scholarly journals Evaluating Real-World COVID-19 Vaccine Effectiveness Using a Test-Negative Case-Control Design

Author(s):  
Matthew W Reynolds ◽  
Alex Secora ◽  
Alice Joules ◽  
Lisa Albert ◽  
Emma Brinkley ◽  
...  

It is important to assess the extent to which the real-world effectiveness of marketed vaccines is consistent with that observed in the clinical trials, and to characterize how well vaccines prevent COVID-19 symptoms. We conducted a modified test-negative design (TND) to evaluate the RW effectiveness of three COVID-19 vaccines by leveraging data from an on-going, US community-based registry. Vaccine effectiveness was examined in two ways: considering cases who (1) tested positive for COVID-19 (695 cases, 1,786 controls) and who (2) tested positive with at least one moderate/severe COVID-19 symptom (165 cases, 2,316 controls). Any vaccination (full or partial) was associated with a 95% reduction in the odds of having a positive COVID-19 test [adjusted odds ratio (aOR) = 0.05 (95% confidence interval (CI): 0.04, 0.06)]. Full vaccination was associated with an aOR of 0.03 (95% CI: 0.03, 0.05) while partial vaccination had an aOR of 0.08 (95% CI: 0.06, 0.12). Any vaccination was associated with a 71% reduction in the odds of testing positive and having at least one moderate/severe symptom (aOR=0.29 (95% CI: 0.20, 0.40)). High effectiveness was observed across all three vaccine manufacturers both for prevention of positive COVID-19 test results and prevention of moderate/severe COVID-19 symptoms.

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0249005
Author(s):  
Masayoshi Shinjoh ◽  
Norio Sugaya ◽  
Yoshio Yamaguchi ◽  
Ichiro Ookawara ◽  
Yuji Nakata ◽  
...  

During influenza epidemics, Japanese clinicians routinely conduct rapid influenza diagnostic tests (RIDTs) in patients with influenza-like illness, and patients with positive test results are treated with anti-influenza drugs within 48 h after the onset of illness. We assessed the vaccine effectiveness (VE) of inactivated influenza vaccine (IIV) in children (6 months–15 years old, N = 4243), using a test-negative case-control design based on the results of RIDTs in the 2018/19 season. The VE against influenza A(H1N1)pdm and A(H3N2) was analyzed separately using an RIDT kit specifically for detecting A(H1N1)pdm09. The adjusted VE against combined influenza A (H1N1pdm and H3N2) and against A(H1N1)pdm09 was 39% (95% confidence interval [CI], 30%–46%) and 74% (95% CI, 39%–89%), respectively. By contrast, the VE against non-A(H1N1)pdm09 influenza A (presumed to be H3N2) was very low at 7%. The adjusted VE for preventing hospitalization was 56% (95% CI, 16%–77%) against influenza A. The VE against A(H1N1)pdm09 was consistently high in our studies. By contrast, the VE against A(H3N2) was low not only in adults but also in children in the 2018/19 season.


2021 ◽  
Author(s):  
Nick Andrews ◽  
Julia Stowe ◽  
Freja Kirsebom ◽  
Samuel Toffa ◽  
Tim Rickeard ◽  
...  

Abstract Background A rapid increase in cases due to the SARS-CoV-2 Omicron (B.1.1.529) variant in highly vaccinated populations has raised concerns about the effectiveness of current vaccines. Methods We used a test-negative case-control design to estimate vaccine effectiveness (VE) against symptomatic disease caused by the Omicron and Delta variants in England. VE was calculated after primary immunisation with two BNT162b2 or ChAdOx1 doses, and at 2+ weeks following a BNT162b2 booster. Results Between 27 November and 06 December 2021, 581 and 56,439 eligible Omicron and Delta cases respectively were identified. There were 130,867 eligible test-negative controls. There was no effect against Omicron from 15 weeks after two ChAdOx1 doses, while VE after two BNT162b2 doses was 88.0% (95%CI: 65.9 to 95.8%) 2-9 weeks after dose 2, dropping to between 34 and 37% from 15 weeks post dose 2.From two weeks after a BNT162b2 booster, VE increased to 71.4% (95%CI: 41.8 to 86.0%) for ChAdOx1 primary course recipients and 75.5% (95%CI: 56.1 to 86.3%) for BNT162b2 primary course recipients. For cases with Delta, VE was 41.8% (95%CI: 39.4-44.1%) at 25+ weeks after two ChAdOx1 doses, increasing to 93.8% (95%CI: 93.2-94.3%) after a BNT162b2 booster. With a BNT162b2 primary course, VE was 63.5% (95%CI: 61.4 to 65.5%) 25+ weeks after dose 2, increasing to 92.6% (95%CI: 92.0-93.1%) two weeks after the booster. Conclusions Primary immunisation with two BNT162b2 or ChAdOx1 doses provided no or limited protection against symptomatic disease with the Omicron variant. Boosting with BNT162b2 following either primary course significantly increased protection.


PLoS ONE ◽  
2015 ◽  
Vol 10 (8) ◽  
pp. e0136539 ◽  
Author(s):  
Masayoshi Shinjoh ◽  
Norio Sugaya ◽  
Yoshio Yamaguchi ◽  
Yuka Tomidokoro ◽  
Shinichiro Sekiguchi ◽  
...  

2021 ◽  
Author(s):  
Patrick Tang ◽  
Mohammad Rubayet Hasan ◽  
Hiam Chemaitelly ◽  
HADI M. YASSINE ◽  
Fatiha Benslimane ◽  
...  

The SARS-CoV-2 Delta (B.1.617.2) variant of concern is expanding globally. Here, we assess real-world effectiveness of the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines against this variant in the population of Qatar, using a matched test-negative, case-control study design. BNT162b2 effectiveness against any Delta infection, symptomatic or asymptomatic, was 64.2% (95% CI: 38.1-80.1%) ≥14 days after the first dose and before the second dose, but was only 53.5% (95% CI: 43.9-61.4%) ≥14 days after the second dose, in a population in which a large proportion of fully vaccinated persons received their second dose several months earlier. Corresponding effectiveness measures for mRNA-1273 were 79.0% (95% CI: 58.9-90.1%) and 84.8% (95% CI: 75.9-90.8%), respectively. Effectiveness against any severe, critical, or fatal COVID-19 disease due to Delta was 89.7% (95% CI: 61.0-98.1%) for BNT162b2 and 100.0% (95% CI: 41.2-100.0%) for mRNA-1273, ≥14 days after the second dose. Both BNT162b2 and mRNA-1273 are highly effective in preventing Delta hospitalization and death, but less so in preventing infection, particularly for BNT162b2.


2016 ◽  
Vol 21 (14) ◽  
Author(s):  
Hanne Dorthe Emborg ◽  
Tyra Grove Krause ◽  
Lene Nielsen ◽  
Marianne Kragh Thomsen ◽  
Claus Bohn Christiansen ◽  
...  

In Denmark, both influenza A(H1N1)pdm09 and influenza B co-circulated in the 2015/16 season. We estimated the vaccine effectiveness (VE) of the trivalent influenza vaccine in patients 65 years and older using the test-negative case–control design. The adjusted VE against influenza A(H1N1)pdm09 was 35.0% (95% confidence interval (CI): 11.1–52.4) and against influenza B 4.1% (95% CI: −22.0 to 24.7). The majority of influenza A(H1N1)pdm09 circulating in 2015/16 belonged to the new genetic subgroup subclade 6B.1.


2014 ◽  
Vol 143 (7) ◽  
pp. 1417-1426 ◽  
Author(s):  
M. HABER ◽  
Q. AN ◽  
I. M. FOPPA ◽  
D. K. SHAY ◽  
J. M. FERDINANDS ◽  
...  

SUMMARYAs influenza vaccination is now widely recommended, randomized clinical trials are no longer ethical in many populations. Therefore, observational studies on patients seeking medical care for acute respiratory illnesses (ARIs) are a popular option for estimating influenza vaccine effectiveness (VE). We developed a probability model for evaluating and comparing bias and precision of estimates of VE against symptomatic influenza from two commonly used case-control study designs: the test-negative design and the traditional case-control design. We show that when vaccination does not affect the probability of developing non-influenza ARI then VE estimates from test-negative design studies are unbiased even if vaccinees and non-vaccinees have different probabilities of seeking medical care against ARI, as long as the ratio of these probabilities is the same for illnesses resulting from influenza and non-influenza infections. Our numerical results suggest that in general, estimates from the test-negative design have smaller bias compared to estimates from the traditional case-control design as long as the probability of non-influenza ARI is similar among vaccinated and unvaccinated individuals. We did not find consistent differences between the standard errors of the estimates from the two study designs.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhu-Xia Shen ◽  
Yu-Min Sun ◽  
Hui-Hui Gu ◽  
Yan Zhang ◽  
Zhi-Wen Shen ◽  
...  

Abstract Background The association between anxiety and atrial fibrillation (AF) remains unclear. Moreover, this association has rarely been studied in Chinese individuals aged 60 years or older. This study investigated the association between anxiety and AF in a community-based case-control study of older adult residents in urban China. Methods The cases and controls were from a community-based study conducted in the Jingansi community in Shanghai, China, between January 2010 and December 2012. A total of 3622 residents aged 60 years or older without severe vision, hearing, or speaking impairments were eligible to participate in the physical examinations and questionnaire survey. AF was assessed based on a previous physician’s diagnosis, electrocardiogram, ambulatory electrocardiogram, or echocardiogram. Anxiety was evaluated using the Zung Self-Rating Anxiety Scale (ZSAS). Using the AF group as a reference, the control group consisted of randomly selected age- and sex-matched individuals in a 1:5 ratio (case:control = 1:5). The association between anxiety and AF in the AF group and the multifactor-matched control group was explored using logistic regression. Results In the AF and control groups, after adjusting for a history of coronary heart disease, valvular heart disease, hypertension, stroke, hyperlipidemia, and diabetes, as well as depression score, ZSAS scores (odds ratio 1.07; 95% confidence interval 1.02–1.12; p = 0.003), and anxiety symptoms (odds ratio 3.94; 95% confidence interval 1.06–14.70; p = 0.041) were associated with AF. Conclusions Anxiety symptoms were associated with AF in a Chinese older population. This suggests that older adults who have anxiety symptoms may need psychological intervention or treatment in daily life and care.


Author(s):  
Suchitra Rao ◽  
Angela Moss ◽  
Molly M Lamb ◽  
Edwin J Asturias

Abstract A test-negative case-control analysis of 1478 children aged 6 months to 8 years of age seeking care at an emergency/urgent care setting with influenza like illness during the 2016-17 and 2018-19 (H3N2 predominant) influenza seasons demonstrated that influenza vaccine effectiveness did not vary significantly by the prior seasons’ vaccination status. Clinical Trials Registration NCT02979626.


Author(s):  
A. NURUL AMALIAH ◽  
AMI FEBRIZA

The aim of this research was to know about the correlation between cataract occurance with Diabetes Mellitus. This research was performed in Medical Record Departement of Balai Kesehatan Mata Masyarakat Makassar using medical record on the period of January 2016 to October 2016 with case control design, consist of 74 subjects which were divided into cataract as case, consist of 37 subjects and without cataract as control, consist of 37 subjects. Data of diabetes mellitus history were collected from patient medical recordand analyzed by Chi Square with the significance’s degree was p<0.05. The result showed moderate correlation between cataract occurance and diabetes mellitus (p=0.002) with Odds Ratio (OR) 4,563 (IC :1,683 – 12,371)KEYWORDS : Cataract, Diabetes Melitus


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