Influence of vaccination on critical COVID-19 patients with acute respiratory failure: a retrospective cohort study.

BACKGROUND: Despite vaccines' effectiveness in reducing COVID-19 infection rates and disease severity, their impact on critical patients presenting with acute respiratory failure is elusive. The aim of this study was to further investigate the influence of vaccination on mortality rates among severely ill COVID-19 patients experiencing acute respiratory failure. METHODS: This retrospective cohort study was carried out at a tertiary medical center in Taiwan. From April to September 2022, patients who tested positive for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through reverse transcription polymerase chain reaction (RT-PCR) and subsequently experienced acute respiratory failure were included in the study. Baseline characteristics, including vaccination history, along with information regarding critical illness and clinical outcomes, were gathered and compared between patients who received the vaccine and those who did not. RESULTS: A total of 215 patients with COVID-19 exhibiting acute respiratory failure, as confirmed via RT‒PCR, were included in the analysis. Of this cohort, sixty-six (30.7%) patients died within 28 days. Neither administration of the vaccine nor achievement of primary series vaccination status had a significantly different effect on 28 day mortality, number of viral shedding events, acute respiratory distress syndrome (ARDS) incidence or other clinical outcomes. Patients who received the booster vaccine and completed the primary series showed a tendency of increased 28 days of ventilator-free status, though this difference was not statistically significant (p = 0.815). CONCLUSIONS: Vaccination status did not significantly influence mortality rates, the occurrence of ARDS, or the viral shedding duration in COVID-19 patients with acute respiratory failure.

New-onset or flare-up of bullous pemphigoid associated with COVID-19 vaccines: a systematic review of case report and case series studies.

Background: Numerous cutaneous manifestations have been associated with the Coronavirus Disease 2019 (COVID-19) outbreak and vaccination, but new-onset bullous pemphigoid (BP) or flaring up of pre-existing BP is a rare side effect of COVID-19 vaccines that has been mentioned to a lesser extent in the literature. Therefore, we aimed to conduct a systematic review focused on the association between the new- onset or flare-up of BP and the COVID-19 vaccination. Method: A comprehensive literature search was conducted using PubMed (MEDLINE), Scopus, and the Web of Science databases up to 11 March 2023. The search aimed to identify English-language studies reporting new-onset or flare-ups of BP as a potential side effect of the COVID-19 vaccination. The search terms included bullous pemphigoid and COVID-19 vaccination-related MeSH terms. Results: The systematic review of 40 articles investigating the incidence of BP in individuals who received various COVID-19 vaccines revealed pertinent findings. Among the 54 patients with new-onset BP, the median age was 72.42 years, and most were men (64%). Conversely, the median age of the 17 patients experiencing a flare-up of BP was 73.35 years, with a higher proportion of women (53%). Regarding vaccination types, a significant number of patients (56%) developed new-onset BP after receiving the BNT162b2 vaccine (Pfizer-BioNTech). Conclusion: This study indicates a potential association between COVID-19 vaccinations, particularly mRNA vaccines, and the occurrence of BP. It suggests that this rare autoimmune disorder may be triggered as an adverse event following the COVID-19 vaccination. However, it is important to note that the majority of BP patients in our study were unaffected by the COVID-19 vaccine, and even those who experienced worsening of their conditions were managed without significant consequences. These findings provide additional evidence supporting the safety of COVID-19 vaccines. Physicians should be mindful of this uncommon adverse event and encourage patients to complete their planned vaccination schedules.

The effect of COVID-19 vaccine to the Omicron variant in children and adolescents: a systematic review and meta-analysis.

Background: Omicron (B.1.1.529), a variant of SARS-CoV-2, has emerged as a dominant strain in COVID-19 pandemic. This development has raised concerns about the effectiveness of vaccination to Omicron, particularly in the context of children and adolescents. Our study evaluated the efficacy of different COVID-19 vaccination regimens in children and adolescents during the Omicron epidemic phase. Methods: We searched PubMed, Cochrane, Web of Science, and Embase electronic databases for studies published through March 2023 on the association between COVID-19 vaccination and vaccine effectiveness (VE) against SARS-CoV-2 infection in children and adolescents at the Omicron variant period. The effectiveness outcomes included mild COVID-19 and severe COVID-19. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and was prospectively registered in PROSPERO (CRD42023390481). Results: A total of 33 studies involving 16,532,536 children were included in the analysis. First, in children and adolescents aged 0-19 years, the overall VE of the COVID-19 vaccine is 45% (95% confidence interval [CI]: 40 to 50%). Subgroup analysis of VE during Omicron epidemic phase for different dosage regimens demonstrated that the VE was 50% (95% CI: 44 to 55%) for the 2-dose vaccination and 61% (95% CI: 45 to 73%) for the booster vaccination. Upon further analysis of different effectiveness outcomes during the 2-dose vaccination showed that the VE was 41% (95% CI: 35 to 47%) against mild COVID-19 and 71% (95% CI: 60 to 79%) against severe COVID-19. In addition, VE exhibited a gradual decrease over time, with the significant decline in the efficacy of Omicron for infection before and after 90 days following the 2-dose vaccination, registering 54% (95% CI: 48 to 59%) and 34% (95% CI: 21 to 56%), respectively. Conclusion: During the Omicron variant epidemic, the vaccine provided protection against SARS-CoV-2 infection in children and adolescents aged 0-19 years. Two doses of vaccination can provide effective protection severe COVID-19, with booster vaccination additionally enhancing VE.

Co-Administration of Influenza and COVID-19 Vaccines: A Cross-Sectional Survey of Canadian Adults' Knowledge, Attitudes, and Beliefs.

Vaccination rates against both influenza and COVID-19 fall short of targets, especially among persons at risk of influenza complications. To gain insights into strategies to boost influenza vaccine coverage, we surveyed 3000 Canadian residents aged ≥ 18 years and examined their knowledge and receipt of co-administered influenza and COVID-19 vaccines. During the 2022-2023 influenza season, 70% of respondents reported being aware the influenza and COVID-19 vaccines could be co-administered, but only 26.2% (95% CI, 23.6% to 28.8%) of respondents received them together. The most common reason for not getting the vaccines together was receipt of the COVID-19 vaccine before the annual influenza vaccine was available (reported by 34.5% [31.2% to 37.7%]). Lack of interest in co-administration was reported by 22.6% (20.8% to 24.3%); of this group, 20.8% (17.1% to 24.5%) reported seeing no benefit in receiving the two vaccines together and 17.2% (13.5% to 20.9%) were concerned about compounded adverse effects from the two vaccines. These results support the willingness of most Canadians to receive COVID-19 and influenza vaccines at the same time. Co-administration is a viable strategy to improve uptake of influenza vaccines, especially if health professionals proactively offer education and co-administration of influenza and COVID-19 (or other) vaccines as appropriate to clinical need.

BBIBP-CorV vaccine effectiveness against COVID-19 in patients aged 60 years and older during the Delta-dominant period in the Federation of Bosnia and Herzegovina, a test-negative case-control study.

COVID-19 vaccine uptake in the Federation of Bosnia and Herzegovina (FBiH) accelerated in the second half of 2021, with greater vaccine availability. In this study, we estimated the vaccine effectiveness (VE) of complete primary series BBIBP-CorV vaccine against COVID-19 in patients aged 60 years and older, during the Delta-dominant period, using a test-negative case-control design. Surveillance sites were 11 primary health care centers (PHC) collecting patient data from October 1, 2021, to January 4, 2022, retrospectively according to a common protocol. In total, we included 1711 participants in the analysis: 933 cases and 778 controls. Of the 933 cases, 508 (54.4 %) had mild and 425 (45.6 %) had moderate to severe disease presentation. We observed no effectiveness against mild COVID-19. Overall vaccine effectiveness was 65.0 % (95 %CI: 40.1-79.5) against moderate to severe COVID-19. In time since vaccination analysis, VE was 78.7 % (95 % CI: 54.8-89.9) in patients who received their last dose < 90 days before onset; 66.0 % (95 % CI: -0.5-88.5) in those 90-119 days before onset; 42.1 % (95 % CI: -88.6-82.3) in those 120-149 days before onset and 45.0 % (95 % CI: -94.0-84.4) in those ≥ 150 days before onset. In our study, two doses of BBIBP-CorV provided considerable protection against moderate to severe COVID-19 in older adults, highest within 3 months after second dose, during the Delta-dominant period. Point estimates declined thereafter, suggesting a need for additional doses.

Patient concerns and physician strategies for addressing COVID-19 vaccine hesitancy.

OBJECTIVE: COVID-19 vaccination is critical for reducing serious illness and hospitalizations, yet many remain hesitant. We conducted a survey of frontline physicians to identify patient concerns and physician strategies to address COVID-19 vaccine-hesitancy. METHODS: A national random sample of physicians in frontline specialties selected from a comprehensive list of practicing physicians in the U.S. were emailed a survey in August 2021. Multiple choice and open-ended questions inquired about patient concerns related to the COVID-19 vaccines and strategies used by physicians to counter vaccine misinformation and encourage vaccine-hesitant patients. Weighting was applied to achieve representativeness and reduce non-response bias. Network analysis examined co-occurring patient concerns. Open-ended responses on communication strategies were coded via thematic analysis. Multi-variable logistic regression examined associations between physician and pandemic characteristics with patient concerns and use of communication strategies. RESULTS: 531 physicians responded: primary care (241); emergency medicine (142); critical care (84); hospitalists (34); and infectious disease (30). Weighted response balance statistics showed excellent balance between respondents and nonrespondents. On average, physicians reported four patient vaccine concerns. Safety, side effects, vaccine misinformation, and mistrust in government were most common, and often co-occurring. 297 physicians described communication strategies: 180 (61 %) provided vaccine education and 94 (32 %) created a safe space for vaccine discussion. Narrative responses from physicians provided compelling examples of both successes and communication challenges arising from misinformation. Compared with emergency medicine, critical care (OR 2.45, 95 % CI 1.14, 5.24), infectious disease (OR 2.45, 95 % CI 1.00, 6.02), and primary care physicians (OR 1.66, 95 % CI 1.02, 2.70) were more likely to provide communication strategies. CONCLUSIONS: Many physicians engage with vaccine hesitant patients using a variety of strategies. Dissemination of effective system and physician-level communication interventions could enhance physician success.

Severe acute respiratory syndrome coronavirus 2 infection in hematopoietic stem cell transplant recipients in Mexico City.

BACKGROUND: Hematopoietic stem cell transplant (HSCT) recipients are among patients with highest risk of adverse coronavirus disease 2019 (COVID-19) outcomes. OBJECTIVE: We compared clinical outcomes in post-HSCT patients with COVID-19 before and during the Omicron period. STUDY DESIGN: This was a retrospective study including patients post-HSCT with severe acute respiratory syndrome coronavirus 2 infection from April 2020 to March 2023 at Instituto Nacional de Cancerología, Mexico City. We describe their clinical characteristics and report the variables associated with severe clinical disease, hospitalization, and death. RESULTS: Fifty-three patients were included; 31 (58.5%) from the pre-Omicron period and 22 (41.5%) from the Omicron period. Median age was 42-years old (interquartile range 26-53), and 31 patients (59%) were men. Only four patients (16%) had received a vaccine prior to COVID-19 diagnosis in the pre-Omicron period versus 20 (91%) in the Omicron period (p < 0.001). COVID-19 severe cases were more common before Omicron: seven patients (23%) versus two patients (9%). Only one patient (3%) received an antiviral in the pre-Omicron period compared to 11 patients (50%) during the Omicron period (p < 0.01). COVID-19-associated mortality was almost double in the pre-Omicron period (16% vs. 9%, p = 0.6). CONCLUSIONS: This study reports patients with a high proportion of severe outcomes during the first 2 years of the pandemic. Outcomes improved during Omicron with better access to vaccines and antivirals and no in-hospital cases. Variables associated with worse outcomes were similar to other reports. Strengthening infection control measures in the hospital and better access to preventive strategies and therapeutic options are mandatory in these high-risk patients.

Assessing New York City's COVID-19 Vaccine Rollout Strategy: A Case for Risk-Informed Distribution.

This study reviews the impact of eligibility policies in the early rollout of the COVID-19 vaccine on coverage and probable outcomes, with a focus on New York City. We conducted a retrospective ecological study assessing age 65+, area-level income, vaccination coverage, and COVID-19 mortality rates, using linked Census Bureau data and New York City Health administrative data aggregated at the level of modified zip code tabulation areas (MODZCTA). The population for this study was all individuals in 177 MODZCTA in New York City. Population data were obtained from Census Bureau and New York City Health administrative data. The total mortality rate was examined through an ordinary least squares (OLS) regression model, using area-level wealth, the proportion of the population aged 65 and above, and the vaccination rate among this age group as predictors. Low-income areas with high proportions of older people demonstrated lower coverage rates (mean vaccination rate 52.8%; maximum coverage 67.9%) than wealthier areas (mean vaccination rate 74.6%; maximum coverage 99% in the wealthiest quintile) in the first 3 months of vaccine rollout and higher mortality over the year. Despite vaccine shortages, many younger people accessed vaccines ahead of schedule, particularly in high-income areas (mean coverage rate 60% among those 45-64 years in the wealthiest quintile). A vaccine program that prioritized those at greatest risk of COVID-19-associated morbidity and mortality would have prevented more deaths than the strategy that was implemented. When rolling out a new vaccine, policymakers must account for local contexts and conditions of high-risk population groups. If New York had focused limited vaccine supply on low-income areas with high proportions of residents 65 or older, overall mortality might have been lower.

Pharmacist-implemented intervention to surmount COVID-19 vaccination hesitancy in adults with substance use disorders.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: Substance use disorders (SUDs) increase the risk and severity of infectious diseases, including coronavirus disease 2019 (COVID-19). Adults with a co-occurring SUD and psychiatric disorder were studied to elucidate the association between SUD severity and (1) COVID-19 vaccination status, (2) receptivity to a one-session intervention with a pharmacist advocating the benefits of vaccination, and (3) acceptance of referral for vaccination following the intervention. METHODS: COVID-19 vaccination status was recorded in 460 adults with SUD (324 males and 136 females) upon entry into inpatient treatment. A 2-parameter item response theory (IRT) model quantified SUD severity. Pharmacist-delivered intervention, modeled after the screening, brief intervention, and referral to treatment (SBIRT) protocol, was offered to unvaccinated participants. RESULTS: Higher SUD severity was associated with a lower vaccination rate. Nicotine, opioid, and sedative use disorders were most frequently associated with unvaccinated status. SUD severity was not associated with receptivity to intervention advocating vaccination or subsequent acceptance of a referral for vaccination. The portion of the sample that received the intervention was over 7 times more likely to accept a referral for vaccination when compared to participants who rejected the intervention (20.8% vs 2.8%). CONCLUSION: Pharmacist-administered intervention produced motivation for vaccination in a number of recipients; however, receptivity to the intervention was not related to SUD severity.

Who is getting COVID-19 boosters? A latent class analysis in a nationally representative sample of Mexican adults 60 years and over.

OBJECTIVE: Estimate COVID-19 vaccine booster uptake and identify sociodemographic profiles associated with vaccine booster uptake in Mexican adults aged 60 and older. METHODS: Using data from the 2022 National Health and Nutrition Survey, we estimated COVID-19 booster uptake in Mexican adults 60 and older. We conducted a latent class analysis using sociodemographic characteristics and then estimated group-specific booster prevalence. RESULTS: Adults aged 60 and older with a completed vaccination schedule had 80.3% booster coverage. Two groups showed the lowest coverage: 1) unemployed and informal working men with elementary education with low socioeconomic status (73.8% boosted), and 2) female homekeepers with elementary education or less living in rural areas (77.0% boosted). CONCLUSIONS: Our analysis points to the need to reach out to men and women with elementary education or less who live in rural areas to strengthen booster campaigns in the future.

Overview of U.S. COVID-19 vaccine safety surveillance systems.

The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. Clinical consultation for individual cases of adverse events following vaccination was performed, and monitoring of special populations, such as pregnant persons, was conducted. This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program.

SARS-CoV-2-specific mucosal immune response in vaccinated versus infected children.

The anti-COVID-19 intramuscular vaccination induces a strong systemic but a weak mucosal immune response in adults. Little is known about the mucosal immune response in children infected or vaccinated against SARS-CoV-2. We found that 28% of children had detectable salivary IgA against SARS-CoV-2 even before vaccination, suggesting that, in children, SARS-CoV-2 infection may be undiagnosed. After vaccination, only receptor-binding domain (RBD)-specific IgA1 significantly increased in the saliva. Conversely, infected children had significantly higher salivary RBD-IgA2 compared to IgA1, indicating that infection more than vaccination induces a specific mucosal immune response in children. Future efforts should focus on development of vaccine technologies that also activate mucosal immunity.

Glomerulonephritis following COVID-19 infection or vaccination: a multicenter study in South Korea.

BACKGROUND: Despite the widespread impact of the severe acute respiratory syndrome coronavirus 2 (coronavirus disease 2019, COVID-19) and vaccination in South Korea, our understanding of kidney diseases following these events remains limited. We aimed to address this gap by investigating the characteristics of glomerular diseases following the COVID-19 infection and vaccination in South Korea. METHODS: Data from multiple centers were used to identify de novo glomerulonephritis (GN) cases with suspected onset following COVID-19 infection or vaccination. Retrospective surveys were used to determine the COVID-19-related histories of patients who were initially not implicated. Bayesian structural time series and autoregressive integrated moving average models were used to determine causality. RESULTS: Glomerular diseases occurred shortly after the infection or vaccination. The most prevalent postinfection GN was podocytopathy (42.9%), comprising primary focal segmental glomerulosclerosis and minimal change disease, whereas postvaccination GN mainly included immunoglobulin A nephropathy (IgAN; 57.9%) and Henoch-Schönlein purpura nephritis (HSP; 15.8%). No patient progressed to end-stage kidney disease. Among the patients who were initially not implicated, nine patients with IgAN/HSP were recently vaccinated against COVID-19. The proportion of glomerular diseases changed during the pandemic in South Korea, with an increase in acute interstitial nephritis and a decrease in pauci-immune crescentic GN. CONCLUSION: This study showed the characteristics of GNs following COVID-19 infection or vaccination in South Korea. Understanding these associations is crucial for developing effective patient management and vaccination strategies. Further investigation is required to fully comprehend COVID-19's impact on GN.

Efficacy of the combination of BRII-196/BRII-198 in the treatment of COVID-19 vaccine breakthrough infections.

BACKGROUND: BRII-196 and BRII-198 are two recombinant human immunoglobulin (Ig) G1 monoclonal antibodies (mAbs) that non-competitively target distinct epitope regions within the receptor-binding domain (RBD) of the coronavirus spike glycoproteins. These antibodies are derived directly from human B cells of individuals who recovered from COVID-19. OBJECTIVE: To analyze the efficacy of BRII-196/BRII-198 in the treatment of coronavirus disease 2019 (COVID-19) vaccine breakthrough infections. METHODS: COVID-19 patients at high risk of progressing to severe and critical illness, with an initial SARS-CoV-2 immunoglobulin (Ig) G antibody level < 1.0 S/CO (detected within 24-48 hours post COVID-19 diagnosis), were treated with BRII-196/BRII-198 within three days of symptom onset. Treatment continued until the antibody level exceeded 1.0 S/CO. Patients whose absolute lymphocyte count (ALC) at first detection (within 24-48 h post-diagnosis) was < 0.8 × 109/L received thymalfasin therapy within three days of symptom onset, continuing until the ALC level surpassed 0.8 × 109/L. We determined the correlation of SARS-CoV-2 IgG antibody level and ALC with the condition of COVID-19 patients. Additionally, we analyzed the effects of BRII-196/BRII-198 on SARS-CoV-2 nucleic acid (NA) negative conversion, lymphocyte count recovery, and the change in SARS-CoV-2 IgG antibody level from the first positive NA test for SARS-CoV-2 to negative conversion in COVID-19 patients. RESULTS: A total of 61 cases of breakthrough infections were observed, classified as 10 mild cases, 31 ordinary cases, and 20 severe cases. Among these, 20%, 48.4% and 75% of the patients with mild, ordinary, and severe COVID-19, respectively, had initial SARS-CoV-2 IgG antibody level < 1.0 S/CO. Additionally, 0%, 35% and 70% had initial ALC < 0.8 × 109/L, respectively. Fifteen ordinary and 15 severe COVID-19 patients were treated with BRII-196/BRII-198. In severely infected patients, BRII-196/BRII-198 treatment showed statistically significant differences in NA negative conversion time and changes in SARS-CoV-2 IgG antibody levels (P < 0.05). However, in patients classified with ordinary severity, BRII-196/BRII-198 treatment did not lead to notable differences in NA negative conversion time or changes in SARS-CoV-2 IgG antibody level (P > 0.05). BRII-196/BRII-198 therapy was not associated with lymphocyte count recovery time in patients with either ordinary and/or severe COVID-19 (P > 0.05). CONCLUSIONS: The initial levels of SARS-CoV-2 IgG antibody and lymphocytes in fully vaccinated patients with breakthrough infections are inversely correlated with the severity of the disease. Early treatment with BRII-196/BRII-198 can shorten NA negative conversion time in severe COVID-19 patients and increase in vivo neutralizing antibody levels post-conversion, providing lasting protection. However, BRII-196/BRII-198 does not influence lymphocyte count recovery in patients with either ordinary and/or severe COVID-19.

Engaging Long-Term Care Workers in Research: Recruitment Approaches and Participant Characteristics From a Randomized Controlled Trial to Improve COVID-19 Vaccine Confidence.

OBJECTIVE: To describe and compare the recruitment methods employed in a randomized controlled trial targeting long-term care workers, and resulting participant baseline characteristics. DESIGN: We used a multifaceted recruitment process to enroll long-term care workers in our 3-arm randomized controlled trial comparing 2 interventions to enhanced usual practice, for improving COVID-19 vaccine confidence and other outcomes. SETTING AND PARTICIPANTS: Adult long-term care workers living in the United States employed within the last 2 years were invited to join the study. Participants also had to meet specific screening criteria related to their degree of worry about the vaccine and/or their vaccination status. METHODS: We used a participatory approach to engage our long-term care stakeholders in codesigning and executing a combination of recruitment methods, including targeted e-recruitment, paid e-recruitment, and in-person recruitment. Participants were screened, consented, and enrolled online. We implemented a participant verification process to ensure the integrity of our study data, and used a tailored participant management platform to manage enrollment. RESULTS: We enrolled 1930 long-term care workers between May 2022 and January 2023. We met our enrollment target, despite each recruitment method having limitations. Total variable costs of approximately $102,700 were incurred and differed on a per-enrolled participant basis across methods: $25.72 for targeted e-recruitment, $57.12 for paid e-recruitment, and $64.92 for in-person methods. Our sample differed from the national population in age, gender, race/ethnicity, education, and role in long-term care. Differences were also observed between online and in-person recruitment methods. CONCLUSIONS AND IMPLICATIONS: Our results support the feasibility of enrolling a large number of long-term care workers in a randomized controlled trial to increase COVID-19 vaccine confidence. Findings build upon the evidence base for engaging this important population in research, a critical step to improving long-term care resident health and well-being. Results from our trial are anticipated in 2024.

COVID-19 Vaccine decision-making: trust among the transgender and disability communities in India.

BACKGROUND: Historical marginalisation and ongoing trust deficits in health and government systems shape present-day vaccine perceptions among marginalised communities. This paper sought to understand the role of trust in decision-making about COVID-19 vaccine uptake in the transgender and disability communities in India. METHODS: Using a participatory approach we interviewed 24 community representatives, identifying themselves as transgender individuals or as persons with disability, and 21 key informants such as vaccine programme managers, vaccine providers, and community advocates. We undertook an inductive thematic analysis of the data using a socio-ecological model. RESULTS: Fear of side effects in relation to specific needs of the two communities and mistrust of systems involved in vaccination shaped four different pathways for vaccine decision-making. Mistrust of systems was influenced by past negative experiences with the health system, creating contexts in which information and misinformation are shared and interpreted. Participants negotiated their doubts about safety and mistrust of systems by interacting with different sources of influence showing patterns of decision-making that are dynamic, context-dependent, and intersectional. CONCLUSION: These findings will help in determining the content, strategies and approaches to equitable vaccine communication for these two communities. The two communities ought to be included in vaccine trials. Vaccine information must respond to the specific needs of these two communities which could be enabled by collaboration and engagement with community members and influencers. Finally, long-term investment towards the needs of marginalised communities is vital to dismantle cycles of marginalisation and distrust and in turn improve vaccine acceptance and uptake.

COVID-19 infection among people with disabilities in 2021 prior to the Omicron-dominant period in the Republic of Korea: a cross-sectional study.

Objectives: This study investigated the characteristics of coronavirus disease 2019 (COVID-19) among individuals with disabilities on a nationwide scale in the Republic of Korea, as limited research has examined this population. Methods: Between January 1 and November 30, 2021, a total of 5,687 confirmed COVID-19 cases among individuals with disabilities were reported through the Korea Disease Control and Prevention Agency's COVID-19 web reporting system. Follow-up continued until December 24, and demographic, epidemiological, and clinical characteristics were analyzed. Results: Individuals with disabilities represented approximately 1.5% of confirmed cases, with a mean age of 58.1 years. Most resided in or near metropolitan areas (86.6%) and were male (60.6%). Frequent sources of infection included home (33.4%) and contact with confirmed cases (40.7%). Many individuals (75.9%) had underlying conditions, and 7.7% of cases were severe. People with disabilities showed significantly elevated risk of severe infection (adjusted odds ratio [aOR], 1.63; 95% confidence interval [CI], 1.47-1.81) and mortality (aOR, 1.65; 95% CI, 1.43-1.91). Vaccination against COVID-19 was associated with significantly lower risk of severe infection (aORs for the first, second, and third doses: 0.6 [95% CI, 0.42-0.85], 0.28 [95% CI, 0.22-0.35], and 0.16 [95% CI, 0.05-0.51], respectively) and death (adjusted hazard ratios for the first and second doses: 0.57 [95% CI, 0.35-0.93] and 0.3 [95% CI, 0.23-0.40], respectively). Conclusion: Individuals with disabilities showed higher risk of severe infection and mortality from COVID-19. Consequently, it is critical to strenghthenCOVID-19 vaccination initiatives and provide socioeconomic assistance for this vulnerable population.

Psychiatric adverse events associated with the COVID-19 vaccines approved in the Republic of Korea: a systematic review.

This systematic review evaluated psychiatric adverse events (AEs) following vaccination against coronavirus disease 2019 (COVID-19). We included studies that reported or investigated psychiatric AEs in individuals who had received an approved COVID-19 vaccine in the Republic of Korea. Systematic electronic searches of Ovid-Medline, Embase, CENTRAL, and KoreaMed databases were conducted on March 22, 2023. Risk of bias was assessed using the Risk of Bias Assessment Tool for Non-randomized Studies 2.0. The study protocol was registered in the International Prospective Register of Systematic Reviews (CRD42023449422). Of the 301 articles initially selected, 7 were included in the final analysis. All studies reported on sleep disturbances, and 2 highlighted anxiety-related AEs. Sleep disorders like insomnia and narcolepsy were the most prevalent AEs, while depression was not reported. Our review suggests that these AEs may have been influenced by biological mechanisms as well as the broader psychosocial context of the COVID-19 pandemic. Although this study had limitations, such as a primary focus on the BNT162b2 vaccine and an observational study design, it offered a systematic, multi-vaccine analysis that fills a critical gap in the existing literature. This review underscores the need for continued surveillance of psychiatric AEs and guides future research to investigate underlying mechanisms, identify risk factors, and inform clinical management.

Impact of the vaccination against SARS-CoV-2 campaign on disproportionality indicator from the WHO pharmacovigilance database: A competition bias study from case/non-case analysis.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) vaccination campaign has resulted in numerous pharmacovigilance's safety reports which were recorded in the World Health Organization (WHO) pharmacovigilance database (VigiBase) and represent in July 2022 more than 10% of cases recorded. The information component (IC) is a statistical disproportionality measure based on the observed and expected numbers of case reports. A positive value of the lower endpoint of a 95% credibility interval for the information component (IC0.25) suggests a possible causal relationship between the drug and the adverse reaction. This study aimed to evaluate the impact of the wave of COVID-19 vaccines safety declarations on IC0.25 from Vigilyze and thus illustrate with a concrete example the competition bias. METHODS: We arbitrarily selected 21 adverse drug reactions using Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs), divided in two types: PTs known to be related to COVID-19 vaccines ("expected") and others (type "unexpected"). Data were extracted from VigiLyze. We created two groups: V+ (the full database, including COVID-19 vaccines reports) and V- (the same extraction without COVID-19 vaccine reports). IC0.25 was recomputed for the group V- and we compared the positive signal evolution in the two settings of selection (V+ and V- groups). RESULTS: The number of positive potential signals was significantly different in the groups V+ and V- for IC0.25. We observed that most of the "unexpected" PTs lost potential signal after the withdrawal of COVID-19 reports. On the contrary, the majority of 'expected' PTs had potential new signals after the withdrawal of COVID-19 reports. DISCUSSION: This study is one of the first to evaluate the effect of COVID-19 vaccines reporting on Automated Signal Detection of Pharmacovigilance. In this study, we observed that a wave of pharmacovigilance reporting can affect disproportionality estimators such as IC0.25 and then have an impact on automated signal detection; some signals disappear (almost with all PTs related to COVID-19 vaccines) and others appear (mostly with PTs not related to COVID-19 vaccines), illustrating the competition bias. CONCLUSION: We show that a health crisis involving a change in drug use can affect adverse drug reactions reporting and pharmacovigilance databases, leading to competition bias and a change in the disproportionality analyses. For health professionals who use quantitative disproportionality analysis, it is important not only to use the crude values of indicators but also the kind of PTs and the evolution of the signal over time (take into account major events such as crises).