EMA ने EU में COVID-19 वैक्सीन की पहली रोलिंग समीक्षा शुरू की

यूरोपीय मेडिसिन एजेंसी (ईएमए) ने एस्ट्राजेनेका ऑक्सफोर्ड SARS-CoV-2 वैक्सीन उम्मीदवार की "रोलिंग समीक्षा" शुरू कर दी है। दवाओं के लिए सामान्य नियामक प्रक्रियाओं में नैदानिक परीक्षणों के पूरा होने पर एजेंसी को सभी सुरक्षा और प्रभावकारिता डेटा जमा करना शामिल है। "रोलिंग समीक्षा" का अर्थ है कि एजेंसी डेटा उपलब्ध होते ही उसका मूल्यांकन शुरू कर सकती है। अनुमोदन की इस पद्धति को नियोजित करने से, विनियमन प्रक्रिया अपनी सामान्य गुणवत्ता और सुरक्षा मानकों को बनाए रखेगी, लेकिन डेटा उपलब्ध होने पर उसकी समीक्षा करने में लगने वाले समय के कारण सामान्य प्रक्रिया से छोटी होगी। 

अधिक जानने के लिए कृपया नीचे पढ़ें:

EMA ने EU में COVID-19 वैक्सीन की पहली रोलिंग समीक्षा शुरू की

द्वारा ऐलिस ब्लैक

इम्यूनोलॉजी में सीमांत: प्रभावी SARS-CoV-2 (कोविड-19) टीकों की खोज में प्रगति और नुकसान

With over 200 COVID-19 vaccine candidates currently in pre-clinical and clinical trials, the following article reviews what we know about the immune response to SARS-CoV-2 infection and explores the various vaccine platforms being utilised to develop a safe and effective vaccine. Potential issues including adverse effects and the need for mass production are also discussed, as well as the challenges of rapid and equitable vaccine delivery.  

लेख को पूरा यहां पढ़ें: 

इम्यूनोलॉजी में सीमांत: प्रभावी SARS-CoV-2 (कोविड-19) टीकों की खोज में प्रगति और नुकसान

द्वारा ऐलिस ब्लैक

COVID19 Road to a vaccine episode 15: Professor Lynn Gillam

In episode 15, our host, Associate Professor Nigel Crawford, speaks to Professor Lynn Gillam. Lynn is a clinical ethicist who trained in philosophy and bioethics. She is a Professor in the Centre for Health Equity, in the Melbourne School of Population and Global Health at the University of Melbourne; and the Academic Director of The Children’s Bioethics Centre at the Royal Children’s Hospital in Melbourne, Australia. The Children’s Bioethics Centre provides support including ethical decision making for clinicians in relation to patient care issues. Nigel and Lynn will discuss some of the ethical issues raised in the setting of SARS-CoV-2 vaccines, utilising a framework of points raised by Dr John Lantos from the Children’s Mercy Hospital in Kansas City, USA, at the recent Bioethics E-Conference hosted by The Children’s Bioethics Centre:

  • The importance of realising that not doing something or not conducting research is a decision in itself
  • The notion of “too fast can’t be safe” – some steps need to take the time they have always taken, some things can be done more quickly, recognising that if you do nothing, you are allowing harm to happen
  • The role of ethical boards and the way vaccines are developed, i.e. the use of younger, healthier participants in research, not the individuals who are getting the worst disease
  • The involvement of children and elderly people in clinical trials and the key differences in the ethical considerations of this
  • Global equity of access to SARS-CoV-2 vaccines when they become available, who gets them first and how should these decisions be made?
  • The role of Citizens’ Juries in deciding who has priority of access to vaccines in a pandemic situation
  • अनिवार्य टीकाकरण
  • The use of foetal embryonic cell lines in vaccine development

Links

Listen to the episode here:

स्प्रेकर - सेब - Spotify 

 

 

द्वारा ऐलिस ब्लैक

एनईजेएम: कोविड-19 टीकों का मूल्यांकन और तैनाती - पारदर्शिता, वैज्ञानिक अखंडता और सार्वजनिक विश्वास का महत्व

न्यू इंग्लैंड जर्नल ऑफ मेडिसिन में प्रकाशित निम्नलिखित लेख में, जब कोविड-19 वैक्सीन को मंजूरी देने की बात आती है, तो अच्छी तरह से स्थापित और पारदर्शी नियामक प्रक्रियाओं का पालन करने के महत्व पर चर्चा की जाती है। राजनीतिक लाभ के प्रयोजनों के लिए सरकारों के हस्तक्षेप के बिना, स्वतंत्र निकायों से मजबूत वैज्ञानिक मूल्यांकन के साथ जनता को आश्वस्त करना, जनता के विश्वास को बढ़ावा देने और टीकाकरण कार्यक्रमों की सफलता सुनिश्चित करने के लिए आवश्यक है। 

लेख को पूरा यहां पढ़ें:

एनईजेएम: कोविड-19 टीकों का मूल्यांकन और तैनाती - पारदर्शिता, वैज्ञानिक अखंडता और सार्वजनिक विश्वास का महत्व

द्वारा ऐलिस ब्लैक

New immunisation reference page: Identifying AEFI in diverse skin colour

The assessment of skin for clinical signs and symptoms is important when identifying adverse events following immunisation (AEFI). Since most dermatological assessment guidelines commonly refer to the presentation of symptoms in patients with light skin tones, the identification of AEFI in a timely manner in diverse skin colours can be challenging for immunisation providers.

Our new reference page details how symptoms such as pallor, cyanosis, erythema and urticaria may appear in diverse skin colours and discusses alternate methods of recognition. For more information please follow the link below:

MVEC: Identifying AEFI in diverse skin colour

 

 

 

द्वारा ऐलिस ब्लैक

COVID19 Road to a vaccine episode 14: Dr Bruce Gellin

In episode 14, our host, Associate Professor Nigel Crawford, speaks to Dr Bruce Gellin. Bruce is the President of Global Immunization at the Sabin Vaccine Institute in Washington. The Sabin Vaccine Institute’s mission is to make vaccines more accessible, enable innovation and expand immunisation across the globe. Bruce took up this role in 2017, prior to this serving as the Deputy Assistant Secretary of the National Vaccine Program Office at the US Department of Health and Human Services where he served as technical and policy advisor to the WHO, focusing on influenza vaccines and global issues of vaccine hesitancy. Bruce has also worked at the Centers for Disease Control and Prevention (CDC), consulted for GAVI and is one of America’s principle spokespeople on vaccines and immunisations. He and Nigel discuss the following in the context of vaccine confidence:

  • The recent halting of the Oxford Astrazeneca trial and how the system that is in place did exactly what is supposed to
  • “The Cutter Incident” and the ongoing impact this has had on vaccine safety, particularly from the manufacturing perspective
  • The vast importance of ensuring immunisation providers understand the vaccine development process as if they don’t understand it and are sceptical this can have a huge impact on vaccine uptake 
  • The importance of open disclosure in the vaccine development pathway
  • How the Sabin Vaccine Institute is meeting the challenge of vaccine hesitancy
  • Sabin’s‘Boost’ program for healthcare workers 
  • How vaccines are monitored once they are in use, also called phase IV surveillance

 लिंक:

Listen to the episode here:

स्प्रेकर - सेब - Spotify 

 

द्वारा ऐलिस ब्लैक

New immunisation reference page: Injection site nodules

Injection site nodules are a rare but known adverse event following immunisation. They can occur following any vaccine and are most commonly asymptomatic and self resolving. Our new reference page describes what injection site nodules are and the implications on future immunisations.

To learn more follow the link below:

एमवीईसी: इंजेक्शन साइट नोड्यूल

द्वारा ऐलिस ब्लैक

COVID19 Road to a vaccine episode 13: Professor Kim Mulholland

In episode 13, our host, Associate Professor Nigel Crawford, speaks to Professor Kim Mulholland. Kim is a paediatrician and Professor of Child Health from the Murdoch Children’s Research Institute, the University of Melbourne department of Paediatrics and the London School of Hygiene and Tropical Medicine. With post-graduate training in immunology, respiratory medicine and tropical medicine, his vast experience includes developing a program of research covering all aspects of childhood pneumonia which helped guide WHO policies. He has been involved in the oversight of many vaccine trials and has served on steering committees or DSMBs for a range of vaccines including pneumococcal, dengue, RSV and COVID-19. He and Nigel discuss:

  • global issues brought about by the SARS-CoV-2 pandemic and some of the surprising ways the virus has spread globally
  • what we can learn from seroprevalence in countries such as India
  • vaccine nationalism and the push for global solidarity
  • the role of Australia in the pacific region in regards to vaccine preparedness
  • global, equitable access to COVID-19 vaccines

लिंक:

Listen here:

स्प्रेकर - सेब - Spotify 

 

द्वारा ऐलिस ब्लैक

Check your knowledge on cold chain with MVEC's new quiz

MVEC and the Victorian DHHS Immunisation section have developed a new quiz for immunisation providers, aiming to check their knowledge on vaccine cold chain. Adherence to cold chain guidelines is essential to ensure that any vaccine administered to patients is safe and efficacious.

To access this quiz please head to the एमवीईसी शिक्षा पोर्टल or click on the link below:

MVEC: Quizzes

 

 

द्वारा ऐलिस ब्लैक

Halting the Oxford vaccine trial doesn't mean it's not safe- it shows they're following the right process

Due to a single event of an unexplained illness, the AstraZeneca Oxford group have announced a voluntary pause on all vaccinations across all sites of their COVID-19 vaccine candidate clinical trial. This pause will allow an independent committee to review the safety data and investigate the incident. 

The following article, published in The Conversation, outlines how this halt doesn't necessarily indicate that the vaccine is not safe, but reflects the robust processes for clinical trials. It is important to recognise that whilst these clinical trials are moving at pandemic speed, safety is not being compromised.

The Conversation: Halting the Oxford vaccine trial doesn't mean it's not safe- it shows they're following the right process

द्वारा ऐलिस ब्लैक