for patients who have had at least 2 relapses in the previous 2 years., Classification of Evidence: This study provides Class III evidence that COVID-19 vaccination does not increase the risk of severe relapse in patients with MS.

Abstract: Children and adults with sickle cell disease (SCD) have increases in morbidity and mortality with COVID-19 infections. The American Society of Hematology Research Collaborative Sickle Cell Disease Research Network performed a prospective COVID-19 vaccine study to assess antibody responses and analyze whether messenger RNA (mRNA) vaccination precipitated any adverse effects unique to individuals with SCD. Forty-one participants received 2 doses of the Pfizer-BioNTech vaccine and provided baseline blood samples before vaccination and 2 months after the initial vaccination for analysis of immunoglobulin G (IgG) reactivity against the receptor binding domain (RBD) of the severe acute respiratory syndrome coronavirus 2 spike protein. Six-month IgG reactivity against the viral RBD was also available in 37 patients. Postvaccination reactogenicity was common and similar to the general population. There were no fevers that required inpatient admission. Vaso-occlusive pain within 2 to 3 days of first or second vaccination was reported by 5 participants (12%) including 4 (10%) who sought medical care. Twenty-seven participants (66%) were seropositive at baseline, and all 14 initially seronegative participants (34%) converted to seropositive after vaccination. Overall, mRNA vaccination had a good risk-benefit profile in individuals with SCD. This mRNA vaccine study also marks the first evaluation of vaccine safety and antibody response in very young children with SCD. This trial was registered at www.ClinicalTrials.gov as #NCT05139992., (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)

The cruise ship sector is a major part of the tourism industry, and an estimated over 30 million passengers are transformed worldwide each year. Cruise ships bring diverse populations into proximity for many days, facilitating the transmission of respiratory illnesses. The objective of this study is to develop a modeling framework to inform the development of viable disease risk management policies and measures to control disease outbreaks on cruises. Our model, parameterized and calibrated using the data of the COVID-19 outbreak on the Diamond Princess cruise ship in 2020, is used to assess the impact of the mitigation measures such as mask wearing, vaccination, on-board and pre-traveling testing measures. Our results indicate mask wearing in public places as the cheapest and most affordable measure can drop the number of cumulative confirmed cases by almost 50%. This measure along with the vaccination by declining the number of the cumulative confirmed cases by more than 94% is the most effective measure to control outbreaks on cruises. According to our findings, outbreaks are more predominant in the passenger population than the crew members, however, the protection measures are more beneficial if they are applied by both crew members and passengers. Regarding the testing measure, pre-traveling testing is more functional than the on-board testing to control outbreaks on cruises., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Monoclonal antibodies (mAbs) represent a promising modality for the prevention and treatment of viral infections. For infections that initiate from the respiratory tract, direct administration of specific neutralizing mAbs into lungs has advantages over systemic injection of the same mAbs. Herein, using AUG-3387, a human-derived mAb with high affinity to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its various variants, as a model mAb, we formulated the mAb into dry powders by thin-film freeze-drying, confirmed that the AUG-3387 mAb reconstituted from the dry powders retained their integrity, high affinity to the SARS-CoV-2 spike protein receptor binding domain (RBD), as well as ability to neutralize RBD-expressing pseudoviruses. Finally, we showed that one of the AUG-3387 mAb dry powders had desirable aerosol properties for pulmonary delivery into the lung. We concluded that thin-film freeze-drying represents a viable method to prepare inhalable powders of virus-neutralizing mAbs for pulmonary delivery into the lung., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Cui reports a relationship with TFF Pharmaceuticals, Inc. that includes: equity or stocks and funding grants. Williams reports a relationship with TFF Pharmaceuticals, Inc. that includes: consulting or advisory, equity or stocks, and funding grants. Xu and Moon report a relationship with TFF Pharmaceuticals, Inc. that includes: consulting or advisory. Cui, Williams, Christensen, Emig, Mena, Vitug and Henry are inventors on IP related to this work. Christensen was a consultant for TFF Pharmaceuticals. Emig, Mena, Vitug, Henry, and Ventura are or were employees of Augmenta Bioworks, Inc. ZC serves as the Editor of the International Journal of Pharmaceutics for North America. This paper was subject to all the Journal’s usual procedures. The peer review was handled, and the editorial decision was made independently of ZC and his research group., (Copyright © 2024 Elsevier B.V. All rights reserved.)

The surge in face mask use due to COVID-19 has raised concerns about micro(nano)plastics (MNPs) from masks. Herein, focusing on fabric structure and polymer composition, we investigated MNP generation characteristics, mechanisms, and potential risks of surgical polypropylene (PP) and fashionable polyurethane (PU) masks during their wearing and photoaging based on stereomicroscope, μ-Fourier transform infrared spectroscopy (μ-FTIR), and scanning electron microscope (SEM) techniques. Compared with new PP and PU masks (66 ± 16 MPs/PP-mask, 163 ± 83 MPs/PU-mask), single- and multiple-used masks exhibited remarkably increased MP type and abundance (600-1867 MPs/PP-mask, 607-2167 MPs/PU-mask). Disinfection exacerbated endogenous MP generation in masks, with washing (416 MPs/PP-mask, 30,708 MPs/PU-mask) being the most prominent compared to autoclaving (219 MPs/PP-mask, 553 MPs/PU-mask) and alcohol spray (162 MPs/PP-mask, 18,333 MPs/PU-mask). Photoaging led to massive generation of MPs (8.8 × 10 4 -3.7 × 10 5 MPs/PP-layer, 1.0 × 10 5 MPs/PU-layer) and NPs (5.2 × 10 9 -3.6 × 10 13 NPs/PP-layer, 3.5 × 10 12 NPs/PU-layer) from masks, presenting highly fabric structure-dependent aging modes as "fragmentation" for fine fiber-structure PP mask and "erosion" for 3D mesh-structure PU mask. The MNPs derived from PP/PU mask caused significant deformities of Zebrafish (Danio rerio) larvae. These findings underscore the potential adverse effects of masks on humans and aquatic organisms, advocating to enhance proper use and rational disposal for masks., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

In this study, a latest version of COVID-19 pandemic is hand overed. A Stochastic post COVID-19 delayed model is developed to explore the spread of COVID-19 as well as omicron variant with the correlation of heart attack. This article provides an eradication of the COVID-19 and omicron variant as well as the population who have heart attack after post COVID-19 of these epidemic diseases. Then the existence and uniqueness of global positive solution are studied. Ensuing, In this article, we classify COVID-19 virus and omicron variant which go to extinction and become persistent in mean. By using Lyapunov function, the existence of ergodic stationary distribution are established. Later from the persistent disease as well as extinction, heart disease are ready to develop in the human body. By Eventually, an optimal control strategies are introduced in the form of stochastic post COVID-19 delayed model to control two different types of virus. Finally, the numerical simulation are presented to determine the behavior of dynamical system by utilizing the real data of United Kingdom., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

We aimed to investigate the preventive effect of vitamin D2 on COVID-19 and the improvement of symptoms after COVID-19 infection. The study recruited 228 health care workers who tested negative PCR or antigen for COVID-19. Subjects were randomly allocated to vitamin D2 or non-intervention at a ratio 1:1. Subjects recorded PCR or antigen tests and the symptoms of COVID-19 twice a week during the follow-up visit. The concentration of serum 25-hydroxyvitamin D (25(OH)D), C-reaction protein (CRP), complement component C1q and inflammatory cytokines were measured. The rates of COVID-19 infection were 50.5% in the vitamin D2 group and 52.4% in the non-intervention group (P = 0.785). There was no difference in the COVID-19 symptoms between the two groups. The mean 25(OH)D level significantly increased from 14.1 to 31.1 ng/mL after administration (P < 0.001). The difference between the two groups was not significant for the concentrations of CRP, C1q and inflammatory cytokines on the thirtieth day of the trial. According to the second level of vitamin D, there was a 14.3% difference in positive infection rates between the vitamin D adequate (> 30 ng/mL) and deficient groups (< 20 ng/mL). Adequate vitamin D had a tendency to prevent COVID-19.Trial registration: ClinicalTrials.gov NCT05673980, dated: 12/2022., (© 2024. The Author(s).)

This study focused on the challenges posed by the fluctuating demand for COVID-19 vaccines, considering factors such as side effects, religious objections, and absenteeism, which result in the accumulation of excess vaccines. Recognizing the resulting social, economic, and environmental issues, this study investigated the application of a lateral transshipment policy for the management of the inventory of short-term vaccines, considering related unpredictabilities. A discrete event simulation built on foundational principles derived from a mixed-integer linear programming model was employed to explore the dynamics of mRNA-based vaccine distribution among two hospitals based on lateral transshipment and reordering policies. Through the simulation of various scenarios over periods of 1-30 days, transshipment based on the availability policy is employed to determine the quantity of vaccines to be transshipped, constrained to vial amounts, and the (s, S) inventory system for reordering. The results of this study underscore the efficacy of lateral transshipment, particularly in situations where demand discrepancies exist between hospitals, thereby revealing its superiority over non-transshipment strategies within 7 days., (© 2024. The Author(s).)

mRNA-based COVID-19 vaccines have played a critical role in reducing severe outcomes of COVID-19. Humoral immune responses against SARS-CoV-2 after vaccination have been extensively studied in blood; however, limited information is available on the presence and duration of SARS-CoV-2 specific antibodies in saliva and other mucosal fluids. Saliva offers a non-invasive sampling method that may also provide a better understanding of mucosal immunity at sites where the virus enters the body. Our objective was to evaluate the salivary immune response after vaccination with the COVID-19 Moderna mRNA-1273 vaccine. Two hundred three staff members of the U.S. Centers for Disease Control and Prevention were enrolled prior to receiving their first dose of the mRNA-1273 vaccine. Participants were asked to self-collect 6 saliva specimens at days 0 (prior to first dose), 14, 28 (prior to second dose), 42, and 56 using a SalivaBio saliva collection device. Saliva specimens were tested for anti-spike protein SARS-CoV-2 specific IgA and IgG enzyme immunoassays. Overall, SARS-CoV-2-specific salivary IgA titers peaked 2 weeks after each vaccine dose, followed by a sharp decrease during the following weeks. In contrast to IgA titers, IgG antibody titers increased substantially 2 weeks after the first vaccine dose, peaked 2 weeks after the second dose and persisted at an elevated level until at least 8 weeks after the first vaccine dose. Additionally, no significant differences in IgA/IgG titers were observed based on age, sex, or race/ethnicity. All participants mounted salivary IgA and IgG immune responses against SARS-CoV-2 after receiving the mRNA-1273 COVID-19 vaccine. Because of the limited follow-up time for this study, more data are needed to assess the antibody levels beyond 2 months after the first dose. Our results confirm the potential utility of saliva in assessing immune responses elicited by immunization and possibly by infection., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Parents were at the forefront of responding to the needs of children during the COVID-19 pandemic. This study used the RE-AIM framework to examine the Reach, Effectiveness, Adoption, Implementation, and Maintenance of a global inter-agency initiative that adapted evidence-based parenting programs to provide immediate support to parents., Methods: Data were collected via short surveys sent via email, online surveys, and analysis of social media metrics and Google Analytics. Retrospective surveys with 1,303 parents and caregivers in 11 countries examined impacts of the resources on child maltreatment, positive relationship building, parenting efficacy, and parenting stress., Results: The parenting resources were translated into over 135 languages and dialects; reached an estimated minimum 212.4 million people by June 2022; were adopted by 697 agencies, organizations, and individuals; and were included in 43 national government COVID-19 responses. Dissemination via social media had the highest reach (n = 144,202,170, 67.9%), followed by radio broadcasts (n = 32,298,525, 15.2%), text messages (n = 13,565,780, 6.4%), and caseworker phone calls or visits (n = 8,074,787, 3.8%). Retrospective surveys showed increased parental engagement and play, parenting self-efficacy, confidence in protecting children from sexual abuse, and capacity to cope with stress, as well as decreased physical and emotional abuse. Forty-four organizations who responded to follow-up surveys in April 2021 reported sustained use of the resources as part of existing services and other crisis responses., Conclusion: This study highlights the importance of a) establishing an international collaboration to rapidly adapt and disseminate evidence-based content into easily accessible resources that are relevant to the needs of parents; b) creating open-source and agile delivery models that are responsive to local contexts and receptive to further adaptation; and c) using the best methods available to evaluate a rapidly deployed global emergency response in real-time. Further research is recommended to empirically establish the evidence of effectiveness and maintenance of these parenting innovations., (© 2024. The Author(s).)

Introduction: Medical mis- and disinformation are on the rise and impact patient health outcomes. The complexity of modern medicine and health care delivery necessitates that care be delivered by an interprofessional team of providers well versed in addressing this increased prevalence of medical misinformation. Health professions educational curricula often lack opportunities for students to learn how to address medical misinformation, employ advanced communication techniques, and work collaboratively., Methods: Based on literature and our previous qualitative research, we created a module offering prework learning on COVID-19 and addressing misinformation through advanced communication techniques and interprofessional collaboration. After completing prework, students participated in a standardized patient encounter addressing COVID misinformation. Health professions student dyads completed a preencounter planning huddle and together interviewed a standardized patient. Students received global and checklist-based feedback from standardized patients and completed pre- and postsession self-assessments., Results: Twenty students participated (10 third-year medical, nine third-year pharmacy, one fourth-year pharmacy). Key findings included the following: Nine of 15 survey questions demonstrated statistically significant improvement, including all three questions assessing readiness to have difficult conversations and six of 10 questions assessing interprofessional collaboration and team function., Discussion: Students participating in this novel curriculum advanced their readiness to address medical misinformation, including COVID-19 vaccine disinformation, with patients and coworkers to improve health decision-making and patient care. These curricular methods can be customized for use with a range of health professions learners., (© 2024 Hayman et al.)

The objective of this study is to evaluate users' perceptions and preferences on the design features of the COVID-19 prevention promotion icon from the perspective of users' aesthetic and perceptual needs. In this study, 120 officially published icons from 24 countries and regions were collected from online platforms for ranking tests, and then the top-ranked icons were subjectively rated by the semantic differential method. By evaluating the quality of users' perceptions of multiple semantic dimensions of icons, we extracted the perceptual semantic words that users valued as the main icon design features. Spearmen correlations were applied to derive possible correlations between user rankings and semantic scales, and a Friedman test was also conducted to determine the true differences in user perceptions and preferences for different styles of icons. Factor analysis was conducted to extract six perceptual words that influence the design features of the COVID-19 prevention promotion icon. The methodology adopted in this study facilitated the screening of design features related to icon effectiveness, and the findings show that "Interesting," "Simple," "Familiar, "Recognizable," "Concrete," and "Close(semantic distance)" are the key features that influence users' perception and preference of COVID-19 icon design. The results of this study can be used as the basis for designing and improving publicity icons for preventive measures in COVID-19, and the methods adopted in this study can be applied to evaluate other types of icon design., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Lujie et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Following the initial acute phase of COVID-19, health care resource use has escalated among individuals with SARS-CoV-2 infection., Objective: This study aimed to compare new diagnoses of long COVID and the demand for health services in the general population after the Omicron wave with those observed during the pre-Omicron waves, using similar assessment protocols for both periods and to analyze the influence of vaccination., Methods: This matched retrospective case-control study included patients of both sexes diagnosed with acute SARS-CoV-2 infection using reverse transcription polymerase chain reaction or antigen tests in the hospital microbiology laboratory during the pandemic period regardless of whether the patients were hospitalized. We included patients of all ages from 2 health care departments that cover 604,000 subjects. The population was stratified into 2 groups, youths (<18 years) and adults (≥18 years). Patients were followed-up for 6 months after SARS-CoV-2 infection. Previous vaccination, new diagnoses, and the use of health care resources were recorded. Patients were compared with controls selected using a prospective score matched for age, sex, and the Charlson index., Results: A total of 41,577 patients with a history of prior COVID-19 infection were included, alongside an equivalent number of controls. This cohort encompassed 33,249 (80%) adults aged ≥18 years and 8328 (20%) youths aged <18 years. Our analysis identified 40 new diagnoses during the observation period. The incidence rate per 100 patients over a 6-month period was 27.2 for vaccinated and 25.1 for unvaccinated adults (P=.09), while among youths, the corresponding rates were 25.7 for vaccinated and 36.7 for unvaccinated individuals (P<.001). Overall, the incidence of new diagnoses was notably higher in patients compared to matched controls. Additionally, vaccinated patients exhibited a reduced incidence of new diagnoses, particularly among women (P<.001) and younger patients (P<.001) irrespective of the number of vaccine doses administered and the duration since the last dose. Furthermore, an increase in the use of health care resources was observed in both adult and youth groups, albeit with lower figures noted in vaccinated individuals. In the comparative analysis between the pre-Omicron and Omicron waves, the incidence of new diagnoses was higher in the former; however, distinct patterns of diagnosis were evident. Specifically, depressed mood (P=.03), anosmia (P=.003), hair loss (P<.001), dyspnea (<0.001), chest pain (P=.04), dysmenorrhea (P<.001), myalgia (P=.011), weakness (P<.001), and tachycardia (P=.015) were more common in the pre-Omicron period. Similarly, health care resource use, encompassing primary care, specialist, and emergency services, was more pronounced in the pre-Omicron wave., Conclusions: The rise in new diagnoses following SARS-CoV-2 infection warrants attention due to its potential implications for health systems, which may necessitate the allocation of supplementary resources. The absence of vaccination protection presents a challenge to the health care system., (©Bernardo Valdivieso-Martinez, Victoria Lopez-Sanchez, Inma Sauri, Javier Diaz, Jose Miguel Calderon, Maria Eugenia Gas-Lopez, Laura Lidon, Juliette Philibert, Jose Luis Lopez-Hontangas, David Navarro, Llanos Cuenca, Maria Jose Forner, Josep Redon. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 03.09.2024.)

Background: About 1.35 million deaths annually are attributed to tobacco use in India. The main challenge, given the magnitude of tobacco use and limited resources, is delivering cessation support at scale, low cost, and through a coordinated cross-system effort; one such example being brief advice interventions. However, highly credentialed staff to identify and counsel tobacco users are scarce. Task-shifting is an important opportunity for scaling these interventions., Objective: The LifeFirst SWASTH (Supporting Wellbeing among Adults by Stopping Tobacco Habit) program-adapted from the LifeFirst program (developed by the Narotam Sekhsaria Foundation, Mumbai, India)-is a tobacco cessation program focusing on lower-socioeconomic status patients in Mumbai receiving private health care. This parallel-arm, cluster randomized controlled trial investigates whether the LifeFirst SWASTH program increases tobacco cessation rates in low-resource, high-reach health care settings in Mumbai., Methods: This study will target tuberculosis-specific nongovernmental organizations (NGOs), dental clinics, and NGOs implementing general health programs serving lower-socioeconomic status patients. Intervention arm patients will receive a pamphlet explaining tobacco's harmful effects. Practitioners will be trained to deliver brief cessation advice, and interested patients will be referred to a Narotam Sekhsaria Foundation counselor for free telephone counseling for 6 months. Control arm patients will receive the same pamphlet but not brief advice or counseling. Practitioners will have a customized mobile app to facilitate intervention delivery. Practitioners will also have access to a peer network through WhatsApp. The primary outcome is a 30-day point prevalence abstinence from tobacco. Secondary outcomes for patients and practitioners relate to intervention implementation., Results: The study was funded in June 2020. Due to the COVID-19 pandemic, the study experienced some delays, and practitioner recruitment commenced in November 2023. As of July 2024, all practitioners have been recruited, and practitioner recruitment and training are complete. Furthermore, 36% (1687/4688) of patients have been recruited., Conclusions: It is hypothesized that those patients who participated in the LifeFirst SWASTH program will be more likely to have been abstinent from tobacco for 30 consecutive days by the end of 6 months or at least decreased their tobacco use. LifeFirst SWASTH, if found to be effective in terms of cessation outcomes and implementation, has the potential to be scaled to other settings in India and other low- and middle-income countries. The study will be conducted in low-resource settings and will reach many patients, which will increase the impact if scaled. It will use task-shifting and an app that can be tailored to different settings, also enabling scalability. Findings will build the literature for translating evidence-based interventions from high-income countries to low- and middle-income countries and from high- to low-resource settings., Trial Registration: ClinicalTrials.gov NCT05234983; https://clinicaltrials.gov/study/NCT05234983., International Registered Report Identifier (irrid): DERR1-10.2196/57236., (©Sitara L Mahtani, Kasisomayajula Viswanath, Himanshu A Gupte, Gauri Mandal, Dinesh Jagiasi, Ratandeep Chawla, Marina D'Costa, Ziming Xuan, Sara Minsky, Shoba Ramanadhan. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.09.2024.)

Infection control measures to prevent viral and bacterial infection spread are critical to maintaining a healthy environment. Pathogens such as viruses and pyogenic bacteria can cause infectious complications. Viruses such as SARS-CoV-2 are known to spread through the aerosol route and on fomite surfaces, lasting for a prolonged time in the environment. Developing technologies to mitigate the spread of pathogens through airborne routes and on surfaces is critical, especially for patients at high risk for infectious complications. Multifunctional coatings with a broad capacity to bind pathogens that result in inactivation can disrupt infectious spread through aerosol and inanimate surface spread. This study uses C-POLAR, a proprietary cationic, polyamine, organic polymer with a charged, dielectric property coated onto air filtration material and textiles. Using both SARS-CoV-2 live viral particles and bovine coronavirus models, C-POLAR-treated material shows a dramatic 2-log reduction in circulating viral inoculum. This reduction is consistent in a static room model, indicating simple airflow through a static C-POLAR hanging can capture significant airborne particles. Finally, Gram-positive and Gram-negative bacteria are applied to C-POLAR textiles using a viability indicator to demonstrate eradication on fomite surfaces. These data suggest that a cationic polymer surface can capture and eradicate human pathogens, potentially interrupting the infectious spread for a more resilient environment., Importance: Infection control is critical for maintaining a healthy home, work, and hospital environment. We test a cationic polymer capable of capturing and eradicating viral and bacterial pathogens by applying the polymer to the air filtration material and textiles. The data suggest that the simple addition of cationic material can result in the improvement of an infectious resilient environment against viral and bacterial pathogens., Competing Interests: The authors declare no conflict of interest.

Schools frequently adopt new interventions for each new public health issue, but this is both time- and resource-intensive. Adversity exposure is an example of a pervasive public health issue that emerged during Coronavirus Disease 2019 (COVID-19) with notable consequences, including an elevated risk of developing substance use disorders and mental illnesses. Adapting existing, universal, evidence-based interventions, such as the Michigan Model for HealthTM (MMH), by incorporating trauma-sensitive content is a promising approach to meet this need. We examined critical steps in promoting MMH adaptability as part of the Enhanced REP (Replicating Effective Programs) implementation strategy during the COVID-19 pandemic. We share usability testing from the 2020 to 2021 school year and describe how we apply the results to inform the group randomized trial pilot study. We applied key steps from implementation adaptation frameworks to integrate trauma-sensitive content as COVID-19 unfolded, documenting the process through field notes. We conducted initial usability testing with two teachers via interviews and used a rapid qualitative analysis approach. We conducted member checking by sharing the information with two health coordinators to validate results and inform additional curriculum refinement. We developed an adapted MMH curriculum to include trauma-sensitive content, with adaptations primarily centered on adding content, tailoring content, substituting content, and repeating/reinforcing elements across units. We designed adaptations to retain the core functional elements of MMH. Building foundational relationships and infrastructure supports opportunities to user-test intervention materials for Enhanced REP that enhance utility and relevance for populations that would most benefit. Enhanced REP is a promising strategy to use an existing evidence-based intervention to meet better the needs of youth exposed to adversity. Building on the foundations of existing evidence-based interventions, is vital to implementation success and achieving desired public health outcomes., (© Society of Behavioral Medicine 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: The COVID-19 pandemic has resulted in great incertitude and overwhelming changes in healthcare that have had a direct impact on antibiotic prescription. However, the influence of this pandemic on antibiotic consumption in patients undergoing surgery has not yet been analysed. The goal of this study was to analyse antimicrobial consumption and prescription in the same period of 2019 (pre-COVID-19), 2020 (beginning of the COVID-19 pandemic) and 2021 (established COVID-19) according to the DDD system in surgical patients at a tertiary-level hospital., Methods: A prospectively maintained database was analysed. All patients who underwent elective or emergency gastrointestinal surgery during the same period (2019, 2020 and 2021) were included. Those who received at least 1 of the 10 most frequently prescribed antimicrobials during those periods were analysed., Results: A total of 2975 patients were included in this study. In 2020, the number of procedures performed decreased significantly (653 versus 1154 and 1168 in 2020 versus 2019 and 2021, respectively; P = 0.005). Of all patients who underwent surgery during these periods, 45.08% received at least one of the antimicrobials studied (45.8% in 2020 versus 22.9% and 22.97% in 2019 and 2021, respectively; P = 0.005). Of these, 22.97% of the patients received a combination of these antimicrobials, with ceftriaxone/metronidazole being the most frequent. Hepato-Pancreato-Biliary and Liver Transplant, Emergency Surgery and Colorectal Surgery units had higher antibiotic consumption., Conclusions: The COVID-19 pandemic has resulted in a significant decrease in surgical activity and higher post-operative antimicrobial prescription compared with previous and subsequent years., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Although COVID-19 is no longer classified as a pandemic, variants of SARS-CoV-2 continue to arise. It is critical to understand how changes in viral characteristics, public policy, and behavior affect disease load and mortality. An analysis by Otto et al. (2024) shows that changes in transmission rate and immunological properties have differing effects on disease load, even among variants with similar selective advantages. The impact of various strategies aimed at countering disease spread is also analyzed., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Society for the Study of Evolution (SSE). All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Objective: To determine the effectiveness of nirmatrelvir/ritonavir and molnupiravir among vaccinated and unvaccinated non-hospitalized adults with COVID-19., Methods: Observational studies of nirmatrelvir/ritonavir or molnupiravir compared to no antiviral drug treatment for COVID-19 in non-hospitalized adults with data on vaccination status were included. We searched MEDLINE, EMBASE, Scopus, Web of Science, WHO COVID-19 Research Database and medRxiv for reports published between 1 January 2022 and 8 November 2023. The primary outcome was a composite of hospitalization or mortality up to 35 days after COVID-19 diagnosis. Risk of bias was assessed with ROBINS-I. Risk ratios (RR), hazard ratios (HR) and risk differences (RD) were separately estimated using random-effects models., Results: We included 30 cohort studies on adults treated with nirmatrelvir/ritonavir (n = 462 279) and molnupiravir (n = 48 008). Nirmatrelvir/ritonavir probably reduced the composite outcome (RR 0.62, 95%CI 0.55-0.70; I2 = 0%; moderate certainty) with no evidence of effect modification by vaccination status (RR Psubgroup = 0.47). In five studies, RD estimates against the composite outcome for nirmatrelvir/ritonavir were 1.21% (95%CI 0.57% to 1.84%) in vaccinated and 1.72% (95%CI 0.59% to 2.85%) in unvaccinated subgroups.Molnupiravir may slightly reduce the composite outcome (RR 0.75, 95%CI 0.67-0.85; I2 = 32%; low certainty). Evidence of effect modification by vaccination status was inconsistent among studies reporting different effect measures (RR Psubgroup = 0.78; HR Psubgroup = 0.08). In two studies, RD against the composite outcome for molnupiravir were -0.01% (95%CI -1.13% to 1.10%) in vaccinated and 1.73% (95%CI -2.08% to 5.53%) in unvaccinated subgroups., Conclusions: Among cohort studies of non-hospitalized adults with COVID-19, nirmatrelvir/ritonavir is effective against the composite outcome of severe COVID-19 independent of vaccination status. Further research and a reassessment of molnupiravir use among vaccinated adults are warranted., Registration: PROSPERO CRD42023429232., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.)

Person-generated health data (PGHD) are valuable for studying outcomes relevant to everyday living, for obtaining information not otherwise available, for long-term follow-up, and in situations where decisions cannot wait for traditional clinical research to be completed. While there is no dispute that these data are subject to bias, insights gained may be better than having an information void, provided the biases are understood and addressed. People will share information known uniquely to them about exposures that may affect drug tolerance, safety, and effectiveness (eg, nonprescription and complementary medications, alcohol, tobacco, illicit drugs, exercise, etc). Patients may be the best source of safety information when long-term follow-up is needed (eg, the 5- to 15-year follow-up required for some gene therapies). Validation studies must be performed to evaluate what people can accurately report and when supplementary confirmation information is needed. However, PGHD has already proven valuable in quantifying and contrasting COVID-19 vaccine benefits and risks and for evaluating disease transmission and the accuracy of COVID-19 testing. Going forward, PGHD will be used for patient-measured and patient-relevant outcomes, including for regulatory purposes, and will be linked to broader health data networks using tokenization, becoming a mainstay for signals about risks and benefits for diverse populations. This article is part of a Special Collection on Pharmacoepidemiology., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Coronavirus disease 2019 (COVID-19) causes more deaths in older adults than in younger adults. Older adults are a vulnerable group with a high need for coronavirus vaccines to decrease the severity of the disease. The aim of this analytical cross-sectional study was to determine the factors influencing third COVID-19 vaccine booster dose acceptance among older adults in northern Thailand., Methods: The study samples were composed of 2,155 older adults living in Kamphaeng Phet Province, northern Thailand. They were randomly selected by multistage random sampling. Data were collected in a self-administered questionnaire consisting of 7 parts: (1) personal factors, (2) knowledge about COVID-19, (3) perceived susceptibility to COVID-19 infection, (4) perceived severity of COVID-19, (5) perceived benefits of the third COVID-19 vaccine booster dose, (6) perceived barriers to the third COVID-19 vaccine booster dose vaccination, and (7) the third COVID-19 vaccine booster dose acceptance. Data were analyzed via frequency, percentage, mean, standard deviation, and binary logistic regression. All the significance levels were set to 0.05., Results: The results indicated that only 28.5% of older adults accepted the third COVID-19 vaccine booster dose. The factors influencing third COVID-19 vaccine booster dose acceptance among older adults included 5 variables. The participants aged ≥ 70 years was 1.37 times (95%CI = 1.12-1.69) greater than those aged < 70 years who accepted the vaccine. Participants who were married were more likely to accept the vaccine by 1.39 times (95%CI = 1.09-1.79) compared with single individuals. Those with underlying diseases tended to accept the vaccine by 1.56 times (95%CI = 1.26-1.92) more than those without underlying diseases. Those who had high perceived benefit from the COVID-19 vaccine possibly accepted the vaccine by 1.50 times (95%CI = 1.10-2.04) more than those with low perceived benefit, and those who had a low perceived barrier to the third COVID-19 booster dose vaccination seemed to accept the vaccine by 1.29 times (95%CI = 1.01-1.52) more than those with a high perceived benefit., Conclusion: Older adults should receive health education regarding the perceived benefit of the COVID-19 vaccine and the perceived barrier to COVID-19 vaccination, especially older adults aged < 70 years, those who are single, and those who are free of underlying diseases., (© 2024. The Author(s).)

Background: Key populations (KP), including men who have sex with men (MSM), female sex workers (FSW), and transgender women (TGW), experience a disproportionate burden of HIV, even in generalized epidemics like South Africa. Given this disproportionate burden and unique barriers to accessing health services, sustained provision of care is particularly relevant. It is unclear how the COVID-19 pandemic and its associated restrictions may have impacted this delivery. In this study, we aimed to describe patterns of engagement in HIV prevention and treatment services among KP in South Africa and assess the impact of different COVID-19 restriction levels on service delivery., Methods: We leveraged programmatic data collected by the US President's Emergency Plan for AIDS Relief (PEPFAR)-supported KP partners in South Africa. We divided data into three discrete time periods based on national COVID-19 restriction periods: (i) Pre-restriction period, (ii) High-level restriction period, and (iii) After-high level restriction period. Primary outcomes included monthly total HIV tests, new HIV cases identified, new initiations of pre-exposure prophylaxis (PrEP), and new enrollments in antiretroviral therapy (ART). We conducted interrupted time series segmented regression analyses to estimate the impact of COVID-19 restrictions on HIV prevention and treatment service utilization., Results: Between January 2018 and June 2022, there were a total of 231,086 HIV tests, 27,051 HIV positive cases, 27,656 pre-exposure prophylaxis (PrEP) initiations, and 15,949 antiretroviral therapy initiations among MSM, FSW and TGW in PEPFAR-supported KP programs in South Africa. We recorded 90,457 total HIV tests during the 'pre-restriction' period, with 13,593 confirmed new HIV diagnoses; 26,134 total HIV tests with 2,771 new diagnoses during the 'high-level restriction' period; and 114,495 HIV tests with 10,687 new diagnoses during the after high-level restriction period. Our Poisson regression model estimates indicate an immediate and significant decrease in service engagement at the onset of COVID-19 restrictions, including declines in HIV testing, treatment, and PrEP use, which persisted. As programs adjusted to the new restrictions, there was a gradual rebound in service engagement, particularly among MSM and FSW. Towards the end of the high-level restriction period, with some aspects of daily life returning to normal but others still restricted, there was more variability. Some indicators continued to improve, while others stagnated or decreased., Conclusion: Service provision rebounded from the initial shock created by pandemic-related restrictions, and HIV services were largely maintained for KP in South Africa. These results suggest that HIV service delivery among programs designed for KP was able to be flexible and resilient to the evolving restrictions. The results of this study can inform plans for future pandemics and large-scale disruptions to the delivery of HIV services., (© 2024. The Author(s).)

Background: The COVID-19 pandemic has led to the broad acceptance of distance education (DE), with university professors and students conducting the teaching-learning process remotely from their homes. The propose of this study to investigate the prevalence of musculoskeletal disorders (MSDs) before and during the COVID-19 pandemic and identify risk factors associated with DE that may contribute to an increased incidence of these disorders among university professors., Methods: This cross-sectional analytical study took a comparative approach and involved 310 university professors in Iran. Data were gathered using an online questionnaire. Initially, demographic and occupational information of the professors, hours of physical activity, and hours spent using electronic devices were recorded. Participants were then asked to report MSDs in various body areas throughout the previous year and the previous seven days. Finally, MSDs risk factors such as workstation ergonomics during computer, laptop, smartphone, and tablet use, as well as working postures during online teaching or offline content development during the COVID-19 pandemic, were examined., Results: The majority of the participants were male (66.13%), with a PhD (46.77%) and a faculty member position (74.2%). On average, the use of computers and laptops increased by 2.67 h and 2.72 h, respectively, during the pandemic compared to before the pandemic. This increase was statistically significant (P < 0.001). MSDs incidence increased significantly before and during the COVID pandemic was observed in the areas of the neck, shoulders, lower and upper back, arms, forearms, wrists and fingers (P < 0.05). The highest cumulative incidence (Cin) of MSDs was related to the neck (Cin = 24.20%), upper back (Cin = 21.29%), low back (Cin = 18.06%) and fingers (Cin = 16.13%). The prevalence of MSDs during the COVID pandemic was significantly associated with employment status (P = 0.042), work experience (P = 0.016), age (P = 0.027), increase in the use of computers/ laptops (P < 0.001), decrease of the smartphone/tablet distance from the body (P = 0.047), workstation (smartphone-tablet, computer, laptop) (P < 0.05), head position (smartphone-tablet) (P = 0.029), display height (computer/laptop) (P = 0.045) and physical activity (P = 0.006)., Conclusions: It appears that the increased duration of smartphone, computer, and laptop use, combined with decreased physical activity and detrimental changes in ergonomic conditions of workstations during the quarantine period caused by the COVID-19 pandemic, has resulted in a shift from dynamic to static tasks and an increase in the prevalence and incidence of MSDs among university professors., (© 2024. The Author(s).)

Introduction: During 2020-2021 Australia maintained comparatively low rates of COVID-19 in the community and residential aged care facilities (RAC) due to stringent public health measures such as lockdowns. However, the public health measures implemented may have had unintended impacts on critical RAC resident health outcomes, such as falls, due to routine care disruptions and aged care resident isolation. We utilised a longitudinal data to assess the association between COVID-19 lockdowns and the rate of falls in RAC settings., Methods: A longitudinal cohort study was conduct using routinely collected data from 25 RAC facilities from one non-profit aged care provider in Sydney, Australia. The study included 2,996 long term residents between March 2019 and March 2021. The outcome measures were all falls, injurious falls, and falls assessed as requiring hospitalisation. Generalised estimating equations (GEE) were applied to determine the association between COVID-19 lockdown periods and fall-related outcomes while adjusting for confounders and seasonality., Results: During the study period 11,658 falls were recorded. Residents frequently experienced at least one fall during the study period (median: 1, interquartile range: 0-4). During Lockdown 1 (March-June 2020) the rate of all falls increased 32% (IRR 1.32, 95% CI 1.19-1.46, p < 0.01) and the rate of injurious falls increased by 28% (IRR 1.28, 95% CI 1.12-1.46, p < 0.01) compared to pre-pandemic rates. The rate of falls assessed as requiring hospitalisation remained unchanged during Lockdown 1 (IRR 1.07, 95% CI 0.86-1.32, p = 0.519). During Lockdown 2 (Dec 2020-Jan 2021) the rate of all falls, injurious falls, and falls assessed as requiring hospitalisation did not change significantly compared to pre-pandemic rates., Conclusion: These findings suggest that the consequences of stringent COVID-19 restrictions, as seen in Lockdown 1, produced changes in residents' care which contributed to more falls and associated harm. The subsequent lockdown, which were less restrictive and occurred after staff had gained experience, was associated with no significant increase in falls rate. The nature and extent of lockdowns implemented for infection control in RAC need to balance multiple potential adverse effects. Factors which facilitated resilience during this period require exploration in future research., (© 2024. The Author(s).)