scholarly journals Effectiveness of the BNT162b2 mRNA COVID-19 Vaccine in Pregnancy

2021 ◽  
Author(s):  
Ran Balicer ◽  
Noa Dagan ◽  
Noam Barda ◽  
Tal Biron-Shental ◽  
Maya Makov-Assif ◽  
...  
Keyword(s):  
General Population ◽  
Pregnant Women ◽  
Phase Iii ◽  
Severe Illness ◽  
Vaccine Acceptance ◽  
Documented Infection ◽  
Phase Iii Clinical Trials ◽  
Kaplan Meier ◽  
History Of ◽  
Vaccination Campaigns

Abstract Background: As mass vaccination campaigns against COVID-19 accelerate worldwide, there remains only limited evidence regarding vaccine effectiveness (VE) among pregnant women. Pregnant women have been shown to be at risk for severe COVID-19, resulting in adverse obstetrics outcomes, and their immune system is known to undergo alterations during pregnancy. Phase III clinical trials of the approved mRNA COVID-19 vaccines excluded pregnant women, yet current guidelines encourage offering the vaccine to pregnant women. In this study, we examine data from Israel’s largest healthcare organization to evaluate the effectiveness of the BNT162b2 mRNA vaccine among pregnant women. Methods: We conducted an observational cohort study of pregnant women 16 years or older, with no history of SARS-CoV-2, who were vaccinated between December 20, 2020 and June 3, 2021. Vaccinated subjects were matched to unvaccinated controls according to a set of demographic and clinical characteristics. Study outcomes included documented infection with SARS-CoV-2, symptomatic COVID-19, COVID-19-related hospitalization, severe illness and death. For each outcome, VE was estimated at several periods following vaccination as one minus the risk ratio using the Kaplan–Meier estimator. Results: 10,861 vaccinated women were matched to an identical number of unvaccinated controls. Estimated VE from 7 through 28 days after the second dose was 97% (95% CI 91%-100%) for any documented infection, 96% (86-100%) for infections with documented symptoms, and 85% (32%-100%) for COVID-19-related hospitalization. Only one event of severe illness was observed in the unvaccinated group, and no deaths were observed in either group -- insufficient incidence for estimating VE for these outcomes. Discussion: The BNT162b2 mRNA vaccine was found to have high VE among pregnant women. Since high VE has been reported as one of the strongest predictors of COVID-19 vaccine acceptance among pregnant women, the high VE estimates found in this study have the potential to increase vaccine acceptance in this group. In addition, the present VE estimates are similar to those reported in the general population for the same variants, suggesting that it may be possible to infer the VE for pregnant women from studies in the general population for both current and future variants.

scholarly journals Acceptability of the COVID-19 Vaccine among Adults in Saudi Arabia: A Cross-Sectional Study of the General Population in the Southern Region of Saudi Arabia

Vaccines ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 41
Author(s):  
Yahya S. Alqahtani
Keyword(s):  
Saudi Arabia ◽  
General Population ◽  
Healthcare System ◽  
Perceived Risk ◽  
Seasonal Influenza ◽  
Southern Region ◽  
Cross Sectional ◽  
Vaccine Acceptance ◽  
History Of ◽  
The Impact

Vaccines afford protection against infectious diseases. However, a sizeable part of the population refuse vaccinations and continue to dispute the evidence supporting vaccinations. The objective of this study was to determine the prevalence of COVID-19 vaccination uptake and its determinants among the Saudi population in the southern region of Saudi Arabia. A cross-sectional survey studied COVID-19 vaccine acceptance in adults in Saudi Arabia, targeting the general population in the southwestern region. Data were collected through an online survey questionnaire tool. All data were analysed using SPSS version 23.0. The majority (57.29%) of the participants were willing to receive the new COVID-19 vaccine, whereas almost 64% believed it is necessary to take the COVID-19 vaccine to protect oneself and that the vaccine is safe, efficient and effective. The data showed that perceived risk of COVID-19 (p = 0.015), history of previous vaccination against seasonal influenza (p = 0.000), and trust in the healthcare system (p = 0.025) were significant predictors for COVID-19 vaccine acceptance. We conclude that participants’ trust in the healthcare system, perceived risk of contracting COVID-19, and history of previous vaccination against seasonal influenza were significant predictors for COVID-19 vaccine acceptance. Knowing the acceptance rates for the COVID-19 vaccination can aid state agencies, medical practitioners, and other entities in reducing the impact of vaccine avoidance.

A weighted-adjusted indirect comparison of everolimus (EVE) versus axitinib (AXI) in second-line metastatic renal cell carcinoma (mRCC) patients who previously failed sunitinib therapy.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 491-491
Author(s):  
Steven A. Sherman ◽  
Xufang Wang ◽  
Billy Amzal ◽  
Roman Casciano ◽  
Haitao Gao ◽  
...  
Keyword(s):  
Indirect Comparison ◽  
Progression Free Survival ◽  
Similar Efficacy ◽  
Phase Iii ◽  
Second Line ◽  
Two Phase ◽  
Phase Iii Clinical Trials ◽  
Kaplan Meier ◽  
Adjusted Indirect Comparison ◽  
Baseline Characteristics

491 Background: Both EVE and AXI have been approved for second-line treatment of mRCC after VEGFR-TKI therapy failure. No head-to-head clinical trial has compared clinical outcomes between EVE and AXI in this setting. This study aims to compare progression free survival (PFS) from two phase III clinical trials among mRCC patients with SUN as their only prior antineoplastic therapy and subsequently treated with EVE in the RECORD-1 trial vs. AXI in the AXIS trial, after adjusting for cross-trial differences. Methods: A weighted-adjusted indirect comparison using patient-level data from RECORD-1 and summary data from the AXIS trial publication was performed to align baseline characteristics from both trials and compare PFS (central review). A subset of N=43 second-line SUN -refractory mRCC patients treated with EVE were identified in RECORD-1 to correspond to a similar subset of patients (N=194) treated with AXI in AXIS. Logistic regression was used to identify factors predicting PFS in RECORD-1. The RECORD-1 subset was weighted to align the distributions of these key factors (i.e., MSKCC risk, gender, and time on prior SUN) with the AXIS subset. Weights were calculated for each patient using the following equation: Wi = [Pi (AAXIS)/Pi (ARECORD-1)] * [Pi (BAXIS)/Pi (BRECORD-1)] * [Pi (CAXIS)/Pi (CRECORD-1)], where A=Gender, B=MSKCC risk, and C=time on prior SUN. A weighted median PFS estimate with 95% bootstrap confidence interval (CI) and corresponding Kaplan-Meier (KM) curve were derived for EVE patients. Results: After weighting, the three key baseline characteristics were mostly comparable between the two studies, with the exception of MSKCC where a higher proportion of poor risk patients was evident in RECORD-1 (42%) vs. AXIS (33%). A median PFS of 5.1 months (95% CI: 3.6-10.7) was observed for weighted EVE patients compared to 4.8 months (95% CI: 4.5-6.4) reported in AXIS. Conclusions: The PFS estimates suggest similar efficacy between EVE and AXI in SUN-refractory mRCC patients. Further research is needed to confirm these results, which should be interpreted as those from an observational study.

scholarly journals COVID-19 VACCINE ACCEPTANCE: BELIEFS AND BARRIERS ASSOCIATED WITH VACCINATION AMONG THE GENERAL POPULATION IN INDIA

2020 ◽  
Vol 8 (Spl-1-SARS-CoV-2) ◽  
pp. S210-S218
Author(s):  
Khan Sharun ◽  
◽  
C. K. Faslu Rahman ◽  
C. V. Haritha ◽  
Bosco Jose ◽  
...  
Keyword(s):  
General Population ◽  
Online Questionnaire ◽  
Vaccine Acceptance ◽  
The Public ◽  
Potential Barriers ◽  
Several Variables ◽  
Key Barrier ◽  
Vaccination Campaigns ◽  
Self Administered Questionnaire ◽  
China Development

Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel zoonotic coronavirus that emerged from Wuhan, China. Development of SARS-CoV-2 specific vaccine is considered as the only solution that could control this pandemic. However, the success of COVID-19 vaccination programme will be dependent on the development of effective and safer vaccines and also on the public acceptance which in turn reliant on the beliefs and perception towards the vaccine. Therefore, this study was aimed to analyse the beliefs and barriers associated with COVID-19 vaccination among the general population in India. The study conducted using an online self-administered questionnaire that was distributed among the general population of India during the month of October 2020. The online questionnaire addressed several variables including the socio-demographic parameters, beliefs toward COVID-19 vaccine/vaccination, COVID-19 vaccine acceptance, potential barriers that may prevent from being vaccinated and factors that can improve COVID-19 vaccine acceptance. Among the 351 participants, 55% believed that the COVID-19 vaccination will be safe while only 46.2% believed that it will be effective. Majority of the participants (86.3%) were planning to get COVID-19 vaccination, whereas 13.7% admitted hesitancy. However, only 65.8% of the participants responded that they will receive vaccination as soon as possible whenever the vaccine is available. The study also identified that the concerns regarding the vaccine side effects acted as the key barrier for vaccine acceptance. The major findings of this study can be utilized in planning vaccination campaigns. Furthermore, the level of vaccine acceptance can be increased within the population if additional studies can confirm the safety and effectiveness of available vaccine candidates.

scholarly journals Beliefs and Barriers Associated with COVID-19 Vaccination Among the General Population in Saudi Arabia

2020 ◽  
Author(s):  
Rania M Magadmi ◽  
Fatemah O. Kamel
Keyword(s):  
Saudi Arabia ◽  
Vaccine Development ◽  
Demographic Variables ◽  
Education History ◽  
Vaccine Acceptance ◽  
Potential Barriers ◽  
History Of ◽  
Key Barrier ◽  
Vaccination Campaigns ◽  
Self Administered Questionnaire

Abstract Background: Developing a vaccine against COVID-19 is considered a key strategy to end the pandemic. However, public acceptance is reliant on beliefs and perception toward the vaccine. Therefore, the study aimed to assess the beliefs and barriers associated with COVID-19 vaccination among the Saudi population. Methods: An online self-administered questionnaire was distributed across the main regions of Saudi Arabia on May 2020. The questionnaire addressed the socio-demographic variables, beliefs toward COVID-19 vaccination, and potential barriers that may prevent participants from being vaccinated. The association between COVID-19 vaccine acceptance and sociodemographic variables were analyzed. Logistic regression analysis was used to identify the predicting variables of vaccine acceptance.Results: Out of 3,101 participants, 44.7% are accepting of COVID-19 vaccination if available, whereas 55.3% admitted hesitancy. Younger, male, with secondary education, history of taking previous seasonal influenza vaccine, and positive belief toward COVID-19 vaccination are more likely to accept. The study found that concerns about side effects were the key barrier for vaccine acceptance. Furthermore, the majority of refusers will accept the vaccine if additional studies confirmed safety and effectiveness. Conclusion: Results can be utilized in planning vaccination campaigns while waiting for vaccine development.

Changing prognosis of metastatic colorectal adenocarcinoma (mCRC) 1988-2008 within the general population: Has everyone benefitted?

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14143-e14143 ◽  
Author(s):  
Yaacov Richard Lawrence ◽  
Talia Golan ◽  
Dan Aderka ◽  
Adi Shani ◽  
Leor Zach ◽  
...  
Keyword(s):  
General Population ◽  
Population Based ◽  
New Drugs ◽  
Phase Iii ◽  
Proportional Hazard ◽  
Net Benefit ◽  
Kaplan Meier ◽  
Phase Iii Trials ◽  
Disease Site ◽  
Study Population

e14143 Background: Between 1991 and 2008 the FDA approved 7 new drugs for the treatment of mCRC. The results of randomized phase III trials, performed on selected (e.g. younger) patient populations, may not reflect net benefit seen within the general population. We therefore performed a population-based survival analysis of patients who initially presented with mCRC. Methods: Survival statistics were extracted from the Survival, Epidemiology and End Results (SEER) Database for patients diagnosed with mCRC between 1988-2008. Survival was analyzed using the Kaplan-Meier method and proportional hazard models as appropriate. Exclusion criteria included diagnosis at autopsy, non-adenocarcinoma and unknown histology. Results: The study population consisted of 42,347 patients diagnosed with mCRC from 1988-2008, 52% female. Mean age 67 years; 46% were aged 70 or over. Prognostic variables included race, gender, age, marital status, disease site, surgical resection and year of diagnosis (for all p<0.001). For the entire population median OS improved from 8 months in 1988 to 14 months in 2007. Net improvement in OS was highly dependant upon age: for pts<50 yr OS improved from 9m to 21m; for pts 50-69 yr from 10m to 17m; for pts >=70 yr from 7 to 8m. Conclusions: There has been a continuous improvement in OS of patients diagnosed with mCRC between 1988 and 2008. We could not determine if this was due to new therapeutic agents or improved imaging leading to earlier diagnosis. Little improvement has been seen in patients >70 years age. The disparity in median OS between younger and older patients with mCRC over this period has widened from 2 months in 1988 to 13 months in 2008.

scholarly journals Tiempo de inicio de complicación obstétrica en embarazadas de alto riesgo de una comunidad Maya de Yucatán, México

2019 ◽  
pp. 1-5
Author(s):  
Elsa RODRÍGUEZ-ANGULO ◽  
Alejandro OSORIO-EUÁN ◽  
Ricardo OJEDA-RODRÍGUEZ ◽  
Jolly HOIL-SANTOS
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Onset Time ◽  
Timely Manner ◽  
Kaplan Meier ◽  
History Of ◽  
The Mean ◽  
Time Of Presentation ◽  
In Pregnancy

Objectives. To assess the onset time to present obstetric complications in high-risk pregnant women from the Mayan community of Mayapan, Yucatan, Mexico. Methodology. Longitudinal, retrospective, observational, descriptive, survival analysis type study. Follow-up was carried out for 46 weeks of 100 high-risk pregnant women. The event was the beginning time of presentation of the complication of the pregnant woman. Kaplan-Meier method was used for follow-up analysis. The mean follow-up time and overall survival at the end of pregnancy were calculated. Contribution. Provide the population with better prenatal control, refer in a timely manner to patients classified as high risk and have better control of records of pregnant women with a gyneco-obstetric history of risks, in order to reduce the incidence of complications in pregnancy and contribute to Maternal mortality reduction.

Rome I versus Rome II; Overlap in patients enrolled in tegaserod phase III clinical trials for irritable bowel syndrome (IBS)

2001 ◽  
Vol 120 (5) ◽  
pp. A284-A284
Author(s):  
B NAULT ◽  
S SUE ◽  
J HEGGLAND ◽  
S GOHARI ◽  
G LIGOZIO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Irritable Bowel ◽  
Rome I

Neovastat, a naturally occurring multifunctional antiangiogenic drug, in phase III clinical trials

2001 ◽  
Vol 28 (6) ◽  
pp. 620-625 ◽  
Author(s):  
Pierre Falardeau ◽  
Pierre Champagne ◽  
Patrick Poyet ◽  
Claude Hariton ◽  
[Eacute]ric Dupont
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Naturally Occurring ◽  
Antiangiogenic Drug

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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