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).
CONCLUSIONS: The study provides evidence that SARS-CoV-2 booster vaccination does not acutely worsen glycemia in people with T1D receiving insulin pump therapy.

BACKGROUND: The COVID-19 pandemic adversely affected the severity and prognosis of patients with acute myocardial infarction (MI) caused by atherothrombosis (type 1 MI). The effect, if any, of COVID-19 vaccination and natural SARS-CoV2 serologic immunity in these patients is unclear. Our aim was to analyze the association between the severity and outcome of patients with type 1 MI and their previous SARS-CoV2 vaccination and serostatus.
METHODS: A single-center retrospective cohort study conducted between March 1, 2020 and March 1, 2023. Clinical and follow-up information was collected from medical records and patients. Total antibodies (IgM, IgA, IgG) to nucleocapsid (N) antigens were measured by ECLIA (electrochemiluminescence-based immunoassay) to test the immune response to natural infection. If positive, IgM and IgG antibodies to spike (S) surface antigens were measured by CLIA to test the immune response to vaccine or natural infection. Multivariable logistic regression analysis was performed, adjusting for age, sex, hypertension, diabetes, and dyslipidemia.
RESULTS: Total sample of 949 patients, 656 with ST-segment elevation MI (STEMI) and 293 with non-ST-segment elevation MI (NSTEMI). Mean age was 64 (SD 13) years, 80 % men. Pre-admission vaccination status was: ≥ 1 dose, 53 % of patients; complete vaccination, 49 %; first booster dose, 25 %. The majority (84 %) of vaccines administered were mRNA-based. Six months after MI, 92 (9.7 %) patients had a major adverse cardiac event (MACE) and 50 died; 11 % of patients had severe heart failure or cardiogenic shock (Killip III-IV) after STEMI. Vaccinated patients with STEMI and positive serology (Pos/Vax group) had a higher risk of Killip III-IV on admission: OR 2.63 (1.27-5.44), p = 0.010. SARS-CoV-2 S-specific IgG titers were highest in this group (median > 2080 AU/mL, [IQR 1560- >2080] vs 91 [32-198] in the unvaccinated group). In the overall sample, a higher incidence of 6-month MACE was not demonstrated (OR 1.89 [0.98-3.61], p = 0.055).
CONCLUSIONS: The combination of vaccination and natural SARS-CoV2 infection was associated with the development of severe heart failure and cardiogenic shock in patients with STEMI, possibly related to an increased serological response.

The continued emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants necessitates updating coronavirus disease 2019 (COVID-19) vaccines to match circulating strains. The immunogenicity and efficacy of these vaccines must be tested in pre-clinical animal models. In Syrian hamsters, we measured the humoral and cellular immune response after immunization with the nanoparticle recombinant Spike (S) protein-based COVID-19 vaccine (Novavax, Inc.). We also compared the efficacy of the updated monovalent XBB.1.5 variant vaccine with previous COVID-19 vaccines for the induction of XBB.1.5 and EG.5.1 neutralizing antibodies and protection against a challenge with the EG.5.1 variant of SARS-CoV-2. Immunization induced high levels of S-specific IgG and IgA antibody-secreting cells and antigen-specific CD4+ T cells. The XBB.1.5 and XBB.1.16 vaccines, but not the Prototype vaccine, induced high levels of neutralizing antibodies against the XBB.1.5, EG.5.1, and JN.1 variants of SARS-CoV-2. Upon challenge with the Omicron EG.5.1 variant, the XBB.1.5 and XBB.1.16 vaccines reduced the virus load in the lungs, nasal turbinates, trachea, and nasal washes. The bivalent vaccine (Prototype rS + BA.5 rS) continued to offer protection in the trachea and lungs, but protection was reduced in the upper airways. By contrast, the monovalent Prototype vaccine no longer offered good protection, and breakthrough infections were observed in all animals and tissues. Thus, based on these study results, the protein-based XBB.1.5 vaccine is immunogenic and increased the breadth of protection against the Omicron EG.5.1 variant in the Syrian hamster model.
OBJECTIVE: As SARS-CoV-2 continues to evolve, there is a need to assess the immunogenicity and efficacy of updated vaccines against newly emerging variants in pre-clinical models such as mice and hamsters. Here, we compared the immunogenicity and efficacy between the updated XBB.1.5, the original Prototype Wuhan-1, and the bivalent Prototype + BA.5 vaccine against a challenge with the EG.5.1 Omicron variant of SARS-CoV-2 in hamsters. The XBB.1.5 and bivalent vaccine, but not the Prototype, induced serum-neutralizing antibodies against EG.5.1, albeit the titers were higher in the XBB.1.5 immunized hamsters. The presence of neutralizing antibodies was associated with complete protection against EG.5.1 infection in the lower airways and reduced virus titers in the upper airways. Compared with the bivalent vaccine, immunization with XBB.1.5 improved viral control in the nasal turbinates. Together, our data show that the updated vaccine is immunogenic and that it offers better protection against recent variants of SARS-CoV-2.

BACKGROUND: An association has been reported between political affiliations and vaccination worldwide. In Japan, a significant proportion of the population are non-partisans, and major political parties advocate COVID-19 vaccination. The association between supporting political parties and COVID-19 vaccination coverage in Japan remains unclear. This study aims to investigate the relationship between political party affiliation and COVID-19 vaccination status in Japan.  Methods: This study utilized data from large-scale nationwide internet surveys conducted in Japan in 2022, with a sample size of 21,162 participants. The surveys collected information on participants\' COVID-19 vaccination status and political party affiliation. The political parties included in the analysis were the Liberal Democratic Party, the Constitutional Democratic Party, the Komeito, the Japanese Communist Party, the Japan Innovation Party (Nippon Ishin no Kai), and the Reiwa Shinsengumi, as well as non-partisans. Logistic regression analysis was performed to examine the relationship between political partisanship and COVID-19 vaccine status. The analysis controlled for potential confounding variables such as age, gender, socioeconomic status, and geographic location.
RESULTS: The odds of being unvaccinated were lower for supporters of large political groups (e.g. Liberal Democratic Party {OR 0.6; 95% CI, 0.5-0.7}), while higher for small political groups (e.g. Reiwa Shinsengumi {OR 2.6; 95% CI, 1.9-3.6}), in comparison with non-partisan.
CONCLUSIONS: Political affiliation may be associated with vaccination disparities in Japan. Supporters of minor parties were more likely to be unvaccinated than those of the larger parties. However, this study has several limitations, including self-reporting bias and selection bias due to the Internet survey methodology.

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.
CONCLUSIONS: 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.

BACKGROUND: COVID-19 vaccination has been inconsistently associated with an increased risk of heavy menstrual bleeding in previous studies. This study aimed to assess the risk of heavy menstrual bleeding requiring hospital care following COVID-19 vaccination according to the number of doses received and the time elapsed since vaccination.
METHODS: Using comprehensive data of the French National Health Data System, we carried out a case-control study. Non-pregnant 15-50 years old women who had a hospital discharge diagnosis of heavy menstrual bleeding between May 12, 2021, and August 31, 2022 (cases) were randomly matched to up to 30 controls of same age, place of residence, social deprivation index, and contraceptive use profile at the date of case hospital admission (index date). Conditional logistic regression models were used to estimate the risk of hospital care for heavy menstrual bleeding associated with primary or booster doses and delay since last COVID-19 vaccination at index date, adjusting for socio-demographic characteristics, comorbidities, healthcare use indicators, and recent SARS-CoV-2 infection.
RESULTS: A total of 4610 cases and 89,375 matched controls were included (median age, 42 years). Compared to unvaccinated women, the risk of hospital care for heavy menstrual bleeding was increased in those having received a last dose of primary vaccination in the preceding 1-3 months (Odds Ratio, 1.20 [95% confidence interval, 1.07-1.35]). This association was marked among women residing in the most deprived municipalities (1.28 [1.07-1.52]) and those who were not using hormonal contraception (1.28 [1.11-1.48]). Assuming a causal relationship, a total of 103 cases [54-196] were estimated to be attributable to primary vaccination in France.
CONCLUSIONS: These findings provide evidence of an increased risk of heavy menstrual bleeding during the three-month period following primary COVID-19 mRNA vaccination. No increased risk was found beyond 3 months after primary vaccination nor following booster doses.

Coronavirus disease 2019 (COVID-19) vaccines reduce severe disease and mortality and may lessen transmission, measured by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load (VL). Evaluating vaccine associations in VL at COVID-19 diagnosis in 4 phase 3 randomized, placebo-controlled vaccine trials, July 2020 to July 2021, VL reductions were 2.78 log10 copies/mL (95% confidence interval [CI], 1.38-4.18; n = 60 placebo, 11 vaccine) and 2.12 log10 copies/mL (95% CI, 1.44-2.80; n = 594 placebo, 36 vaccine) for NVX-CoV2373 and mRNA-1273, respectively. Associations were not significant for AZD1222 (0.59 log10 copies/mL; 95% CI, -.19 to 1.36; n = 90 placebo, 78 vaccine) or Ad26.COV2.S (0.23 log10 copies/mL; 95% CI, -.01 to .47; n = 916 placebo, 424 vaccine). Thus, vaccines potentially decreased transmission when ancestral SARS-CoV-2 predominated. Clinical Trials Registration. NCT04470427, NCT04505722, NCT04516746, NCT04611802.

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.
CONCLUSIONS: 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.

Previous history of COVID-19 infection is a natural booster of the vaccine response in the general population. The response to COVID-19 vaccines is lessened in Inflammatory Bowel Disease patients on selected class of immunosuppressive treatments.
The study was to assess anti-SARS-CoV-2 spike-specific IgG antibody response in Inflammatory Bowel Disease patients with a history of COVID-19 infection.
This single-center prospective study involved 504 Inflammatory Bowel Disease patients. Demographic data and clinical data were gathered through questionnaires and patient charts. Anti-SARS-CoV-2 spike-specific and antinucleocapsid antibody levels were measured at T1, T2 (after the 2-dose series), and T3 or T4 (booster vaccine).
This study included 504 Inflammatory Bowel Disease patients, and 234 completed one year follow-up with blood tests. Positive anti-nucleocapsid serology or history of COVID-19 infection was significantly associated with increased median anti- SARS-CoV-2 spike-specific IgG titers after the 2-dose series (1930 BAU/mL vs. 521 BAU/mL p < 0.0001) and the booster vaccine (4390 BAU/mL vs. 2160 BAU/mL, p = 0.0156). Multivariate analysis showed that higher anti-SARS-CoV-2 spike-specific IgG levels were independently associated with anti-nucleocapsid antibodies at T2 (OR=2.23, p < 0.0001) and T3 (OR=1.72, p = 0.00011). Immunosuppressive treatments did not impact the antibody response or levels in patients with a history of COVID-19 infection or positive anti-nucleocapsid serology.
In Inflammatory Bowel Disease, prior COVID-19 infection or positive anti-nucleocapsid serology leads to increased anti-SARS-CoV-2 spike-specific IgG levels after vaccination, regardless of immunosuppressive treatments. This emphasizes the significance of accounting for previous infection in vaccination approaches.

Adolescents are vulnerable to Coronavirus disease 2019 (COVID-19) infections; thus, their antibodies should be maintained above the protective value. This study aimed to evaluate the immune response and safety to the SARS-CoV-2 protein subunit recombinant vaccine (IndoVac®) as a heterologous booster dose against COVID-19 in Indonesian adolescents. This open-label prospective intervention study enrolled 150 clinically healthy adolescents aged 12-17 years who had received complete primary doses of the CoronaVac® vaccine from Garuda Primary Care Centres in Bandung City. The result of immunogenicity was presented with a 95% confidence interval (CI) and analyzed with t-tests from 14 days and 3, 6, and 12 months. The neutralizing antibody geometric mean titers (GMTs) (IU/mL) at baseline and 14 days after booster dose were 303.26 and 2661.2, respectively. The geometric mean fold rises (GMFR) at 3, 6, and 12 months after booster dose were 6.67 (5.217-8.536), 3.87 (3.068-4.886), and 2.87 (2.232-3.685), respectively. Both the neutralizing antibody and IgG antibody were markedly higher in the adolescents than in the adults at every timepoint. The incidence rate of adverse effects (AEs) until 28 days after booster dose was 82.7%, with a higher number of local events reported. Most reported solicited AEs were local pain followed by myalgia with mild intensity. Unsolicited AEs varied with each of the incidence rates < 10%, mostly with mild intensity. Adverse events of special interest (AESI) were not observed. At the 12-month follow-up after the booster dose, four serious adverse events (SAEs) not related to investigational products and research procedures were noted. This study showed that IndoVac® has a favorable immunogenicity and safety profile as a booster in adolescents and that the antibody titer decreases over time.