Third Shot vaccination for COVID-19 in Israel

2021 ◽  
Vol 6 ◽  
Keyword(s):  
Clinical Trials ◽  
Vaccine Efficacy ◽  
Vaccination Campaign ◽  
Vaccine Delivery ◽  
Vaccine Effectiveness ◽  
High Quality ◽  
Equitable Distribution ◽  
Correlates Of Protection ◽  
Scientific Questions ◽  
Global Population

After several manufacturers announced COVID-19 vaccine efficacy in clinical trials for disease, a comprehensive post-efficacy strategy for the following steps to ensure vaccination of the global population is now required. These considerations should include: how to manufacture billions of doses of high-quality vaccines, support for vaccine purchase, coordination of supply, the equitable distribution of vaccines, and the logistics of global vaccine delivery, all of which are a prelude to a massive vaccination campaign targeting people of all ages. Furthermore, additional scientific questions about the vaccines remain, and that should be answered to improve vaccine efficacy, including questions regarding the optimization of vaccination regimens, booster doses, the correlates of protection, vaccine effectiveness, safety, and enhanced surveillance. The timely and coordinated execution of these post-efficacy tasks will bring the pandemic effective and efficient [1].

Prerequisites to support high-quality clinical trials in children and young people

2020 ◽  
pp. archdischild-2019-318677
Author(s):  
Steven Hirschfeld ◽  
Florian B Lagler ◽  
Jenny M Kindblom
Keyword(s):  
Clinical Trials ◽  
Healthcare Delivery ◽  
Paediatric Population ◽  
Ecosystem Functions ◽  
Healthcare Delivery System ◽  
High Quality ◽  
Children And Young People ◽  
The Right ◽  
Support Decision Making

Children have the right to treatment based on the same quality of information that guides treatment in adults. Without the proper evaluation of medicinal products and devices in paediatric clinical trials that are designed to meet the rigorous standards of the competent authorities, children are discriminated from advances in medicine. There are regulatory, scientific and ethical incentives to address the knowledge gap regarding efficacy and safety of medicines in the paediatric population. High-quality clinical trials involving children of all ages can generate data that will ultimately close the knowledge gaps and support decision making.For clinical trials that enrol children, the needs are specialised and often resource intensive. Prerequisites for successful paediatric clinical trials are personnel with training in both paediatrics and neonatology and expertise in clinical trials in these populations. Moreover, national and international networks for efficient collaboration, dissemination of information, and sharing of resources and expertise are also needed, together with competent, efficient and high-quality local infrastructure with effective processes. Monitoring and oversight bodies with the relevant competence, including expertise in paediatrics, is also an important prerequisite for paediatric clinical trials. Compromise in any of these components will compromise the downstream results.This paper discusses the structures and competences needed in order to perform effective, high-quality paediatric clinical trials with the ultimate goal of better medicines and treatments for children. We propose a model of examining the process as a series of components that each has to be optimised, then all the components are actively optimised to function together as an ecosystem, and the resulting ecosystem functions well with the general research system and the healthcare delivery system.

scholarly journals In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Lessons Learned ◽  
Patient Access ◽  
High Quality ◽  
Virtual Imaging ◽  
Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

scholarly journals Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

2021 ◽  
Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
High Quality ◽  
High Quality Evidence ◽  
Patient Reported ◽  
Quality Evidence

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247

scholarly journals Recombinant Zoster Vaccine (Shingrix) real-world effectiveness in the first two years post-licensure

2021 ◽  
Author(s):  
Hector S Izurieta ◽  
Xiyuan Wu ◽  
Richard Forshee ◽  
Yun Lu ◽  
Heng-Ming Sung ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Herpes Zoster ◽  
Real World ◽  
Postherpetic Neuralgia ◽  
Vaccine Effectiveness ◽  
Community Dwelling ◽  
Zoster Vaccine ◽  
Post Market ◽  
Recombinant Zoster Vaccine ◽  
Dose Vaccine

Abstract Background Shingrix™ (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as two doses given 2–6 months apart, among adults ages ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster,but post-market vaccine performance has not been evaluated. Efficacy of a single dose, delayed second dose, or among persons with autoimmune or general immunosuppressive conditions have also not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix. Methods We conducted a cohort study among vaccinated and unvaccinated Medicare Part D community dwelling beneficiaries ages >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance, and marginal structural models to estimate hazard ratios. Results We found a vaccine effectiveness of 70.1% (95% CI, 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for two and one doses, respectively. The two-dose vaccine effectiveness was not significantly lower for beneficiaries 80+ years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4-81.8). Conclusions This large real-world observational study of effectiveness of Shingrix demonstrates the benefit of completing the two-dose regimen. Second doses administered beyond the recommended 6 months did not impair vaccine effectiveness.Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.

scholarly journals Estimation of the correlates of protection of the rVSVΔG-ZEBOV-GP Zaire ebolavirus vaccine: a post-hoc analysis of data from phase 2/3 clinical trials

2021 ◽  
Vol 2 (2) ◽  
pp. e70-e78 ◽  
Author(s):  
Rebecca F Grais ◽  
Stephen B Kennedy ◽  
Barbara E Mahon ◽  
Sheri A Dubey ◽  
Rebecca J Grant-Klein ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase 2 ◽  
Post Hoc Analysis ◽  
Correlates Of Protection ◽  
Zaire Ebolavirus ◽  
Post Hoc

Predicting the Effectiveness of the Pfizer-BioNTech BNT162b2 Vaccine from SARS-CoV-2 Variants Neutralisation Data

2021 ◽  
Author(s):  
Oleg Volkov ◽  
Svetlana Borozdenkova ◽  
Alexander Gray
Keyword(s):  
Real Life ◽  
Vaccine Effectiveness ◽  
Vaccine Protection ◽  
Life Effectiveness ◽  
Correlates Of Protection ◽  
Antibody Titres ◽  
Effectiveness Studies

Modelling frameworks for vaccine protection are sorely needed to fight the Covid-19 pandemic with vaccines. We propose such a framework for the BNT162b2 and potentially other vaccines. It identifies correlates of protection based on live SARS-CoV-2 variants neutralising antibody titres from vaccinated individuals. We applied it to predict vaccine effectiveness in overall populations and age subgroups. It was validated by predicting effectiveness against the B.1.167.2 (Delta) variant. The predictions, of 51.7% (34%, 69%) after one and of 88.6% (76%, 97%) after two vaccine doses, were close to the corresponding means, 49% and 85.4%, of observations in real-life effectiveness studies. We illustrate its applications to inform decisions, such as about the doses and timing of vaccine boosters.

scholarly journals Measles Outbreak Associated With Low Vaccine Effectiveness Among Adults in Pohnpei State, Federated States of Micronesia, 2014

2016 ◽  
Vol 3 (2) ◽  
Author(s):  
Craig M. Hales ◽  
Eliaser Johnson ◽  
Louisa Helgenberger ◽  
Mark J. Papania ◽  
Maribeth Larzelere ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Vaccination Campaign ◽  
Vaccine Effectiveness ◽  
Mass Vaccination ◽  
Cold Chain ◽  
Primary Case ◽  
Federated States Of Micronesia ◽  
Measles Outbreak ◽  
Mass Vaccination Campaign ◽  
Vaccination Campaigns

Abstract Background.  A measles outbreak in Pohnpei State, Federated States of Micronesia in 2014 affected many persons who had received ≥1 dose of measles-containing vaccine (MCV). A mass vaccination campaign targeted persons aged 6 months to 49 years, regardless of prior vaccination. Methods.  We evaluated vaccine effectiveness (VE) of MCV by comparing secondary attack rates among vaccinated and unvaccinated contacts after household exposure to measles. Results.  Among 318 contacts, VE for precampaign MCV was 23.1% (95% confidence interval [CI], −425 to 87.3) for 1 dose, 63.4% (95% CI, −103 to 90.6) for 2 doses, and 95.9% (95% CI, 45.0 to 100) for 3 doses. Vaccine effectiveness was 78.7% (95% CI, 10.1 to 97.7) for campaign doses received ≥5 days before rash onset in the primary case and 50.4% (95% CI, −52.1 to 87.9) for doses received 4 days before to 3 days after rash onset in the primary case. Vaccine effectiveness for most recent doses received before 2010 ranged from 51% to 57%, but it increased to 84% for second doses received in 2010 or later. Conclusions.  Low VE was a major source of measles susceptibility in this outbreak; potential reasons include historical cold chain inadequacies or waning of immunity. Vaccine effectiveness of campaign doses supports rapid implementation of vaccination campaigns in outbreak settings.

scholarly journals Measles Outbreak in Complex Emergency: Estimating Vaccine Effectiveness and Evaluation of the Vaccination Campaign in Borno State, Nigeria, 2019

2020 ◽  
Author(s):  
Anne Eudes Jean Baptiste ◽  
John Wagai ◽  
Richard Ray Luce ◽  
Balcha Girma Masresha ◽  
Don Klinkenberg ◽  
...  
Keyword(s):  
Vaccination Campaign ◽  
Screening Method ◽  
Population Level ◽  
Vaccine Effectiveness ◽  
Sensitivity Analyses ◽  
Outbreak Response ◽  
Internally Displaced ◽  
Complex Emergency ◽  
Campaign Coverage ◽  
Measles Outbreaks

Abstract Background: From January to May 2019, large measles outbreaks affected Nigeria. Borno state was the most affected, recording 15,237 suspected cases with the state capital of Maiduguri having 1,125 cases investigated and line-listed by March 2019. In Borno state, 22 of the 27 Local Government Areas (LGAs or Districts), including 37 internally displaced persons (IDPs) camps were affected. In response to the situation, an outbreak response immunization (ORI) campaign was conducted in the 13 most affected LGAs. In addition to conventional vaccination teams, special teams were deployed in security compromised areas, areas with migrants, and for nomadic and IDPs. Here we describe the outbreak and the ORI campaign. We also assess the measles-containing vaccine (MCV) coverage and vaccine effectiveness (VE) in order to quantify the population-level impactMethods: We reviewed the ORI activities, and conducted an analysis of the surveillance and the outbreak investigation reports. We assessed VE of MCV by applying the screening-method. Sensitivity analyses were also conducted to assess the effect of final classification of cases on the VE of MCV. The MCV coverage was assessed by a post-campaign coverage survey (PCCS) after completion of the ORI through a quantitative survey in the 12 LGAs that were accessible. . Results: Of the total 15,237 reported measles cases, 2,002 cases were line-listed and investigated, and 737 were confirmed for measles by week 9 of 2019. Of the investigated cases 67.3% (n = 1,348) were between 9 and 59 months of age. Among the 737 confirmed cases, only 9% (n = 64) stated being vaccinated with at least 1 dose of MCV. The overall VE for MCV was 98.4 (95%CI: 97.8 – 98.8). No significant differences were observed in the VE estimates of lab-confirmed and epi-linked cases when compared to the original estimates. The aggregated weighted vaccination coverage was 85.7% (95% CI: 79.6 – 90.1).Conclusion: The experience in Borno demonstrates that adequate VE can be obtained in conflict-affected areas. In complex emergency affected by measles outbreaks, health authorities may consider integration with other health strategies and the engagement of security personnel as part of the ORI activities.

Clinical trials of COVID 19 vaccines and vaccination campaign: ethical issues

2021 ◽  
Author(s):  
VE Goncharova
Keyword(s):  
Clinical Trials ◽  
Preventive Measures ◽  
Ethical Issues ◽  
Vaccine Development ◽  
Vaccination Campaign ◽  
Public Confidence ◽  
Basic Principles ◽  
Literary Sources ◽  
The World ◽  
Decisive Action

For many centuries, infectious diseases have posed a serious threat: epidemics and pandemics claim lives and multiply the burden on health systems and countries' economies. Humanity managed to defeat a number of infections only thanks to specific preventive measures, i.e., vaccination. In 2020, society faced the new COVID-19 virus that has swept the whole world. The situation required swift and decisive action, including in what concerned vaccine development. It has also raised a number of ethical issues. The article analyzes ethical issues related to clinical trials and vaccination against COVID-19 by studying the regulations, literary sources and bioethical incidents. The key problems identified are: human participation in clinical trials during a pandemic, availability and, simultaneously, voluntariness of vaccination, public confidence in the SARS-Cov-2 vaccines approved for clinical practice. The study showed that the basic principles of clinical trials, voluntariness and awareness, are violated. It was revealed that despite all the efforts of public organizations and WHO initiatives in the world, there is a pronounced imbalance in the availability of the developed vaccines, while the vaccination voluntariness principle is violated by application of various mechanisms to put pressure on people, and public confidence in the developed vaccines can be called insufficient. In general, the problem of vaccination against COVID-19 remains relevant and requires comprehensive discussion.

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