scholarly journals Regulatory issues in pandemic influenza vaccine development

2006 ◽  
Vol 27 (4) ◽  
pp. 172
Author(s):  
Gary Grohmann
Keyword(s):  
Pandemic Influenza ◽  
Adverse Reactions ◽  
Vaccine Development ◽  
Vaccine Safety ◽  
Influenza Vaccines ◽  
Efficacy And Safety ◽  
Batch Release ◽  
Post Market ◽  
Release Testing ◽  
Selection Of

The Therapeutic Goods Administration (TGA) is responsible for the licensing of vaccines used in Australia. This includes pre-market evaluation aspects (such as assessing the quality, efficacy and safety of vaccines) and post-market aspects (such as batch release testing and the monitoring of adverse reactions). For inter-pandemic and pandemic influenza vaccines, TGA is also involved in the selection of appropriate vaccine viruses and the calibration and supply of reagents for the production of influenza vaccines. Together with industry, TGA has a responsibility to ensure that all regulatory and good manufacturing requirements (GMP) are met to ensure vaccine safety and efficacy.

scholarly journals An Overview of Influenza Viruses and Vaccines

Vaccines ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1032
Author(s):  
Rina Fajri Nuwarda ◽  
Abdulsalam Abdullah Alharbi ◽  
Veysel Kayser
Keyword(s):  
Seasonal Influenza ◽  
Vaccine Development ◽  
Influenza Infection ◽  
Influenza Viruses ◽  
Influenza Vaccines ◽  
Efficacy And Safety ◽  
Testing Methods ◽  
Health Concerns ◽  
Global Pandemic ◽  
And Control

Influenza remains one of the major public health concerns because it causes annual epidemics and can potentially instigate a global pandemic. Numerous countermeasures, including vaccines and antiviral treatments, are in use against seasonal influenza infection; however, their effectiveness has always been discussed due to the ongoing resistance to antivirals and relatively low and unpredictable efficiency of influenza vaccines compared to other vaccines. The growing interest in vaccines as a promising approach to prevent and control influenza may provide alternative vaccine development options with potentially increased efficiency. In addition to currently available inactivated, live-attenuated, and recombinant influenza vaccines on the market, novel platforms such as virus-like particles (VLPs) and nanoparticles, and new vaccine formulations are presently being explored. These platforms provide the opportunity to design influenza vaccines with improved properties to maximize quality, efficacy, and safety. The influenza vaccine manufacturing process is also moving forward with advancements relating to egg- and cell-based production, purification processes, and studies into the physicochemical attributes and vaccine degradation pathways. These will contribute to the design of more stable, optimized vaccine formulations guided by contemporary analytical testing methods and via the implementation of the latest advances in the field.

scholarly journals Pandemic influenza A/H1N1 vaccination coverage, adverse reactions, and reasons for vaccine refusal among medical students in Brazil

2012 ◽  
Vol 54 (2) ◽  
pp. 77-82 ◽  
Author(s):  
Eduardo Pernambuco de Souza ◽  
Marcelo de Souza Teixeira
Keyword(s):  
Medical Students ◽  
Vaccination Coverage ◽  
Pandemic Influenza ◽  
Influenza A ◽  
Adverse Reactions ◽  
Vaccine Safety ◽  
Age Group ◽  
H1n1 Vaccine ◽  
Vaccine Refusal ◽  
Influenza A H1n1

The aim of this cross-sectional study was to determine, among medical students at a public university in Rio de Janeiro, Brazil, the acceptance of the pandemic influenza A/H1N1 vaccine during the 2010 mass immunization campaign and the vaccine safety in this group and, among unvaccinated students, the reasons for refusing vaccination. Of a total of 858 students, 678 (79%) participated in the study. Vaccination coverage was 60.4% among students aged 20 to 39 years (an age group targeted for vaccination) and 43.8% among those who did not belong to this age group. The most frequent adverse reactions to the vaccine were pain at the injection site (8.7%) and fever (7.9%). There were no serious adverse reactions. Among students aged 20 to 39 years, the most common reasons for refusing the vaccine were "lack of time" (42.4%), "fear of adverse reactions" (41.9%), and "difficult access to the vaccine" (11.5%). Other reasons for vaccine refusal were "uncertainties about vaccine safety and efficacy" and "vaccination was not needed". To increase the acceptance of the influenza vaccine, a comprehensive immunization program should be offered to these students.

scholarly journals Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring

Vaccine ◽  
2009 ◽  
Vol 27 (15) ◽  
pp. 2114-2120 ◽  
Author(s):  
Claudia Vellozzi ◽  
Dale R. Burwen ◽  
Azra Dobardzic ◽  
Robert Ball ◽  
Kimp Walton ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Pandemic Influenza ◽  
Safety Monitoring ◽  
Vaccine Safety ◽  
Influenza Vaccines

scholarly journals Considerations for bioanalytical characterization and batch release of COVID-19 vaccines

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Gautam Sanyal ◽  
Anna Särnefält ◽  
Arun Kumar
Keyword(s):  
Vaccine Development ◽  
Scale Up ◽  
Novel Technologies ◽  
Technology Platforms ◽  
Successful Vaccine ◽  
Batch Release ◽  
History Of ◽  
And Control ◽  
Selection Of

AbstractThe COVID-19 pandemic has prompted hundreds of laboratories around the world to employ traditional as well as novel technologies to develop vaccines against SARS-CoV-2. The hallmarks of a successful vaccine are safety and efficacy. Analytical evaluation methods, that can ensure the high quality of the products and that can be executed speedily, must be in place as an integral component of Chemistry, Manufacturing, and Control (CMC). These methods or assays are developed to quantitatively test for critical quality attributes (CQAs) of a vaccine product. While clinical (human) efficacy of a vaccine can never be predicted from pre-clinical evaluation of CQA, precise and accurate measurements of antigen content and a relevant biological activity (termed “potency”) elicited by the antigen allow selection of potentially safe and immunogenic doses for entry into clinical trials. All available vaccine technology platforms, novel and traditional, are being utilized by different developers to produce vaccines against SARS-CoV-2. It took less than a year from the publication of SARS-CoV-2 gene sequence to Emergency Use Authorization (EUA) of the first vaccine, setting a record for speed in the history of vaccine development. The largest ever global demand for vaccines has prompted some vaccine developers to enter multiple manufacturing partnerships in different countries in addition to implementing unprecedented scale-up plans. Quantitative, robust, and rapid analytical testing for CQA of a product is essential in ensuring smooth technology transfer between partners and allowing analytical bridging between vaccine batches used in different clinical phases leading up to regulatory approvals and commercialization. We discuss here opportunities to improve the speed and quality of the critical batch release and characterization assays.

ОЦЕНКА ЭФФЕКТИВНОСТИ И БЕЗОПАСНОСТИ 10% ВНУТРИВЕННОГО ИММУНОГЛОБУЛИНА ПРИВИДЖЕН В РЕАЛЬНОЙ КЛИНИЧЕСКОЙ ПРАКТИКЕ

2019 ◽  
Author(s):  
L.G. Khludova ◽  
I.A. Manto ◽  
E.A. Latysheva ◽  
T.V. Latysheva ◽  
M.R. Khaitov
Keyword(s):  
Replacement Therapy ◽  
Primary Immunodeficiency ◽  
Adverse Reactions ◽  
Efficacy And Safety ◽  
High Efficacy ◽  
Antibody Synthesis ◽  
Human Immunoglobulins ◽  
Severe Adverse Reactions ◽  
Common Variable ◽  
Real Clinical Practice

Актуальность. Заместительная терапия иммуноглобулинами человека является ведущим патогенетическим методом лечения первичных иммунодефицитов с нарушением синтеза антител. В настоящее время в России доступно несколько препаратов иммуноглобулинов человека нормальных для внутривенного введения. Цель. Оценить эффективность и безопасность препарата Привиджен (10 раствор иммуноглобулина для внутривенного введения) в реальной клинической практике в течение 12 клинических месяцев. Материалы и методы. 20 взрослых с диагнозом общая вариабельная иммунная недостаточности и Х-сцепленная агаммаглобулинемия получали внутривенный иммуноглобулин Привиджен к интервалом 243 дня в течение 12 мес. Первичными критериями оценки была частота инфекционных осложнений и нежелательных явлений. Результаты. У большинства пациентов в ходе исследования достигнут удовлетворительный претранс-фузионный уровень IgG. Тяжелых нежелательных явлений, связанных с введением препарата, не зарегистрировано. Заключение. В ходе исследования препарат продемонстрировал высокую эффективность и безопасность у пациентов, нуждающихся в ежемесячной заместительной терапииRelevance. Replacement therapy with human immunoglobulins is the leading pathogenetic method of treatment of primary immunodeficiency with impaired antibody synthesis. Currently, several preparations of human immunoglobulins for intravenous administration are available in Russia. Purposes. Evaluation of the efficacy and safety of Privigen immunoglobulin intravenous 10 liquid in real clinical practice within 12 clinical months. Methods. Twenty adults diagnosed with common variable immunodeficiency or X-linked agammaglobulinemia received intravenous Privigen infusions (0.2-0.4 mg/kg) at 243 intervals over a 12-month period. The primary endpoint was the annual rate of infections and adverse events. Results. Sufficient level of IgG was achieved in most patients during the study. Severe adverse reactions during the treatment were not registered. Conclusions. High efficacy and safety of monthly replacement therapy in patients with primary immunodeficiency with impaired antibody synthesis has been demonstrated.

scholarly journals Faster than warp speed: early attention to COVD-19 by anti-vaccine groups on Facebook

2021 ◽  
Author(s):  
Seth C Kalichman ◽  
Lisa A Eaton ◽  
Valerie A Earnshaw ◽  
Natalie Brousseau
Keyword(s):  
Social Media ◽  
Vaccine Development ◽  
Rapid Development ◽  
Development Program ◽  
Vaccine Safety ◽  
Vaccine Hesitancy ◽  
Conspiracy Theories ◽  
The Us ◽  
Us Government ◽  
Vaccine Information

Abstract Background The unprecedented rapid development of COVID-19 vaccines has faced SARS-CoV- (COVID-19) vaccine hesitancy, which is partially fueled by the misinformation and conspiracy theories propagated by anti-vaccine groups on social media. Research is needed to better understand the early COVID-19 anti-vaccine activities on social media. Methods This study chronicles the social media posts concerning COVID-19 and COVID-19 vaccines by leading anti-vaccine groups (Dr Tenpenny on Vaccines, the National Vaccine Information Center [NVIC] the Vaccination Information Network [VINE]) and Vaccine Machine in the early months of the COVID-19 pandemic (February–May 2020). Results Analysis of 2060 Facebook posts showed that anti-vaccine groups were discussing COVID-19 in the first week of February 2020 and were specifically discussing COVID-19 vaccines by mid-February 2020. COVID-19 posts by NVIC were more widely disseminated and showed greater influence than non-COVID-19 posts. Early COVID-19 posts concerned mistrust of vaccine safety and conspiracy theories. Conclusion Major anti-vaccine groups were sowing seeds of doubt on Facebook weeks before the US government launched its vaccine development program ‘Operation Warp Speed’. Early anti-vaccine misinformation campaigns outpaced public health messaging and hampered the rollout of COVID-19 vaccines.

Exposure–Response Analysis for Selection of Optimal Dosage Regimen of Anifrolumab in Patients With Systemic Lupus Erythematosus

Rheumatology ◽  
2021 ◽  
Author(s):  
Yen Lin Chia ◽  
Linda Santiago ◽  
Bing Wang ◽  
Denison Kuruvilla ◽  
Shiliang Wang ◽  
...  
Keyword(s):  
Type I Interferon ◽  
Drug Clearance ◽  
Optimal Dosage ◽  
Type I ◽  
Efficacy And Safety ◽  
Response Relationship ◽  
Phase 3 ◽  
Optimal Dosage Regimen ◽  
Exposure Response ◽  
Selection Of

Abstract Objectives The randomized, double-blind, phase 2 b MUSE study evaluated the efficacy and safety of the type I interferon receptor antibody anifrolumab (300 mg or 1000 mg every 4 weeks) compared with placebo for 52 weeks in patients with chronic, moderate to severe SLE. Characterizing the exposure–response relationship of anifrolumab in MUSE will enable selection of its optimal dosage regimen in two phase 3 studies in patients with SLE. Methods The exposure–response relationship, pharmacokinetics (PK), and SLE Responder Index (SRI[4]) efficacy data were analysed using a population approach. A dropout hazard function was also incorporated into the SRI(4) model to describe the voluntary patient withdrawals during the 1-year treatment period. Results The population PK model found that type I IFN test–high patients, and patients with a higher body weight, had significantly greater clearance of anifrolumab. Stochastic clinical simulations demonstrated that doses <300 mg would lead to a greater-than-proportional reduction in drug exposure owing to type I interferon alpha receptor–mediated drug clearance (antigen-sink effect, more rapid drug clearance at lower concentrations) and suboptimal SRI(4) responses with wider confidence intervals. Conclusions Based on PK, efficacy, and safety considerations, anifrolumab 300 mg every 4 weeks was recommended as the optimal dosage for pivotal phase 3 studies in patients with SLE.

scholarly journals Informing selection of drugs for COVID-19 treatment through adverse events analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Wenjing Guo ◽  
Bohu Pan ◽  
Sugunadevi Sakkiah ◽  
Zuowei Ji ◽  
Gokhan Yavas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Safety Concern ◽  
Clinical Practices ◽  
Safety Concerns ◽  
Post Market ◽  
Z Scores ◽  
Favorable Safety ◽  
Effective Drugs ◽  
Selection Of

AbstractCoronavirus disease 2019 (COVID-19) is an ongoing pandemic and there is an urgent need for safe and effective drugs for COVID-19 treatment. Since developing a new drug is time consuming, many approved or investigational drugs have been repurposed for COVID-19 treatment in clinical trials. Therefore, selection of safe drugs for COVID-19 patients is vital for combating this pandemic. Our goal was to evaluate the safety concerns of drugs by analyzing adverse events reported in post-market surveillance. We collected 296 drugs that have been evaluated in clinical trials for COVID-19 and identified 28,597,464 associated adverse events at the system organ classes (SOCs) level in the FDA adverse events report systems (FAERS). We calculated Z-scores of SOCs that statistically quantify the relative frequency of adverse events of drugs in FAERS to quantitatively measure safety concerns for the drugs. Analyzing the Z-scores revealed that these drugs are associated with different significantly frequent adverse events. Our results suggest that this safety concern metric may serve as a tool to inform selection of drugs with favorable safety profiles for COVID-19 patients in clinical practices. Caution is advised when administering drugs with high Z-scores to patients who are vulnerable to associated adverse events.

scholarly journals “A matter of time”: Evidence-making temporalities of vaccine development in the COVID-19 media landscape

2021 ◽  
pp. 0961463X2110322
Author(s):  
Mia Harrison ◽  
Kari Lancaster ◽  
Tim Rhodes
Keyword(s):  
Knowledge Production ◽  
News Media ◽  
Science Communication ◽  
Development Time ◽  
Vaccine Development ◽  
Efficacy And Safety ◽  
Calendar Time ◽  
Public Science ◽  
Communication Practices ◽  
Epistemic Object

This article investigates how evidence of the safety and efficacy of COVID-19 vaccines is enacted in news media via a focus on the temporality of vaccine development. We argue that time constitutes a crucial object of and mechanism for knowledge production in such media and investigate how time comes to matter in vaccine evidence-making communication practices. In science communication on vaccine development, the vaccine object (along with the practices through which it is produced) undergoes a material-discursive shift from an imagined “rushed” product to being many years in the making and uninhibited by unnecessarily lengthy processes. In both these enactments of vaccine development, time itself is constituted as evidence of vaccine efficacy and safety. This article traces how time (performed as both calendar time and as a series of relational events) is materialized as an affective and epistemic object of evidence within public science communication by analyzing the material-discursive techniques through which temporality is enacted within news media focused on the timeline of COVID-19 vaccine development. We contend that time (as evidence) is remade through these techniques as an ontopolitical concern within the COVID-19 vaccine assemblage. We furthermore argue that science communication itself is an important actor in the hinterland of public health practices with performative effects and vital evidence-making capacities.

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