Unvaccinated Cohort Research Articles

Effectiveness of the ChAdOx1 nCoV-19 vaccination among COVID-19 patients: a retrospective cohort study

It is currently unknown how effective the COVID-19 vaccine is at preventing new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections among the general population. The study suggests that a safe and efficient vaccination against the COVID-19 could help manage this pandemic if widely distributed. The present study aimed to investigate the effectiveness of the ChAdOx1 nCoV-19 vaccine in between vaccinated and unvaccinated cohorts. A retrospective multicenter cohort study comprised 1244 COVID-19 positive patients enrolled in this study from three different hospitals among patients who had been appropriately vaccinated or not between April and June 2021. Data were collected by face-to-face survey, and clinical investigations were obtained by observation. Descriptive statistics and the Cox proportional hazard model of survival analysis were performed in the study. Among the participants, 69% of vaccinated cohorts did not require hospitalization, and 97% successfully recovered from the infection. In respect of age, compared with unvaccinated cohorts, the vaccine effectiveness varied from 81% to 92%. The ChAdOx1 nCoV-19 vaccine was more effective among those aged 60-69 years old and reduced 92% hazard of death than the unvaccinated group [HR ratio - 0.081(.036-.179), P=0.0001]. The study found the ChAdOx1 nCoV-19 vaccine is highly effective for receivers. The COVID-19 vaccination demonstrated a significant correlation with a reduced probability of disease severity, hospital admission rate, early recovery from illness, and mortality. Asian J. Med. Biol. Res. 2022, 8 (4), 251-263

1928. A Population-Based Propensity Score-Matched Study of COVID-19 Vaccination on Clinical Outcomes in Hospitalized Adult Patients with COVID-19

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can cause significant morbidity and mortality in hospitalized patients. We aimed to evaluate the impact of 2-dose COVID-19 vaccination on ICU admissions and in-hospital deaths in adult patients with COVID-19. Methods Laboratory-confirmed COVID-19 adult patients hospitalized at Memorial Healthcare System, Hollywood, Florida, between June 01, 2021 and September 20, 2021, were retrospectively reviewed. We used 1:1 propensity score matching for demographic characteristics and underlying diseases to construct an unvaccinated cohort similar to the vaccinated cohort. “Fully vaccinated” was defined as a patient who received 2-dose vaccines. Risk of in-hospital mortality or ICU admission was estimated using logistic regression models adjusting for age, gender, race/ethnicity, body mass index, and comorbidities. Results 3067 unvaccinated and 284 fully vaccinated patients were included. The propensity score–matched cohort included 262 unvaccinated and 262 fully vaccinated patients. The median age was 71.0 (IQR, 60-81) years, 51.3% were men, and 36.2% were white participants. The most common comorbidities were hypertension (452; 86.3%), diabetes (236; 45.0%), and chronic kidney disease (163; 31.1%). At the study closeout of Oct 18, 2021, 70 (13.4%) patients required ICU admission, and 81 (15.5%) patients died. In multivariable-adjusted models, fully vaccinated patients had lower risks of ICU admission and in-hospital mortality compared to unvaccinated patients (Figure 1). Patients who received the Pfizer BioNTech vaccines had comparable risks of ICU admission (adjusted odds ratio [aOR], 0.80; 95% CI, 0.23—2.79; p=0.731) and in-hospital mortality (aOR, 2.99; 95% CI, 0.59—15.3; p=0.187) compared to those received the Moderna vaccines (Figure 2). No difference in hospital length of stay or in ICU length of stay were noted between fully vaccinated and unvaccinated patients. Figure 1.Vaccination reduces the risk of disease severity in propensity score–matched COVID-19 patients admitted to the MHS from June 01 to Sep 20, 2021. Forest plot showing adjusted odds ratio (aOR, diamond) estimates with 95% confidence interval (CI, indicated by the horizontal line) of association between vaccination and risk of disease severity. aORs comparing the vaccinated group with the unvaccinated group were obtained from the multivariable logistic regression models for binary dependent variables. The models were adjusted for age, gender, race/ethnicity, body mass index, and comorbidities (chronic lung disease, chronic kidney disease, chronic heart disease, hypertension, diabetes). ICU, intensive care unit.Figure 2.Comparison of vaccine type on risk of disease severity of COVID-19 among fully vaccinated patients. Forest plot showing adjusted odds ratio (aOR, diamond) estimates with 95% confidence interval (CI, indicated by the horizontal line) of association between vaccine type and risk of disease severity. aORs comparing the Pfizer BioNTech group with the Moderna group were obtained from the multivariable logistic regression models for binary dependent variables. The models were adjusted for age, gender, race/ethnicity, body mass index, and comorbidities (chronic lung disease, chronic kidney disease, chronic heart disease, hypertension, diabetes). ICU, intensive care unit. Conclusion Fully vaccinated patients hospitalized with COVID-19 have lower risks of ICU admission and in-hospital mortality than unvaccinated patients. No significant differences were noted in ICU admission and in-hospital mortality between patients who received Moderna vaccines and those received Pfizer BioNTech vaccines. Disclosures All Authors: No reported disclosures.

PP85 The Cost-Effectiveness Of The Anti-COVID Vaccination Campaign In The Italian Healthcare Setting

IntroductionCoronavirus disease 2019 (COVID-19) is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Symptoms of COVID-19 are variable, but often include fever, cough, headache, fatigue, breathing difficulties, and loss of smell and taste. Symptoms may begin one to fourteen days after exposure to the virus. COVID-19 transmits when people breathe in air contaminated by droplets and small airborne particles containing the virus. The present analysis aims to define the cost-effectiveness profile of the anti-COVID vaccination campaign in the Italian healthcare setting.MethodsThe analysis was based on the collection and analysis of data regarding the number of hospitalizations (ordinary regime and intensive care) and infections recorded by the Italian Ministry of Health in vaccinated and unvaccinated patient cohorts. The acquisition costs of the available vaccine alternatives were considered as well as the cost of the personnel involved in the vaccination campaign. The reduction in hospitalizations was considered as a measure of effectiveness. We have compared the current scenario of campaign vaccination versus a scenario in which the total of the eligible population would be vaccinated. Results are reported in terms of Incremental Cost Effectiveness Ratio (ICER). Deterministic and probabilistic sensitivity analyses were carried out in order to test the robustness of the results.ResultsThe vaccination campaign allowed for savings amounting to EUR 9,398,012.10 (EUR 60,499,053.25 vs EUR 69,897,065.35) and 6,647 hospitalizations avoided (715 and 5,932 in the intensive care and ordinary regimen, respectively), thus resulting a dominant strategy as compared with the alternative (no vaccination). As the cost-effectiveness profile of the campaign improves, we should consider the period (May-July 2021), during which the daily threshold of 500,000 doses administered on a national basis was consistently exceeded.ConclusionsThe analysis underlined how the vaccination campaign represents a cost-saving alternative in the Italian healthcare setting.

Genetic risk and incident venous thromboembolism in middle‐aged and older adults following COVID‐19 vaccination

BackgroundCOVID‐19 vaccination has been associated with increased venous thromboembolism (VTE) risk. However, it is unknown whether genetic predisposition to VTE is associated with an increased risk of thrombosis following vaccination. MethodsUsing data from the UK Biobank, which contains in‐depth genotyping and linked vaccination and health outcomes information, we generated a polygenic risk score (PRS) using 299 genetic variants. We prospectively assessed associations between PRS and incident VTE immediately after first‐ and the second‐dose vaccination and among historical unvaccinated cohorts during the pre‐ and early pandemic. We estimated hazard ratios (HR) for PRS‐VTE associations using Cox models. ResultsOf 359 310 individuals receiving one dose of a COVID‐19 vaccine, 160 327 (44.6%) were males, and the mean age at the vaccination date was 69.05 (standard deviation [SD] 8.04) years. After 28‐ and 90‐days’ follow‐up, 88 and 299 individuals developed VTE, respectively, equivalent to an incidence rate of 0.88 (95% confidence interval [CI] 0.70–1.08) and 0.92 (0.82–1.04) per 100 000 person‐days. The PRS was significantly associated with a higher risk of VTE (HR per 1 SD increase in PRS, 1.41 (1.15–1.73) in 28 days and 1.36 (1.22–1.52) in 90 days). Similar associations were found in the historical unvaccinated cohorts. ConclusionsThe strength of genetic susceptibility with post‐COVID‐19‐vaccination VTE is similar to that seen in historical data. Additionally, the observed PRS‐VTE associations were equivalent for adenovirus‐ and mRNA‐based vaccines. These findings suggest that, at the population level, the VTE that occurred after the COVID‐19 vaccination has a similar genetic etiology to the conventional VTE.

Clinical Impact of Sars-Cov-2 Vaccination in COVID-19 Outcomes in Patients Diagnosed with Hematologic Malignancies: Real-World Evidence of Two Years of Pandemic

Background: Real-world data about the effectiveness of SARS-CoV-2 vaccination and implementation of booster campaigns in an immunocompromised population such as patients diagnosed with hematologic malignancies (HM) are scarce. Our aim was to compare morbidity and mortality of COVID-19 according to SARS-CoV-2 vaccination status and immunological response to vaccination in a cohort of patients diagnosed with HM, considering a scenario affected by the succession of diverse virus variants and the advent of COVID-19 specific therapies. Methods: We retrospectively collected clinical data from the patients with a current or prior history of HM at Vall d´Hebron Universitary Hospital who suffered a laboratory-confirmed SARS-CoV-2 infection between March 2020 and May 2022. The main endpoints included severity of COVID-19 (WHO classification), rate of hospitalization, ICU admission, need for supplemental oxygen or COVID-19 specific therapy (steroids, antivirals, IL-6 inhibitors, hydroxychloroquine, anti-SARS-CoV-2 monoclonal antibodies). We also genotyped viral variants and assessed humoral immunogenicity induced by the vaccine (anti-spike[S] IgG >260 BAU/mL measured by LIAISON® Diasorin) or the infection (anti-nucleocapsid[N] IgM/IgG/IgA positivization by Elecsys® Roche). Results: A total of 326 patients developed COVID-19, 182 vaccinated cases between 03/21 and 05/22, and 134 unvaccinated cases between 03/20 and 02/22. Both groups were similar in age (median 68 and 71 years) and gender (51% and 46% women, respectively). In both cohorts the main diagnosis was lymphoma (46% and 43%), the majority of patients were under active treatment (73% and 58%) and the most frequent active therapy was anti-CD20 monoclonal antibodies+/- chemotherapy (35% and 30%) (Table 1). Among the 113 vaccinated sequenced cases, 80% were omicron (predominantly BA.1 [36%] and BA.1.1 [28%]), 19% delta (B.1.617.2 [6%] and AY lineage [15%]) and 1% alfa variant. Genotype analysis of 87 unvaccinated cases showed predominance of B.1 and B.1.177 lineages in 53% and 35% of the cases, respectively. The vaccines most frequently administered were mRNA-1273 (70%) and BNT162b2 (25%). A 5% of patients were partially vaccinated (one dose), 26% fully vaccinated (2 doses), whereas 67% received a third boost dose and 2% a fourth dose prior infection. Considering patients with available basal serology prior infection, only 20% (1/5) of partially vaccinated, 39% (13/33) of fully vaccinated patients, and 47% (42/90) of boosted patients had developed positive anti-S IgG antibodies. In 38% (34/90) of patients with basal negative anti-N antibodies a seroconversion was observed after the infection. In the unvaccinated cohort the most frequent COVID-19 specific therapies administered were hydroxychloroquine (46%), steroids (28%), lopinavir/ritonavir (20%) and tocilizumab (19%); while in the vaccinated cohort were remdesivir (38%), steroids (28%), tocilizumab (14%) and anti-SARS-CoV-2 monoclonal antibodies (7%). In comparison with the unvaccinated cohort of patients, vaccinated patients had less severe (17% vs. 27%; p=0.006) and critical (12% vs 38%; p=<0.001) COVID-19, lower rates of hospitalization (32% vs. 80%; p=<0.001) and fewer patients needed supplemental oxygen (28% vs. 64%; p=<0.001). Admission rates to ICU were similar between both cohorts. Mortality rate was lower in the vaccinated patients in comparison with the unvaccinated cohort (HR: 0.48 (95%CI 0.31-0.74); p=<0.001) (Figure 1). Of note, only 15% (6/39) of patients who suffered a severe/critical infection had developed humoral vaccine immunogenicity. In contrast, 56% (50/89) of mild/moderate cases had created vaccine-induced seroconversion. None of the 17 vaccinated patients who died had developed anti-S antibodies. Finally, in 23% (30/131) of the vaccinated cohort the follow-up RT-PCR remained persistently positive >21 days. Conclusion: In this real-world analysis, and despite the heterogeneity of infection by different viral variants and treatment availability for COVID-19 during the evolution of the pandemic, vaccination has resulted widely effective at reducing need of hospitalization, severity and mortality of the SARS-CoV-2 infection in patients with HM. Patients who develop a suboptimal humoral immunogenicity after vaccination are at higher risk to develop a severe/critical infection and would benefit from an early intervention. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Predictors of Hospitalizations and Death from COVID-19 in Patients with Multiple Myeloma

The COVID-19 (SARS-CoV-2) pandemic has led to unprecedented challenges in providing cancer care to patients all over the world. Compared to the general population, it is assumed that patients with hematologic malignancies are more susceptible to develop viral infections like COVID-19 and will experience more severe symptoms and complications given their immunocompromised status. METHODS This retrospective chart review included 57 patients who had multiple myeloma (MM), tested positive for COVID-19 and were hospitalized between 1/1/2020 until 5/1/2021. We report epidemiological, clinical, and laboratory characteristics along with outcomes. RESULTS 57 MM patients were included in the study. The mean age of our cohort was 70.54 years with a standard deviation of 11.65, and 57.89% (n=33) patients were male. 45.61% (n=26) were non-smokers, 22.81% (n=13) were currently smokers and 31.58% (n=18) were former smokers. While the odds of hospitalization were not significantly increased with age (OR 1.03 95% CI 0.98-1.09, p=0.163), the odds of death were slightly increased with age, and the results were statistically significant (OR 1.07 95%1.00 -1.14, p=0.03). Race, ethnicity, gender and BMI, smoking status and flu/pneumovax vaccination did not have any effect on the odds of neither hospitalization nor death. Between all comorbidities that were present in our cohort, none significantly affected the odds of hospitalization. However, patients with heart failure had higher odds of death (OR 4.11 95% CI 0.98-17.22, p=0.05), and those with asthma had lower odds of death (OR 0.08 95% CI 0.009-0.67, p=0.02). Between all multiple myeloma subtypes, no specific subtype affected the odds of death, and only the light chain disease significantly reduced the odds of hospitalization (OR 0.11 95% CI 0.02-0.72, p=0.021). No specific medication or treatment regimen influenced the odds of hospitalization or death. As for pretesting biochemical parameters, elevated blood urea nitrogen significantly increased the odds of hospitalization (OR 1.08 95% CI 1.01-1.16, p=0.023), while elevated bilirubin decreased those odds (OR 0.19 95% CI 0.05-0.79, p=0.022). On the other side, elevated pretesting procalcitonin increased the odds of death (OR 3.77 95% CI 1.09-13.07, p=0.036), unlike elevated albumin levels that lowered the odds of death (OR 0.41 95% CI 0.19-0.84, p=0.015). On admission, elevated LDH was the only parameter that significantly increased the odds of death (OR 1.01 95% CI 1-1.02, p=0.024). CONCLUSION In a predominantly unvaccinated cohort, several demographic factors and comorbidities increased the risk of hospitalization and mortality. Elevated LDH, BUN, procalcitonin were linked with higher odds of mortality, nature of myeloma therapy and presence of immunoparesis did not influence outcomes. More data is required to understand the effect of COVID-19 in vaccinated patients with multiple myeloma and other hematologic malignancies. Some limitations of this dual center institution study are the small sample size.

Rapid elimination of cervical cancer while maintaining the harms and benefits ratio of cervical cancer screening: a modelling study

BackgroundHuman papillomavirus (HPV) vaccination and intensifying screening expedite cervical cancer (CC) elimination, yet also deteriorate the balance between harms and benefits of screening. We aimed to find screening strategies that eliminate CC rapidly but maintain an acceptable harms-benefits ratio of screening.MethodsTwo microsimulation models (STDSIM and MISCAN) were applied to simulate HPV transmission and CC screening for the Dutch female population between 2022 and 2100. We estimated the CC elimination year and harms-benefits ratios of screening for 228 unique scenarios varying in vaccination (coverage and vaccine type) and screening (coverage and number of lifetime invitations in vaccinated cohorts). The acceptable harms-benefits ratio was defined as the number of women needed to refer (NNR) to prevent one CC death under the current programme for unvaccinated cohorts (82.17).ResultsUnder current vaccination conditions (bivalent vaccine, 55% coverage in girls, 27.5% coverage in boys), maintaining current screening conditions is projected to eliminate CC by 2042, but increases the present NNR with 41%. Reducing the number of lifetime screens from presently five to three and increasing screening coverage (61% to 70%) would prevent an increase in harms and only delay elimination by 1 year. Scaling vaccination coverage to 90% in boys and girls with the nonavalent vaccine is estimated to eliminate CC by 2040 under current screening conditions, but exceeds the acceptable NNR with 23%. Here, changing from five to two lifetime screens would keep the NNR acceptable without delaying CC elimination.ConclusionsDe-intensifying CC screening in vaccinated cohorts leads to little or no delay in CC elimination while it substantially reduces the harms of screening. Therefore, de-intensifying CC screening in vaccinated cohorts should be considered to ensure acceptable harms-benefits ratios on the road to CC elimination.

The Incidence of a New Coronavirus Infection in Medical Workers and the Evaluation of the Effectiveness of Individual Technologies for their Protection at Different Stages of the Pandemic

Relevance. The study of the incidence of medical workers with a new coronavirus infection during the COVID-19 pandemic is one of the topical areas of epidemiological research at this stage. The search for effective practices to reduce the incidence and risk of SARS-CoV-2 spread among employees of medical organizations is a promising area of research that is in demand in practice. Аim. Analysis of COVID-19 morbidity among health care staff during the pandemic and determination of the significance of selected specific and nonspecific prophylaxis measures in minimizing the risk of their occupational infection with SARS-CoV-2. Materials and methods. The reporting forms «General information about patients with positive COVID-19», «General information about patients with community-acquired pneumonia with positive COVID-19» (497 units of information), 2 176 cards of epidemiological investigation of cases of COVID-19 among employees of three municipalities were analyzed. We used epidemiological and statistical research methods. Conclusions. When analyzing the incidence of COVID-19 among employees of the medical worckers of the Khanty-Mansi autonomous оkrug – Yugra in the period from the 19th calendar week of 2020 to the 36th week of 2021, which corresponded to three epidemic rises, it was found that its level exceeded such in the unorganized adult population by 2.2 times, as well as the frequency of severe clinical forms of infection with lung damage. In the first two epidemic rises in the incidence, the highest incidence rate was recorded when the chances (OR) of getting COVID-19 among workers in the medical organizations compared to the adult population were the highest. In the first «wave» of the pandemic, they were 3.0, and in the second 2.6 times higher, as were the chances of developing clinical forms of COVID-19 with lung damage, which differed by 2.2 and 1.7 times, respectively, from those of an adult population (p&lt;0.05). During the third epidemic rise, the situation changed radically. The incidence of new coronavirus infection in ,medical worckers as well as the chances of getting sick, were equal to those in the adult population (OR 1.1), while the frequency of clinical forms of infection with lung involvement was even lower than in the population (P=95.7‰). The reason for the positive changes in the dynamics of the epidemic process was due to the formation among medical workers of a higher stratum of people protected from infection due to active, emergency vaccination and people with post-infection immunity as a result of infection in its various clinical forms than in the population. A detailed analysis of the incidence of COVID-19 in three medical organizations of Khanty-Mansiysk autonomous okrug - Yugra made it possible to obtain information that among employees of medical organizations vaccinated against a new coronavirus infection, the incidence of COVID-19 was 4.4 times lower than among those who were not vaccinated. In the cohort of those vaccinated, the frequency of clinical forms of the disease complicated by pneumonia was 4.7 times less, and the number of those hospitalized for inpatient treatment was 20.8 times lower. In medical workers who received a booster dose of the drug after vaccination, the incidence was 5.8 times lower compared to the unvaccinated cohort. Compared with the unvaccinated, there were 12.8 times fewer complicated clinical forms of the disease and 6.25 times the number of hospitalizations among them. A correlation was also found between the incidence of COVID-19 among employees of the medical workers and the area of premises per employee. Increasing the area of the premises per employee per 1 sq. m. led to a decrease in incidence by 2.1%.

Effectiveness of the Inactivated SARS-CoV-2 (Vero Cell) Vaccine in Peruvian Health Workers.

Introduction: The COVID-19 pandemic has caused a global health crisis. Vaccines against this disease have demonstrated variable efficacy and safety, although effectiveness has not been evaluated. In February 2021, the Ministry of Health of Peru approved the emergency use of the inactivated SARS-CoV-2 (Vero Cell) vaccine and initiated vaccination with health personnel at the national level. The objective of the study is to determine the effectiveness of this vaccine to reduce infections, hospitalizations, and deaths due to COVID-19. Methodology: We performed a retrospective cohort study in the period from 23 February to 26 June 2021; data were obtained from the Ministry of Health (including demographic, epidemiologic, clinical, hospital, laboratory results, deaths, and both date and quantity of vaccine doses delivered). The exposed cohort were those who received one or two vaccine doses and the non-exposed were unvaccinated. The events studied were infections, hospitalizations and deaths in the cohorts. We consider a case confirmed for COVID-19 if the test result was positive for SARS-CoV-2, via PCR or antigen test. Effectiveness was measured with incidence density ratio and risk. Confounding factors were controlled using a Poisson model with robust variance. Results: We enlisted 520,733 health workers, of whom 415,212 had two vaccine doses and 105,521 were unvaccinated. The median age was 40 years (IQR: 32–50), and 65.6% were female. The effectiveness of two vaccine doses fourteen days after application adjusted by age, sex, hospitalization, and antecedent of having the infection was 90.9% (95% CI: 85.5–94.2%); effectiveness to avoid death from COVID-19; 67.7% (60.1–73.8%) effectiveness to avoid hospitalizations; and 26.3% (23.8–28.6%) effectiveness to reduce the risk of infection by SARS-CoV-2 relative to the unvaccinated cohort. Conclusions: The inactivated SARS-CoV-2 (Vero Cell) vaccine used in two doses has an acceptable effectiveness against death and risk of hospitalization, whereas it has less effectiveness in preventing COVID-19 infection.

Impact of variant of concern and vaccination status on COVID-19 infection virological dynamics in end stage kidney disease patients receiving haemodialysis.

BackgroundIt is unclear if variant of concern and vaccination status impact COVID‐19 infection virological dynamics in haemodialysis patients and affect de‐isolation protocol for dialysis centres.MethodWe performed a retrospective observational cohort study between February 2020 to September 2021, to examine the virological kinetics of vaccinated and unvaccinated haemodialysis patients with polymerase chain reaction (PCR)‐confirmed COVID‐19 infection of the delta and pre‐delta variants.ResultsOf the 38 subjects with PCR‐confirmed COVID‐19 infection, we found that individuals infected during the delta‐variant period had higher viral load at presentation and required longer duration to achieve a negative PCR swab, compared to those infected in the pre‐delta variant period. Time to achieve negative PCR swab was longest in unvaccinated individuals infected during delta‐variant period. However, vaccinated and unvaccinated individuals achieved high PCR cycle threshold value of ≥25 and ≥30 at similar timing.ConclusionOur study suggests that patients infected during delta‐variant period of COVID‐19 illness, have higher viral load at presentation and prolonged viral shedding, especially in the unvaccinated cohort. However, prolonged time to negative PCR is likely due to inactive virus shedding, and that conversion to negative PCR may not be a necessary pre‐requisite for de‐isolation.

Seropositivity of SARS-CoV-2 in an unvaccinated cohort in British Columbia, Canada: a cross-sectional survey with dried blood spot samples

ObjectivesGathering population-based data on prevalence of SARS-CoV-2 infection is vital to the public health response and planning. Current seroprevalence data in BC are limited with respect to considerations of how...

The Protective Effects of Influenza Vaccination in Elderly Patients with Breast Cancer in Taiwan: A Real-World Evidence-Based Study.

In elderly patients with newly diagnosed breast cancer, clarity is lacking regarding the effects of influenza vaccines, particularly on clinical outcomes. This study conducted two nationwide, population-based, and propensity score-matched cohorts to estimate and compare the protective effects of influenza vaccine in elderly women and elderly patients with breast cancer. Data were derived from the National Health Insurance Research Database and Cancer Registry Database. Generalized estimating equations (GEEs) were used to compare outcomes between the vaccinated and unvaccinated cohorts. Adjusted odds ratios (aORs) were used to estimate the relative risks, and stratified analyses in the breast cancer cohort were performed to further evaluate elderly breast cancer patients undergoing a variety of adjuvant therapies. The GEE analysis showed that the aORs of death and hospitalization, including for influenza and pneumonia, respiratory diseases, respiratory failure, and heart disease, did not significantly decrease in vaccinated elderly patients with newly diagnosed breast cancer. Conversely, the aORs of all influenza-related clinical outcomes were significantly decreased in elderly women. No protective effects of influenza vaccination were found in the elderly patients with a newly diagnosed breast cancer. More studies focusing on identifying strategies to improve the real-world effectiveness of influenza vaccination to the immunocompromised are needed. Our clinical outcomes will be valuable for future public health policy establishment and shared decision making for influenza vaccine use in elderly patients with newly diagnosed breast cancer. According to our findings, regular influenza vaccine administration for elderly patients with newly diagnosed breast cancer may be reconsidered, with potential contraindications for vaccination. On the other hand, implementing the vaccination of close contacts of patients with breast cancer may be a more important strategy for enhancing protection of those fragile patients.

Impact of health insurance type on access to vaccination and mortality due to COVID-19 on patients with cancer in Colombia: a cohort study

BackgroundIn Colombia, all paid workers earning minimum wage or higher contribute part of their salary for access to the national health-care system through a type of insurance called contributive plan, which supports the remaining low-income population that is enrolled on the subsidised plan. During the COVID-19 pandemic, Colombia documented high mortality rate in patients with cancer, with higher mortality among low-income patients, according to data from our national registry of COVID-19 infection in patients with cancer. The aim of this research was to establish the differential access to COVID-19 vaccination depending on health insurance type, and its impact on mortality due to COVID-19 infection.MethodsA cohort study was conducted with data from the Colombian National Cancer and COVID-19 Registry. Data were collected between June 1, 2021, when COVID-19 vaccines became available for patients with cancer in Colombia, and Oct 31, 2021. Included patients were aged 18 years or older, had a diagnosis of a solid tumour, were receiving active treatment or on follow-up, and had a confirmed SARS-CoV-2 infection. The cumulative incidence of mortality in the vaccinated and unvaccinated cohorts was compared. The estimation of the effect was done through relative risk (RR), and a multivariate analysis (generalised linear model, binomial family) was then done to estimate the effect of the type of health insurance.Findings896 patients were included. 470 (52%) were older than 60 years; 530 (59%) were women and 366 (41%) were men. 172 (19%) patients were vaccinated and 724 (81%) patients were not vaccinated (resulting in a ratio of 1:4). According to the type of health insurance, the vaccine was administered to 26 (12%) of 211 patients in the subsidised plan and to 146 (21%) of 685 patients in the contributive plan. The rate of vaccination according with socioeconomic status was 69 (16%) of 430 patients in the low-income group, 75 (23%) of 329 in middle-income group, and 12 (29%) of 42 in high-income group. The cumulative incidence of mortality for all causes was 17% (n=123) in the non-vaccinated cohort and 5% (n=8) in vaccinated cohort. The cumulative incidence of mortality per health-care insurance was 24% (n=50) in the subsidised plan and 12% (n=81) in the contributive plan. The adjusted RR for mortality was 3·4 (95% CI 1·7–6·8) in unvaccinated versus vaccinated patients, and 1·8 (1·3–2·4) in patients on the subsidised versus the contributive plan.InterpretationPatients on the subsidised health plan in Colombia had higher mortality due to COVID-19 infection and less access to vaccines than patients with a contributive plan. Strategies to promote COVID-19 vaccination for all patients with cancer should be strengthened, with implementation of special measures to improve care for the low-income population.FundingNone.

Effectiveness of COVID-19 Vaccination in Preventing All-Cause Mortality among Adults during the Third Wave of the Epidemic in Hungary: Nationwide Retrospective Cohort Study.

Our investigation aimed to describe the all-cause mortality rates by COVID-19 vaccination groups in Hungary for an epidemic period (1 April 2021–20 June 2021) and a nonepidemic period (21 June 2021–15 August 2021), and to determine the vaccines’ effectiveness in preventing all-cause mortality utilizing nonepidemic effectiveness measures to adjust for the healthy vaccinee effect (HVE). Sociodemographic status, comorbidity, primary care structural characteristics, and HVE-adjusted survival difference between fully vaccinated and unvaccinated cohorts in the epidemic period had been computed by Cox regression models, separately for each vaccine (six vaccines were available in Hungary). Hazard ratio (HR) reduction in epidemic period corrected with nonepidemic period’s HR with 95% confidence interval for each vaccine was used to describe the vaccine effectiveness (VE). The whole adult population (N = 6,404,702) of the country was followed in this study (4,026,849 fully vaccinated). Each vaccine could reduce the HVE-corrected all-cause mortality in the epidemic period (VEOxford/AstraZeneca = 0.592 [0.518–0.655], VEJanssen = 0.754 [0.628–0.838], VEModerna = 0.573 [0.526–0.615], VEPfizer-BioNTech = 0.487 [0.461–0.513], VESinopharm = 0.530 [0.496–0.561], and VESputnik V = 0.557 [0.493–0.614]). The HVE-corrected general mortality for COVID-19 vaccine cohorts demonstrated the real-life effectiveness of vaccines applied in Hungary, and the usefulness of this indicator to convince vaccine hesitants.

P1588: A SINGLE CENTER COMPARATIVE CLINICAL ANALYSIS OF THE SARS-COV-2 INFECTION BEFORE AND AFTER VACCINATION IN PATIENTS DIAGNOSED WITH HEMATOLOGIC MALIGNANCIES

Background: An impaired humoral and cellular immunogenicity to the mRNA SARS-CoV-2 vaccines has been reported in patients diagnosed with hematologic malignancies. Data regarding the effectiveness of SARS-CoV-2 vaccination on COVID-19 evolution an immunocompromised population are still scarce. Aims: To compare disease severity and mortality in a real-life cohort according to the vaccination status of patients diagnosed with hematologic malignancies developing COVID-19 disease. Methods: We retrospectively collected clinical data from the patients with a current or prior history of hematologic malignancy in the last 5 years at Vall d´Hebron Hospital whom suffered a SARS-CoV-2 infection. Patients were unvaccinated between March 2020 and May 2021, and partially or completely vaccinated between May 2021 and January 2022. The primary endpoint was COVID-related mortality according to vaccination status. Secondary endpoints included rate and length of hospitalization, ICU admission, need for supplemental oxygen including high flow oxygen therapy and mechanical ventilation, and severity of COVID-19 disease. Results: Overall, 113 vaccinated and 81 unvaccinated patients developed COVID-19. Both groups were similar in age (median 69 and 72 years, respectively), gender predominance, diagnosis (mainly lymphoproliferative diseases [58% and 53%]), and administered active treatment (mostly anti-CD20 monoclonal antibodies [38% and 37%]). In contrast, more patients received active treatment (78% vs. 48%; p=<0.001) in the vaccinated cohort. Vaccinated patients developed infection by the delta variant in 27% (17/62) and by the omicron variant in 73% of the sequenced cases (45/62). Genotype analysis of the variant in unvaccinated cases is ongoing. Despite the fact that 96% of patients received 2 vaccine doses and 73% also a third boost dose, in only 67% (59/88) of patients basal IgG anti-spike antibodies were detected after vaccination. In comparison with the unvaccinated cohort of patients, vaccinated patients had less severe (17% vs. 42%; p=0.01) and critical (13% vs 28%; p=0.03) COVID-19 infection, lower rates of hospitalization (42% vs. 90%; p=<0.001) with shorter length of stay (median 13 days (IQR 7-34) vs. 11 days (IQR 6-16), and fewer patients needed supplemental oxygen (34% vs. 73%; p=0). Admission rates to ICU were similar between both cohorts. Finally, mortality rate was lower in the vaccinated patients in comparison with the unvaccinated cohort (HR: 0.19 (95%CI 0.09, 0.38); p=<0.001). Of note, in hospitalized patients only, the mortality of the vaccinated cohort was also lower (HR: 0.38 (95%CI 0.19, 0.76); p=0.007). Among vaccinated patients who suffered a severe/critical infection, 52% did not have vaccine seroconversion. Of the vaccinated patients who died (11/113), 6/8 had negative anti-S IgG, 5/9 were infected by the delta variant and 4/9 by omicron, and 10/11 were on active treatment (5/11 with monoclonal antibodies). Image:Summary/Conclusion: In our series, despite the heterogeneity of infection by different viral variants and treatment availability for COVID-19 during the evolution of the pandemic, vaccination has been widely effective at reducing need of hospitalization, severity and mortality of the SARS-CoV-2 infection in hematological patients. Nevertheless, a subgroup of vaccinated patients remains with an adverse outcome and requires further identification and management improvement.

Characterizing Anchoring Bias in Vaccine Comparator Selection Due to Health Care Utilization With COVID-19 and Influenza: Observational Cohort Study.

BackgroundObservational data enables large-scale vaccine safety surveillance but requires careful evaluation of the potential sources of bias. One potential source of bias is the index date selection procedure for the unvaccinated cohort or unvaccinated comparison time (“anchoring”).ObjectiveHere, we evaluated the different index date selection procedures for 2 vaccinations: COVID-19 and influenza.MethodsFor each vaccine, we extracted patient baseline characteristics on the index date and up to 450 days prior and then compared them to the characteristics of the unvaccinated patients indexed on (1) an arbitrary date or (2) a date of a visit. Additionally, we compared vaccinated patients indexed on the date of vaccination and the same patients indexed on a prior date or visit.ResultsCOVID-19 vaccination and influenza vaccination differ drastically from each other in terms of the populations vaccinated and their status on the day of vaccination. When compared to indexing on a visit in the unvaccinated population, influenza vaccination had markedly higher covariate proportions, and COVID-19 vaccination had lower proportions of most covariates on the index date. In contrast, COVID-19 vaccination had similar covariate proportions when compared to an arbitrary date. These effects attenuated, but were still present, with a longer lookback period. The effect of day 0 was present even when the patients served as their own controls.ConclusionsPatient baseline characteristics are sensitive to the choice of the index date. In vaccine safety studies, unexposed index event should represent vaccination settings. Study designs previously used to assess influenza vaccination must be reassessed for COVID-19 to account for a potentially healthier population and lack of medical activity on the day of vaccination.

A Longitudinal Study of COVID-19 Sequelae and Immunity: Baseline Findings.

A substantial proportion of persons who develop COVID-19 report persistent symptoms after acute illness. Various pathophysiologic mechanisms have been implicated in the pathogenesis of postacute sequelae of SARS-CoV-2 infection (PASC). To characterize medical sequelae and persistent symptoms after recovery from COVID-19 in a cohort of disease survivors and controls. Cohort study. (ClinicalTrials.gov: NCT04411147). National Institutes of Health Clinical Center, Bethesda, Maryland. Self-referred adults with laboratory-documented SARS-CoV-2 infection who were at least 6 weeks from symptom onset were enrolled regardless of presence of PASC. A control group comprised persons with no history of COVID-19 or serologic evidence of SARS-CoV-2 infection, recruited regardless of their current health status. Both groups were enrolled over the same period and from the same geographic area. All participants had the same evaluations regardless of presence of symptoms, including physical examination, laboratory tests and questionnaires, cognitive function testing, and cardiopulmonary evaluation. A subset also underwent exploratory immunologic and virologic evaluations. 189 persons with laboratory-documented COVID-19 (12% of whom were hospitalized during acute illness) and 120 antibody-negative control participants were enrolled. At enrollment, symptoms consistent with PASC were reported by 55% of the COVID-19 cohort and 13% of control participants. Increased risk for PASC was noted in women and those with a history of anxiety disorder. Participants with findings meeting the definition of PASC reported lower quality of life on standardized testing. Abnormal findings on physical examination and diagnostic testing were uncommon. Neutralizing antibody levels to spike protein were negative in 27% of the unvaccinated COVID-19 cohort and none of the vaccinated COVID-19 cohort. Exploratory studies found no evidence of persistent viral infection, autoimmunity, or abnormal immune activation in participants with PASC. Most participants with COVID-19 had mild to moderate acute illness that did not require hospitalization. The prevalence of reported PASC was likely overestimated in this cohort because persons with PASC may have been more motivated to enroll. The study did not capture PASC that resolved before enrollment. A high burden of persistent symptoms was observed in persons after COVID-19. Extensive diagnostic evaluation revealed no specific cause of reported symptoms in most cases. Antibody levels were highly variable after COVID-19. Division of Intramural Research, National Institute of Allergy and Infectious Diseases.

MP37-12 COVID-19 VACCINATION IS ASSOCIATED WITH A DECREASED RISK OF ORCHITIS AND/OR EPIDIDYMITIS IN MEN

You have accessJournal of UrologyCME1 May 2022MP37-12 COVID-19 VACCINATION IS ASSOCIATED WITH A DECREASED RISK OF ORCHITIS AND/OR EPIDIDYMITIS IN MEN Chase Carto, Sirpi Nackeeran, and Ranjith Ramasamy Chase CartoChase Carto More articles by this author , Sirpi NackeeranSirpi Nackeeran More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002591.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Vaccine hesitancy is a major public health obstacle to fighting the ongoing COVID-19 epidemic. Due to studies that show COVID-19 infection can affect sperm parameters and lead to orchitis, the public are concerned about how the COVID vaccines may impact male reproduction. In this study, we investigated the association between COVID-19 vaccination and risk of developing orchitis and/or epididymitis outcomes in a cohort of men using a large, US-based, electronic health record database (TriNetX). METHODS: We queried the database for male patients ages 12 years and older who received a single-dose COVID-19 vaccine or at least 1 dose of a 2-dose regimen using specific ICD-10 medication and procedure codes and compared them to a cohort of men who had no record of any COVID-19 vaccination in their health record. The outcome for analysis was diagnosis of orchitis and/or epididymitis (ICD-10-CM: N45-N45.4, N51) between 1-9 months after the index event of COVID-19 vaccination. The two cohorts were balanced for the following potentially confounding variables through propensity score matching: age at index event, race, urinary tract infection, and unspecified sexually transmitted disease. We determined the association between COVID-19 vaccination and orchitis and/or epididymitis using logistic regression analysis with statistical significance assessed at p<0.05. RESULTS: We identified 663,774 men in the database who had received at least one dose of a COVID-19 vaccine, and 9,985,154 who did not. Prior to propensity score matching, 0.051% of men in the vaccinated cohort and 0.083% in the unvaccinated cohort received a diagnosis of orchitis and/or epididymitis in the time window (OR=0.619; 95% CI: 0.556 - 0.690; p<0.0001). After balancing for potentially confounding variables, the COVID-19 vaccine remained protective against development of orchitis and/or epididymitis (OR=0.568; 95% CI: 0.497 - 0.649; p<0.0001). CONCLUSIONS: In this retrospective cohort study, we demonstrated that receiving a COVID-19 vaccine is associated with a decreased risk of developing orchitis and/or epididymitis. These findings have important implications in the counseling of patients that are hesitant to receive the COVID-19 vaccine and refute misinformed claims on social media regarding the effect of the vaccines on male fertility. Source of Funding: This work was supported by National Institutes of Health Grant R01 DK130991 and the Clinician Scientist Development Grant from the American Cancer Society to Ranjith Ramasamy © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e613 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Chase Carto More articles by this author Sirpi Nackeeran More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement PDF DownloadLoading ...

Human papillomavirus prevalence among unvaccinated young female college students in Botswana: A cross-sectional study

Background. Human papillomavirus (HPV) is a sexually transmitted infection and a causative agent of cervical cancer. It is common in adolescent girls and young women, and the majority of infections are transient and asymptomatic. In Botswana, there are currently no data on the HPV prevalence against which the impact of prophylactic HPV vaccines can be measured. Objectives. To establish a baseline HPV prevalence in an unvaccinated cohort of young women. Methods. Women aged ≥18 years were recruited from the University of Botswana between September 2016 and May 2020. Demographic and behavioural characteristics of participants were collected. Subsequently, cervicovaginal swabs were obtained and tested for HPV using polymerase chain reaction-restriction fragment length polymorphism. We determined the prevalent HPV types, and evaluated the risk factors associated with HPV positivity. Results. A total of 978 young women were recruited. Overall, there were 589 (60.2%) participants with HPV infection and 12 (1.2%) with HIV. The median (interquartile range) age of the study participants was 19 (18 - 20) years. Multivariate logistic regression analysis showed that significant factors associated with HPV positivity were sexual activity (adjusted odds ratio (aOR) 2.06; 95% confidence interval (CI) 1.49 - 2.63; p&lt;0.001), number of sex partners ≥3 (aOR 2.10; 95% CI 1.39 - 3.18; p&lt;0.001), and smoking (aOR 2.00; 95% CI 1.26 - 3.20; p=0.004). Conclusion. Our results demonstrate for the first time the prevalence of HPV in unvaccinated young women in Botswana. We found a high prevalence of HPV infection, with statistical differences with different risk factors. This finding supports the need for HPV vaccination strategies for females prior to sexual debut to reduce the future burden of cervical cancer in Botswana.

Health and economic burden associated with 15-valent pneumococcal conjugate vaccine serotypes in Korea and Hong Kong

ABSTRACT Use of pneumococcal conjugate vaccines (PCVs) has greatly reduced the incidence of invasive pneumococcal disease (IPD). V114 (VAXNEUVANCE™, Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. Kenilworth, NJ, USA) is a 15-valent PCV currently approved in adults in the United States, containing the 13 serotypes in licensed PCV13 and 2 additional serotypes (22F and 33F) which are important contributors to residual pneumococcal disease. This study quantified the health and economic burden of IPD attributable to V114 serotypes in hypothetical birth cohorts from Korea and Hong Kong. A Markov model was used to estimate the case numbers and costs of IPD in unvaccinated birth cohorts over 20 years. The model was applied to 3 scenarios in Korea (pre-PCV7, pre-PCV13, and post-PCV13) and to 2 scenarios in Hong Kong (pre-PCV7 and post-PCV13). For Korea, the model predicted 62, 26, and 8 IPD cases attributable to V114 serotypes in the pre-PCV7, pre-PCV13, and post-PCV13 scenarios, respectively. Costs of V114-type IPD fell from $1.691 million pre-PCV7 to $.212 million post-PCV13. For Hong Kong, the model estimated 62 V114-associated IPD cases in the pre-PCV7 scenario and 46 in the post-PCV13 scenario. Costs attributed to all V114 serotypes were $2.322 million and $1.726 million in the pre-PCV7 and post-PCV13 periods, respectively. Vaccine-type serotypes are predicted to cause continuing morbidity and cost in Korea (19A) and Hong Kong (3 and 19A). New pediatric pneumococcal vaccines must continue to protect against serotypes in licensed vaccines to maintain disease reduction, while extending coverage to non-vaccine serotypes.