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.
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.
This important presentation encompasses all the vaccines of COVID at current point of time; it's mechanism of action, its efficacy data's and advantages and disadvantages
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 Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH
Speaker: Dr.Benedict Sim Lim Heng is a Consultant Infectious Disease Physician at the Sungai Buloh Hospital, Ministry of Health Malaysia.
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.
This important presentation encompasses all the vaccines of COVID at current point of time; it's mechanism of action, its efficacy data's and advantages and disadvantages
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 Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH
Speaker: Dr.Benedict Sim Lim Heng is a Consultant Infectious Disease Physician at the Sungai Buloh Hospital, Ministry of Health Malaysia.
This slide presentation historically, statistically and attractively explains various vaccines for covid19 available in India. (Please update the statistical data to current values)
Severe Acute Respiratory Syndrome (SARS) : Treatment and prophylaxis with Re...Dmitri Popov
Severe acute respiratory syndrome (SARS) is a serious form of pneumonia. It is caused by a virus that was first identified in 2003.Infection with the SARS virus causes acute respiratory distress (severe breathing difficulty) and sometimes death.
Disclaimer -
The Content belongs to WHO (World Health Organisation). Sharing here is just to spread awareness about Covid-19.
https://www.who.int/docs/default-source/coronaviruse/risk-comms-updates/update37-vaccine-development.pdf?sfvrsn=2581e994_6
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.
A brief overview of the process of vaccine production, clinical trials, and licensing, along with a summary of the different vaccines platforms and vaccine candidates.
this presentation is prepared with the intention to create an insight about coronavirus among the undergraduate medical students in their pre and para clinical years
SARS stands for severe acute respiratory syndrome . caused by a corona virus . major outbreak in south china in 2002 with fatality of about 10% and 800 deaths in a single outbreak.
Webinar Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH
Speaker: Dr. Low Lee Lee, Infectious Disease Physician at the Hospital Sultanah Bahiyah, Ministry of Health Malaysia.
This slide presentation historically, statistically and attractively explains various vaccines for covid19 available in India. (Please update the statistical data to current values)
Severe Acute Respiratory Syndrome (SARS) : Treatment and prophylaxis with Re...Dmitri Popov
Severe acute respiratory syndrome (SARS) is a serious form of pneumonia. It is caused by a virus that was first identified in 2003.Infection with the SARS virus causes acute respiratory distress (severe breathing difficulty) and sometimes death.
Disclaimer -
The Content belongs to WHO (World Health Organisation). Sharing here is just to spread awareness about Covid-19.
https://www.who.int/docs/default-source/coronaviruse/risk-comms-updates/update37-vaccine-development.pdf?sfvrsn=2581e994_6
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.
A brief overview of the process of vaccine production, clinical trials, and licensing, along with a summary of the different vaccines platforms and vaccine candidates.
this presentation is prepared with the intention to create an insight about coronavirus among the undergraduate medical students in their pre and para clinical years
SARS stands for severe acute respiratory syndrome . caused by a corona virus . major outbreak in south china in 2002 with fatality of about 10% and 800 deaths in a single outbreak.
Webinar Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH
Speaker: Dr. Low Lee Lee, Infectious Disease Physician at the Hospital Sultanah Bahiyah, Ministry of Health Malaysia.
COVID vaccination and prevention strategiesShinjan Patra
This presentation deals with all the vaccines available for COVID-19 at current times; It has a special mention and discussion about the Indian vaccines and it's utilities and uses
This webinar is organized by MyICID and Institute for Clinical Research (ICR), NIH, Ministry of Health in conjunction with Neglected Tropical Disease Day 2022. The purpose of this webinar is to refresh and update our knowledge on Dengue fever, which has been overshadowed by COVID-19 since the beginning of the pandemic.
Presenter: Dr Ong Hang Cheng, Infectious Disease Physician at University Malaya Medical Center
#dengue #WorldNTDDay #BeatNTDs #BestScienceforAll
In this section of the coronavirus pandemic series, we discuss the current capacity of local healthcare systems and the need for effective treatment options as well as the pathogenesis of the coronavirus. Current treatment options include RNA, monoclonal antibodies (mAb), antibodies, convalescent plasma, and others. Critical stage implications such as cytokine storm and the need for immunomodulatory agents would also be discussed. Therapeutic pathways would are also compared.
ISO 15189 2022 standards for laboratory quality and competencePathKind Labs
The fourth edition of standards for laboratory quality and competence are available. Labs need to perform gap analysis to identify areas that need to be developed to fulfill the new requirements.
recently the fourth edition of ISO 15189 2022 have been released. It has aligned itself to its parent document ISO 17025 and focused on risk assessment
management of childhood tuberculosis in 2023.pptxPathKind Labs
diagnosis of childhood TB is a challange, but if we follow a system of screening and then appropriate diagnostic tests following contact tracing, we are likely to identify children with infection or disease and put them on appropriate treatment.
Recently ISO 15189:2022 have become available. This would help laboratories set up processes which would yield reproducible results and improve the quality of work.
viral markers in diagnosis monitoring and treatment of hepatitis b and c.pptxPathKind Labs
Hepatitis B Virus and Hepatitis C Virus infections are transmitted by parentral route. Early diagnosis and treatment can prevent cirrhosis of liver in HCV cases as drugs which can cure the infection are now available.
Covid-19 pandemic has caused over 6 million deaths and has been acknowledged as one of the worst pandemic in living memory. But antimicrobial resistance as invisble pandemic may clain more deaths every year if suitable action is not taken soon.
While MIC is a good measure of antibiotic activity, it is static and reflects in vitro activity. PK and PD of the drug needs to be considered together with MIC if we wish to obtain an in vivo prediction of drug action and success.
clinical standards for ds tb treatment 2022 (1).pptxPathKind Labs
To diagnose and treat drug susceptible pulmonary tuberculosis is of paramount importance in our efforts to eliminate tuberculosis. This describes seven clincal standards which should be practiced to obtain optimum results
what is new in prevention, diagnosis and treatment of tuberculosis tb short.pptxPathKind Labs
Many changes have been made recently in Tuberculosis. The first important change is that instead of control now the focus is on eradication. for that to happen we need to change the way we detect, diagnose and treat tuberculosis.
Procalcitonin is an excellent biomarker for antibiotic use in bacterial infections alone. POCT guided PCT levels can help decide whether to add antibiotics or not in opd settings for respiratory tract infection.
While the world was focused on covid 19, WHO has made and issued consolidated guidelines making changes in how to prevent, diagnose and treat tuberculosis.
Understanding and implementing quality management system in medical laboratoriesPathKind Labs
QMS is essential to run a good laboratory, but the various requirements pose a big challenge. Once you understand the reason for these requirements compliance may be easier.
RT PCR is too slow for effective control of spread of cov 2 infection, rapid antigen test by giving results in less than 30 minutes can help identify infected persons leading to quick isolation.Lack of sensitivity can be compensated by repeating RAT after a day or so.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Couples presenting to the infertility clinic- Do they really have infertility...
Essential information on covid 19 vaccinations
1. Essential Information on Covid-19 vaccination
Developing Vaccine at Pandemic Speed
&
using it to control the pandemic
2. Eradication of Small Pox, Near Elimination of Polio & Neonatal Tetanus & Reduction of Measles have been possible by vaccines
20 additional vaccines have prevented 2 to 3 million deaths annually
Vaccines are considered the
safest & most cost effective
intervention for control of
Covid – 19 disease & to bring
an end to this pandemic by
providing individual protection
& subsequently Herd Immunity
3.
4. Consequence of whole genome of nCoV being
available by 10th Jan 2020
Diagnostics
• Identification of SARS CoV 2
• RT PCR base on N gene
(CDC,USA)
• RT PCR based on E & RdRp
genes by Koch Institute, Berlin
• RT LAMP
• Crispr
Vaccines
• mRNA vaccine design
• DNA vaccine using Viral vector
design
• Both novel approaches had been
tried for HIV & HCV and
• Gene therapy
• Correlates of immunity
6. Vaccines
Most cost effective approach
once immune correlates of protection are known
1. Viral culture / Gene sequence
2. Cell line in which it grows (Vero)
3. Immune equivalent of protection
4. Animal model : Syrian Hamster & monkey
5. Method of delivery
6. Clinical Trials: Safety, Immunogenicity Protection
(Efficacy)
7. Manufacturing
8. Logistics of getting it to the end user
9. • The longitudinal tracking of re-exposure after the disappeared symptoms of the
SARS-CoV-2-infected monkeys :
• weight loss in some monkeys, viral replication mainly in nose, pharynx, lung and
gut, as well as moderate interstitial pneumonia at 7 days post-infection (dpi) were
clearly observed in rhesus monkeys after the primary infection.
• After the symptoms were alleviated and the specific antibody tested positively,
• half of infected monkeys were re-challenged with the same strain
• Neither viral loads in nasopharyngeal and anal swabs along timeline nor viral
replication in all primary tissue compartments at 5 days post-reinfection (dpr) was
found in re-exposed monkeys.
• Monkeys with re-exposure showed no recurrence of COVID-19, similarly to the
infected monkey without re-challenge.
Bao et al: Beijing Key Laboratory for Animal Models of Emerging and Remerging Infectious Diseases
20. Covid-19 Vaccines in different stages of development
Type of vaccine Preclinical Phase I Phase I/II Phase II Phase II/III Phase III Licensed
Virus Live
attenuated
3 1
Inactivated 11 1 2 1 3 1
Viral vector Replicating 18 1 2 1
Non
replicating
26 6 4 1
Nucleic acid DNA 16 2 5
RNA 29 2 2 1 1 2
Protein
based
Protein
subunit
64 9 5 2 1
Virus like
particle
17 1 1
Not
disclosed
31 3
Total 215 25 17 5 1 10 4*
21. Indian Landscape of Covid-19 vaccines
Product Indian Manufacturer Collaborator Stage
Covishield Serum Institute of India Astra Zeneca /Oxford Licensed
Covaxin Bharat Biotech International ICMR [Phase III] EUA Licensed
ZyCo V-D Cadila Healthcare Dept of Biotechnology Phase II III
Sputinik V Trial & manufacture in India Dr Reddy’s
Lab; Mankind Pharma for distribution
Gamaleya National Centre,
Russia
III review
NVX-CoV 2373
Protein subunit
Serum Institute of India Novavax II/III
R Protein Antigen based Biological E MIT, USA I/II
HGCO 19
(mRNA based)
Genova HDT, USA PC
Inactivated rabies
vector platform
Bharat Biotech International Thomas Jefferson Univ,
USA
PC
Vesiculo Vax Platform Aurobindo Pharma Aurovaccine, USA PC
22. MoHFW Covid-19 Vaccines Fact sheet
• Authorized Age Group:
• 18 years and above
• Co-administration of vaccine:
• If required Covid-19 vaccine and other vaccines should be separated by an
interval of at least 14 days
• Interchangeability of Covid-19 Vaccines:
• Not permitted. Second dose should also be of the same Covid-19 vaccine
which was administered as the first dose.*
• [UK is going to initiate Pfizer followed by Oxford & vice versa]
• [Prime with Oxford, boost with Sputnik V as both contain Adenovirus vector]
23. Contraindicated
• Persons with history of:
– Anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine
– Anaphylaxis or allergic reaction to vaccines or injectable therapies,
pharmaceutical products, food-items etc.
• Pregnancy and Lactating women.
MMWR on Pfizer Vaccine
24. Provisional / Temporary contra-indication
• Defer Covid Vaccination for 4-8 weeks after recovery
• 1. Persons having active symptoms of COIVD-19 infection.
• 2. COVID-19 patients who have received monoclonal antibodies or
convalescent plasma
• 3. Acutely unwell and hospitalized (with or without intensive care) patients
due to any illness
• Special Precautions:
• Administer with caution in persons with history of any bleeding or
coagulation disorder.
25. Conditions Not Contraindicated
• Persons with a past history of COVID infection*
• Chronic diseases and morbidities (cardiac, neurological, pulmonary,
metabolic, renal, malignancies)
• Immuno-deficiency, HIV, patients on immune suppression due to any
condition (the response to the COVID-19 vaccines may be less in
these individuals)
27. Covid 19 vaccines in the pipeline in India
ZyCo V- D of Cadila (DNA vaccine) Sputnik V (Human Adenovirus vaccine) r Protein vaccine of Biological E
28. Information for Healthcare Professional
Covishield
• One Dose = 0.5 ml IM, contains 5 x 1010 viral particles (vp)
• Recombinant, replication-deficient chimpanzee adenovirus vector
encoding SARS CoV 2 Spike (S) glycoprotein, produced in genetically
modified human embryonic kidney (HEK) 293 cells
• Solution is colourless to slightly brown, clear to slightly opaque
• Particle free, pH 6.6
• Donot shake before use
• Two doses of 0.5 ml each IM (preferably Deltoid) , 4 to 12 weeks apart
• Complete vaccination course using same vaccine
29. • Elderly (> 65 yrs); No dosage adjustment required
• Paediatrics : Not approved for children < 18 yrs
• Contraindications: hypersensitivity to active substance or excipients
• Concurrent illness: postpone if there is an acute severe febrile illness
• But, Minor infections, eg. Cold, low grade fever shouldnot delay vaccination
• Thrombocytopenia & coagulation disorders. Give with caution
• Immunocompromised: no data
• Duration & level of protection: not yet established, but > 6 months
• Interchangeability : no data
• Sodium: 1 mmol sodium (23 mg) per dose, essentially sodium free
Information for Healthcare Professional
Covishield
30. • Fertility, pregnancy, lactation
• Pregnancy: limited experience, no direct or indirect harmful effect
• Breast feeding : unknown if vaccine is excreted in human milk
• Fertility : no direct or indirect harmful effect
• Ability to drive & use machines
• No or negligible influence on ability to drive or use machines
Information for Healthcare Professional
Covishield
31. Summary of safety profile
Covishield
• all participants need to be followed up for 12 months
• Interim analysis of pooled data from 4 clinical trials in UK, Brazil &
South Africa
• 23,745 participants >18 yrs, randomised to covid or control vaccine
• 12,021 received at least one dose of Covid 19
• Medium duration of follow up 105 days post dose 1 & 62 days post
dose 2 [ideally one year]
• Age between 18 – 64 yrs 90.3%, >65 9.7%
• White 75.5%; Black 10.1% ; Asians 3.5
• Female 55.8% Male 44.2%
32. • Injection site tenderness > 60 %
• Injection site pain, headache, fatigue > 50 %
• Myalgia, malaise > 40 %
• Pyrexia, chills > 30 %
• Arthralgia, nausea > 20 %
• Most were mild to moderate & resolved within a few days
• By 7th day post dose local reaction in 4% ; systemic reaction 13%
• After Second dose, reactions were milder & less frequent
• Adverse reactions were milder & reported less frequently in older adults (>65)
• Paracetamol took care of most
Summary of safety profile
Covishield
33. Adverse Drug Reactions
Covishield
MedDRA SOC Frequency Adverse Reactions
Blood & lymphatic system Uncommon Lymphadenopathy
Metabolism & nutritional Uncommon Decreased appetite
Nervous system disorder Very common headache
Uncommon dizziness
Gastrointestinal Very common Nausea
Common Vomiting
Uncommon Abdominal pain
Skin & subcutaneous Uncommon Hyperhidrosis, pruritus, rash
Musculoskeletal & connective tissue Very common Myalgia, arthralgia
General disorders & administration site
conditions
Very common Injection site tenderness, pain, warmth, erythema,
pruritus, swelling, bruising, fatigue, pyrexia, chills
Common Injection site induration, influenza like illness
SOC System Organ Class
Very common (> 1/10); Common (>1/100 to <1/10); uncommon (><1/1000 to <1/100); rare (>1/10,000 to <1/1000)
34. Pharmacological Properties
Covishield
• Mechanism of action : Covishield is a monovalent vaccine composed of a
single recombinant replication deficient chimpanzee adenovirus (ChAdOx1)
vector encoding the S glycoprotein of SARS CoV 2.
• Following administration the S glycoprotein of SARS CoV 2 is expressed
locally stimulating neutralizing antibodies and CMI
• Clinical efficacy: all participants need to be followed up for 12 months
• Study enrolment excluded participants with history of anaphylaxis or
angioedema, severe CVS, GIT, Liver, Renal, Metabolic or Neurological
disease
• Two doses were administered but because of logistical constrains interval
between dose 1 and dose 2 ranged from 4 to 26 weeks.
• One group in UK was administered half the standard dose
35. Covishield Efficacy against Covid-19
Population Covishield Vaccine Control Vaccine efficacy
% (CI)
N Number of Covid-19 cases N Number of covid-19 cases
Primary 5,807 5,829
Covid-19 cases 30
(0.52)
101
(1.73)
70.42
(58.84 80.63)
Hospitalization 0 5 (0.09)
Severe disease 0 1 (0.02)
Any dose 10,014 10,000
Covid-19 cases
after dose 1
108
(1.08)
227
(2.27)
52.69
(40.52 62.37)
Hospitalization
after dose 1
2
(0.02)
16
(0.16)
Severe disease
after dose 1
0 2
(0.02)
37. Titre Number
100 11
91 – 100 7
81 – 90 9
71 – 80 9
61 – 70 11
51 – 60 16
41 – 50 26
31 – 40 41
21 – 30 60
11 – 20 80
>1 251
< 1 1919
TNP 18
Total negative 2271
Total Positive 552
Titre Number
1000 2
500 1
> 400 1
300 – 399 17
200 – 299 58
100 – 199 275
80 – 99 103
40 – 79 294
15 – 39 368
12 – 15 58
< 12 1120
< 3.5 1462
TNP 28
Total Negative 2582
Total Positive 1119
Total Antibodies against NCP IgG Antibodies against S1/S2
N = 2841 N = 3787
38. Information for Healthcare Professional
Covaxin
• One Dose = 0.5 ml IM, each vial contains 20 doses
• Shelf life is 6 months, store between 2 and 8 C
• Solution is white translucent
• Shake well before use
• Freeze sensitive, discard if frozen or presence of particulate matter
• Two doses of 0.5 ml each IM (preferably Deltoid) , 4 weeks apart
• Complete vaccination course using same vaccine
40. 4 arms, 3 vaccine + 1 control
3ug Algel-IMDG; 6 ug Algel-IMDG; 6Ug Algel; Algel
2 doses IM, 14 days (accelerated schedule)
Primary end points: 1. Reactogencity; 2. Safety
Secondary: 1. Immunogencity
anti spike IgG, Nx, CMI
Results:
Mild reactions, absent in majority, quickly resolved
Less after second dose
Robust immune response comparable to convalescent plasma
No significant difference between 3 & 6 ug Algel-IMDG
Nx antibodies detected
CMI was biased to a Th 1 phenotype
Covaxin
41. • Objective: Immunogenicity & Safety of BBV 152
• 380 healthy children & adults; 2 arms: 3 ug Algel-IMDG & 6 ug Algel-IMDG
• 2 doses IM, 4 weeks apart
• Primary end point: Seroconversion (> 4 fold) based on Nx antibodies (PRNT)
• Secondary end point: Reactogenicity & Safety
• Results:
• PRNT50 seroconvertion of Nx on day 56 in 92.9 & 98.3%
• More Th 1 cytokines
• Reaction was 9.7 % & 10.3%
• Seroconvertion on day 104
• 3 ug Algel-IMDG 73.5% (63.6 81.9%)
• 6 ug Algel-IMDG 81.1% (71.4 88.1%)
• 6 ug Algel 73.1% (62.9 81.8%)
• 6 ug Algel IMDG was selected for Phase III efficacy trials
Covaxin
47. Information for Healthcare Professional
Pfizer mRNA Vaccine
• One multidose vial must be diluted before use, 1 vial (0.45 ml) contains 5 doses
30 microgram of BNT 162b2 RNA (embedded in lipid nanoparticles)
• Covid-19 mRNA Vaccine BNT 162b2 is highly purified single stranded, 5’-capped
messenger RNA (mRNA) produced by cell free in vitro transcription from the
corresponding DNA templates, encoding the viral spike (S) protein of SARS CoV -2.
• Pharmaceutical form : concentrate for solution for injection. The vaccine is a
white to off white frozen solution
• Active immunization to prevent Covid-19, in 16 yrs and older
• Two doses of 0.3 ml each IM (preferably Deltoid) , 21 days apart
• Complete vaccination course using same vaccine, no data on interchangeability
• Individuals maynot be maximally protected until atleast 7 days after their second
dose of the vaccine.
• The multidose vial is stored frozen and must be thawed prior to dilution.
48.
49.
50.
51.
52.
53. • Elderly (> 65 yrs); No dosage adjustment required
• Paediatrics : Not approved for children < 16 yrs
• Contraindications: hypersensitivity to active substance or excipients
• Concurrent illness: postpone if there is an acute severe febrile illness
• But, Minor infections, eg. Cold, low grade fever shouldnot delay vaccination
• Thrombocytopenia & coagulation disorders. Give with caution
• Immunocompromised: no data
• Duration & level of protection: not yet established, but > 6 months
• Interchangeability : no data
• Potassium: 1 mmol potassium (39mg) per dose, essentially potassium free,
contains less than 1 mmol sodium (23 mg) per dose, so essentially sodium free
Information for Healthcare Professional
Pfizer mRNA Vaccine
54. • Fertility, pregnancy, lactation
• Pregnancy: limited experience, no direct or indirect harmful effect
• Breast feeding : unknown if vaccine is excreted in human milk
• Fertility : no direct or indirect harmful effect
• Ability to drive & use machines
• No or negligible influence on ability to drive or use machines
Information for Healthcare Professional
Pfizer mRNA Vaccine
55. Summary of safety profile
Pfizer mRNA Vaccine
• all participants need to be followed up for 12 months
• Interim analysis of pooled data from 2 clinical trials in USA, Europe,
Turkey, South Africa & South America.
• Sudy 1 enrolled 60, study 2 enrolled 44,000 participants, 12 yrs &
above; atleast 21,720 participants 16 yrs or older received atleast one
dose; 19,063 of participants evaluated for safety 2 months after
second dose
• 51.5% males; 48.5% females
• White 82.1%; Blacks 9.6%; Hispanics 26.1%; Asian 4.3% ; Native
Americans 0.7%
56. • Injection site tenderness > 80 %
• Injection site pain, headache, fatigue > 50 %
• Myalgia, malaise > 30 %
• chills > 30 %
• Arthralgia, nausea > 20 %
• Pyrexia > 10 %
• Most were mild to moderate & resolved within a few days
• By 7th day post dose local reaction in 4% ; systemic reaction 13%
• After Second dose, reactions were milder & less frequent
• Adverse reactions were milder & reported less frequently in older adults (>65)
Summary of safety profile
Pfizer mRNA Vaccine
57. Adverse Drug Reactions
Pfizer mRNA Vaccine
MedDRA SOC Frequency Adverse Reactions
Blood & lymphatic system Uncommon Lymphadenopathy
Immune system disorders Not known Anaphylaxis, hypersensitivity
Nervous system disorder Very common headache
rare Acute peripheral facial paralysis [4 in vaccine group]
Gastrointestinal common Nausea
Musculoskeletal & connective tissue Very common Myalgia, arthralgia
General disorders & administration site
conditions
Very common Injection site tenderness, pain, warmth, erythema,
pruritus, swelling, bruising, fatigue, pyrexia, chills
Common Injection site induration, influenza like illness
Uncommon Malaise
SOC System Organ Class
Very common (> 1/10); Common (>1/100 to <1/10); uncommon (><1/1000 to <1/100); rare (>1/10,000 to <1/1000)
58. Pharmacological Properties
Pfizer mRNA Vaccine
• Mechanism of action : The nucleoside modified messenger RNA in Covid-
19 mRNA vaccine BNT 162n2 is formulated in lipid nanoparticles, which
enables delivery of the RNA into host cells to allow expression of SARS CoV-
2 S antigen. The vaccine elicits both neutralizing antibodies & cellular
immune responses to the spike (S) antigen
• Clinical efficacy in 16 yrs and older: it is planned to follow up all
participants for 24 months
• Study enrolment excluded participants with history of anaphylaxis or
angioedema, severe CVS, GIT, Liver, Renal, Metabolic or Neurological
disease
• Two doses were administered 21 days apart
59. Pfizer mRNA Vaccine Efficacy against Covid-19
Population Covishield Vaccine Control Vaccine efficacy
% (CI)
N Number of Covid-19 cases N Number of covid-19 cases
Primary 2214 2222
Covid-19 cases 9 172 95
(90.3 97.6)
Participants
> 65 yrs
> 75 yrs
94.7%
66.7 99.9
63. Information for Healthcare Professional
Moderna
• Multidose vial, one vial contains 10 doses
• One dose (0.5 ml) contains 100 microgram of mRNA (embedded in lipid
nanoparticles) to persons 18 yrs or older
• Covid-19 mRNA vaccine is single stranded 5’capped messenger RNA
(mRNA) produced by using cell free in vitro transcription, encoding the pre-
fusion stabilized Spike (S) glycoprotein of SARS CoV-2.
• Phramaceutical form : Dispersion for injection
• White to off white frozen dispersion (pH 7 to 8).
• Vaccine Moderna is a two dose regimen. Each dose is 0.5 ml. second dose
should be administered after 28 days.
• No data on interchangeability
64. • Paediatrics : Not approved for children < 18 yrs
• Contraindications: hypersensitivity to active substance or excipients
• Anaphylaxis has been reported. Close observation for atleast 15 minutes after
vaccination is recommended.
• Donot give second dose to those who experienced severe allergic reaction.
• Anxiety related reaction including vasovagal reactions (syncope),
hyperventilation or stress related reactions may occur.
• Precautions must be in place to prevent injury from fainting.
• Efficacy, safety & immunogenicity have not been assessed in
immunocompromised individuals
• Should be administered with caution in persons with bleeding disorders such
as haemophilia or those on anticoagulant therapy.
Information for Healthcare Professional
Moderna
65. • Postpone in individuals with severe febrile illness
• Protection maynot occur until 14 days after second dose
• Duration of protection is unknown.
• Fertility, pregnancy, lactation
• Pregnancy: limited experience, no direct or indirect harmful effect
• Breast feeding : unknown if vaccine is excreted in human milk
• Fertility : no direct or indirect harmful effect
• Ability to drive & use machines
• No or negligible influence on ability to drive or use machines
Information for Healthcare Professional
Moderna
66. Summary of safety profile
Moderna
• all participants need to be followed up for 12 months
• Interim analysis one phase III trial in USA involving 30,351 individuals
18 years or older
• Mean age 52 yrs (range 18 – 95); 22,831 (75%) of participants were
18 to 64 yrs of age and 7520 (24.8%) were older than 65 yrs.
67. • Injection site pain > 92 %
• fatigue > 70 %
• Headache > 65 %
• Myalgia > 62 %
• Arthralgia > 46 %
• Chills > 46 %
• nausea / vomiting > 23 %
• Most were mild to moderate & resolved within a few days
• Adverse reactions were milder & reported less frequently in older adults (>65)
• Paracetamol took care of most
Summary of safety profile
Moderna
68. Adverse Drug Reactions
Moderna
MedDRA SOC Frequency Adverse Reactions
Blood & lymphatic system Very common Lymphadenopathy
Immune system disorders Not known Anaphylaxis
Not known hypersensitivity
Nervous system disorder Very common Headache
Gastrointestinal Very common Nausea / Vomiting
Skin & subcutaneous common rash
Musculoskeletal & connective tissue Very common Myalgia, arthralgia
General disorders & administration site
conditions
Very common Injection site pain, fatigue, pyrexia, chills
Common Injection site erythema
Injection site urticarial
Injection site rash
SOC System Organ Class
Very common (> 1/10); Common (>1/100 to <1/10); uncommon (><1/1000 to <1/100); rare (>1/10,000 to <1/1000)
69. Pharmacological Properties
Moderna
• Mechanism of action : Covid-19 Vaccine Moderna encodes for the pre-
fusion stabilized Spike protein of SARS CoV-2. After IM injection, cells at the
site take up lipid nanoparticles, effectively delivering the mRNA sequence
into cells for translation into protein. The mRNA delivery system is based
on the principle and observation that cells in vivo can take up mRNA,
translate it, and express viral protein antigen in the desired conformation.
The delivered mRNA doesnot enter the cellular nucleus or interact with the
genome, is nonreplicating and is expressed transiently. Both T cell & B cell
responses are elicited.
• Clinical efficacy: all participants need to be followed up for 12 months
• Subjects were 18 yrs and older. Pre specified cohorts either > 65 or with
comorbidity were included.
75. Shelf Life
Moderna
• 7 months at –25C to – 15 C
• After thawing
• Shouldnot be refrozen
• May be stored at 2 C to 8 C protected from light for up to 30 days
• Chemical & physical stability of unopened vial after removal from refrigerated
conditions is 12 hours at 8 C to 25 C
• Donot refreeze
• Punctured vial : chemical & physical in use stability is 6 hours at 2 to 25 C
76. Indicators Covishield Covaxin Pfizer Moderna
Type Chimpenzae Adenovirus
with spike DNA of SARS
CoV2
Killed whole cell mRNA of spike protein mRNA of spike protein
No. of doses 10; 5x 1010 viral
particles
20 ; 6 ug in Alum IMDG 5 ; 30 ug of mRNA 10; 100 ug mRNA
Shelf life 6 M 6 M 6 M 7 M
Storage
conditions
2 – 8 C 2 - 8 C --70 C -- 20 C
Physical
appearance
Clear White translucent Frozen White frozen dispersion
Route IM IM IM IM
Dose 0.5 ml 0.5 ml 0.3 ml 0.5 ml
Course 2 doses, 28 days apart 2 doses 28 days apart 2 doses 21 days apart 2 doses 28 days apart
Participants in
clinical trial
23,745
12021 atleast one dose
28,000 underway 44,000; 21720 atleast
one dose; 19,063 two
doses
30,351
Volunteers > 65 9.7% ?? ++ 7520 (24.8%)
Volunteers > 75 0 ?? + 630
Youngest
approved
> 18 > 18 > 12 > 18
77. Indicator Covishield Covaxin Pfizer Moderna
Side effects
Local
Systemic
60 % local tenderness
Headache
9.7 %
10.3 %
80 % local tenderness
A few anaphylaxis
92 % injection site
pain
Bells palsy
Immunogenicity
Anti Spike
PRNT
1st dose: 8386 AU/ml
2nd dose: 29,034 AU/ml
If 12 wks:
63,181 AU/ml
Seroconversion
81.1%
PRNT 98.3%
Th1 response
104 on day 28
103 in 65 to 85 yrs old
PRNT 103 on day 28
RBD ELISA 105 AU/ml
PRNT 1024 on day 42
Efficacy
Vaccinated
Control
70.42 %
30
101
No data in public
domain
95 %
9
172
94.1 %
11
185
Efficacy against
mutant strains
Wild
D614G (Doug)
N501Y (Nelly)
P681H (Pooh)
E484K (Eeek)
++
++
?
?
?
++
++
?
?
?
++
++
?
?
?
++
++
+
+
+
Suitability for India Yes Yes No No
78. Vaccines Near Approval
• 1. Sputnik V [ Viral vector using Human Adenovirus]
• 2. Johnson & Johnsons [single dose]
• 3. Novavax [effective against mutants]
82. Implications of the available evidence
These analyses show that higher vaccine efficacy is obtained with a longer interval
between the first and second dose, and that a single dose of vaccine is highly efficacious
in the first 90 days, providing further support for current policy
83.
84. 1. generated an isogenic Y501 SARS-CoV-2 on the genetic
background of the N501 clinical strain USA-WA1/2020,
2. Sera of 20 participants in the previously reported trial,1,2
drawn 2 or 4 weeks after immunization with two 30-μg
doses of BNT162b2 spaced three weeks apart, were
tested for neutralization of N501 and Y501 viruses by a
50% plaque reduction neutralization assay (PRNT50;
Figure 1).
3. The ratio of the 50% neutralization GMT of the sera
against the Y501 virus to that against the N501 virus was
1.46, indicating no reduction in neutralization activity
against the virus bearing the Y501 spike
Pfizer