Public Health and Economic Impact of Periodic COVID-19 Vaccination with BNT162b2 for Old Adults and High-Risk Patients in an Illustrative Prefecture of Japan: A Budget Impact Analysis.

INTRODUCTION: Japan will be transitioning from the free-of-charge COVID-19 vaccination program to annual periodic vaccination under a national immunization program for old adults and high-risk patients from 2024 fall/winter season. The policy transition including out-of-pocket payment requirement may discourage vaccination, leading to a lower vaccination rate. This study aimed to estimate the impact of varying vaccination rates with BNT162b2 COVID-19 mRNA vaccine on economics and public health in an illustrative prefecture which administers and promotes the periodic vaccination program, using budget impact analysis. METHODS: A combined cohort Markov decision tree model estimated the public health outcomes of COVID-19-related symptomatic cases, hospitalizations and deaths; and the economic outcomes including vaccine-related cost, non-vaccine-related medical cost, and productivity loss from the societal perspective. The base case examined the impact on the outcomes when vaccination coverage changed from the reference value of 50% to upper and lower values, respectively. Scenario analyses were performed based on multiple scenarios. RESULTS: Increase in the vaccination rate demonstrated improvement in all public health outcomes. At 50% vaccination, the vaccine-related cost for 3 years in a prefecture was estimated at JPY 7.58 billion (USD 57.67 million), the non-vaccine-related medical cost at JPY 79.22 billion (USD 602.48 million), the productivity loss at JPY 253.11 billion (USD 1.92 billion), and the total cost at JPY 339.92 billion (USD 2.59 billion). When the vaccination rate increased to 90%, the total cost decreased by JPY 4.88 billion (USD 37.11 million) (1.4%). When the vaccination rate decreased to 10%, the total cost increased by JPY 5.73 billion (USD 43.58 million) (1.7%). Results were consistent across almost all scenario analyses. CONCLUSIONS: Maintaining a high vaccination rate with BNT162b2 is important from both public health and economic perspectives in Japan. The findings highlight to local governments the importance of continued effort to promote vaccination.

Policies for the immunization against serogroup B meningococcus for adolescents immunized during the first two years of life: A mini review.

Two vaccines are available to prevent serogroup B meningococcal disease, i.e. the four-component meningococcal serogroup B vaccine (4CMenB) and the bivalent-factor-H-binding-protein meningococcal serogroup B vaccine (MenB-fHbp). Currently, 4CMenB is offered as part of routine infant immunization schedules. Available immunogenicity data showed a progressive decline in protective serum bactericidal antibodies (SBA) titers, with a re-enhancement following a booster dose during infancy. Responses did not seem to be long-lasting and vaccinated individuals might be at risk of meningococcal diseases during adolescence. Only one study evaluated the possibility to administer a single booster dose to immunocompetent adolescents who received a primary series during infancy. Despite a high proportion of enrollees achieving protective SBA levels 28 days post-booster, titers tended to decrease 1 year after. Immunocompetent adolescents who received a primary series and a booster during the first two years of life might rather benefit from re-vaccination against MenB; current evidence does not support the possibility of a booster.

Immunogenicity and safety of different combinations involving a third booster dose of SARS-CoV-2 inactivated vaccine, inactivated quadrivalent influenza vaccine, and 23-valent pneumococcal polysaccharide vaccine in adults aged ≥60 years: a phase 4, randomized, open-label study.

Background: Concomitant administration of COVID-19, influenza, and pneumococcal vaccines could reduce the burden on healthcare systems. However, the immunogenicity and safety of various combinations of a third booster dose of SARS-CoV-2 inactivated vaccine (CoronaVac), inactivated quadrivalent influenza vaccine (IIV4), and 23-valent pneumococcal polysaccharide vaccine (PPV23), particularly in different age groups, is still unknown. Methods: A phase 4, randomized, open-label, controlled trial was conducted in Beijing, China. 636 healthy adults were divided into two age groups (18-59 and ≥60 years) and randomized equally into three groups: CoronaVac and IIV4 followed by PPV23; CoronaVac and PPV23 followed by IIV4; or CoronaVac followed by IIV4 and PPV23, with a 28-day interval between vaccinations. Immunogenicity was evaluated by measuring antibody titers, and safety was monitored. ClinicalTrials.gov Identifier: NCT05298800. Results: Co-administration of a third dose of CoronaVac, IIV4, and PPV23 in any combination was safe. Among adults aged 18-59, co-administration with PPV23 maintained non-inferiority of antibody levels for CoronaVac and IIV4, despite a slight reduction in antibody responses. This reduction was not observed in participants ≥60 years. Furthermore, co-administration of IIV4 and PPV23 affected seroconversion rates for both vaccines. Conclusions: Co-administration of the third dose of SARS-CoV-2 inactivated vaccine with the influenza vaccine, followed by PPV23, may be optimal for adults aged 18-59. In adults ≥60, all vaccine combinations were immunogenic, suggesting a flexible vaccination approach. Since antibody measurements were taken 28 days post-vaccination, ongoing surveillance is essential to assess the longevity of the immune responses.

Vaccine-induced humoral response of BNT162b2 and mRNA-1273 against BA.1, BA.5, and XBB.1.5. (sub)variants 6 months after a homologous booster: is immunogenicity equivalent?

Introduction: Some studies suggest that the monovalent mRNA-1273 vaccine is more effective than BNT162b2 in producing higher levels of antibodies. However, limited data are available, and the methods used are not directly comparable. Material and methods: Blood samples were obtained before the booster (third dose) and after 14, 90, and 180 days in two similar cohorts who received the original BNT162b2 or mRNA-1273 vaccine designed to target wild type SARS-CoV-2. The aim of our study is to compare their effectiveness by assessing the levels of binding and neutralizing antibodies specifically against each of the BA.1 variant, BA.5 variant, and the XBB.1.5 subvariant. Results: Once the peak was reached after two weeks, a drastic decline in binding and neutralizing antibodies was observed up to 6 months after the homologous booster administration. The humoral response was however more sustained with the mRNA-1273 booster, with half-lives of 167, 55, and 48 days for binding, BA.1, and BA.5 neutralizing antibodies compared to 144, 30, and 29 days for the BNT162b2 booster, respectively. Compared to the BA.1 variant, the neutralizing capacity was significantly decreased at 6 months with the BA.5 variant (fold-decrease: 1.67 to 3.20) and the XBB.1.5. subvariant (fold-decrease: 2.86 to 5.48). Conclusion: Although the decrease in the humoral response was observed with both mRNA vaccines over time, a more sustained response was observed with the mRNA-1273 vaccine. Moreover, the emergence of Omicron-based variants causes a reduced neutralizing capacity, notably with the XBB.1.5. subvariant. The administration of subsequent boosters would therefore be needed to restore a sufficiently high neutralizing response.

SARS-CoV-2 booster vaccination does not worsen glycemia in people with type 1 diabetes using insulin pumps: an observational study.

BACKGROUND: Despite an increased risk for adverse outcomes from SARS-CoV-2 infection among individuals with type 1 diabetes (T1D), vaccine hesitancy persists due to safety concerns including dysglycemia. The impact of booster vaccination on individuals using automated insulin delivery (AID) systems remains unclear. METHODS: We used continuous glucose monitoring (CGM) data from 53 individuals with T1D using insulin pump therapy who received their third and/or fourth COVID-19 vaccination. CGM data from the 14 days before and 3 and 7 days after each vaccination were compared. The primary outcome was glucose time in range (TIR) (70-180 mg/dL) 3 and 7 days post-vaccination compared with the 14 days prior. Secondary outcomes included other CGM metrics such as time below range (< 70 mg/dL), time above range (> 180 mg/dL), mean glucose, co-efficient of variation and average total daily insulin. RESULTS: The cohort comprised 53 adults (64% women, 64% AID), totaling 74 vaccination periods (84% Pfizer-BioNTech boosters), mean ± SD age 40.0 ± 15.9 years, duration of diabetes 26.0 ± 15.4 years. There was no significant difference between pre-vaccination TIR (61.0%±18.5) versus 3 (60.5%±22.8) and 7 days post-vaccination (60.2%±21.8; p = 0.79). Level 1 hypoglycemia, time in range 54-69 mg/dL, was lower 3 (1.1%±1.7) and 7 days post-vaccination (1.1%±1.6), compared with 14 days pre-vaccination (1.4%±1.4; p = 0.021). CONCLUSION: The study provides evidence that SARS-CoV-2 booster vaccination does not acutely worsen glycemia in people with T1D receiving insulin pump therapy.

Immunogenicity of mRNA vs. BBV152 vaccine boosters against Omicron subvariants: Final results from Phase B of the PRIBIVAC study, a randomized clinical trial.

BACKGROUND: BBV152 (Covaxin™) is a whole-virion inactivated SARS-CoV-2 vaccine mixed with an immune adjuvant. We aimed to compare immune responses after booster vaccination with heterologous BBV152 versus homologous mRNA vaccine. METHODS: We conducted a randomized, participant-blinded, controlled trial. Fifty mRNA-vaccinated participants were enrolled and randomized to receive an mRNA booster (n = 26) or BBV152 (n = 24). Blood samples were collected pre-vaccination, and at Day 7, 28, 180 and 360 post-booster for analysis of humoral and cellular immune responses. Primary end point was the SARS-CoV-2 anti-spike antibody titer at day 28. RESULTS: Recruitment began in January 2022 and was terminated early due to the BBV152 group meeting pre-specified criteria for futility. At Day 28 post-boost, mean SARS-CoV-2 spike antibody titers were lower with BBV152 (2004 IU/mL; 95 % confidence interval [CI], 1132-3548) vs mRNA (26,669 IU/mL; 95 % CI, 21,330-33,266; p < 0.0001), but comparable levels of spike-specific CD4 and cytotoxic T-cells were observed. Anti-spike antibody titers remained significantly different at Day 180: BBV152 4467 IU/mL (95 % CI, 1959-10,186) vs mRNA 20,749 IU/mL (95 % CI, 12,303-35,075; p = 0.0017). Levels of surrogate virus neutralizing antibodies against ancestral and Omicron subvariants BA.1 and BA.2 were significantly higher among mRNA recipients at Day 180, including after adjusting for intercurrent infection. By Day 360, anti-spike antibody titers and neutralizing antibody levels against Omicron subvariants became similar between vaccine groups. By the end of the study, 16 in each arm (mRNA 64 % and BBV152 69.6 %) had breakthrough infections and time to COVID-19 infection between vaccine groups were similar (p = 0.63). CONCLUSIONS: Wild-type SARS-CoV-2 anti-spike antibody titer and surrogate virus neutralizing test levels against wild-type SARS-CoV-2 and Omicron subvariants BA.1/BA.2/BA.5 were significantly higher at Day 28 and 180 in individuals who received booster vaccination with an mRNA vaccine compared with BBV152. CLINICAL TRIAL REGISTRATION NUMBER: NCT05142319.

A review of the immunogenicity and safety of booster doses of omicron variant-containing mRNA-1273 COVID-19 vaccines in adults and children.

INTRODUCTION: Vaccination against SARS-CoV-2 is an integral pillar of the public health approach to COVID-19. With the emergence of variants of concern that increase transmissibility and escape from vaccine- or infection-induced protection, vaccines have been developed to more closely match the newly circulating SARS-CoV-2 strains to improve protection. The safety and immunogenicity of multiple authorized messenger RNA (mRNA)-based COVID-19 vaccines targeting the omicron sublineage (BA.1, BA.4/BA.5, and XBB.1.5) have been demonstrated in several clinical trials among adults and children. AREAS COVERED: This review will comprehensively detail the available evidence (published through July 2024) from ongoing clinical trials on omicron variant-containing mRNA-1273 vaccines administered as additional doses in previously vaccinated target demographics. EXPERT OPINION: Across three clinical trials, omicron variant-containing mRNA-1273 vaccines induced immune responses to vaccine-matched omicron strains as well as ancestral SARS-CoV-2, with a safety and reactogenicity profile comparable to the original mRNA-1273 vaccine. Combined with pivotal data demonstrating the safety, efficacy, and effectiveness of the original mRNA-1273 vaccine, these findings support the use of variant-containing mRNA-1273 vaccines and provide confidence that expeditious development of updated vaccines using this established mRNA platform can maintain protection against COVID-19.

"Life as We Knew It": Continued Challenges in Getting Up-to-Date COVID-19 Vaccinations Amongst Black and Latinx Michigan Residents.

BACKGROUND: Minority communities are disproportionately impacted by COVID-19. In Michigan in 2024, 59% of Latinx residents, 46% of Black residents, and 57% of White residents have received at least one dose of the vaccine. However, just 7% of Black residents and 6% of Latinx residents report being up-to-date per CDC definition, versus 13% of White residents. Drawing from protection motivation theory, we aimed to identify barriers to COVID-19 vaccination. METHODS: Interviews with 24 Black and 10 Latinx Michigan residents self-reported as not up-to-date (n = 15) or up-to-date (n = 19) on COVID-19 vaccines were conducted in 2022-2023. We used a community-based participatory approach in collaboration with 16 leaders from 15 organizations to develop research questions, interview protocols, and methods for data collection and analysis. Thematic coding of interviews was conducted. RESULTS: Findings indicate participants' lack of confidence in the COVID-19 vaccine's efficacy, with those not up-to-date expressing greater doubt. Participants were also concerned about vaccine benefits versus risks, safety, and side effects. Distrust in medicine, confusion about public health guidelines, and conspiracy theories were often reported. Younger unvaccinated individuals cited low health risk as reason to remain unvaccinated. Many participants felt that health education, especially through medical professionals, was beneficial. CONCLUSION: There is great need for more data to make informed decisions given ongoing lack of understanding of the public health benefits of COVID-19 vaccination. Identifying drivers of vaccine uptake, particularly boosters, in communities of color and developing age-appropriate and culturally responsive interventions to increase vaccination rates are of utmost importance.

Factors influencing the third COVID-19 vaccine booster dose acceptance among older adults in northern Thailand.

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.

Using cluster analysis to explore COVID-19 vaccine booster hesitancy by levels of medical mistrust in fully vaccinated US adults.

BACKGROUND: Underlying causes of vaccine hesitancy could significantly affect successful uptake of the SARS-CoV2 vaccine booster doses during new waves of COVID-19. Booster rates among US adults are far below what is needed for immunity, but little is known about booster hesitancy among fully vaccinated adults and whether medical mistrust exacerbates barriers to uptake. METHODS: A cross-sectional survey was completed among 119 adults in Philadelphia, PA who reported having received the primary SARS-CoV2 vaccine series but not a booster dose. Using the LaVeist Medical Mistrust (MM) Index, a k-means cluster analysis showed two clusters (Low MM, High MM) and differences in attitudes and perceptions about COVID-19 booster vaccines were assessed using F-tests. RESULTS: Respondents were 62% Black and female; mean age was 41; 46% reported earning less than $25,000 and 53% had a high school education or less. Overall intention to get boosted was low (mean 3.3 on 0-10 scale). Differences in COVID-19 booster perceptions between those with High (n = 56) vs. Low (n = 59) MM were found, independent of any demographic differences. Most statements (7/10) related to reasons to not be boosted were significant, with those with High MM indicating more concern about feeling sick from the vaccine (F=-3.91, p≤ .001), beliefs that boosters are ineffective for vaccinated people (F= -3.46, p≤ .001), and long-term side effect worries (F=-4.34, p≤ .001). Those with High MM were also more concerned about the adverse effects of the vaccine (F=-2.48, p=.02), but were more likely to trust getting information from doctors or healthcare providers (F= -2.25, p=.03). CONCLUSIONS: Results indicate that medical mistrust is an important independent construct when understanding current COVID-19 booster hesitancy. While much work has looked at demographic differences to explain vaccine hesitancy, these results suggest that further research into understanding and addressing medical mistrust could be important for implementing interventions to increase booster rates.

Modelling on COVID-19 control with double and booster-dose vaccination.

COVID-19 vaccines have been illustrated to lessen the growth of sickness caused by the virus effectively. In any case, inoculation has consistently been controversial, with differing opinions and viewpoints. This has compelled some individuals to decide against receiving the vaccine. These divergent viewpoints have had a trivial impact on the epidemic's dynamics and the disease's development. In response to vaccinated individuals still falling ill, many countries have implemented booster vaccines to protect further. In this specific investigation, a mathematical model composed of seven compartments is employed to examine the effectiveness of a booster dose in preventing and treating the transmission of COVID-19. The principles of mathematics are employed to analyse and investigate the dynamics of the disease. Using a qualitative prototype analysis, we acquired valuable insights into its effectiveness. One essential aspect is the basic reproduction number, a critical determinant of the disease's spread. This calculation is determined by studying the system's equilibrium and evaluating its stability. Furthermore, we examined the balance from a local and global viewpoint, considering the possibility of bifurcation and the model's reproductive number sensitivity index. Through numerical simulations, we have visually illustrated the analytical findings outlined in this research paper and presented a thorough examination of the efficacy of booster shots as a preventive and therapeutic measure in the spread dynamics of COVID-19.

Comparison of adverse events following the second/third dose of BNT162b2 in a medical institute in Japan.

Background: Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are crucial for ending the pandemic of coronavirus disease 2019 (COVID-19). Currently, the cumulative effect of booster shots of mRNA vaccines on adverse events is not sufficiently characterized. Methods: A survey-based study on vaccine adverse events was conducted in a Japanese medical institute after the third dose of Pfizer BNT162b2. Adverse events were grouped using network analysis, and a heteroscedastic probit model was built to analyse adverse events. Results: There were two main clusters of adverse events, systemic and local injection site-associated events. Subject background and the experience of previous vaccine-related adverse events were variably associated with the occurrence and intensity of adverse events following the third dose. Among adverse events, only lymphadenopathy increased prominently following the third dose, while the largest increase in other systemic adverse events occurred generally following the second dose. Conclusions: The effect of repeated booster vaccines on the frequency and intensity of adverse events differs depending on the kind of adverse event.

Effect of Wei Qi Booster on immune and anti-oxidative function in aged mice.

This research was conducted to examine the impact of Wei Qi Booster (WQB) on immune parameters and anti-oxidative function in aged mice. Fifty aged mice were randomly assigned to five different groups. Group A was designated as the control group. Mice in Group B were receiving Levamisole at 10 mg/kg body weight. Each mouse in groups C, D and E received 0.1, 1, and 2% WQB, respectively. Another ten young mice, designated as group F, were fed regularly. The mice were fed according to the above methods for 28 days. Results showed that relative to the control group, the body weight and immune organs indexes experienced a substantial rise in the group with 1% WQB. In addition, 1% WQB could improve the activity of SOD and reduce the MDA levels. Expressions of CD4 and sIgA increased while CD8 decreased in the jejunum of aged mice treated with WQB. IL2 and IFN-γ levels increased in the 1% WQB group, showing no notable difference compared to the young mice group. The results demonstrated that WQB can elevate immune levels and enhance anti-oxidative functions in aged mice.

How Healthy Lifestyle Habits Have Interacted with SARS-CoV-2 Infection and the Effectiveness of COVID-19 Vaccinations: Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study.

Introduction: To examine the interaction between lifestyle habits and the COVID-19 vaccinations for preventing SARS-CoV-2 infection, we analyzed 11,016 adult participants registered in the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study. Methods: Lifestyle variables, including regular exercise, smoking and drinking habits, sleep status, body mass index, and daily breakfast consumption, were assessed from 2014 to 2019 using baseline questionnaires. Information on SARS-CoV-2 infection and the COVID-19 vaccination were also collected from March 2020 to May 2023. The study period was divided into two in the postvaccination phase: the first period (the beginning of the vaccination program) and the second period (the fourth shot onward). Results: In the Cox proportional-hazards model analysis, the five-time vaccinations group showed a significantly lower risk of SARS-CoV-2 infection adjusted age, sex, underlying health condition, and lifestyle variables (hazard ratio [HR] 0.81, 95% confidence interval [CI] 0.76-0.86). Logistic regression analysis revealed that a higher number of vaccinations was significantly associated with a low risk of SARS-CoV-2 infection regardless of lifestyle habits (three times in the first period: odds ratio [OR] 0.19, 95% CI 0.15-0.24; five times in the second period: OR 0.07, 95% CI 0.05-0.11 vs. none). Regarding lifestyle habits, the risk reduction in those who had sleep satisfaction (OR 0.12, 95% CI 0.08-0.18) was slightly larger than in those who had sleep dissatisfaction (OR 0.23, 95% CI 0.17-0.32) in the group with the highest number of vaccinations in the first period; however, this interaction was hardly confirmed in the second period when the number of infected cases significantly increased. Conclusions: Our findings indicated that a higher number of COVID-19 vaccinations was associated with reduced risk of SARS-CoV-2 infection; otherwise, we may need to understand the advantages and limitations of a healthy lifestyle for preventing infection depending on the situation with vaccinations and infection spreading.

Australian parental decisions about transitioning children from booster seats in a randomised trial: greater support may be needed.

BACKGROUND: Premature graduation to an adult seatbelt is common and detrimental to optimal crash protection. While there is an existing tool (the 5-step test) to support a parent's decision to graduate their child, its effectiveness is unknown. The aim of this study was to evaluate the 5-step test. METHOD: A randomised controlled design was used. Participants were parents of children aged 7-12 years. After exposure to information about the 5-step test or control material, participants assessed belt fit in three seating conditions and 'thought aloud' while making their assessment. Seating conditions provided a good, poor and partially good seatbelt fit based on the child's anthropometry. Participants were also assessed on their knowledge of good seatbelt fit criteria. RESULTS: Participants exposed to the 5-step test (n=18) had significantly improved their knowledge of the criteria required to achieve good seatbelt with, on average, 1.0 higher score in the 6-point assessment (95% CI 0.23 to 1.7, p=0.012) than those in the control group. There was also a greater percentage of participants in this group (44.4% intervention vs 27.8% control) who made accurate decisions about seatbelt fit, but this difference did not reach significance (OR 2.08, 95% CI 0.52 to 8.34). CONCLUSION: The results demonstrate that the 5-step test is effective in improving knowledge but are inconclusive about its effectiveness in promoting accurate decision-making. However, the proportion of participants making accurate decisions in the intervention group remained low. This suggests that parents may require greater assistance than what is currently provided.

A Prospective Study of the Relationship of COVID-19 Vaccination to Menstrual Cycle Characteristics in Adolescent Girls.

PURPOSE: The current study aimed to evaluate the impact of the COVID-19 booster vaccine on menstrual cycle characteristics in adolescent girls (aged 13-20) compared to those who did not receive a booster vaccine. METHODS: This prospective study measured menstrual cycle length for three cycles prior to and four cycles after vaccination (booster group), seven cycles without vaccination (control group). Menstrual flow, menstrual pain, and menstrual symptoms were assessed at baseline and monthly for 3 months. Stress was assessed at baseline using the PROMIS Pediatric Psychological Stress Experiences scale. Generalized linear mixed effects models were used to examine the changes in menstrual characteristics. RESULTS: 65 adolescent girls (47 booster; 18 control) were recruited via social media and from ongoing studies in the United States. Girls in the booster group experienced shorter postbooster cycles by an average 5.35 days (p = .03) compared to prebooster cycle lengths, specifically in the second postbooster cycle, while the control group did not show any changes in cycle length pre-to postbooster. Participants who received the booster in the follicular phase had shorter mean postbooster cycle length (p = .0157) compared to their prebooster cycle length. Higher stress was associated with shorter cycles (p = .03) and increased menstrual symptoms (p = <.001), regardless of group. There were no differences in menstrual flow, menstrual pain, or menstrual symptoms in either group. DISCUSSION: The COVID-19 booster vaccine was associated with shorter cycles in adolescent girls. These data demonstrate the need for further investigation regarding potential mechanisms of these observed changes.

Knowledge, attitude, and practice of Egyptian medical students towards healthcare workers' recommended vaccines: a nationwide cross-sectional survey.

BACKGROUND: Vaccination of healthcare workers (HCWs) is pivotal in decreasing the incidence of contagious infections in hospital settings. In this study, we assessed the knowledge, attitude, and practice regarding HCWs' recommended vaccines among medical students and interns in Egypt. METHODS: A multicenter, cross-sectional study was conducted using a structured, pilot-tested, and self-administered questionnaire among Egyptian medical students and interns. We invited 1332 participants to our survey using a systematic random sampling that included participants across nine medical schools in Egypt during the 2021-2022 academic year. RESULTS: Out of 1332 participants, 1141 completed our questionnaire with a response rate of 85.7%. Overall, 43% of the participants had intermediate knowledge (knew 2-3 HCWs' recommended vaccines). Furthermore, 36.7% had received a booster dose of at least one of the HCWs' recommended vaccines over the last 10 years, with only 6.1% having received all recommended vaccines. Hepatitis B vaccine was the most widely known (71%) and received (66.7%). Interns were more likely to know, receive, and recommend HCWs' recommended vaccines. The majority (> 90%) agreed that vaccination is beneficial and safe, with a median score of eight (interquartile range [IQR: Q25-Q75]: 7-9) out of ten for vaccine efficacy and eight (IQR: 7-8) for safety. However, the median score for hesitancy was five (IQR: 2-7). The most common influential and limiting factors for vaccination were scientific facts (60.1%) and fear of vaccine side effects (44.9%). CONCLUSION: Although medical students in Egypt have good knowledge of and attitudes towards vaccination, there is a gap in their practices. Interventions are needed to improve vaccination uptake among medical students in Egypt.

Safety and 6-month immune persistence of inactivated poliovirus vaccine (Sabin strains) simultaneously administrated with other vaccines for primary and booster immunization in Jiangxi Province, China.

OBJECTIVES: This study aims to evaluate the safety of a new inactivated poliomyelitis vaccine (Sabin strains) (sIPV) for large-scale use in primary and booster immunizations, whether simultaneously administered with other vaccines or not and to explore the persistence of all vaccines at approximately six months after vaccination. METHOD: A total of 3200 infants were recruited into this study, including 2000 infants aged 2-3 months randomly assigned (1:1) into the "sIPV basic" or the "sIPV+DTaP" group for primary immunization of sIPV. Another 1200 children aged 18 months old and above were randomly assigned (2:2:1:1) into the "sIPV booster," "sIPV+HepA-I," "sIPV+MMR", or "sIPV+HepA-L" group for booster immunization of sIPV. Adverse events within 30 days of each vaccination dose in all participants were self-reported by guardians using a WeChat mini-program. Approximately 200 blood samples were collected at 5-7 months after the final vaccination to test for antibodies against poliovirus and other viruses. RESULTS: 3198 participants in total were included in the safety study, including 1999 infants aged 2-3 months old and 1199 children aged 18-26 months old. For primary immunization, the incidence of adverse reactions in the "sIPV basic" and the "sIPV+DTaP" group were 3.19 and 6.21% (P = 0.001), respectively. For booster immunization, the incidences of adverse reaction for the "sIPV booster" group were 2.25%, while the incidence for the "sIPV +others" group in total was 2.50% (P = 0.788). Most adverse reactions were mild. Fever was the most common symptom in all groups. No vaccine-related serious adverse events (SAEs) were observed in this study. The seropositivity rates of antibodies in the "sIPV basic" and the "sIPV+DTaP" group were 92.31 and 100% against type 1 poliovirus (P = 0.031); 96.15% and 98.57% against type 2 poliovirus (P = 0.575); 98.08% and 91.43% against type 3 poliovirus (P = 0.237), respectively. Regarding booster vaccination with sIPV, whether co-administered with other vaccines or not, the seropositivity rates of antibodies against the three types of polioviruses were all 100%. Seropositivity rates of antibodies against hepatitis A, measles, mumps, and rubella were all no <77%, except for pertussis, which was <30%. CONCLUSION: sIPV demonstrated good safety and immune persistence for primary and booster vaccinations, whether administered singly or simultaneously. Antibodies against hepatitis A, measles, mumps and rubella were not disrupted by the co-vaccination. However, the seropositivity rates and geometric mean concentrations (GMCs) of antibodies against pertussis indicate the necessity for a booster dose.

Left atrial strain by cardiac MRI feature tracking in mitral stenosis before and after balloon valvuloplasty.

The aim was to investigate LA strain by feature tracking cardiac MRI in mitral stenosis (MS) patients before and after percutaneous balloon mitral valvuloplasty (PBMV). Patients underwent cardiac MRI before and after successful PBMV (n = 18). Mitral valve area, transmitral velocity and gradients, LA volumes and ejection fraction (LAEF) were measured. LA strain feature tracking analysis was used to calculate LA reservoir, conduit, and booster strain. LA strain, LA volumes, LAEF and mitral valve severity indices were compared before and after PBMV. Correlations between LA strain and other cardiac MRI parameters were assessed. After PBMV, mitral valve area increased from 1.18 ± 0.25 cm2 to 2.26 ± 0.27 cm2, p < 0.001. Transmitral peak velocity decreased from 1.7 ± 0.37 m/s to 1.3 ± 0.27 m/s, p < 0.001. Transmitral peak gradient decreased from 12.4 ± 4.8 mmHg to 6.8 ± 2.9 mmHg, p < 0.001, and mean gradient decreased from 6.9 ± 3.8 mmHg to 2.9 ± 1.4 mmHg, p < 0.001. Maximal LA volume decreased from 73.1 ± 14.2 ml/m2 to 62.7 ± 16.3 ml/m2, p = 0.018; corrected p value = 0.054. LAEF increased from 36.3 ± 8.7% to 44.4 ± 9.5%, p = 0.010. Reservoir strain increased from 11.7 ± 3.1% to 14.9 ± 3.6% after PBMV, p = 0.009, and conduit strain from 3.8 ± 2% to 6 ± 2.3%, p = 0.005. Booster strain insignificantly increased after PBMV. Cardiac MRI feature tracking provides information on the 3 LA functional phases. Significant improvement was observed in reservoir and conduit functions after successful PBMV.

XBB.1.16-RBD-based trimeric protein vaccine can effectively inhibit XBB.1.16-included XBB subvariant infection.

The newly identified XBB.1.16-containing sublineages, including XBB.1.5, have become the prevailing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant in circulation. Unlike previous Omicron XBB variants (e.g., XBB.1.5 and XBB.1.9) harboring the F486P substitution, XBB.1.16 also carries a T478R substitution in the receptor-binding domain (RBD). Numerous researchers have delved into the high transmissibility and immune evasion of XBB.1.16 subvariant. Therefore, developing a new vaccine targeting XBB.1.16, including variants of concern (VOCs), is paramount. In our study, we engineered a recombinant protein by directly linking the S-RBD sequence of the XBB.1.16 strain of SARS-CoV-2 to the sequences of two heptad repeat sequences (HR1 and HR2) from the SARS-CoV-2 S2 subunit. Named the recombinant RBDXBB.1.16-HR/trimeric protein, this fusion protein autonomously assembles into a trimer. Combined with an MF59-like adjuvant, the RBDXBB.1.16-HR vaccine induces a robust humoral immune response characterized by high titers of neutralizing antibodies against variant pseudovirus and authentic VOCs and cellular immune responses. Additionally, a fourth heterologous RBDXBB.1.16-HR vaccine enhances both humoral and cellular immune response elicited by three-dose mRNA vaccines. These findings demonstrate that the recombinant RBDXBB.1.16-HR protein, featuring the new T478R mutation, effectively induces solid neutralizing antibodies to combat newly emerged XBB variants.