The document summarizes different aspects of COVID-19 vaccines, including how they work, types of vaccines, and specific vaccines like Covaxin, Pfizer, Moderna, and more. It discusses inactivated vaccines like Covaxin and CoronaVac, viral vector vaccines like AstraZeneca and Sputnik V, protein subunit vaccines like Novavax, and nucleic acid vaccines such as Pfizer and Moderna. Each vaccine is described in 1-2 sentences focusing on technology, efficacy, and development process. The document also covers general topics like vaccine development, immunity, and adjuvants that enhance vaccine effectiveness.
viral vaccine production basics and manufacturing basics involved in development in research. Cell lines and characteristics of cell substrates and mode of operation useful for increased cell density. Basics of vaccine types and their features.
DNA vaccines work by injecting DNA encoding antigens from pathogens. The host cells use this DNA to produce antigens, which are then displayed on the cell surface and trigger both humoral and cellular immune responses. DNA vaccines offer advantages over traditional vaccines like avoiding infectious organisms, not requiring refrigeration, and stimulating both arms of the immune system. They have shown protection against diseases in animal studies and have potential applications for influenza, hepatitis B, HIV, and malaria vaccines. However, DNA vaccines also have disadvantages like weak immune responses in humans.
The document describes the industrial manufacturing process for vaccines. It involves upstream and downstream processes. Upstream involves selecting a seed strain, propagating microorganisms through cell culture or eggs, and isolating/purifying the microorganisms. Downstream involves inactivating organisms, formulating the vaccine, and performing quality control tests. An example of hepatitis B vaccine production using recombinant yeast is provided, involving strain selection, fermentation, antigen expression, purification, and formulation. Potential challenges discussed include vaccine hesitancy, ethical issues, inadequate preclinical data, and the need for new development techniques.
The document provides information on several COVID-19 vaccines that are currently in development or have received emergency use authorization. It discusses the technology behind mRNA vaccines such as Moderna and Pfizer/BioNTech, viral vector vaccines like AstraZeneca/Oxford and Sputnik V, DNA vaccines including Zydus Cadila's ZyCoV-D, and inactivated whole virus vaccines like Bharat Biotech's Covaxin. It also summarizes trial results, dosing schedules, storage requirements, manufacturing processes, and safety profiles of these vaccine candidates. The document aims to inform readers about the different approaches being used globally in the race to end the COVID-19 pandemic.
The highest point for Deaths/Day was 1281 on 15th September. This peak has held till now (67 days)
Deaths/Day have crossed 1000 on only 1 day after 3rd October. Declining trend had set in but is now plateauing/trending upwards due to a spike in Delhi and North India.
New/Active cases have also peaked and were declining.
The highest no of cases was on 16th September at 97,856. That peak has held till now.
Active Cases peaked at 10,17,718 on 17th September
Both New and Active cases are plateauing/trending upwards now
Vaccine developments hold promise for India via Astra Zeneca and Novavax tie up with Serum Institute of India, Sputnik with Dr Reddy’s, J&J with Biological E and Bharat Biotech. All these vaccines are in Phase 3. Cadila in Phase 2 is also promising.
This document summarizes Dr. Hui-Wen Chen's presentation on nanovaccine research and industry-academia collaboration experiences. It discusses her lab's development of nanoparticle vaccines for MERS-CoV, influenza, and cancer which showed strong antibody and T cell immune responses in animal studies. Her lab is currently working on COVID-19 RBD and T cell vaccines. The document also notes some challenges faced, including changes in research directions, funding issues, and market saturation concerns from industry partners.
viral vaccine production basics and manufacturing basics involved in development in research. Cell lines and characteristics of cell substrates and mode of operation useful for increased cell density. Basics of vaccine types and their features.
DNA vaccines work by injecting DNA encoding antigens from pathogens. The host cells use this DNA to produce antigens, which are then displayed on the cell surface and trigger both humoral and cellular immune responses. DNA vaccines offer advantages over traditional vaccines like avoiding infectious organisms, not requiring refrigeration, and stimulating both arms of the immune system. They have shown protection against diseases in animal studies and have potential applications for influenza, hepatitis B, HIV, and malaria vaccines. However, DNA vaccines also have disadvantages like weak immune responses in humans.
The document describes the industrial manufacturing process for vaccines. It involves upstream and downstream processes. Upstream involves selecting a seed strain, propagating microorganisms through cell culture or eggs, and isolating/purifying the microorganisms. Downstream involves inactivating organisms, formulating the vaccine, and performing quality control tests. An example of hepatitis B vaccine production using recombinant yeast is provided, involving strain selection, fermentation, antigen expression, purification, and formulation. Potential challenges discussed include vaccine hesitancy, ethical issues, inadequate preclinical data, and the need for new development techniques.
The document provides information on several COVID-19 vaccines that are currently in development or have received emergency use authorization. It discusses the technology behind mRNA vaccines such as Moderna and Pfizer/BioNTech, viral vector vaccines like AstraZeneca/Oxford and Sputnik V, DNA vaccines including Zydus Cadila's ZyCoV-D, and inactivated whole virus vaccines like Bharat Biotech's Covaxin. It also summarizes trial results, dosing schedules, storage requirements, manufacturing processes, and safety profiles of these vaccine candidates. The document aims to inform readers about the different approaches being used globally in the race to end the COVID-19 pandemic.
The highest point for Deaths/Day was 1281 on 15th September. This peak has held till now (67 days)
Deaths/Day have crossed 1000 on only 1 day after 3rd October. Declining trend had set in but is now plateauing/trending upwards due to a spike in Delhi and North India.
New/Active cases have also peaked and were declining.
The highest no of cases was on 16th September at 97,856. That peak has held till now.
Active Cases peaked at 10,17,718 on 17th September
Both New and Active cases are plateauing/trending upwards now
Vaccine developments hold promise for India via Astra Zeneca and Novavax tie up with Serum Institute of India, Sputnik with Dr Reddy’s, J&J with Biological E and Bharat Biotech. All these vaccines are in Phase 3. Cadila in Phase 2 is also promising.
This document summarizes Dr. Hui-Wen Chen's presentation on nanovaccine research and industry-academia collaboration experiences. It discusses her lab's development of nanoparticle vaccines for MERS-CoV, influenza, and cancer which showed strong antibody and T cell immune responses in animal studies. Her lab is currently working on COVID-19 RBD and T cell vaccines. The document also notes some challenges faced, including changes in research directions, funding issues, and market saturation concerns from industry partners.
COLDCHAIN“Bringing high-quality vaccines and refrigerated medicine to patient...Diego Alberto Tamayo
Create a system to track the temperature of vaccine using Smart IoT Edge
devices, Smart IoT cloud Eco Systems, Blockchain and Smart Analytics from
manufacturing to storage to transport to consumption – Reduce Wastage and
Improve distribution and lower Inventory!
This document discusses biosafety testing for cell and gene therapies performed by BioReliance, a testing services division of Merck KGaA. It outlines the comprehensive testing performed at various stages of development, including testing of cell banks, viral vectors, and final drug products. Testing evaluates important product attributes like identity, purity, potency and residuals to ensure safety and quality. A wide range of assays are used to characterize products and identify potential contaminants.
Vaccine Development & GMP Manufacturing - Creative BiolabsCreative-Biolabs
This slide is about knowleges of vaccine development. It mainly explains the following contents: goals of vaccine development, vaccine development stages, vaccine manufacturing, challenges for vaccine development, and the services Creative Biolabs can provide.
Production and purification of Viral vectors for gene and cell therapy appli...Dr. Priyabrata Pattnaik
The cell and gene therapy market is growing rapidly and is projected to reach $10 billion in 5 years. There are three main segments: gene therapy, stem cell therapy, and cell immunotherapy. Gene therapy uses viral vectors like lentivirus or adenovirus to deliver nucleic acids. The production of viral vectors like AAV involves growing HEK 293 cells in bioreactors, transfecting them with plasmids, harvesting and purifying the virus through clarification, filtration, and chromatography. CAR-T cell therapy is also discussed as an example of cell immunotherapy, which uses lentivirus to modify patient T-cells that are then reintroduced to the patient.
India's first indigenous covid 19 vaccine.Rucha Tiwari
1) The document summarizes information about Covaxin, India's first indigenous COVID-19 vaccine developed by Bharat Biotech.
2) It provides details on how the inactivated vaccine works, the phases of clinical trials conducted, safety and efficacy data, and countries interested in procuring the vaccine.
3) Covaxin uses whole virion inactivated SARS-CoV-2 virus and generates antibodies against the spike protein to protect against COVID-19 with a two dose regimen.
TOPIC-ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) COVISHIELD
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.
approved standard Leaflet based information by serum institute, pune.
at present scenario, its a big challenge to face public with varying queries on vaccination and effects followed by post vaccination
AS a clinical pharmacist we are here to know you the things and helps in leading easier way with respect to safety concerns of the public.
IN these slides the main focus was adverse reactions of vaccine(COVISHIELD) and even at certain point it covers treatment of adverse reactions i.e. paracetamol containing products.
best part of the slides were how to handle ,administer and storage of the vaccine for effective results
exceptions for studies were pharmacokinetic studies and few others like interactions.
Covaxin is India's first indigenous COVID-19 vaccine developed by Bharat Biotech. It uses an inactivated form of the SARS-CoV-2 virus that has had its replication capacity destroyed to increase immunity without risk of infection. It is codenamed BBV152, targets SARS-CoV-2, requires storage at 2-8°C, and is an inactivated whole-virion vaccine with 81% efficacy. Its clinical trials had three phases and showed excellent safety without reactogenicity, inducing antibody response. Common minor side effects include pain, swelling or redness at the injection site, weakness in the arm, headache, and fever.
Bridging The Valley Of Death A Tale Of Two Culturesrwmalonemd
This document discusses the challenges of transitioning biotechnology discoveries from research to commercial products, known as crossing the "valley of death". It notes that on average only 1 in 4 to 1 in 5 biotechnology products in development achieve approval due to fundamental differences between the cultures of research and product development. Bridging this gap requires addressing regulatory, capital, and project management challenges throughout the product development process. The future of biotechnology will rely on rigorous project planning, outsourcing, earlier consideration of development pathways, and continual engagement between research and development teams.
Vaccine development for COVID-19 is a global race against time. Many public and private organizations are working to develop a vaccine, using different approaches like mRNA, DNA, and viral vectors. Malaysia is also involved through collaboration between IMR, MVP and TIDREC to test a vaccine based on previous coronavirus research. The country is also participating in international solidarity trials of potential drug treatments. Locally, blood plasma from recovered patients is being analyzed for antibodies and may help treat other patients. While plasma therapy shows promise, more controlled studies are still needed to confirm efficacy and safety. The development of an effective vaccine remains a high priority in battling the pandemic.
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
More than 150 coronavirus vaccines are in development across the world—and hopes are high to bring one to market in record time to ease the global crisis.
The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021.
Hello guys , today I am discussing about various stages of vaccine development and types of vaccines already developed by various biotech companies all over the world and their current status in clinical trial till now .
Hope , Very early we can get a ideal corona virus vaccine which would be safe and effective to human and also eradicate this disease from the world .
For more information please follow these link :
https://www.nytimes.com/interactive/2...
https://www.precisionvaccinations.com...
https://www.who.int/publications/m/it...
Webinar: Re-imagining vaccine manufacturing to address global health challengesMilliporeSigma
Participate in the interactive on demand webinar: http://bit.ly/ReimaginingVaccinesWebinar
In this webinar, you will learn:
- The evolution of vaccine production in response to pandemics and outbreaks
- Key considerations and perspectives on how vaccine processing and facilities could change to address future global health challenges
Vaccine development is a long process that involves extensive research and clinical testing to ensure safety and effectiveness. It begins with discovery and preclinical development to identify potential vaccine antigens. Candidate vaccines then undergo three phases of clinical trials in human subjects to evaluate safety, immunogenicity and efficacy. If successful, the vaccine manufacturer submits a Biologics License Application to the FDA including all clinical data. Upon approval, the FDA provides ongoing monitoring through lot release testing, facility inspections and adverse event reporting systems. The goal is to develop vaccines that help prevent disease, benefit both individuals and public health through herd immunity, and advance modern medicine.
The presentation depicts the supply chain management of the Covid-19 vaccination drive in India. It also focuses on the implementation of Industry 4.0 and digitization of the process to make the vaccination drive a success, Asides, it also briefs about the vaccine candidates in use and prospected to be used in India until 6th June '21. SWOT analysis of the vaccination drive in India is also provided in this presentation.
In this webinar, you will learn:
Trends in vaccine manufacturing
Innovative solutions in facility design
Case studies and proposals for future vaccine factories
Considerations while setting up Quality Management Systems (QMSs)
How validation helps accelerate regulatory approval
Detailed description:
How we see vaccine manufacturing evolving due to the COVID-19 pandemic, how could it further transform, and what are some solutions we can incorporate to prepare ourselves for next-generation facilities?
The unprecedented COVID-19 pandemic has driven significant tech acceleration around the world, including methods of vaccine manufacturing. Together with the concept of Bioprocessing 4.0, digital biomanufacturing enables centralized orchestration of production process and data management, and a "Facility of the Future" characterized by intensified, continuous, predictive, and autonomous operations. In this presentation, we will explore trends in vaccine manufacturing, including fully single-use processes, closed processing, modular facilities, and platform manufacturing. We will also discuss some key considerations when setting up Quality Management Systems for novel facilities, and how to speed up regulatory approval through best practices in facility validation.
Dr. X.J. Meng - Designing PRRSV Vaccines for Heterologous ProtectionJohn Blue
1) PRRSV remains a major problem for the global swine industry, causing $664 million in losses annually in the US alone. The emergence of more virulent strains and heterogeneity have complicated vaccine development.
2) DNA shuffling techniques are being used to generate chimeric PRRSV vaccines containing structural genes from multiple heterologous strains, which have shown promise in inducing cross-neutralizing antibodies and protection against diverse strains.
3) Targeting shuffled PRRSV antigens to dendritic cells through DC-SIGN enhances antigen-specific CD4+ and CD8+ T cell immune responses in pigs. These approaches aim to overcome obstacles in developing a broadly protective PRRSV vaccine.
Emerging Viral Risks and Mitigation Strategies in Biologics ManufacturingMilliporeSigma
This document discusses emerging viruses that pose risks as contaminants in raw materials used to manufacture vaccines and biological products. It outlines various risk mitigation strategies, including risk assessments of potential contaminating viruses to inform detection methods. Specific viruses that are addressed include porcine circovirus type 3, hepatitis E virus, Schmallenberg virus, Zika virus, and Borna disease virus. Next-generation sequencing is presented as an advantageous method for the holistic screening of raw materials to identify both known and novel viruses. Quality by design approaches are emphasized to continuously reassess risks from emerging viruses.
Gene (DNA) vaccines work by injecting DNA into the body to produce antibodies against target antigens. Since the 1950s, direct injection of plasmid DNA has been found to induce strong immune responses. Current applications have effectively treated diseases like bird flu and West Nile virus. DNA vaccines have advantages like a focused immune response on the antigen of interest and ease of development and production. However, risks include possible effects on genes controlling cell growth and inducing antibodies against DNA. DNA vaccines are administered via injection or gene gun and work by replicating the vaccine DNA to create antibodies. Future research may enhance their applications.
COVID-19 VACCINESMyths Vs Facts
Vaccines types
How they work ?
Recombinant vaccines
Why Covid Vaccines?
Covid Vaccines
Vaccine Usage in the world
In the discussion
Facts vs Myths-
Some Tips for Vaccination
Mechanism of different types of vaccines in developmentEmilioMolina23
This document discusses five main types of vaccine technologies: live-attenuated vaccines, inactivated vaccines, subunit vaccines, viral vector vaccines, and messenger RNA (mRNA) vaccines. For each technology, it provides examples of existing vaccines and candidates in development for COVID-19. Live-attenuated vaccines contain weakened live pathogens, while inactivated vaccines use killed whole pathogens. Subunit vaccines contain fragments of pathogens, and viral vector vaccines use harmless viruses to deliver genetic code for antigens. mRNA vaccines teach the body to produce protein antigens to trigger immunity. The Pfizer and Moderna COVID-19 vaccines are mRNA-based.
COLDCHAIN“Bringing high-quality vaccines and refrigerated medicine to patient...Diego Alberto Tamayo
Create a system to track the temperature of vaccine using Smart IoT Edge
devices, Smart IoT cloud Eco Systems, Blockchain and Smart Analytics from
manufacturing to storage to transport to consumption – Reduce Wastage and
Improve distribution and lower Inventory!
This document discusses biosafety testing for cell and gene therapies performed by BioReliance, a testing services division of Merck KGaA. It outlines the comprehensive testing performed at various stages of development, including testing of cell banks, viral vectors, and final drug products. Testing evaluates important product attributes like identity, purity, potency and residuals to ensure safety and quality. A wide range of assays are used to characterize products and identify potential contaminants.
Vaccine Development & GMP Manufacturing - Creative BiolabsCreative-Biolabs
This slide is about knowleges of vaccine development. It mainly explains the following contents: goals of vaccine development, vaccine development stages, vaccine manufacturing, challenges for vaccine development, and the services Creative Biolabs can provide.
Production and purification of Viral vectors for gene and cell therapy appli...Dr. Priyabrata Pattnaik
The cell and gene therapy market is growing rapidly and is projected to reach $10 billion in 5 years. There are three main segments: gene therapy, stem cell therapy, and cell immunotherapy. Gene therapy uses viral vectors like lentivirus or adenovirus to deliver nucleic acids. The production of viral vectors like AAV involves growing HEK 293 cells in bioreactors, transfecting them with plasmids, harvesting and purifying the virus through clarification, filtration, and chromatography. CAR-T cell therapy is also discussed as an example of cell immunotherapy, which uses lentivirus to modify patient T-cells that are then reintroduced to the patient.
India's first indigenous covid 19 vaccine.Rucha Tiwari
1) The document summarizes information about Covaxin, India's first indigenous COVID-19 vaccine developed by Bharat Biotech.
2) It provides details on how the inactivated vaccine works, the phases of clinical trials conducted, safety and efficacy data, and countries interested in procuring the vaccine.
3) Covaxin uses whole virion inactivated SARS-CoV-2 virus and generates antibodies against the spike protein to protect against COVID-19 with a two dose regimen.
TOPIC-ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) COVISHIELD
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.
approved standard Leaflet based information by serum institute, pune.
at present scenario, its a big challenge to face public with varying queries on vaccination and effects followed by post vaccination
AS a clinical pharmacist we are here to know you the things and helps in leading easier way with respect to safety concerns of the public.
IN these slides the main focus was adverse reactions of vaccine(COVISHIELD) and even at certain point it covers treatment of adverse reactions i.e. paracetamol containing products.
best part of the slides were how to handle ,administer and storage of the vaccine for effective results
exceptions for studies were pharmacokinetic studies and few others like interactions.
Covaxin is India's first indigenous COVID-19 vaccine developed by Bharat Biotech. It uses an inactivated form of the SARS-CoV-2 virus that has had its replication capacity destroyed to increase immunity without risk of infection. It is codenamed BBV152, targets SARS-CoV-2, requires storage at 2-8°C, and is an inactivated whole-virion vaccine with 81% efficacy. Its clinical trials had three phases and showed excellent safety without reactogenicity, inducing antibody response. Common minor side effects include pain, swelling or redness at the injection site, weakness in the arm, headache, and fever.
Bridging The Valley Of Death A Tale Of Two Culturesrwmalonemd
This document discusses the challenges of transitioning biotechnology discoveries from research to commercial products, known as crossing the "valley of death". It notes that on average only 1 in 4 to 1 in 5 biotechnology products in development achieve approval due to fundamental differences between the cultures of research and product development. Bridging this gap requires addressing regulatory, capital, and project management challenges throughout the product development process. The future of biotechnology will rely on rigorous project planning, outsourcing, earlier consideration of development pathways, and continual engagement between research and development teams.
Vaccine development for COVID-19 is a global race against time. Many public and private organizations are working to develop a vaccine, using different approaches like mRNA, DNA, and viral vectors. Malaysia is also involved through collaboration between IMR, MVP and TIDREC to test a vaccine based on previous coronavirus research. The country is also participating in international solidarity trials of potential drug treatments. Locally, blood plasma from recovered patients is being analyzed for antibodies and may help treat other patients. While plasma therapy shows promise, more controlled studies are still needed to confirm efficacy and safety. The development of an effective vaccine remains a high priority in battling the pandemic.
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
More than 150 coronavirus vaccines are in development across the world—and hopes are high to bring one to market in record time to ease the global crisis.
The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021.
Hello guys , today I am discussing about various stages of vaccine development and types of vaccines already developed by various biotech companies all over the world and their current status in clinical trial till now .
Hope , Very early we can get a ideal corona virus vaccine which would be safe and effective to human and also eradicate this disease from the world .
For more information please follow these link :
https://www.nytimes.com/interactive/2...
https://www.precisionvaccinations.com...
https://www.who.int/publications/m/it...
Webinar: Re-imagining vaccine manufacturing to address global health challengesMilliporeSigma
Participate in the interactive on demand webinar: http://bit.ly/ReimaginingVaccinesWebinar
In this webinar, you will learn:
- The evolution of vaccine production in response to pandemics and outbreaks
- Key considerations and perspectives on how vaccine processing and facilities could change to address future global health challenges
Vaccine development is a long process that involves extensive research and clinical testing to ensure safety and effectiveness. It begins with discovery and preclinical development to identify potential vaccine antigens. Candidate vaccines then undergo three phases of clinical trials in human subjects to evaluate safety, immunogenicity and efficacy. If successful, the vaccine manufacturer submits a Biologics License Application to the FDA including all clinical data. Upon approval, the FDA provides ongoing monitoring through lot release testing, facility inspections and adverse event reporting systems. The goal is to develop vaccines that help prevent disease, benefit both individuals and public health through herd immunity, and advance modern medicine.
The presentation depicts the supply chain management of the Covid-19 vaccination drive in India. It also focuses on the implementation of Industry 4.0 and digitization of the process to make the vaccination drive a success, Asides, it also briefs about the vaccine candidates in use and prospected to be used in India until 6th June '21. SWOT analysis of the vaccination drive in India is also provided in this presentation.
In this webinar, you will learn:
Trends in vaccine manufacturing
Innovative solutions in facility design
Case studies and proposals for future vaccine factories
Considerations while setting up Quality Management Systems (QMSs)
How validation helps accelerate regulatory approval
Detailed description:
How we see vaccine manufacturing evolving due to the COVID-19 pandemic, how could it further transform, and what are some solutions we can incorporate to prepare ourselves for next-generation facilities?
The unprecedented COVID-19 pandemic has driven significant tech acceleration around the world, including methods of vaccine manufacturing. Together with the concept of Bioprocessing 4.0, digital biomanufacturing enables centralized orchestration of production process and data management, and a "Facility of the Future" characterized by intensified, continuous, predictive, and autonomous operations. In this presentation, we will explore trends in vaccine manufacturing, including fully single-use processes, closed processing, modular facilities, and platform manufacturing. We will also discuss some key considerations when setting up Quality Management Systems for novel facilities, and how to speed up regulatory approval through best practices in facility validation.
Dr. X.J. Meng - Designing PRRSV Vaccines for Heterologous ProtectionJohn Blue
1) PRRSV remains a major problem for the global swine industry, causing $664 million in losses annually in the US alone. The emergence of more virulent strains and heterogeneity have complicated vaccine development.
2) DNA shuffling techniques are being used to generate chimeric PRRSV vaccines containing structural genes from multiple heterologous strains, which have shown promise in inducing cross-neutralizing antibodies and protection against diverse strains.
3) Targeting shuffled PRRSV antigens to dendritic cells through DC-SIGN enhances antigen-specific CD4+ and CD8+ T cell immune responses in pigs. These approaches aim to overcome obstacles in developing a broadly protective PRRSV vaccine.
Emerging Viral Risks and Mitigation Strategies in Biologics ManufacturingMilliporeSigma
This document discusses emerging viruses that pose risks as contaminants in raw materials used to manufacture vaccines and biological products. It outlines various risk mitigation strategies, including risk assessments of potential contaminating viruses to inform detection methods. Specific viruses that are addressed include porcine circovirus type 3, hepatitis E virus, Schmallenberg virus, Zika virus, and Borna disease virus. Next-generation sequencing is presented as an advantageous method for the holistic screening of raw materials to identify both known and novel viruses. Quality by design approaches are emphasized to continuously reassess risks from emerging viruses.
Gene (DNA) vaccines work by injecting DNA into the body to produce antibodies against target antigens. Since the 1950s, direct injection of plasmid DNA has been found to induce strong immune responses. Current applications have effectively treated diseases like bird flu and West Nile virus. DNA vaccines have advantages like a focused immune response on the antigen of interest and ease of development and production. However, risks include possible effects on genes controlling cell growth and inducing antibodies against DNA. DNA vaccines are administered via injection or gene gun and work by replicating the vaccine DNA to create antibodies. Future research may enhance their applications.
COVID-19 VACCINESMyths Vs Facts
Vaccines types
How they work ?
Recombinant vaccines
Why Covid Vaccines?
Covid Vaccines
Vaccine Usage in the world
In the discussion
Facts vs Myths-
Some Tips for Vaccination
Mechanism of different types of vaccines in developmentEmilioMolina23
This document discusses five main types of vaccine technologies: live-attenuated vaccines, inactivated vaccines, subunit vaccines, viral vector vaccines, and messenger RNA (mRNA) vaccines. For each technology, it provides examples of existing vaccines and candidates in development for COVID-19. Live-attenuated vaccines contain weakened live pathogens, while inactivated vaccines use killed whole pathogens. Subunit vaccines contain fragments of pathogens, and viral vector vaccines use harmless viruses to deliver genetic code for antigens. mRNA vaccines teach the body to produce protein antigens to trigger immunity. The Pfizer and Moderna COVID-19 vaccines are mRNA-based.
Essential information on covid 19 vaccinationsPathKind Labs
The document provides information on Covid-19 vaccination and vaccine development. It discusses how available genome sequence allowed for rapid diagnostic and vaccine development. Multiple vaccine platforms are highlighted, including mRNA, viral vectors, and protein-based. Operation Warp Speed is aiming to deliver hundreds of millions of doses of leading candidates by January 2021. Challenges of vaccine development include safety testing and failure is common. Long-term safety and efficacy data is still needed.
The document discusses various aspects of COVID vaccines in India, including their development and clinical trials. It describes the Covishield and Covaxin vaccines in detail - Covishield is developed by Oxford University and AstraZeneca, while Covaxin is an inactivated vaccine developed by Bharat Biotech. It provides statistics on vaccination rates in India and challenges like vaccine hesitancy. Other vaccines mentioned include Sputnik V, Pfizer and Moderna.
1) The document discusses different types of COVID-19 vaccines including mRNA, inactivated, live attenuated, viral vector, and subunit vaccines. It explains how each type works to generate an immune response without causing illness.
2) Details are provided on several specific COVID-19 vaccines like Moderna, Pfizer, Covishield, Covaxin, and others in clinical trials. Information is given on dosage schedules, effectiveness, and temperature storage requirements.
3) Herd immunity through widespread vaccination is described as the safest approach, rather than intentional exposure, to prevent unnecessary illness and death while protecting populations.
In this presentation, we discuss the clinical trial process for the new Covid-19 vaccines. We discuss the different vaccine types. We also discuss the Covid-19 vaccines that the UK is currently using in the NHS, as well as vaccines likely to be used in the next year.
There are four main types of COVID-19 vaccines: viral vector vaccines like AstraZeneca, genetic vaccines like Moderna and Pfizer, inactivated vaccines like Sinovac, and protein-based vaccines like Novavax. Viral vector and genetic vaccines work by introducing genetic material that causes cells to produce viral proteins to stimulate an immune response. Inactivated vaccines contain killed virus to trigger immunity. Protein vaccines contain synthesized spike proteins to teach the immune system to recognize the virus. Common side effects include pain at the injection site, tiredness, and fever.
Vaccine Development for COVID-19 virus, ranging from all the technologies such as DNA Vaccine, mRNA Vaccine, Whole Inactivated Vaccine, Viral Vector Vaccine. SARS-CoV-2 viral pathology is also shared in this slide.
The document summarizes the background and methods of a clinical trial evaluating the safety and immunogenicity of an investigational Ebola vaccine (cAd3-EBO) in healthy adults. The trial is a phase 1, dose-escalation study testing two dose levels of the vaccine. The vaccine uses a chimpanzee adenovirus vector encoding Ebola glycoproteins. Safety monitoring and immune responses will be evaluated over 4 weeks following vaccination. The study aims to provide data to support accelerated development of the vaccine for the 2014 Ebola outbreak in West Africa.
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
coronavirus caused millions of deaths around the world recently .
not only knowing the structure of this virus matters but also the vaccines preventing its deadly effects is of importance .
in this power point which I prepared for my university advisor almost 1.5 year ago I mentioned all types of vaccines which then were approved or were on clinical trials.
Steve Berger - Manufacturing & Development UpdateJohn Blue
Manufacturing & Development Update - Steve Berger, Development Director, Aptimmune, from the 2018 Aptimmune Pre-AASV Symposium, March 2, 2018, San Diego, CA, USA.
More presentations at http://www.swinecast.com/2018-aptimmune-symposium-aasv
subtopic of COVID- 19 VACCINE DEVELOPMENT AND TYPESGagan Sharma
The document discusses COVID-19 vaccine development and types. It explains that vaccines work by training the immune system to recognize pathogens through immunogens like attenuated live viruses, inactivated viruses, viral proteins, or genetic material. For COVID-19, vaccines in late-stage trials use inactivated viruses, viral vectors, protein subunits, and RNA or DNA. The development process involves pre-clinical and clinical trials through phase III. As of October 2020, 10 candidates were in phase III worldwide trials to evaluate safety and efficacy.
The document provides information on COVID-19 vaccines including their structure, types available worldwide and in India, effectiveness, storage requirements, dosing, and safety. It discusses the four main structural proteins of the COVID-19 virus and their functions. Different vaccine platforms are described including mRNA, viral vectors, and inactivated vaccines. Details are given on vaccines approved for use in India and internationally from Pfizer, Moderna, AstraZeneca, Sputnik V, Covaxin, and Covishield. Guidelines on administration, contraindications, and adverse effects are also summarized.
Bacterial vaccines have helped eliminate or reduce several infectious diseases. Common bacterial vaccines protect against diphtheria, tetanus, pertussis, pneumococcal disease, Hib, meningococcal meningitis, typhoid, cholera and more. Vaccines work through active immunization by vaccination or passive immunization using antibodies. Ongoing research continues to develop new vaccines and improve vaccine effectiveness.
1. The document discusses vaccine delivery systems and focuses on single-shot vaccines and mucosal delivery systems.
2. Single-shot vaccines aim to provide both an initial immune response through free antigen and a booster response through microspheres that encapsulate antigen and provide delayed release.
3. Mucosal delivery of vaccines can induce both mucosal and systemic immunity, targeting the primary sites of infection, but poses challenges due to barriers that protect mucosal surfaces. Developing effective mucosal delivery systems remains an active area of research.
vaccine train user immune system to create antibodies, just as it when it is exposed to a disease. However, because vaccine contain only killed or weakened forms of germs like viruses or bacteria, they do not cause the disease or put you at the risk of complications.
vaccine is a biological preparation that improve immunity to a particular disease.
A vaccine typically contain an agent that resembles a disease causing microorganisms and is often made from weakened or killed forms of the microbes.
This document discusses new generation vaccines and the role of bioinformatics in their development. It defines vaccines and describes problems with conventional vaccines. New generation vaccines include recombinant, DNA, and peptide-based vaccines. Recombinant vaccines use proteins from pathogens produced using genetic engineering. DNA vaccines use only pathogen DNA. Peptide vaccines are built from defined peptide antigens. Bioinformatics plays a key role through genomic analysis, epitope prediction, reverse vaccinology, vaccine design, immunoinformatics, adjuvant prediction, and vaccine surveillance. It integrates various omics data to gain insights into host-pathogen interactions and immune responses to aid vaccine development.
1) The document discusses new generation vaccines, including DNA vaccines, recombinant vaccines, and peptide-based vaccines.
2) It explains how bioinformatics plays a key role in various aspects of developing these new generation vaccines, such as genomic data analysis, epitope prediction, reverse vaccinology, vaccine antigen design, and immunoinformatics.
3) New generation vaccines aim to address limitations of conventional vaccines and leverage cutting-edge technologies enabled by bioinformatics.
ESA/ACT Science Coffee: Diego Blas - Gravitational wave detection with orbita...Advanced-Concepts-Team
Presentation in the Science Coffee of the Advanced Concepts Team of the European Space Agency on the 07.06.2024.
Speaker: Diego Blas (IFAE/ICREA)
Title: Gravitational wave detection with orbital motion of Moon and artificial
Abstract:
In this talk I will describe some recent ideas to find gravitational waves from supermassive black holes or of primordial origin by studying their secular effect on the orbital motion of the Moon or satellites that are laser ranged.
The use of Nauplii and metanauplii artemia in aquaculture (brine shrimp).pptxMAGOTI ERNEST
Although Artemia has been known to man for centuries, its use as a food for the culture of larval organisms apparently began only in the 1930s, when several investigators found that it made an excellent food for newly hatched fish larvae (Litvinenko et al., 2023). As aquaculture developed in the 1960s and ‘70s, the use of Artemia also became more widespread, due both to its convenience and to its nutritional value for larval organisms (Arenas-Pardo et al., 2024). The fact that Artemia dormant cysts can be stored for long periods in cans, and then used as an off-the-shelf food requiring only 24 h of incubation makes them the most convenient, least labor-intensive, live food available for aquaculture (Sorgeloos & Roubach, 2021). The nutritional value of Artemia, especially for marine organisms, is not constant, but varies both geographically and temporally. During the last decade, however, both the causes of Artemia nutritional variability and methods to improve poorquality Artemia have been identified (Loufi et al., 2024).
Brine shrimp (Artemia spp.) are used in marine aquaculture worldwide. Annually, more than 2,000 metric tons of dry cysts are used for cultivation of fish, crustacean, and shellfish larva. Brine shrimp are important to aquaculture because newly hatched brine shrimp nauplii (larvae) provide a food source for many fish fry (Mozanzadeh et al., 2021). Culture and harvesting of brine shrimp eggs represents another aspect of the aquaculture industry. Nauplii and metanauplii of Artemia, commonly known as brine shrimp, play a crucial role in aquaculture due to their nutritional value and suitability as live feed for many aquatic species, particularly in larval stages (Sorgeloos & Roubach, 2021).
The debris of the ‘last major merger’ is dynamically youngSérgio Sacani
The Milky Way’s (MW) inner stellar halo contains an [Fe/H]-rich component with highly eccentric orbits, often referred to as the
‘last major merger.’ Hypotheses for the origin of this component include Gaia-Sausage/Enceladus (GSE), where the progenitor
collided with the MW proto-disc 8–11 Gyr ago, and the Virgo Radial Merger (VRM), where the progenitor collided with the
MW disc within the last 3 Gyr. These two scenarios make different predictions about observable structure in local phase space,
because the morphology of debris depends on how long it has had to phase mix. The recently identified phase-space folds in Gaia
DR3 have positive caustic velocities, making them fundamentally different than the phase-mixed chevrons found in simulations
at late times. Roughly 20 per cent of the stars in the prograde local stellar halo are associated with the observed caustics. Based
on a simple phase-mixing model, the observed number of caustics are consistent with a merger that occurred 1–2 Gyr ago.
We also compare the observed phase-space distribution to FIRE-2 Latte simulations of GSE-like mergers, using a quantitative
measurement of phase mixing (2D causticality). The observed local phase-space distribution best matches the simulated data
1–2 Gyr after collision, and certainly not later than 3 Gyr. This is further evidence that the progenitor of the ‘last major merger’
did not collide with the MW proto-disc at early times, as is thought for the GSE, but instead collided with the MW disc within
the last few Gyr, consistent with the body of work surrounding the VRM.
Unlocking the mysteries of reproduction: Exploring fecundity and gonadosomati...AbdullaAlAsif1
The pygmy halfbeak Dermogenys colletei, is known for its viviparous nature, this presents an intriguing case of relatively low fecundity, raising questions about potential compensatory reproductive strategies employed by this species. Our study delves into the examination of fecundity and the Gonadosomatic Index (GSI) in the Pygmy Halfbeak, D. colletei (Meisner, 2001), an intriguing viviparous fish indigenous to Sarawak, Borneo. We hypothesize that the Pygmy halfbeak, D. colletei, may exhibit unique reproductive adaptations to offset its low fecundity, thus enhancing its survival and fitness. To address this, we conducted a comprehensive study utilizing 28 mature female specimens of D. colletei, carefully measuring fecundity and GSI to shed light on the reproductive adaptations of this species. Our findings reveal that D. colletei indeed exhibits low fecundity, with a mean of 16.76 ± 2.01, and a mean GSI of 12.83 ± 1.27, providing crucial insights into the reproductive mechanisms at play in this species. These results underscore the existence of unique reproductive strategies in D. colletei, enabling its adaptation and persistence in Borneo's diverse aquatic ecosystems, and call for further ecological research to elucidate these mechanisms. This study lends to a better understanding of viviparous fish in Borneo and contributes to the broader field of aquatic ecology, enhancing our knowledge of species adaptations to unique ecological challenges.
Phenomics assisted breeding in crop improvementIshaGoswami9
As the population is increasing and will reach about 9 billion upto 2050. Also due to climate change, it is difficult to meet the food requirement of such a large population. Facing the challenges presented by resource shortages, climate
change, and increasing global population, crop yield and quality need to be improved in a sustainable way over the coming decades. Genetic improvement by breeding is the best way to increase crop productivity. With the rapid progression of functional
genomics, an increasing number of crop genomes have been sequenced and dozens of genes influencing key agronomic traits have been identified. However, current genome sequence information has not been adequately exploited for understanding
the complex characteristics of multiple gene, owing to a lack of crop phenotypic data. Efficient, automatic, and accurate technologies and platforms that can capture phenotypic data that can
be linked to genomics information for crop improvement at all growth stages have become as important as genotyping. Thus,
high-throughput phenotyping has become the major bottleneck restricting crop breeding. Plant phenomics has been defined as the high-throughput, accurate acquisition and analysis of multi-dimensional phenotypes
during crop growing stages at the organism level, including the cell, tissue, organ, individual plant, plot, and field levels. With the rapid development of novel sensors, imaging technology,
and analysis methods, numerous infrastructure platforms have been developed for phenotyping.
hematic appreciation test is a psychological assessment tool used to measure an individual's appreciation and understanding of specific themes or topics. This test helps to evaluate an individual's ability to connect different ideas and concepts within a given theme, as well as their overall comprehension and interpretation skills. The results of the test can provide valuable insights into an individual's cognitive abilities, creativity, and critical thinking skills
Immersive Learning That Works: Research Grounding and Paths ForwardLeonel Morgado
We will metaverse into the essence of immersive learning, into its three dimensions and conceptual models. This approach encompasses elements from teaching methodologies to social involvement, through organizational concerns and technologies. Challenging the perception of learning as knowledge transfer, we introduce a 'Uses, Practices & Strategies' model operationalized by the 'Immersive Learning Brain' and ‘Immersion Cube’ frameworks. This approach offers a comprehensive guide through the intricacies of immersive educational experiences and spotlighting research frontiers, along the immersion dimensions of system, narrative, and agency. Our discourse extends to stakeholders beyond the academic sphere, addressing the interests of technologists, instructional designers, and policymakers. We span various contexts, from formal education to organizational transformation to the new horizon of an AI-pervasive society. This keynote aims to unite the iLRN community in a collaborative journey towards a future where immersive learning research and practice coalesce, paving the way for innovative educational research and practice landscapes.
1. Credit Seminar
on
Corona vaccines
How they work, ways of production and their efficacy
Presented by :- Mageshwar Singh Slathia (J-20-MV-643)
Seminar in charge :- Dr. Maninder Singh Major Advisor:- Dr.H.K. Sharma
2. SARS CoV 2
• Ss RNA
• Order – Nidovirales
Family – coronaviridae
Sub family- coronavirinae
Genera – 4 Alphacoronavirus
Betacoronavirus
Gammacoronavirus
Deltacoronavirus
Source:-
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC718064
9/
Birds
Mammals
3. What are vaccination
• Vaccination is a simple, safe and effective way of protecting people
against harmful diseases, before they come into contact with them.
{WHO}
• The act of introducing a vaccine into the body to produce immunity to
a specific disease. {CDC}
• Immunity and vaccination interchangeable
• The vaccines are administered through needle injections, but can also
be administered by mouth or sprayed into the nose. {CDC} -???
5. Components of a vaccine
• Antigen – active ingredient Or blueprint for active ingredient
• Preservatives- 2- phenoxyethanol, in multi dose vials, not in single
• Stabilizers – prevent reaction
• Surfactants - blending
• Residuals – left after production
• Diluent- sterile water (common)
• Adjuvant- some vaccines, improve
response
7. Why corona vaccine is one of a kind
• Typical vaccine 10-12 years
• Corona vaccine 12-18 months (How its Possible)
In 1960s ,
mumps
vaccine in 4
yrs was made
8. Types of Corona vaccines
• Inactivated vaccines (covaxin,sinovac,sinopharm)
• Viral Vector vaccines (Oxford/AstraZeneca vaccine ,Sputnik V vaccine,j
& J)
• Protein adjuvant vaccines (corbevax,novavax)
• Nucleic acids vaccines (Pfizer/BioNtech vaccine, moderna
vaccine,Zydus cadila ZyCoV-D)
9. Inactivated vaccines
• Exposure of virulent virus to chemical or physical agents (formalin, B-propiolactone)
• Destroy infectivity , retained immunogenicity
• Disadvantage – large amount of antigen
Chemical may damage immunogenicity
requires BSLV- 3
Source :- https://www.sciencedirect.com/topics/medicine-and-dentistry/inactivated-virus-vaccine
10. Covaxin
• India’s 1st indigenous COVID-19 vaccine
• Produced by Bharat Biotech with ICMR and NIV
• Technology used – Whole-Virion Inactivated Vero Cell
• 2 dose vaccination regime given 28 days apart
• Stable at 2-8 degree Celsius
• Adjuvant – Alhydroxiquim- II
• Phase 3 trials – 25,800 participants
(130 confirmed cases, 106 in placebo vs 24 in vaccine)
Efficacy – Symptomatic covid – 77.8% , severe- 93.4% and asymp. – 63.6%
• Source :- https://www.bharatbiotech.com/covaxin.html
11. Efficacy of Covaxin against Covid-19 variants
Proven to neutralize the variants
• B.1.1.7 (Alpha) (UK)
• P.1-B.1.1.28 (Gamma) & P.2-B.1.1.28 (Zeta) (Brazil)
• B.1.617(Kappa) (India)
• B.1.617.2(Delta)(India)
• B.1.351(Beta)(South Africa)
• Efficacy -65.2% (against Delta)
Source:- https://www.bharatbiotech.com/covaxin.html
12. CoronoVac
• Developed by Sinovac Biotech
• Formaldehyde inactivated with alum adjuvant
• Stable at 2-8 degree Celsius
• SAGE (WHO) recommends 2 doses with 2-4 weeks apart
• Efficacy – Phase 3 trials in Brazil (51% against symptomatic, 100 %
against severe) Against P1 and P2 variants (49.6%)
• WHO recommends in Pregnant women under certain condition
• Also for people with comorbidities
• Source:- https://www.who.int/news-room/feature-stories/detail/the-sinovac-covid-19-vaccine-what-you-need-to-know
13. Sinopharm vaccine
• Inactivated COVID – 19 vaccine
Developed by Sinopharm/China National Pharmaceutical Group.
• SAGE recommends 2 doses with 3-4 weeks apart
• Contain the dead coronavirus with Al salts as adjuvant
• Efficacy- Phase 3 trails (same against symptomatic and against
hospitalization i.e. 79%)
• Source:- https://www.who.int/news-room/feature-stories/detail/the-sinopharm-covid-19-vaccine-what-you-need-to-
know
14. Viral vectored vaccine
• The gene from
adenovirus,
which cause the
infection, is
removed while
a gene with the
code of a
protein from
another virus
spike is inserted
• This inserted
element is safe
for the body but
still helps the
immune system
to react and
produce
antibiotics,
which protect
us from the
infection.
• Source :-
https://sputnikvaccine.com/abo
ut-vaccine/
15. (viral vectored vaccines) Contd.
• Harmless cold virus after adding the spike protein DNA and growing it
in cell culture
• Downstream processing- purification of virus vaccine
• Many environmental factors in and around the cell culture –
temperature, oxygen, co2 level, acidity and so on are regulated
16. Covishield
• ChAdox1 ncoV-19 corona virus vaccine (Recombinant)
• Manufactured by Serum Institute of india Pvt Ltd.
With Oxford AstraZeneca
• 1 dose (0.5ml) contains 5 X 10^10 virus particles
• Replication deficient chimpanzee adenovirus vector encoding the SARS-
CoV-2 Spike (S) glycoprotein, produced in genetically modified human
embryonic kidney (HEK) 293 cells
• Different studies regarding the dose interval
• Source :- https://www.seruminstitute.com/pdf/covishield_ChAdOx1_nCoV19_corona_virus_vaccine_insert.pdf
17. Studies carried out in UK regarding dose
interval
• Study 1
D1 D2 (published in Lancet)
(76% after 22 days) (55% Efficacy)
• Study 2
D1 D2
(76%) (81-82% efficacy)
• Study 3 – with low dose
D1 with low dose D2 with standard dose (Not published)
(2.2 * 10^10) (90% efficacy)
4-6 weeks
12 weeks
4-6 weeks
18. Sputnik V
• Viral vectored vaccine (adeno virus ) adeno virus
is used as a container to deliver the corona virus gene
to cells and start synthesizing the new coronavirus envelope protein.
• World’s 1st registered vaccine against corona virus
• Two component vaccine (adenovirus serotypes 5 and 26 serotypes are
used)
• The gameleya National Center of Epidemiology and Microbiology in Russia
• Can be stored at 2-8 degree celsius
• Source:- https://www.precisionvaccinations.com/vaccines/sputnik-v-vaccine
19. Why sputnik V is more advantageous than
other vectored vaccine
Source of
contamination
Unhygienic
condition
Despite this
not approved
by WHO
20. Johnson & Johnson’s Janssen
• Single shot vaccine
• Principal – Viral Vector Vaccine
using Human Adenovirus
• Age – 18 years and above
• Efficacy – 85 % against severe
• Side effects- Guillain- Barre Syndrome (Autoimmune) – serious but
rare (FDA)
21. BBV154
• Novel adenovirus vectored
• Intranasal –
• Many advantages
Broad immune response
Immune response at site of infection (block both infection and
transmission)
• Currently under trials
• Source:- https://www.bharatbiotech.com/intranasal-vaccine.html
22. Sub unit based vaccines
• Very specific parts of a virus or bacterium used
• sugars or proteins
• Non infectious
• Childhood vaccines
Source:- https://www.who.int/news-room/feature-stories/detail/the-race-for-a-covid-19-vaccine-explained
24. Novavax (NVX-CoV2373)
• Protein subunit vaccine using
recombinant protein nanoparticle
technology to generate the antigens derived from corona virus spike(S)
protein
• It utilizes Matrix-M adjuvant(made up of Quillaja saponins formulated with
cholesterol and phospholipids into nanoparticles) to enhance the immune
system
• Reported Overall efficacy – 90.4% and 100% effective against moderate and
severe infection in phase 3 trials
• Undergoing trials in India under brand name Covovax
• 2 doses (21 days apart), stable 2-8 degree
• Source :- https://ir.novavax.com
25. Corbevax
• By Biological E Ltd. Hyderabad
• Indigenous vaccine
• Is expected to launch by August after completing its phase 3 trial
• The capacity to produce vaccine is similar to that of the serum
institute of India
• It is a protein Sub unit vaccine
• Generally considered as the safe
Source :- https://www.livemint.com/science/health/biological-e-likely-to-launch-covid-19-vaccine-by-august-11619022229805.html
26. Nucleic acid vaccines
• Use genetic material of virus or
bacteria
• Instructions for making specific
protein from the pathogen
• It stimulates the immune response
of the host
• New technology
• Safe, non infectious
• Fast as no cell culture
28. How mRNA vaccines are produced
• No cell culture are required
• With the help of a machine, a synthesizer which add each nuleic acid
onto the next in the right sequence so that full length RNA sequence
that encodes the spike protein is achieved
• Mixed with lipid droplets of nanometer size
• Source:- https://theconversation.com/how-are-covid-19-vaccines-made-an-expert-explains-155430
29. Pfizer BioNtech
• Given EUA by the US FDA
• 12 Years or Older
• 2 shots vaccine with 3 weeks apart
• After phase 3 trials, its efficacy – 95%
43,000 participants
170 confirmed (162 in placebo vs 8 in vaccine group)
30. Moderna (mRNA-1273
• mRNA vaccine in which
mRNA is packed by lipid
molecules
• 2 doses are administered with
4 weeks apart
• 94.1 % efficacy
• 30,420 volunteers,195
confirmed
• 184 in placebo vs 11 in
vaccinated (symptomatic)
• 30 severe covid 19 – all in
placebo group
32. Plasmid DNA vaccine
• Zydus Cadila
• World’s 1st plasmid DNA vaccine
• What's the difference
BSL-1 as compared to covaxin
Low cold chain requirements
(25 degree for 3 months)
• 12 years and above
• 66.6% effective (symptomatic) and 100% against moderate
• Given intradermally (using Pharmajet Needle less tech.)
• Administered in 3 doses
Source:- https://www.theweek.in/news/health/2021/07/05/explained-how-does-zydus-cadilas-plasmid-dna-vaccine-work.html
33. Adjuvants: the Unsung heroes of vaccines
• Discovered by a French VET, Gaston Ramon
• Inflammation role in horses vaccinated
against Diptheria
• Experiment with common materials and
Foodstuffs
• 1926- Alexander Glenny – Aluminium salts
• Newly discovered adjuvants made up of oils/fats, saponins, polymers
• Half vaccine dose – adjuvant role in pandemic
Source:- https://theconversation.com/adjuvants-the-unsung-heroes-of-vaccines-156548
34. Problems
• Allergic reaction/ Anaphylaxis
• Maintaining the cold chain
• Accuracy (fastest Vaccine)
• Escape variants evolved in environment of weak immune responses
• Target age groups
• Lacking data about certain conditions like pregnant/lactating women
• Lacking data about other diseased conditions
35. Side effects of Vaccines
• Fever
• Fatigue
• Headache
• Muscle pain
• Chills
• Diarrhea
• Muscle at the injection site
Source :- https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccines-safety
36. Efficacy of the vaccines
• Moderna – 90-94 %
• Pfizer- BioNtech – 90-94%
• Sputnik v – 85-90%
• Novavax- 85-89%
• Covishield – 70- 90 %
• Johnson & johnson Janssen – 70-85%
• Covaxin- 70-80%
• Sinovac/Coronovac – 67-75%
37. WHO approved covid 19 Vaccines
As of 3 June 2021, WHO has evaluated that the following vaccines
against COVID -19 have met the necessary criteria for safety and
efficacy :
• AstraZeneca/Oxford vaccine (Covishield)
• Johnson and Johnson’s janssen
• Moderna
• Pfizer/BioNtech
• Sinopharm
• Sinovac
38. Herd Immunity
• Enough people in a community
are vaccinated, the whole
community including the
individuals that are not
vaccinated, ARE PROTECTED
• Acc. To WHO, 60-70 % of pop.
Must be vaccinated to attain
Herd immunity
44. Corona vaccines still a mystery
• Duration of protection ????
• Mix and Match Experiments – UK and Canada but CDC,FDA,WHO
don’t advice as of now
• Vaccines in pregnant women – recommended by GOI on 1st July,2021
• Vaccines in children – under trials
45. STATS (CO-WIN)
• As of 2nd august 2021, 46,77,95,975 individuals vaccinated
• 36,51,36,972 -1st dose
• 10,26,59,003 – 2nd dose
Which is 7.4 % approx. of total population of India
• Far from the numbers of Herd immunity
• But these are just stats – more vaccine options , increasing capacity
DO YOUR BIT – Get Vaccinated and help attain the HERD IMMUNITY
46.
47. Covid vaccines for pregnant women
• Kerala’s campaign- ‘Mathru kavacham’- all pregnant women ll be
registered for vaccination at ward level by ASHA workers
48. Recent advances
• Covaxin (BBV152) recommended for emergency use authorization for
2- 18 years by the Subject Expert Committee of CDSCO (Central Drug
Standards Control Organisation) – 13th October 2021
• Covaxin gets approval by WHO for emergency use – 3rd November
2021.