scholarly journals Durability analysis of the highly effective BNT162b2 vaccine against COVID-19

2021 ◽  
Author(s):  
Arjun Puranik ◽  
Patrick J. Lenehan ◽  
John C. O’Horo ◽  
Michiel J.M. Niesen ◽  
Abinash Virk ◽  
...  
Keyword(s):  
Conditional Logistic Regression ◽  
Severe Disease ◽  
Negative Control ◽  
Calendar Time ◽  
Symptomatic Infection ◽  
National Medical ◽  
Early Signal ◽  
Durability Analysis ◽  
Negative Case ◽  
Nonpharmaceutical Interventions

AbstractSARS-CoV-2 breakthrough infections have been increasingly reported in fully vaccinated individuals. We conducted a test-negative case-control study to assess the durability of protection after full vaccination with BNT162b2, defined as 14 days after the second dose, against polymerase chain reaction (PCR)-confirmed symptomatic SARS-CoV-2 infection, in a national medical practice between February 1, 2021 and August 22, 2021. We fit conditional logistic regression (CLR) models stratified on residential county and calendar time of testing to assess the association between time elapsed since vaccination and the odds of symptomatic infection or non-COVID-19 hospitalization (negative control), adjusted for several covariates. The primary population included 652 individuals who had a positive symptomatic test after full vaccination with BNT162b2 (cases) and 5,946 individuals with at least one negative symptomatic test after full vaccination (controls). The adjusted odds of symptomatic infection were higher 120 days after full vaccination versus at the date of full vaccination (Odds Ratio [OR]: 3.21, 95% confidence interval [CI]: 1.33-7.74). Importantly, the odds of infection were still lower 150 days after the first BNT162b2 dose as compared to 4 days after the first dose (OR: 0.3, 95% CI: 0.19-0.45), when immune protection approximates the unvaccinated status. Low rates of COVID-19 associated hospitalization or death in this cohort precluded analyses of these severe outcomes. The odds of experiencing a non-COVID-19 hospitalization decreased with time since vaccination, suggesting a possible underestimation of waning protection by this approach due to confounding factors. Taken together, these data constitute an early signal for waning protection against symptomatic illness while also providing reassurance that BNT162b2 continues to protect against symptomatic SARS-CoV-2 infection several months after full vaccination. Continued surveillance of COVID-19 vaccine durability, particularly against severe disease, is critical to guide effective and equitable strategies to respond to the pandemic, including distribution of booster doses, development of new vaccines, and implementation of both pharmaceutical and nonpharmaceutical interventions.

scholarly journals Effectiveness of Covishield vaccine in preventing Covid–19 — A test–negative case–control study

2021 ◽  
Author(s):  
Stuti Pramod ◽  
Dhanajayan Govindan ◽  
Premkumar Ramasubramani ◽  
Sitanshu Sekhar Kar ◽  
Rakesh Aggarwal ◽  
...  
Keyword(s):  
Conditional Logistic Regression ◽  
Severe Disease ◽  
Case Control ◽  
Vaccine Effectiveness ◽  
Separate Analysis ◽  
Occupational Role ◽  
Negative Case ◽  
Protection Rate ◽  
Using Data ◽  
Control Study

Introduction: This study was aimed at assessing the vaccine effectiveness (VE) of Covishield, which is identical to the AstraZeneca vaccine, in preventing laboratory–confirmed Covid–19. Methods: Using a test–negative case–control design, information on vaccination status of cases with Covid–19 among healthcare workers in our institution in Puducherry, India, and an equal number of matched controls, i.e. positive and negative for SARS–CoV–2 by RT–PCR, was obtained. The cases and controls were matched for age (± 3 years) and date of testing (± 3 days). The groups were compared using multivariable conditional logistic regression to calculate odds ratios (OR), with adjustment for gender, occupational role, presence of symptoms and presence of a comorbidity condition. Per cent vaccine effectiveness (VE) was calculated as 100×(1−adjusted odds ratio). Results: Using data from 360 case–control pairs, VE of one dose and of two doses, in providing protection against Covid–19 was 49% (95% CI: 17%–68%) and 54% (27%–71%), respectively. In view of a difference in the proportion of cases and controls who had symptoms, a separate analysis of data from 203 pairs where both the case and the control had symptoms was done, which showed, VE of 58% (28%–75%) and 64% (38%–78%) after one dose and two doses, respectively. Among cases with moderately severe disease that required oxygen therapy, VE following any number of vaccine doses was 95% (44%–100%). Conclusion: Covishield vaccine protected significantly against Covid–19, with the protection after two doses being slightly higher than after one dose, and a particularly high protection rate against severe forms of the disease. Keywords: Covishield, Vaccine effectiveness, Test–negative design

Effect of Bacillus Calmette-Guerin (BCG) exposure on severity of COVID-19 infection: A COVID-19 and Cancer Consortium (CCC19) study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4529-4529
Author(s):  
Andrew Lachlan Schmidt ◽  
Ziad Bakouny ◽  
Chris Labaki ◽  
Babar Bashir ◽  
Jessica M. Clement ◽  
...  
Keyword(s):  
Bladder Carcinoma ◽  
Severe Disease ◽  
Performance Status ◽  
Illness Severity ◽  
Ordinal Scale ◽  
Intravesical Therapy ◽  
Cancer Type ◽  
Calendar Time ◽  
Oncology Patients ◽  
Bcg Vaccination

4529 Background: Oncology patients experience more severe disease outcomes from COVID-19 infection than the general population. BCG is a live bovine tuberculosis bacillus with immunotherapeutic effects in urothelial cancers; it is also used as vaccination against Mycobacterium tuberculosis in parts of the world. As BCG vaccination has been associated with broad protection against viral pathogens, BCG exposure through vaccination or intravesical therapy may modulate host immunity and reduce the severity of COVID-19 infection. We report the effect of BCG exposure on COVID-19 severity in oncology patients from the CCC19 registry. Methods: The CCC19 registry (NCT04354701) was used to identify patients with prior BCG exposure. Cohort A received intravesical treatment for bladder carcinoma, and cohort B received prior BCG vaccination. Each cohort was matched 3:1 to non-BCG-exposed controls by age, sex, race, primary cancer type, cancer status, ECOG performance status (PS) and calendar time of COVID-19 infection. The primary endpoint was COVID-19 severity reported on an ordinal scale (uncomplicated, hospitalized, admitted to ICU +/- ventilated, died within 30 days) of patients exposed to prior BCG compared to matched non-exposed controls. 2-sided Wilcoxon rank-sum tests were used. Results: As of 6-Feb-2021 we included 124 patients with BCG exposure, 68 patients with bladder carcinoma who had received intravesical BCG (Cohort A), and 64 cancer patients with prior BCG vaccination (Cohort B). Median age was 76 years, IQR 69-83 (Cohort A) and 67 years, IQR 62-74 (Cohort B). Bladder cancer pts were predominately male (78%) vs 55% for Cohort B. Patients with PS 2+ were uncommon, 18% in Cohort A and 16% in Cohort B. COVID-19 illness severity was no different in patients exposed to prior intravesicular BCG (p=0.87). COVID-19 illness severity was no different in patients exposed to prior intradermal BCG vaccination (p=0.60). Conclusions: Despite this being the largest such cohort reported to date, we failed to demonstrate an association of prior BCG exposure with modulation of severity of COVID-19 illness. Prospective trials evaluating the protective effect of BCG vaccination are ongoing and will add further insight into the effect of BCG on COVID-19 illness.[Table: see text]

scholarly journals Effectiveness of CoronaVac, ChAdOx1, BNT162b2 and Ad26.COV2.S among individuals with prior SARS-CoV-2 infection in Brazil

2021 ◽  
Author(s):  
Thiago Cerqueira-Silva ◽  
Jason R Andrews ◽  
Viviane S Boaventura ◽  
Otavio T Ranzani ◽  
Vinicius de Araujo Oliveira ◽  
...  
Keyword(s):  
Case Control Study ◽  
Conditional Logistic Regression ◽  
Case Control ◽  
Rt Pcr ◽  
Symptomatic Infection ◽  
Series Completion ◽  
Negative Controls ◽  
Prior Infection ◽  
Control Study ◽  
Dose Vaccine

Background. COVID-19 vaccines have proven highly effective among SARS-CoV-2 naive individuals, but their effectiveness in preventing symptomatic infection and severe outcomes among individuals with prior infection is less clear. Methods. Utilizing national COVID-19 notification, hospitalization, and vaccination datasets from Brazil, we performed a case-control study using a test-negative design to assess the effectiveness of four vaccines (CoronaVac, ChAdOx1, Ad26.COV2.S and BNT162b2) among individuals with laboratory-confirmed prior SARS-CoV-2 infection. We matched RT-PCR positive, symptomatic COVID-19 cases with RT-PCR-negative controls presenting with symptomatic illnesses, restricting both groups to tests performed at least 90 days after an initial infection. We used multivariable conditional logistic regression to compare the odds of test positivity, and the odds of hospitalization or death due to COVID-19, according to vaccination status and time since first or second dose of vaccines. Findings. Among individuals with prior SARS-CoV-2 infection, vaccine effectiveness against symptomatic infection ≥ 14 days from vaccine series completion was 39.4% (95% CI 36.1-42.6) for CoronaVac, 56.0% (95% CI 51.4-60.2) for ChAdOx1, 44.0% (95% CI 31.5-54.2) for Ad26.COV2.S, and 64.8% (95% CI 54.9-72.4) for BNT162b2. For the two-dose vaccine series (CoronaVac, ChAdOx1, and BNT162b2), effectiveness against symptomatic infection was significantly greater after the second dose compared with the first dose. Effectiveness against hospitalization or death ≥ 14 days from vaccine series completion was 81.3% (95% CI 75.3-85.8) for CoronaVac, 89.9% (95% CI 83.5-93.8) for ChAdOx1, 57.7% (95% CI -2.6-82.5) for Ad26.COV2.S, and 89.7% (95% CI 54.3-97.7) for BNT162b2.

scholarly journals 2355. The Association Between Diagnostic Testing Method and Clostridium difficile Infection Severity

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S811-S811
Author(s):  
Anitha Menon ◽  
Donald A Perry ◽  
Jonathan Motyka ◽  
Shayna Weiner ◽  
Alexandra Standke ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Severe Disease ◽  
Diagnostic Testing ◽  
Fold Increase ◽  
Adverse Outcomes ◽  
Clinical Microbiology Laboratory ◽  
Diagnostic Strategy ◽  
Symptomatic Infection ◽  
The University

Abstract Background The optimal diagnostic strategy for Clostridium difficile infection (CDI) is not known, and no test is shown to clearly differentiate colonization from symptomatic infection. We hypothesized that detection and/or quantification of stool toxins would associate with severe disease and adverse outcomes. Methods We conducted a retrospective cohort study among subjects with CDI diagnosed in 2016 at the University of Michigan. The clinical microbiology laboratory tested for glutamate dehydrogenase antigen and toxins A/B by enzyme immunoassay (EIA). Discordant results reflexed to PCR for the tcdB gene. Stool toxin levels were quantified via a modified cell cytotoxicity assay (CCA). C. difficile was isolated by anaerobic culture and ribotyped. Severe CDI was defined by the IDSA criteria: white blood cell count >15,000 cells/µL or a 1.5-fold increase in serum creatinine above baseline. The primary outcomes were all-cause 30-day mortality and a composite of colectomy, ICU admission, and/or death attributable to CDI within 30 days. Analysis included standard bivariable tests and adjusted models via logistic regression. Results From 565 adult patients, we obtained 646 samples; 199 (30.8%) contained toxins by EIA. Toxin positivity associated with IDSA severity (Table 1), but not our primary outcomes on unadjusted analysis. After adjustment for putative confounders, we still did not observe an association between toxin positivity and our primary outcomes. Stool toxin levels by CCA >6.4 ng/mL associated with IDSA severity (Table 1), but not the primary outcomes. Compared with the period from 2010 to 2013, the circulating ribotypes of C. difficile at our institution changed in 2016. Notably ribotype 106 newly emerged, accounting for 10.6% of strains, and ribotype 027 fell to 9.3% (Table 2). The incidence of ribotype 014-027 has remained stable at 18.9%, but this strain was associated with both IDSA severity and 30-day mortality (OR = 3.32; P = 0.001). Conclusion Toxin detection by EIA/CCA associated with IDSA severity, but this study was unable to confirm an association with subsequent adverse outcomes. The molecular epidemiology of C. difficile has shifted, and this may have implications for the optimal diagnostic strategy for CDI. Disclosures All authors: No reported disclosures.

scholarly journals Intraseason Waning of Influenza Vaccine Effectiveness

2018 ◽  
Vol 68 (10) ◽  
pp. 1623-1630 ◽  
Author(s):  
G Thomas Ray ◽  
Ned Lewis ◽  
Nicola P Klein ◽  
Matthew F Daley ◽  
Shirley V Wang ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Conditional Logistic Regression ◽  
Geographic Area ◽  
The United States ◽  
Negative Control ◽  
Polymerase Chain Reaction Test ◽  
Optimal Time ◽  
Optimal Timing ◽  
Syncytial Virus

Abstract Background In the United States, it is recommended that healthcare providers offer influenza vaccination by October, if possible. However, if the vaccine’s effectiveness soon begins to wane, the optimal time for vaccination may be somewhat later. We examined whether the effectiveness of influenza vaccine wanes during the influenza season with increasing time since vaccination. Methods We identified persons who were vaccinated with inactivated influenza vaccine from 1 September 2010 to 31 March 2017 and who were subsequently tested for influenza and respiratory syncytial virus (RSV) by a polymerase chain reaction test. Test-confirmed influenza was the primary outcome and days-since-vaccination was the predictor of interest in conditional logistic regression. Models were adjusted for age and conditioned on calendar day and geographic area. RSV was used as a negative-control outcome. Results Compared with persons vaccinated 14 to 41 days prior to being tested, persons vaccinated 42 to 69 days prior to being tested had 1.32 (95% confidence interval [CI], 1.11 to 1.55) times the odds of testing positive for any influenza. The odds ratio (OR) increased linearly by approximately 16% for each additional 28 days since vaccination. The OR was 2.06 (95% CI, 1.69 to 2.51) for persons vaccinated 154 or more days prior to being tested. No evidence of waning was found for RSV. Conclusions Our results suggest that effectiveness of inactivated influenza vaccine wanes during the course of a single season. These results may lead to reconsideration of the optimal timing of seasonal influenza vaccination.

scholarly journals COVID-19 in Newborns and Infants—Low Risk of Severe Disease: Silver Lining or Dark Cloud?

2020 ◽  
Vol 37 (08) ◽  
pp. 845-849 ◽  
Author(s):  
Munmun Rawat ◽  
Praveen Chandrasekharan ◽  
Mark D. Hicar ◽  
Satyan Lakshminrusimha
Keyword(s):  
Influenza Pandemic ◽  
Severe Disease ◽  
The United States ◽  
Dark Cloud ◽  
Symptomatic Infection ◽  
Key Points ◽  
High Incidence ◽  
1918 Influenza ◽  
Novel Coronavirus ◽  
Low Prevalence

One hundred years after the 1918 influenza pandemic, we now face another pandemic with the severe acute respiratory syndrome–novel coronavirus-2 (SARS-CoV-2). There is considerable variability in the incidence of infection and severe disease following exposure to SARS-CoV-2. Data from China and the United States suggest a low prevalence of neonates, infants, and children, with those affected not suffering from severe disease. In this article, we speculate different theories why this novel agent is sparing neonates, infants, and young children. The low severity of SARS-CoV-2 infection in this population is associated with a high incidence of asymptomatic or mildly symptomatic infection making them efficient carriers. Key Points

scholarly journals Effect of ZnO nanoparticles in treatment of broilers with Eimeria tenella. experimentally infected.

2021 ◽  
Author(s):  
Sadiya Aziz Anah ◽  
Khadeeja Abees Hmood ◽  
Saad Aziz Anah
Keyword(s):  
Zinc Oxide ◽  
Severe Disease ◽  
Treated Group ◽  
Positive Control ◽  
Negative Control ◽  
Eimeria Tenella ◽  
Positive Control Group ◽  
Economic Losses ◽  
Control Group ◽  
New Treatment

Abstract Coccidiosis is one of the common poultry diseases in Iraq and the world, which causes great economic losses. Therefore, this study aimed to use a new treatment represented by nanoparticles of zinc oxide and compare it with the drug (Amprolium). The Oocysts of Eimeria tenella were isolated from the feces of the briolers received at the Veterinary hospital in Diwaniyah Province and initially diagnosed by compound light microscopy,Then it was confirmed molecularly by PCR technique using the internal transcribed space ITS1 gene with a molecular weight of 409bp. The experiment was carried out on 120 birds of broilers, as the animals were divided into 6 groups with 20 birds per group. The first group(G1) was left as a negative control(uninfected), the second group(G2) was inoculated with 50,000 mature Oocysts and left as a positive control group,the third group(G3) was incubated with 50,000 Oocysts + Amprolium (anticoccidial), the fourth, fifth and sixth groups(G4,G5,G6) were also dosed with 50,000 Oocysts followed by an oral dose of nanoparticles of zinc oxide at a concentration of 20,40,60 mg/kg for each of fourth, fifth and sixth groups respectively. The current results showed that the briolers in G2 suffered from severe disease symptoms and high mortality occurred in the first week of infection, amounting to %10 compared to the anticoccidial (Amprolium group and the groups treated with nanoconcentrations 20,40,60 mg/kg respectively.G6 which was dosed with a concentration of 60 mg /kg, showed a significant decrease in the number of Oocysts excreted compared with the positive control group and the anticoccidial group, in addition to the appearance of mild symptoms and a mortality rate of %0.8,While there was a decrease in the number of Oocysts excreted during the second week in the anticoccidial group and the treated groups with the three nanoconcentrations with a decrease in the mortality rates of birds .The number of Oocysts excreted in the litter significantly decreased in the treated group with a concentration of 60 mg/kg compared to all other groups, and all birds of this group recovered during the second week of infection.

scholarly journals SARS-CoV-2 ve İnfluenza Virüs Birlikteliği

2020 ◽  
Vol 25 (4) ◽  
pp. 457-463
Author(s):  
Figen Kaptan
Keyword(s):  
Severe Disease ◽  
World Health ◽  
Respiratory Syndrome Virus ◽  
Chinese City ◽  
Modes Of Transmission ◽  
The World ◽  
Influenza Transmission ◽  
Health Organization ◽  
Nonpharmaceutical Interventions ◽  
Improve Clinical Outcome

Severe acute respiratory syndrome virus 2 was initially identified in the Chinese city Wuhan on 29 December 2019. The infection has rapidly spread all over the world, and the World Health Organization declared the infection a pandemic on 11 March 2020. The disease, named coronavirus disease 19, has similar modes of transmission and clinical features with influenza, and coinfections have also been reported during the course of coronavirus disease 19. Studies have shown that the ratio of coinfections ranged widely among studies, and the clinical presentation in coinfections has varied from mild to severe disease leading to death. Detection of coinfection is important in order to plan the optimal treatment and improve clinical outcome. Studies reveal that nonpharmaceutical interventions such as social distancing and changes in population behavior implemented for coronavirus disease 19 have also reduced influenza transmission.

scholarly journals Vaccine effectiveness and duration of protection of Comirnaty, Vaxzevria and Spikevax against mild and severe COVID-19 in the UK

2021 ◽  
Author(s):  
Nick Andrews ◽  
Elise Tessier ◽  
Julia Stowe ◽  
Charlotte Gower ◽  
Freja Kirsebom ◽  
...  
Keyword(s):  
Severe Disease ◽  
Vaccine Effectiveness ◽  
Real World Data ◽  
Post Vaccination ◽  
Symptomatic Disease ◽  
Negative Case ◽  
The Uk ◽  
Comorbidity Status ◽  
Duration Of Protection ◽  
Over Time

Background COVID-19 vaccines have been used for 9 months in the UK. Real world data have demonstrated the vaccines to be highly effective against COVID-19, severe disease and death. Here, we estimate vaccine effectiveness over time since the second dose of Comirnaty, Vaxzevria and Spikevax in England. Methods We used a test-negative case-control design to estimate vaccine effectiveness against symptomatic disease, hospitalisation and mortality by age, comorbidity status and over time after the second dose to investigate waning separately for Alpha and Delta variants. Results Vaccine effectiveness against symptomatic disease peaked in the early weeks after the second dose and then fell to 47.3 (95% CI 45 to 49.6) and 69.7 (95% CI 68.7 to 70.5) by 20+ weeks against the Delta variant for Vaxzevria and Comirnaty, respectively. Waning of vaccine effectiveness was greater for 65+ year-olds compared to 40-64 year-olds. Vaccine effectiveness fell less against hospitalisations to 77.0 (70.3 to 82.3) and 92.7 (90.3 to 94.6) beyond 20 weeks post-vaccination and 78.7 (95% CI 52.7 to 90.4) and 90.4 (95% CI 85.1 to 93.8) against death for Vaxzevria and Comirnaty, respectively. Greater waning was observed among 65+ year-olds in a clinically extremely vulnerable group and 40-64-year olds with underlying medical conditions compared to healthy adults. Conclusions We observed limited waning in vaccine effectiveness against hospitalisation and death more than 20 weeks post-vaccination with Vaxzevria or Comirnaty. Waning was greater in older adults and those in a clinical risk group, suggesting that these individuals should be prioritised for booster doses.

scholarly journals The incidence of COVID-19 infection following emergency use authorization of BBIBP-CORV inactivated vaccine in frontline workers in the United Arab Emirates

2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Nawal Al Kaabi ◽  
Abderrahim Oulhaj ◽  
Farida Ismail Al Hosani ◽  
Shamma Al Mazrouei ◽  
Omer Najim ◽  
...  
Keyword(s):  
Incidence Rate ◽  
United Arab Emirates ◽  
Absolute Risk ◽  
Seroconversion Rate ◽  
Severe Disease ◽  
Phase Iii ◽  
Inactivated Vaccine ◽  
Serious Adverse Events ◽  
Symptomatic Infection ◽  
Frontline Workers

AbstractBased on the findings from the Phase III clinical trials of inactivated SARS COV-2 Vaccine, (BBIBP-CORV) emergency use authorization (EUA) was granted for the vaccine to frontline workers in the UAE. A prospective cohort study was conducted among frontline workers to estimate the incidence rate and risk of symptomatic COVID-19 infection 14 days after the second dose of inoculation with BBIBP-CORV inactivated vaccine. Those who received two doses of the BBIBP-CORV vaccine in the period from 14th of September 2020 (first dose) to 21st of December 2020 (second dose) were followed up for COVID-19 infections. 11,322 individuals who received the two-dose BBIBP-CORV vaccine were included and were followed up post the second dose plus fourteen days. The incidence rate of symptomatic infection was 0.08 per 1000-person days (95% CI 0.07, 0.10). The estimated absolute risk of developing symptomatic infection was 0.97% (95% CI 0.77%, 1.17%). The confirmed seroconversion rate was 92.8%. There were no serious adverse events reported and no individuals suffered from severe disease. Our findings show that vaccinated individuals are likely to remain protected against symptomatic infection or becoming PCR positive for SARS COV 2 following the second dose of the vaccination.

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