Unvaccinated Cohort Research Articles

Comparison of SARS-COV-2 humoral response between rheumatoid arthritis, psoriatic arthritis and spondyloarthritis patients and controls in two unvaccinated cohorts.

To compare the humoral response after a SARS-CoV-2 infection in an inflammatory rheumatic disease population with a healthy control population in a case-control study. Cases: between March and September 2021, all consecutive unvaccinated patients followed for rheumatoid arthritis (RA), spondyloarthritis (SpA) or psoriatic arthritis (PsA) in 16 hospitals in France were systematically screened with a SARS-CoV-2 serological test. Patients with a positive test were included in the COVID-RIC-2 cohort. between June and July 2020, healthcare professionals working in the Toulouse University Hospital were screened with a SARS-CoV-2 serological test. Those with a positive test were included in the COVID-BIOTOUL cohort and matched to those from COVID-RIC-2 by age, sex and time-sampling on infection date. total SARS-CoV-2 antibody titres were centrally measured and compared. 95 patients from COVID-RIC-2 (mean age 49 years, 76% females, median delay of COVID infection: 149 days) including 48 RA, 33 SpA and 14 PsA were compared to 95 matched controls. Globally, there was no significant difference of SARS-CoV-2 antibody titres between both populations: 155 Binding Antibody Units (BAU) (IQR:7-376) in COVID-RIC-2 vs. 120 BAU (IQR:35-320) in COVID-BIOTOUL. There was a trend towards higher antibody titres in patients from COVID-RIC-2 with severe COVID-19 symptoms. In COVID-RIC-2, there was no impact of age, sex, time-sampling or underlying disease on antibody titres and patients taking glucocorticoids, abatacept or rituximab trended toward having lower antibody titres after COVID-19 infection. This study provides reassuring data on humoral response after COVID-19 infection in patients treated with disease-modifying anti-rheumatic drugs.

Outpatient randomized controlled trials to reduce COVID-19 hospitalization: Systematic review and meta-analysis.

This COVID-19 outpatient randomized controlled trials (RCTs) systematic review compares hospitalization outcomes amongst four treatment classes over pandemic period, geography, variants, and vaccine status.Outpatient RCTs with hospitalization endpoint were identified in Pubmed searches through May 2023, excluding RCTs <30 participants (PROSPERO-CRD42022369181). Risk of bias was extracted from COVID-19-NMA, with odds ratio utilized for pooled comparison.Searches identified 281 studies with 61 published RCTs for 33 diverse interventions analyzed. RCTs were largely unvaccinated cohorts with at least one COVID-19 hospitalization risk factor. Grouping by class, monoclonal antibodies (mAbs)(OR = 0.31 [95% CI = 0.24-0.40]) had highest hospital reduction efficacy, followed by COVID-19 convalescent plasma(CCP) (OR = 0.69 [95% CI = 0.53-0.90]), small molecule antivirals (OR = 0.78 [95% CI = 0.48-1.33]), and repurposed drugs (OR = 0.82 [95% CI: 0.72-0.93]). Earlier in disease onset interventions performed better than later. This meta-analysis allows approximate head-to-head comparisons of diverse outpatient interventions.Omicron sublineages (XBB and BQ.1.1) are resistant to mAbsDespite trial heterogeneity, this pooled comparison by intervention class indicated oral antivirals are the preferred outpatient treatment where available, but intravenous interventions from convalescent plasma to remdesivir are also effective and necessary in constrained medical resource settings or for acute and chronic COVID-19 in the immunocompromised.

2332. COVID-19 Primary Series and Booster Vaccination and Potential for Immune Imprinting

Abstract Background Epidemiological evidence for immune imprinting was investigated in immune histories related to vaccination in Qatar from onset of the omicron wave, on December 19, 2021, through September 15, 2022. Methods Matched, retrospective, cohort studies were conducted to investigate differences in incidence of SARS-CoV-2 reinfection in the national cohort of persons who had a primary omicron infection, but different vaccination histories. History of primary-series (two-dose) vaccination was compared to that of no vaccination, history of booster (three-dose) vaccination was compared to that of two-dose vaccination, and history of booster vaccination was compared to that of no vaccination. Associations were estimated using Cox proportional-hazards regression models. Results The adjusted hazard ratio for incidence of reinfection, including also adjustment for differences in testing rate, in the two-dose cohort relative to that in the unvaccinated cohort was 0.43 (95% CI: 0.39-0.49). The adjusted hazard ratio comparing incidence of reinfection in the three-dose cohort to that in the two-dose cohort was 1.47 (95% CI: 1.23-1.76). The adjusted hazard ratio comparing incidence of reinfection in the three-dose cohort to that in the unvaccinated cohort was 0.57 (95% CI: 0.48-0.68). All adjusted hazard ratios appeared stable over 6 months of follow-up. Divergence in cumulative incidence curves in all comparisons increased markedly when incidence was dominated by BA.4/BA.5 and BA.2.75*. No reinfection in any cohort progressed to severe, critical, or fatal COVID-19. Conclusion History of primary-series vaccination enhanced immune protection against omicron reinfection, but history of booster vaccination compromised protection against omicron reinfection. These findings do not undermine the short-term public health utility of booster vaccination. Disclosures All Authors: No reported disclosures

Association between long COVID and vaccination: A 12-month follow-up study in a low- to middle-income country.

There is a lack of estimates regarding the at-risk population associated with long COVID in Pakistan due to the absence of prospective longitudinal studies. This study aimed to determine the prevalence of long COVID and its association with disease severity and vaccination status of the patient. This prospective cohort study was conducted at the Aga Khan University Hospital and recruited patients aged > 18 years who were admitted between February 1 and June 7, 2021. During this time, 901 individuals were admitted, after excluding patients with missing data, a total of 481 confirmed cases were enrolled. The mean age of the study population was 56.9±14.3 years. Among patients with known vaccination status (n = 474), 19%(n = 90) and 19.2%(n = 91) were fully and partially vaccinated, respectively. Severe/critical disease was present in 64%(n = 312). The mortality rate following discharge was 4.58%(n = 22). Around 18.9%(n = 91) of the population required readmission to the hospital, with respiratory failure (31.8%, n = 29) as the leading cause. Long COVID symptoms were present in 29.9%(n = 144), and these symptoms were more prevalent in the severe/critical (35.5%, n = 111) and unvaccinated (37.9%, n = 105) cohort. The most prominent symptoms were fatigue (26.2%, n = 126) and shortness of breath (24.1%, n = 116), followed by cough (15.2%, n = 73). Vaccinated as compared to unvaccinated patients had lower readmissions (13.8% vs. 21.51%) and post-COVID pulmonary complications (15.4% vs. 24.2%). On multivariable analysis, after adjusting for age, gender, co-morbidity, and disease severity, lack of vaccination was found to be an independent predictor of long COVID with an Odds ratio of 2.42(95% CI 1.52-3.84). Fully and partially vaccinated patients had 62% and 56% reduced risk of developing long COVID respectively. This study reports that the patients continued to have debilitating symptoms related to long COVID, one year after discharge, and most of its effects were observed in patients with severe/critical disease and unvaccinated patients.

Forensic analysis of the 38 subject deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial

The analysis reported here is unique in that it is the first study of the original data from the Pfizer/BioNTech BNT162b2 mRNA vaccine clinical trial (CA4591001) to be carried out by a group unaffiliated with the trial sponsor. Our study is a forensic analysis of the 38 trial subjects who died between July 27, 2020, the start of Phase 2/3 of the clinical trial, and March 13, 2021, the data end date of their 6-Month Interim Report. Phase 2/3 of the trial involved 44,060 subjects who were equally distributed into two groups and received Dose 1 of either the BNT162b2 mRNA vaccinated or the Placebo control (0.9% normal saline). At Week 20, when the BNT162b2 mRNA vaccine received Emergency Use Authorization from the U.S. FDA, subjects in the placebo arm were given the option to be BNT162b2 vaccinated. All but a few accepted. Surprisingly, a comparison of the number of subject deaths per week during the 33 Weeks of this study found no significant difference between the number of deaths in the vaccinated versus placebo arms for the first 20 weeks of the trial, the placebo-controlled portion of the trial. After Week 20, as subjects in the Placebo were unblinded and vaccinated, deaths among this still unvaccinated cohort of this group slowed and eventually plateaued. Deaths in the BNT162b2 vaccinated subjects continued at the same rate. Our analysis revealed inconsistencies between the subject data listed in the 6-Month Interim Report and publications authored by Pfizer/BioNTech trial site administrators. Most importantly, we found evidence of an over 3.7-fold increase in number of deaths due to cardiovascular events in BNT162b2 vaccinated subjects compared to Placebo controls. This significant adverse event signal was not reported by Pfizer/BioNTech. Potential sources of these data inconsistencies are identified.

Effectiveness of various COVID-19 vaccine regimens among 10.4 million patients from the National COVID Cohort Collaborative during Pre-Delta to Omicron periods – United States, 11 December 2020 to 30 June 2022

ObjectiveThis study reports the vaccine effectiveness (VE) of COVID-19 vaccine regimens in the United States, based on the National COVID Cohort Collaborative (N3C) database. MethodsData from 10.4 million adults, enrolled in the N3C from 11 December 2020 to 30 June 2022, were analyzed. VE against infection and death outcomes were evaluated across 13 vaccine regimens in recipient cohorts during the Pre-Delta, Delta, and Omicron periods. VE was estimated as (1-odds ratio) × 100% by multivariate logistic regression, using the unvaccinated cohort as reference. ResultsNatural immunity showed a highly protective effect (70.33%) against re-infection, but the mortality risk among the unvaccinated population was increased after re-infection; vaccination following infection reduced the risk of re-infection and death. mRNA-1273 full vaccination plus mRNA-1273 booster showed the highest anti-infection effectiveness (47.59%) (95% CI, 46.72–48.45) in the overall cohort. In the type 2 diabetes cohort, VE against infection was highest with BNT162b2 full vaccination plus mRNA-1273 booster (61.19%) (95% CI, 53.73–67.75). VE against death was also highest with BNT162b2 full vaccination plus mRNA-1273 booster (89.56%) (95% CI, 85.75–92.61). During the Pre-Delta period, all vaccination regimens showed an anti-infection effect; during the Delta period, only boosters, mixed vaccines, and Ad26.COV2.S vaccination exhibited an anti-infection effect; during the Omicron period, none of the vaccine regimens demonstrated an anti-infection effect. Irrespective of the variant period, even a single dose of mRNA vaccine offered protection against death, thus demonstrating survival benefit, even in the presence of infection or re-infection. Similar patterns were observed in patients with type 2 diabetes. ConclusionsAlthough the anti-infection effect declined as SARS-CoV-2 variants evolved, all COVID-19 mRNA vaccines had sustained effectiveness against death. Vaccination was crucial for preventing re-infection and reducing the risk of death following SARS-CoV-2 infection.

Risk of Worsening Heart Failure and All-Cause Mortality Following COVID-19 Vaccination in Patients With Heart Failure: A Nationwide Real-World Safety Study.

Patients with heart failure are vulnerable to the SARS-CoV-2 infection. However, limited evidence exists on the safety of the SARS-CoV-2 mRNA vaccines in this patient population. The objective of this study was to investigate the risk of all-cause mortality, worsening heart failure, venous thromboembolism, and myocarditis associated with the mRNA vaccines in patients with heart failure. Using Danish nationwide registries, 2 cohorts were constructed: (1) all prevalent heart failure patients in 2019 aged 40 to 95 years and (2) all prevalent heart failure patients in 2021 aged 40 to 95 years, who were vaccinated with either of the 2 mRNA vaccines (BNT162B2 or mRNA-1273). The patients in the 2 cohorts were matched 1:1 using exact exposure matching on age, sex, and duration of heart failure. To estimate standardized absolute risks, outcome-specific Cox regression analyses were performed. The total study population comprised 101 786 patients. The median age of the study population was 74 years (interquartile range, 66-81). The standardized risk of all-cause mortality within 90 days was 2.23% (95% CI, 2.10%-2.36%) in the vaccinated cohort and 2.56% (95% CI, 2.43%-2.70%) in the unvaccinated cohort (90-day risk difference, -0.33% [95% CI, -0.52% to -0.15%]). The standardized risk of worsening heart failure within 90 days was 1.10% (95% CI, -1.01% to 1.19%) in the 2021 (vaccinated) cohort and 1.08% (95% CI, 0.99%-1.17%) in the 2019 (unvaccinated) cohort (risk difference, 0.02% [95% CI, -0.11% to 0.15%]). No significant differences were found regarding venous thromboembolism or myocarditis. Receiving an mRNA vaccine was not associated with an increased risk of worsening heart failure, myocarditis, venous thromboembolism, or all-cause mortality.

Quadrivalent HPV vaccine effectiveness against anogenital warts: A registry-based study of 2,2 million individuals

BackgroundIn 2009, Norway initiated routine quadrivalent HPV (qHPV) vaccination for girls at 12–13 years of age to protect against virus types causing cervical cancer, HPV16/18, and HPV6/11 which cause anogenital warts (AGW). We wanted to investigate qHPV vaccine effectiveness (VE) against AGW in females before and after first AGW episode and to assess the impact of female vaccination in males. Materials and methodsQHPV vaccination and AGW episodes were collected for the time period 2006–2016 for birth cohorts 1975–2003. Cox models were applied to age at first, as well as at second AGW episode. Finally, we estimated the impact of the female vaccination program on unvaccinated males. ResultsThe VE against the first episode of AGW was strongly dependent on vaccination age, with hazard ratios (HRs) compared to unvaccinated individuals of 0.2, 0.2, 0.3, 0.5, 1.0, 1.3, and 2.7, for age groups of ⩽13, 14–15, 16–17, 18–19, 20–24, 25–29, and 30+ years at first vaccination, respectively. Among women who had suffered a first episode of AGW, subsequent qHPV vaccination did not protect against a second episode, with HRs of 0.8, 1.0, and 1.4, for age groups of ⩽17, 18–24, and 25+ years at first vaccination. A gradually decreasing AGW risk was seen in unvaccinated male cohorts neighboring the first routinely vaccinated female 1997 cohort. ConclusionsWhen administered before 14 years of age, qHPV vaccination reduced the probability of AGW about fivefold. The effect decreased sharply with vaccination age, and was not significant among women vaccinated after age 20 years. QHPV administered after the first AGW episode did not protect against a second AGW episode. Herd effects were indicated in unvaccinated males, as we observed a gradual decrease in AGW rates from the 1993 male birth cohort and onwards.

Breakthrough COVID-19 infections - Analyzing our experience.

There are many cases of post-vaccination COVID-19 globally. Also, literature on serum antibodies after vaccination is abundant. Our research focuses on breakthrough infections reported at our institution during the third wave of COVID-19. A total of 177 people recruited at the Indus Hospital Karachi between May to September 2021 with COVID-19 infection were divided into vaccinated, partially vaccinated, and unvaccinated cohorts. Furthermore, a subset of the vaccinated cohort was tested for anti-NP and anti-S antibodies. There were 119 patients with breakthrough infection, however, 74% had mild symptoms. The antibodies against NP and S were found at a higher level in those who had a breakthrough infection in comparison to healthy vaccinated controls. Vaccination does not prevent disease but does confer some immunity causing less severe infection.

Risk of Noninfectious Uveitis after Coronavirus Disease 2019 Vaccination in a United States Claims Database

To assess noninfectious uveitis (NIU) risk after coronavirus disease 2019 (COVID-19) vaccination in patients without a history of uveitis. A retrospective matched cohort study and self-controlled case series (SCCS) analysis using a longitudinal data asset with claims data from the OptumLabs Data Warehouse from December 11, 2020, through November 30,2021. The matched cohort analysis included patients continuously enrolled for 730 days before December 11, 2020, who received a COVID-19 vaccination during the study period. This COVID-19-vaccinated group was matched to a COVID-19-unvaccinated historical cohort enrolled in 2018 and 2019. The SCCS design included individuals from the vaccinated cohort who experienced an NIU event during the study period. Enrollees with a history of uveitis were excluded. Hazard ratios (HRs) were calculated using Cox proportional hazards models in the matched cohort design. Incidence rate ratios (IRRs) comparing NIU incidence in exposed risk periods after vaccination and unexposed control periods within individuals were calculated using conditional Poisson regression models in the SCCS design. Models were adjusted for age, recent receipt of non-COVID-19 vaccinations, corticosteroid or immunosuppressive use, and smoking history. Subgroup analyses were conducted by vaccination type and age group. Rates of NIU identified with International Classification of Diseases, Tenth Revision, codes. The matched cohort analysis included 4 611 378 patients, with 2 305 689 per cohort. The adjusted HR comparing NIU incidence in the COVID-19-vaccinated and unvaccinated cohort was 0.91 (95% confidence interval [CI], 0.75-1.10; P= 0.33). The SCCS analysis included 686 patients. The IRR comparing NIU risk after vaccination with risk during control intervals was 1.05 (95% CI, 0.89-1.23; P= 0.57). An increased risk was found in the subgroup aged 5 to 44 years (IRR, 1.40; 95% CI, 1.04-1.87; P= 0.024). The matched cohort and SCCS analyses did not detect increased NIU risk after COVID-19 vaccination overall in individuals without history of uveitis, providing reassurance about the vaccine's safety. The finding of increased risk in the youngest subgroup suggests heightened immune responses in younger individuals, warranting further investigation. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Risk of herpes zoster following mRNA COVID-19 vaccine administration

ABSTRACTBackgroundAdverse events following mRNA COVID-19 vaccines, including herpes zoster (HZ), have been reported. We conducted a cohort study to evaluate the association between mRNA COVID-19 vaccination and subsequent HZ at Kaiser Permanente Southern California (KPSC).Research design and methodsThe vaccinated cohort consisted of KPSC members who received their first dose of mRNA COVID-19 vaccine (mRNA-1273 and BNT162b2) during 12/2020–05/2021 and were matched to unvaccinated individuals on age and sex. Incident HZ cases occurring within 90 days of follow-up were identified by diagnosis codes and antiviral medications. Cox proportional hazards models estimated adjusted hazard ratios (aHR), comparing HZ incidence between the vaccinated and unvaccinated cohorts.ResultsCohort included 1,052,362 mRNA-1273 recipients, 1,055,461 BNT162b2 recipients, and 1,020,334 comparators. Compared to unvaccinated individuals, aHR for HZ up to 90 days after the second dose of mRNA-1273 and BNT162b2 was 1.14 (1.05–1.24) and 1.12 (1.03–1.22), respectively. In those aged ≥50 years not vaccinated with zoster vaccine, aHR was also increased after the second dose of mRNA-1273 (1.18 [1.06–1.33]) and BNT162b2 (1.15 [1.02–1.29]) vaccine vs. unvaccinated individuals.ConclusionsOur findings suggest a potential increased risk of HZ after a second dose of mRNA vaccines, potentially driven by the increased risk in individuals aged ≥50 years without history of zoster vaccination.

Use of sotrovimab in vaccinated versus unvaccinated COVID-19 patients in a resource-limited emergency department during the omicron surge.

The treatment of outpatient COVID-19 patients at high risk of disease progression has been challenging, as both the virus and available therapeutics change. Here, we sought to evaluate the effect of vaccination status on the use of sotrovimab during the early phase of the Omicron surge. This was a retrospective observational study performed at El Centro Regional Medical Center, a rural hospital on the southern Californian border. The electronic medical record was queried for all emergency department (ED) patients who received an infusion of sotrovimab between January 6 and February 6, 2022. We obtained patient demographics, COVID-19 vaccination status, medical comorbidities, and whether patients returned to the ED within 30 days. We stratified our cohort according to vaccination status and performed a multivariable logistic regression model to evaluate the relationship between these factors. One hundred seventy patients received an infusion of sotrovimab in the ED. The patient cohort had a median age of 65 years, 78.2% were Hispanic, and obesity (63.5%) was the most common comorbidity. A total of 73.5% of patients were vaccinated against COVID-19. A total of 12/125 (9.6%) of vaccinated patients returned to the ED within 30 days, versus 10/45 (22.2%) in the unvaccinated cohort, which was statically significant (P=0.03). The presence of medical comorbidities was not associated with the primary outcome. Of patients who received sotrovimab, those who were vaccinated were less likely to return to the ED within 30 days compared to those who were unvaccinated. Given the effectiveness of the COVID-19 vaccination campaign, and with the emergence of new variants, it is unclear what role monoclonal antibody therapy should play in the treatment of outpatient COVID-19 patients.

Risk assessment of retinal vascular occlusion after COVID-19 vaccination

Coronavirus disease 2019 (COVID-19) vaccines are associated with several ocular manifestations. Emerging evidence has been reported; however, the causality between the two is debatable. We aimed to investigate the risk of retinal vascular occlusion after COVID-19 vaccination. This retrospective cohort study used the TriNetX global network and included individuals vaccinated with COVID-19 vaccines between January 2020 and December 2022. We excluded individuals with a history of retinal vascular occlusion or those who used any systemic medication that could potentially affect blood coagulation prior to vaccination. To compare the risk of retinal vascular occlusion, we employed multivariable-adjusted Cox proportional hazards models after performing a 1:1 propensity score matching between the vaccinated and unvaccinated cohorts. Individuals with COVID-19 vaccination had a higher risk of all forms of retinal vascular occlusion in 2 years after vaccination, with an overall hazard ratio of 2.19 (95% confidence interval 2.00–2.39). The cumulative incidence of retinal vascular occlusion was significantly higher in the vaccinated cohort compared to the unvaccinated cohort, 2 years and 12 weeks after vaccination. The risk of retinal vascular occlusion significantly increased during the first 2 weeks after vaccination and persisted for 12 weeks. Additionally, individuals with first and second dose of BNT162b2 and mRNA-1273 had significantly increased risk of retinal vascular occlusion 2 years following vaccination, while no disparity was detected between brand and dose of vaccines. This large multicenter study strengthens the findings of previous cases. Retinal vascular occlusion may not be a coincidental finding after COVID-19 vaccination.

Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy

Bell palsy (BP) has been reported as an adverse event following the SARS-CoV-2 vaccination, but neither a causative relationship nor a higher prevalence than in the general population has been established. To compare the incidence of BP in SARS-CoV-2 vaccine recipients vs unvaccinated individuals or placebo recipients. A systematic search of MEDLINE (via PubMed), Web of Science, Scopus, Cochrane Library, and Google Scholar from the inception of the COVID-19 report (December 2019) to August 15, 2022. Articles reporting BP incidence with SARS-CoV-2 vaccination were included. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline and was conducted with the random- and fixed-effect models using the Mantel-Haenszel method. The quality of the studies was evaluated by the Newcastle-Ottawa Scale. The outcomes of interest were to compare BP incidence among (1) SARS-CoV-2 vaccine recipients, (2) nonrecipients in the placebo or unvaccinated cohorts, (3) different types of SARS-CoV-2 vaccines, and (4) SARS-CoV-2-infected vs SARS-CoV-2-vaccinated individuals. Fifty studies were included, of which 17 entered the quantitative synthesis. Pooling 4 phase 3 randomized clinical trials showed significantly higher BP in recipients of SARS-CoV-2 vaccines (77 525 vaccine recipients vs 66 682 placebo recipients; odds ratio [OR], 3.00; 95% CI, 1.10-8.18; I2 = 0%). There was, however, no significant increase in BP after administration of the messenger RNA SARS-CoV-2 vaccine in pooling 8 observational studies (13 518 026 doses vs 13 510 701 unvaccinated; OR, 0.70; 95% CI, 0.42-1.16; I2 = 94%). No significant difference was found in BP among 22 978 880 first-dose recipients of the Pfizer/BioNTech vaccine compared with 22 978 880 first-dose recipients of the Oxford/AstraZeneca vaccine (OR, 0.97; 95% CI, 0.82-1.15; I2 = 0%). Bell palsy was significantly more common after SARS-CoV-2 infection (n = 2 822 072) than after SARS-CoV-2 vaccinations (n = 37 912 410) (relative risk, 3.23; 95% CI, 1.57-6.62; I2 = 95%). This systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2-vaccinated vs placebo groups. The occurrence of BP did not differ significantly between recipients of the Pfizer/BioNTech vs Oxford/AstraZeneca vaccines. SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccination.

Risk of COVID-19 among unvaccinated and vaccinated patients with systemic lupus erythematosus: a general population study

ObjectiveTo compare the risk of SARS-CoV-2 infection and its related severe sequelae between patients with systemic lupus erythematosus (SLE) and the general population according to COVID-19 vaccination status.MethodsWe performed cohort...

Maximizing the cost-effectiveness of cervical screening in the context of routine HPV vaccination by optimizing screening strategies with respect to vaccine uptake: a modeling analysis

BackgroundRegarding primary and secondary cervical cancer prevention, the World Health Organization proposed the cervical cancer elimination strategy that requires countries to achieve 90% uptake of human papillomavirus (HPV) vaccines and 70% screening uptake. The optimal cervical screening strategy is likely different for unvaccinated and vaccinated cohorts upon national HPV immunization. However, health authorities typically only provide a one-size-fits-all recommendation for the general population. We aimed to evaluate the cost-effectiveness for determining the optimal screening strategies for vaccinated and unvaccinated cohorts.MethodsWe considered the women population in Hong Kong which has a unique HPV infection and cervical cancer epidemiology compared to other regions in China and Asia. We used mathematical models which comprise a deterministic age-structured compartmental dynamic component and a stochastic individual-based cohort component to evaluate the cost-effectiveness of screening strategies for cervical screening. Following the recommendations in local guidelines in Hong Kong, we considered strategies that involved cytology, HPV testing, or co-testing as primary cervical screening. We also explored the impacts of adopting alternative de-intensified strategies for vaccinated cohorts. The 3-year cytology screening was used as the base comparator while no screening was also considered for vaccinated cohorts. Women’s lifetime life years, quality-adjusted life years, and costs of screening and treatment were estimated from the societal perspective based on the year 2022 and were discounted by 3% annually. Incremental cost-effectiveness ratios (ICERs) were compared to a willingness to pay (WTP) threshold of one gross domestic product per capita (US $47,792). Probabilistic and one-way sensitivity analyses were conducted.ResultsAmong unvaccinated cohorts, the strategy that adds reflex HPV to triage mild cytology abnormality generated more life years saved than cytology-only screening and could be a cost-effective alternative. Among vaccinated cohorts, when vaccine uptake was 85% (based on the uptake in 2022), all guideline-based strategies (including the cytology-only screening) had ICERs above the WTP threshold when compared with no screening if the vaccine-induced protection duration was 20 years or longer. Under the same conditions, HPV testing with genotyping triage had ICERs (compared with no screening) below the WTP threshold if the routine screening interval was lengthened to 10 and 15 years or screening was initiated at ages 30 and 35 years.ConclusionsHPV testing is a cost-effective alternative to cytology for vaccinated cohorts, and the associated optimal screening frequency depends on vaccine uptake. Health authorities should optimize screening recommendations by accounting for population vaccine uptake.

Preliminary results of COVID-19 vaccination among Taiwanese pregnant women: A single-center, prospective, case-control study.

To evaluate the impacts of messenger RNA coronavirus disease 2019 (COVID-19) vaccines in Taiwanese pregnant women in terms of obstetrical and neonatal outcomes. The authors prospectively followed up 450 pregnant women receiving vaccination at a single center. Patients recorded prespecified adverse reactions via a mobile application up to 30 days after the first and second doses. Obstetrical and neonatal outcomes were compared with those of pregnant women, during the same period, who did not undergo vaccination. Among the 387 women who received the first dose and were followed up for 30 days, injection site pain, fatigue, injection site swelling, muscle ache, and headache were the most prevalent side effects. There were 4.7-, 5.7-, 7.1-, and 9.3-fold increases in fatigue, injection site swelling, muscle ache, and headache, respectively, among the 231 women who received the second dose. Most of the side effects resolved by 14 days and all resolved by 30 days after each doses. There were no significant differences (P > 0.05) in obstetrical and neonatal morbidity or mortality between the vaccinated and unvaccinated cohorts. No serious adverse reactions were noted among pregnant women receiving messenger RNA vaccinations with comparable obstetrical and neonatal outcomes to unvaccinated pregnant women.

COVID-19 vaccination and all-cause and non-COVID-19 mortality. A revaluation of a study carried out in an Italian Province.

The COVID-19 vaccination prevents COVID-19 specific mortality. Well planned population-based studies, however, are necessary to evaluate the overall effectiveness of vaccination programmes. A study carried out in the province of Pescara is used to illustrate the potential biases that may affect such studies. The Pescara study analysed total and non-COVID-19 mortality and the occurrence of Potentially Vaccine-Related Serious Adverse Events (PVR-SAEs) in vaccinated and unvaccinated people, from January 2021, when vaccines became available, to July 2022. The study reported a lower probability of both total and non-COVID-19 death in vaccinated people. However, the authors did not include in the denominator of the unvaccinated cohort the population experience of the vaccinated cohort before vaccination (immortal time bias). Correcting the denominator of the unvaccinated cohort, the crude death rate of vaccinated and unvaccinated persons becomes the same. For the same reason, the unvaccinated non-COVID-19 mortality was overestimated, as was the mortality of people receiving only one or two vaccine doses. Confounding by indication and the healthy vaccinee bias will also be discussed, as well as the bias deriving by not considering the evolution of risk over time.

Human mpox (monkeypox): Epidemiologic, pathogenetic and clinical characteristics, and prevention

Mpox (monkeypox) is a zoonotic disease caused by monkeypox virus, which belongs to the orthopoxvirus genus. Concern has recently been expressed over the appearance of the human monkeypox virus and its severe clinical presentation that resembles smallpox. Currently, due to the decrescence of immunity among smallpox-vaccinated residents, and the accumulation of unvaccinated cohorts, people are generally susceptible to mpox. A cumulative number of 79411 laboratory-confirmed cases of mpox and 50 fatalities have been reported to the World Health Organization from 110 countries between 1 January and 13 November 2022. This paper provides an overview of the epidemiology and clinical features of mpox, and control and prevention approaches for mpox to fully understand and prevent human infections.

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