scholarly journals Elapsed time since BNT162b2 vaccine and risk of SARS-CoV-2 infection in a large cohort

2021 ◽  
Author(s):  
Ariel Israel ◽  
Eugene Merzon ◽  
Alejandro A Schäffer ◽  
Yotam Shenhar ◽  
Ilan Green ◽  
...  
Keyword(s):  
Messenger Rna ◽  
Large Scale ◽  
Health Care Organization ◽  
Vaccination Campaign ◽  
Large Population ◽  
Vaccine Dose ◽  
Care Organization ◽  
Test Results ◽  
Rt Pcr ◽  
Pcr Test

Importance: Israel was among the first countries to launch a large-scale COVID-19 vaccination campaign, and quickly vaccinated its population, achieving early control over the spread of the virus. However, the number of COVID-19 cases is now rapidly increasing, which may indicate that vaccine protection decreases over time. Objective: To determine whether time elapsed since the second BNT162b2 messenger RNA (mRNA) vaccine (Pfizer-BioNTech) injection is significantly associated with the risk of post-vaccination COVID-19 infection. Design: This is a retrospective cohort study performed in a large state-mandated health care organization in Israel. Participants: All fully vaccinated adults who have received a RT-PCR test between May 15, 2021 and July 26, 2021, at least two weeks after their second vaccine injection were included. Patients with a history of past COVID-19 infection were excluded. Main Outcome and Measure: Positive result for the RT-PCR test. Results: The cohort included 33,993 fully vaccinated adults, 49% women, with a mean age of 47 years (SD, 17 years), who received an RT-PCR test for SARS-CoV-2 during the study period. The median time between the second dose of the vaccine and the RT-PCR test was 146 days, interquartile range [121-167] days. 608 (1.8%) patients had positive test results. There was a significantly higher rate of positive results among patients who received their second vaccine dose at least 146 days before the RT-PCR test compared to patients who have received their vaccine less than 146 days before: odds ratio for infection was 3.00 for patients aged over 60 (95% CI 1.86-5.11); 2.29 for patients aged between 40 and 59 (95% CI 1.67-3.17); and 1.74 for patients aged between 18 and 39 (95% CI 1.27-2.37); P<0.001 in each age group. Conclusions and Relevance: In this large population study of patients tested for SARS-CoV-2 by RT-PCR following two doses of mRNA BNT162b2 vaccine, we observe a significant increase of the risk of infection in individuals who received their last vaccine dose since at least 146 days ago, particularly among patients older than 60.

scholarly journals Elapsed time since BNT162b2 vaccine and risk of SARS-CoV-2 infection: test negative design study

BMJ ◽  
2021 ◽  
pp. e067873 ◽  
Author(s):  
Ariel Israel ◽  
Eugene Merzon ◽  
Alejandro A Schäffer ◽  
Yotam Shenhar ◽  
Ilan Green ◽  
...  
Keyword(s):  
Positive Result ◽  
Conditional Logistic Regression ◽  
Large Population ◽  
Vaccine Dose ◽  
Orthodox Jews ◽  
Healthcare Organisation ◽  
Rt Pcr ◽  
Design Study ◽  
Vaccine Injection ◽  
Pcr Test

Abstract Objectives To determine whether time elapsed since the second injection of the Pfizer-BioNTech BNT162b2 mRNA vaccine was significantly associated with the risk of covid-19 infection after vaccination in people who received two vaccine injections. Design Test negative design study. Setting Electronic health records of a large state mandated healthcare organisation, Israel. Participants Adults aged ≥18 years who had received a reverse transcription polymerase chain reaction (RT-PCR) test between 15 May 2021 and 17 September 2021, at least three weeks after their second vaccine injection, had not received a third vaccine injection, and had no history of covid-19 infection. Main outcome measures Positive result for the RT-PCR test. Individuals who tested positive for SARS-CoV-2 and controls were matched for week of testing, age category, and demographic group (ultra-orthodox Jews, individuals of Arab ancestry, and the general population). Conditional logistic regression was adjusted for age, sex, socioeconomic status, and comorbid conditions. Results 83 057 adults received an RT-PCR test for SARS-CoV-2 during the study period and 9.6% had a positive result. Time elapsed since the vaccine injection was significantly longer in individuals who tested positive (P<0.001). Adjusted odds ratio for infection at time intervals >90 days since vaccination were significantly increased compared with the reference of <90 days: 2.37 (95% confidence interval 1.67 to 3.36) for 90-119 days, 2.66 (1.94 to 3.66) for 120-149 days, 2.82 (2.07 to 3.84) for 150-179 days, and 2.82 (2.07 to 3.85) for ≥180 days (P<0.001 for each 30 day interval). Conclusions In this large population of adults tested for SARS-CoV-2 by RT-PCR after two doses of mRNA BNT162b2 vaccine, a gradual increase in the risk of infection was seen for individuals who received their second vaccine dose after at least 90 days.

scholarly journals Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand

Vaccines ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. 3
Author(s):  
Zoltán Kis ◽  
Cleo Kontoravdi ◽  
Robin Shattock ◽  
Nilay Shah
Keyword(s):  
Production Process ◽  
Messenger Rna ◽  
Vaccination Campaign ◽  
Vaccine Dose ◽  
Economic Feasibility ◽  
Small Scale ◽  
Production Scale ◽  
Working Volume ◽  
Global Demand ◽  
The Impact

To overcome pandemics, such as COVID-19, vaccines are urgently needed at very high volumes. Here we assess the techno-economic feasibility of producing RNA vaccines for the demand associated with a global vaccination campaign. Production process performance is assessed for three messenger RNA (mRNA) and one self-amplifying RNA (saRNA) vaccines, all currently under clinical development, as well as for a hypothetical next-generation saRNA vaccine. The impact of key process design and operation uncertainties on the performance of the production process was assessed. The RNA vaccine drug substance (DS) production rates, volumes and costs are mostly impacted by the RNA amount per vaccine dose and to a lesser extent by the scale and titre in the production process. The resources, production scale and speed required to meet global demand vary substantially in function of the RNA amount per dose. For lower dose saRNA vaccines, global demand can be met using a production process at a scale of below 10 L bioreactor working volume. Consequently, these small-scale processes require a low amount of resources to set up and operate. RNA DS production can be faster than fill-to-finish into multidose vials; hence the latter may constitute a bottleneck.

Death and COVID-19 Anxiety in Home-Quarantined Individuals Aged 65 and Over During the Pandemic

2021 ◽  
pp. 003022282110598
Author(s):  
Hümeyra Aslaner ◽  
Betül Özen ◽  
Zeliha K. Erten ◽  
Mebrure Beyza Gökçek
Keyword(s):  
Polymerase Chain Reaction ◽  
Death Anxiety ◽  
Short Form ◽  
Anxiety Score ◽  
Test Results ◽  
Rt Pcr ◽  
Chain Reaction ◽  
Polymerase Chain ◽  
Test Result ◽  
Pcr Test

Urgent measures were taken for those at the age of 65 and over who were at the risk group all over the world due to the COVID-19 pandemic. It is known that many individuals at the age of 65 and over have experienced anxiety due to the uncertainties. This study aimed to determine the anxiety and death anxiety in individuals aged 65 and over who were isolation at home due to being diagnosed with COVID-19 or being in contact during the pandemic process. The study is descriptive and cross-sectional. It was performed with 656 home-quarantined individuals aged between 65–80 years with positive or negative real-time polymerase chain reaction (RT-PCR) test result. A form including questions about the death anxiety and the Coronavirus Anxiety Scale Short Form prepared by the researchers were administered to the individuals by phone call. Of the participants, 49.5% were male. Median COVID-19 anxiety score was 4 (0–18). Anxiety scores of the male and female participants were similar. Participants with negative polymerase chain reaction (PCR) results and those with death anxiety had higher COVID anxiety scores. Death anxiety has increased by 1.661 times in male gender, 1.983 times in RT-PCR positivity and 0.146 times in the presence of symptoms. Individuals with positive COVID-19 test results or those aged 65 and over who had death anxiety and negative COVID-19 test result but who were in home-isolation due to being a contact had higher anxiety score. For this reason, those with death anxiety can be supported in line with their religious beliefs to reduce anxiety. Those with negative PCR test results in quarantine can be adequately informed about the COVID-19.

Accuracy of Computed Tomography for Detection of COVID-19 among Suspected Patients

2021 ◽  
Vol 15 (9) ◽  
pp. 2474-2476
Author(s):  
Maham Munir Awan ◽  
Afshan Noreen ◽  
Farah Kalsoom ◽  
Muhammad Tahir ◽  
Umaima Majeed ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Predictive Value ◽  
Gold Standard ◽  
Radiology Department ◽  
True Positive ◽  
Test Results ◽  
Rt Pcr ◽  
Radiological Society ◽  
Medical University ◽  
Pcr Test

Objective: To determine the accuracy of CT chest in diagnosis of COVID-19 taking RT-PCR-testing as gold standard. Materials and Methods: A total of 150 patients of suspicion of COVID-19 who were referred for CT Chest in Radiology Department of Nishtar Medical University Multan from June-2020 to May-2021 were included. In all patients, two RT-PCR test results were obtained with 7 days of admission in hospital. Presence of any of these positive was labelled as COVID-19 infection. CT chest was performed in all patients within 2 days of admission in hospital using 128 slices CT scan machine. The diagnosis of COVID-19 infection was made according to the recommendations by Radiological Society of North America (RSNA) protocol. Results: Mean age was 51.3±14.7 years. 78 (52%) patients were male and 72 (48%) patients were female. RTPCR test was positive in 89 (59.3%) patients. While the CT chest findings were suggestive of COVID-19 infection in 130 (86.7%) patients. The sensitivity of CT chest was 95.5%, specificity 26.2%, PPV wad 65.4% and NPV was 80.0%. Conclusion: CT chest has a very good sensitivity for detection of COVID-19, it can be used as a rapid diagnostic tool especially in areas of pandemic. However, the specificity of CT chest is low, that can limit its use in low COVID-19 affected areas. Keywords: COVID-19, Computed tomography, False Positive, True Positive, Positive Predictive Value, Negative Predictive Value.

DIAGNOSTIC ROLE OF CHEST CT USING CO-RADS CATEGORIZATION IN SARS-COV-2 INFECTION WITH EMPHASIS ON IMPACT OF CT IN PATIENTS WITH DELAYED OR NEGATIVE INITIAL RTPCR TEST

2021 ◽  
pp. 51-52
Author(s):  
Tharani Putta ◽  
Kaushik Deconda
Keyword(s):  
Diagnostic Performance ◽  
Virus Disease ◽  
Vital Role ◽  
Chest Ct ◽  
Lung Involvement ◽  
Test Results ◽  
Rt Pcr ◽  
Diagnostic Role ◽  
Pcr Test

BACKGROUND AND OBJECTIVE: Role of chest CT in diagnosis of corona virus disease 2019 (COVID-19) has been controversial. The purpose of this study is to evaluate the diagnostic performance of chest CT when utilizing COVID-19 Reporting and Data System (CO-RADS). METHODOLOGY: Retrospective study including consecutive patients with positive SARS-CoV-2 RT-PCR test (initial or repeat test) and chest CT done in our institute between June and September 2020. Spectrum of CT ndings, CO-RADS score and 25 point CT severity score (CTSS) were recorded. RESULTS: A total of 300 consecutive patients with SARS-CoV-2 infection were included in the analysis. Out of the 168 patients who underwent CT prior to positive RT-PCR result, 125 (74.4%) had CO-RADS 3, 4 or 5 score on chest CT. 32 study patients (10.6%) had initial negative RT-PCR of which 24 (75%) had CO-RADS 4 or 5 score. Of the total patients with CO-RADS 3 to 5 score (227), 20 (8.8%) had severe lung involvement (CTSS 18-25), 83 (36.6%) had moderate lung involvement (CTSS 8-17) and 124 (54.6%) had mild lung involvement (CTSS 1-7). The mean CTSS was 7.9 with mean lobar score being higher in lower lobes (RLL=1.82, LLL=1.78) compared to the upper and middle lobes (RUL=1.61, RML=1.19, LUL=1.53). CONCLUSION:CT using CO-RADS scoring system has good diagnostic performance. In addition to assessing disease severity, it plays a vital role in triage of patients with suspected COVID-19 especially when there is limited availability of SARS-CoV-2 RT-PCR tests, delay in RT-PCR test results or in negative RT-PCR cases when there is high index of clinical suspicion.

scholarly journals Fast and low-cost detection of SARS-CoV-2 peptides by tandem mass spectrometry in clinical samples

2020 ◽  
Author(s):  
Karina Helena Morais Cardozo ◽  
Adriana Lebkuchen ◽  
Guilherme Goncalves Okai ◽  
Rodrigo Andrade Schuch ◽  
Luciana Godoy Viana ◽  
...  
Keyword(s):  
Real Time ◽  
Large Scale ◽  
Low Cost ◽  
Large Population ◽  
Virus Detection ◽  
Standard Test ◽  
Clinical Samples ◽  
Rt Pcr ◽  
Reverse Transcription Pcr ◽  
Fast Processing

Abstract The current outbreak of severe acute respiratory syndrome associated with coronavirus 2 (SARS-CoV-2) is pressing public health systems around the world, and large population testing is a key step to control this pandemic disease. Real-time reverse-transcription PCR (real-time RT-PCR) is the gold standard test for virus detection but the soaring demand for this test resulted in shortage of reagents and instruments, severely limiting its applicability to large-scale screening. To be used either as an alternative, or as a complement, to real-time RT-PCR testing, we developed a high-throughput targeted proteomics assay to detect SARS-CoV-2 proteins directly from clinical respiratory tract samples. Sample preparation was fully automated by using a modified magnetic particle-based proteomics approach implemented on a robotic liquid handler, enabling a fast processing of samples. The use of turbulent flow chromatography included four times multiplexed on-line sample cleanup and UPLC separation. MS/MS detection of three peptides from SARS-CoV-2 nucleoprotein and a 15N-labeled internal global standard was achieved within 2.5 min, enabling the analysis of more than 500 samples per day. The method was validated using 562 specimens previously analyzed by real-time RT-PCR and was able to detect over 83% of positive cases. No interference was found with samples from common respiratory viruses, including other coronaviruses (NL63, OC43, HKU1, and 229E). The strategy here presented has high sample stability and low cost and should be considered as an option to large population testing.

scholarly journals Evaluation Of Clinical, Laboratory And Radiological Findings In Pediatric Covid-19 Cases And Their Relation With RT-PCR Result

2021 ◽  
Author(s):  
Muhammet Asena ◽  
ilyas yolbaş ◽  
murat Kanğın
Keyword(s):  
Computed Tomography ◽  
Respiratory Distress ◽  
Clinical Laboratory ◽  
Age Groups ◽  
Age Group ◽  
Test Results ◽  
Rt Pcr ◽  
Radiological Findings ◽  
Laboratory Findings ◽  
Pcr Test

Background: The pandemic of the new coronavirus disease (COVID-19) continues to be a major health problem globally. In this study, clinical findings, radiological findings, laboratory findings and polymerase chain reaction (PCR) test results were evaluated according to age groups in pediatric patients with COVID-19. Methods: In this study, PCR (+) and PCR (-) 278 cases diagnosed with COVID-19 between March 15, 2020 and September 30, 2020 were assessed considering clinical symptoms, radiological and laboratory findings and RT-PCR test results. Results: 43.9% of the cases consisted of RT-PCR (+) and 56.1% of RT-PCR (-) cases. Fever was observed at the rate of 64.7%, cough 53.2%, respiratory distress 12.2%, myalgia 24.5%, diarrhea 12.9%, chest X-ray findings 48.2% and computed tomography findings 43.6%. Diarrhea and cough, alanine aminotransferase, aspartate aminotransferase, leukocyte and lymphocyte elevation were determined as significantly higher in younger age group cases, while high myalgia and neutrophilia was observed in older age group children (p <0.05). Fever, high CRP, leukocytosis frequency, high neutrophil, were significantly higher in PCR(-) cases and the frequency of respiratory distress, high lymphocyte and chest computed tomography findings in PCR(+) cases (p <0.05). Conclusion: COVID-19 infection may indicate different nonspecific clinical, laboratory and radiological findings in children according to both adults and pediatric age groups. In addition, the results of the PCR test may give erroneous results in cases due to conditions such as fever, respiratory distress, high CRP, leukocytosis, high neutrophil and CT finding. Keywords: pediatric, COVID-19, RT-PCR

scholarly journals Association of Underlying Diseases and Clinical Characteristics with Mortality in Patients with 2019 Novel Coronavirus in Iran

2020 ◽  
Vol 15 (5) ◽  
Author(s):  
Mohammadhossein Zamanian ◽  
Zohre Foroozanfar ◽  
Zhila Izadi ◽  
Samira Jafari ◽  
Hossein Derakhshankhah ◽  
...  
Keyword(s):  
Heart Disease ◽  
Clinical Characteristics ◽  
Underlying Disease ◽  
Test Results ◽  
Rt Pcr ◽  
Factors Associated ◽  
History Of ◽  
Novel Coronavirus ◽  
Underlying Diseases ◽  
Pcr Test

Objectives: The first case of 2019 novel coronavirus disease (COVID-19) was reported in Iran in February 2020. Here, we report the epidemiological and clinical characteristics of patients with COVID-19 and factors associated with mortality in these patients. Methods: A retrospective cohort study was conducted from February 22, 2020, to March 24, 2020, in Golestan Hospital in Kermanshah, Iran. Demographic data including underlying diseases and clinical data including the presenting symptoms, chest computed tomography (CT) scan, reverse transcription polymerase chain reaction (RT-PCR) test results, and outcomes were extracted from electronic medical records. Simple and multiple logistic regression methods were used to explore the factors associated with mortality. Results: Of 245 patients admitted with COVID-19, 155 (63.30%) were male. The mean age of the subjects was 54.68 ± 19.21. Forty-five (18.48%) patients had underlying diseases. Common symptoms were dyspnea (n = 137; 55.9%), cough (n = 93; 38.0%), and fever (n = 78; 31.8%). All patients had pneumonia with abnormal findings on chest CT scan (100%), and RT-PCR test results were positive in 87 (35.50%) patients. Of the total admitted cases, 38 (15.5%) patients died during hospitalization. An old age (OR = 1.09; 95% CI: 1.02 to 1.06), history of heart disease (OR = 5.07; 95% CI: 1.46 to 17.58), hypertension (OR = 5.82; 95% CI: 1.13 to 30.04), smoking (OR = 11.44; 95% CI: 1.01 to 29.53), history of at least one underlying disease (OR = 3.31; 95%CI: 1.54 to 7.09), and symptoms of decreased consciousness at the time of admission (OR = 24.23; 95% CI: 2.62 to 223.39) were associated with mortality. Also, the symptoms of cough (OR = 0.383; 95% CI: 0.17 to 0.88) and fever (OR = 0.278; 95% CI: 0.10 to 0.74) had a negative association with mortality. Conclusions: In the current study, factors including old age, smoking, symptoms of decreased consciousness, and underlying diseases such as heart disease, hypertension, and history of at least one underlying disease were associated with mortality. Factors associated with mortality should be considered so that we can better manage patients with COVID-19.

scholarly journals Changes in RT-PCR test results and symptoms during the menstrual cycle of a female individual infected with SARS-CoV-2: a case report

2020 ◽  
Author(s):  
Hua Zheng ◽  
Juan Tan ◽  
Ke Ma ◽  
Weihua Meng
Keyword(s):  
Menstrual Cycle ◽  
Hospital Discharge ◽  
Disease Susceptibility ◽  
Menstrual Period ◽  
Test Results ◽  
Rt Pcr ◽  
Case Presentation ◽  
Management Protocol ◽  
History Of ◽  
Pcr Test

Abstract Background: The implications of the menstrual cycle for disease susceptibility, development, and severity of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are largely unknown.Case presentation: We report a 37-year-old woman infected with SARS-CoV-2 who showed a 16-day incubation period. She developed a fever on the first day of her menstrual period, and again on the first day of her next menstrual period after hospital discharge. RT-PCR test results were positive during the first menstrual period before admission, turned negative during hospitalization, and then positive again during the second menstrual period after hospital discharge.Conclusions: This case indicates sex hormones may play an important role in SARS-CoV-2 infection. For women with history of exposure to SARS-CoV-2, the management protocol should include assessment of the menstrual status.

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