scholarly journals Comparison of regulatory approval process for vaccines development and manufacturing in India & USA

2021 ◽  
pp. 18-24
Author(s):  
Bhargavi Thanuja M ◽  
Ramaiah Maddi
Keyword(s):  
Vaccine Development ◽  
Research Committee ◽  
Current Review ◽  
License Application ◽  
Controller General ◽  
The Usa ◽  
Assess Quality ◽  
Assessment Procedures ◽  
Regulatory Procedure ◽  
Stringent Quality

The Vaccine Development is a complex and time-consuming process because of stringent quality assessment procedures. The vaccine is approved for release into the market, a stringent regulatory procedure to assess quality, efficacy and safety must be maintained. The regulation of vaccine in India with the licensing and GMP is controlled by the drug controller general of India (DCGI). The USA regulation was controlled by the USFDA in center biologics evaluation and research committee (CBER) and Biologics license application (BLA). These Authorities are responsible for vaccine regulations in India & USA. The current review articles highlight the comparison of registration process of vaccines in INDIA and USA.  

SARS-CoV-2: Molecular biology and therapeutic target.

Coronaviruses ◽  
2021 ◽  
Vol 02 ◽  
Author(s):  
Vivek Pandey ◽  
Ankita Pathak ◽  
Mohammad Shahar Yar ◽  
Yuba Raj Pokharel
Keyword(s):  
Viral Genome ◽  
Vaccine Development ◽  
Viral Proteins ◽  
Current Review ◽  
The World ◽  
Spanish Flu ◽  
Repurposed Drugs ◽  
Key Features ◽  
Economic Infrastructure ◽  
Viral Outbreak

: A century after the outbreak of the Spanish flu, the world is suffering with another pandemic on because of the coronavirus. The virus took a toll of more than millions of lives worldwide and still continues to affect the health and socio-economic infrastructure all over the world. The study explores the epidemiology, etiology and transmission of the virus and its phylogenetic relationship with SARS and MERS coronavirus responsible for 2002 and 2012 viral outbreak. Highlights about the key features of the viral genome and essential viral proteins responsible for viral life cycle, evading host immune response, and viral immunopathology with therapeutics from “Recovery” and “Solidarity” trials, are major concern of the current review. The review culminated with a discussion on different classes of front-runners vaccines and their efficacy. An overall understanding of essential viral proteins and their role in pathogenesis, repurposed drugs and vaccine development is the rationale of the present review.

scholarly journals Peptides in COVID-19 Clinical Trials—A Snapshot

Biologics ◽  
2021 ◽  
Vol 1 (3) ◽  
pp. 300-311
Author(s):  
Kai Hilpert
Keyword(s):  
Clinical Trials ◽  
Antiviral Activity ◽  
Russian Federation ◽  
Current Situation ◽  
Routine Diagnostics ◽  
Current Review ◽  
The Usa ◽  
The Russian Federation ◽  
The Uk

Since the beginning of the COVID-19 pandemic, there has been a strong drive and desire to find effective treatments for and protection against the disease. On the webpage ClinicalTrials.gov, a total of 6505 clinical trials currently (September 2021) investigating various aspects of COVID-19 are registered. Of these, 124 studies involving peptides were identified. These 124 were further evaluated, and 88 trials that used peptides only for routine diagnostics were excluded. The remaining 36 trials were classified into 5 different classes according to their function: immunomodulatory (5 trials), regain homeostasis (10 trials), diagnostics/biomarkers (8 trials), vaccination (9 trials), and antiviral activity (4 trials, all overlap with immunomodulatory activities). In the current review, these 36 trials are briefly described and tabularly summarised. According to the estimated finish date, 14 trials have not yet finished. All of the finished trials are yet to report their results. Seven trials were based in the USA, and Egypt, France, the UK, Turkey, and the Russian Federation conducted three trials each. This review aims to present a snapshot of the current situation of peptides in COVID-19 clinical trials and provides a template to follow up on trials of interest; it does not claim to be a complete overview.

Search and Research

1985 ◽  
Vol 48 (8) ◽  
pp. 232-232
Keyword(s):  
Occupational Therapy ◽  
Research Committee ◽  
Medical Library ◽  
The Usa ◽  
Fellowship Award

The Journal does NOT have most of the publications listed and readers wishing to refer to any articles, or borrow a book, should apply to their nearest medical library. There is one exception, ‘The Occupational Therapy Journal of Research’ (published in the USA), which is held by the Journal, and readers should apply accordingly. Any suggestions for the next list should be sent to the Secretary of the Fellowship Award and Research Committee.

Search and Research

1983 ◽  
Vol 46 (8) ◽  
pp. 230-230
Keyword(s):  
Occupational Therapy ◽  
Research Committee ◽  
Medical Library ◽  
The Usa ◽  
Fellowship Award

The Journal does NOT have most of the publications listed and readers wishing to refer to any articles, or borrow a book, should apply to their nearest medical library. There is one exception, ‘The Occupational Therapy Journal of Research’ (published in the USA), which is held by the Journal, and readers should apply accordingly. Any suggestions for the next list should be sent to the Secretary of the Fellowship Award and Research Committee.

scholarly journals Control and non-progression of HIV-1 infection in sub-Saharan Africa: A case and review

2012 ◽  
Vol 13 (3) ◽  
pp. 152-155 ◽  
Author(s):  
P Patel ◽  
M Brooks ◽  
G Anabwani ◽  
M A Tolle
Keyword(s):  
Vaccine Development ◽  
Sub Saharan Africa ◽  
Hiv Positive ◽  
Elite Controllers ◽  
Resource Limited ◽  
The Usa ◽  
Sub Saharan ◽  
Positive Population ◽  
Hiv 1

Elite and viraemic controllers represent unique subsets of HIV-infected patients who may also be long-term non-progressors (LTNPs). LNTPs constitute an estimated 1 - 15% of the total HIV-positive population in the USA and Europe, but less is known about their epidemiology in sub-Saharan Africa. Though the exact mechanisms for long-term non-progression appear to be numerous and are still under investigation, research on elite controllers may hold the key to new therapeutics and vaccine development. The clinical management of such patients can be challenging, as there are no standard guidelines for treatment, particularly in resource-limited settings. We describe the case of an HIV-infected Botswanan man who is likely an elite or viraemic controller.

Search and Research

1984 ◽  
Vol 47 (2) ◽  
pp. 54-54
Keyword(s):  
Occupational Therapy ◽  
Research Committee ◽  
Medical Library ◽  
The Usa ◽  
Fellowship Award

The Journal does NOT have most of the publications listed and readers wishing to refer to any articles, or borrow a book, should apply to their nearest medical library. There is one exception, ‘The Occupational Therapy Journal of Research’ (published in the USA), which is held by the Journal, and readers should apply accordingly. Any suggestions for the next list should be sent to the Secretary of the Fellowship Award and Research Committee.

scholarly journals COVID-19: Characteristics and Therapeutics

Cells ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 206 ◽  
Author(s):  
Rameswari Chilamakuri ◽  
Saurabh Agarwal
Keyword(s):  
Molecular Mechanisms ◽  
Vaccine Development ◽  
Clinical Manifestations ◽  
Treatment Strategies ◽  
Drug Repurposing ◽  
World Health ◽  
Pharmacological Intervention ◽  
Multiple Treatment ◽  
The Usa ◽  
Novel Coronavirus

Novel coronavirus (COVID-19 or 2019-nCoV or SARS-CoV-2), which suddenly emerged in December 2019 is still haunting the entire human race and has affected not only the healthcare system but also the global socioeconomic balances. COVID-19 was quickly designated as a global pandemic by the World Health Organization as there have been about 98.0 million confirmed cases and about 2.0 million confirmed deaths, as of January 2021. Although, our understanding of COVID-19 has significantly increased since its outbreak, and multiple treatment approaches and pharmacological interventions have been tested or are currently under development to mitigate its risk-factors. Recently, some vaccine candidates showed around 95% clinical efficacy, and now receiving emergency use approvals in different countries. US FDA recently approved BNT162 and mRNA-1273 vaccines developed by Pfizer/BioNTech and Moderna Inc. for emergency use and vaccination in the USA. In this review, we present a succinct overview of the SARS-CoV-2 virus structure, molecular mechanisms of infection, COVID-19 epidemiology, diagnosis, and clinical manifestations. We also systematize different treatment strategies and clinical trials initiated after the pandemic outbreak, based on viral infection and replication mechanisms. Additionally, we reviewed the novel pharmacological intervention approaches and vaccine development strategies against COVID-19. We speculate that the current pandemic emergency will trigger detailed studies of coronaviruses, their mechanism of infection, development of systematic drug repurposing approaches, and novel drug discoveries for current and future pandemic outbreaks.

scholarly journals nCov2019: an R package for studying the COVID-19 coronavirus pandemic

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e11421
Author(s):  
Tianzhi Wu ◽  
Erqiang Hu ◽  
Xijin Ge ◽  
Guangchuang Yu
Keyword(s):  
Web Application ◽  
Historical Data ◽  
Vaccine Development ◽  
R Package ◽  
Health Crisis ◽  
Medical Progress ◽  
Clinical Phase ◽  
Interactive Analysis ◽  
The Usa ◽  
Access To Data

Background The global spreading of the COVID-19 coronavirus is still a serious public health challenge. Although there are a large number of public resources that provide statistics data, tools for retrospective historical data and convenient visualization are still valuable. To provide convenient access to data and visualization on the pandemic we developed an R package, nCov2019 (https://github.com/YuLab-SMU/nCov2019). Methods We collect stable and reliable data of COVID-19 cases from multiple authoritative and up-to-date sources, and aggregate the most recent and historical data for each country or even province. Medical progress information, including global vaccine development and therapeutics candidates, were also collected and can be directly accessed in our package. The nCov2019 package provides an R language interfaces and designed functions for data operation and presentation, a set of interfaces to fetch data subset intuitively, visualization methods, and a dashboard with no extra coding requirement for data exploration and interactive analysis. Results As of January 14, 2021, the global health crisis is still serious. The number of confirmed cases worldwide has reached 91,268,983. Following the USA, India has reached 10 million confirmed cases. Multiple peaks are observed in many countries. Under the efforts of researchers, 51 vaccines and 54 drugs are under development and 14 of these vaccines are already in the pre-clinical phase. Discussion The nCov2019 package provides detailed statistics data, visualization functions and the Shiny web application, which allows researchers to keep abreast of the latest epidemic spread overview.

scholarly journals Negative sentiment towards COVID-19 vaccines: A comparative study of USA and UK social media posts before vaccination rollout

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 472
Author(s):  
James Lappeman ◽  
Keneilwe Munyai ◽  
Benjamin Mugo Kagina
Keyword(s):  
Social Media ◽  
Vaccine Development ◽  
Health And Safety ◽  
Public Health Response ◽  
Main Driver ◽  
Negative Comments ◽  
The Usa ◽  
Human Validation ◽  
The Uk ◽  
Negative Sentiment

Abstract  Introduction: The global spread of the COVID-19 pandemic was rapid and devastating to humanity. The public health response to the pandemic was rapid too. Completion of COVID-19 vaccine development was achieved in under a year. The USA and the UK were the first countries to rollout COVID-19 vaccines to contain the pandemic. Successful rollout of the vaccines hinges on many factors, among which is public trust.   Aim: To investigate the sentiments towards COVID-19 vaccines in the USA and UK prior to vaccination rollout.  Methods: Neuro-linguistic programming with human validation was used to analyse a sample of 243,883 COVID-19 vaccine related social media posts from the USA and the UK in the period 28 July to 28 August 2020. The sentiment analysis measured polarity (positive, neutral, negative), and the themes present in negative comments.   Results: In the sample of 243,883 social media posts, both the USA and the UK had a net sentiment profile of approximately 28% positive, 8% negative and 63% neutral sentiment. On further analysis, there were distinct differences between the two country’s social media sentiment towards COVID-19 vaccines. The differences were seen in the themes behind the negative sentiment. In the USA, the negative sentiments were mainly due to health and safety concerns, the fear of making a vaccine mandatory, and the role that pharmaceutical companies would play with the release of vaccines. In the UK the main driver of negative sentiment was the fear of making the vaccine mandatory (almost double the size of the sentiment in the USA).  Conclusions: Negative sentiments towards COVID-19 vaccines were prevalent in the third quarter of 2020 in the USA and the UK. Reasons behind the negative sentiments can be used by authorities in the two countries to design evidence-based interventions to address the refusal of vaccination against COVID-19.

Second language learners in special education

1986 ◽  
Vol 3 ◽  
pp. 92-107
Author(s):  
Peggy W. Goldsmith
Keyword(s):  
Special Education ◽  
Second Language ◽  
Language Learners ◽  
Second Language Learners ◽  
Department Of Education ◽  
Adaptive Behaviour ◽  
South Wales ◽  
The Usa ◽  
English Speaking ◽  
Assessment Procedures

During 1984, New South Wales Department of Education conducted a survey of ethnic-specific needs of students of non-English speaking backgrounds (NESB) in schools for specific purposes (SSPs), which are special education schools. This paper indicates the results and outcomes of that survey. The percentage of students of NESBs in responding schools was 15.4%. The distribution of languages other than English spoken in homes of NESB students in SSPs is similar to that of the general population. The issues seen to be of greatest importance for schools with NESB pupils were assistance in communicating with non-English parents, and a knowledge of and contact with ethnic welfare/support agencies. A literature search revealed little in the way of studies on language provision for students of NESB in SSPs in the USA, Canada, Britain or in Australia. Assessment for placement in special education has always posed a difficulty in regard to students whose dominant language is not English. A move towards the use of Adaptive Behaviour Scales is a possible change in assessment procedures. where the level of language development will constitute just one factor among a number of others. The commencement of English as a second language programme and a bilingual programme are seen as innovatory in this field of education.

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