Vaccines work by stimulating the immune system to protect against infectious diseases. There are several types of vaccines including live-attenuated, inactivated, toxoid, and subunit/recombinant vaccines. Clinical trials for new vaccines proceed in three phases - phase 1 evaluates safety in a small group, phase 2 assesses immunogenicity and safety in a larger group, and phase 3 is a pivotal large trial to demonstrate safety and efficacy for regulatory approval. Stringent regulations and guidelines from organizations like WHO govern all stages of vaccine development from preclinical research to post-licensure monitoring to ensure vaccines are safe, effective, and manufactured properly.
Vaccines are designed to elicit an immune response against the particular microbe or bits of the microbe from which the vaccine is made. This idea dates back several centuries, when British surgeon, Edward Jenner developed the first vaccine against a lethal infectious disease, small pox. Between the 18th century and now, more than 65 products have been approved which, together with public health and other developments, have contributed to the tapering and, in some cases, eradication of infectious diseases that used to kill millions. The problem is that the design is based on the physical attributes of the microbe. So, one person might be infected with virus x, which mutates rapidly to become 10 or more different strains. So, between approval and reaching the public, effectiveness may drop or wane over time. The sheer logistics of designing a trial means that follow-up periods are not long enough to account for every possible safety issue. Nevertheless, they remain our go-to defense for lethal infections, such as Ebola, and ones that reduce productivity. In other cases, timely inoculations may protect against the risk of developing specific cancers later in life. They have also contributed to the fact that most people are not at home sick with polio or some of the other ancient plagues.
However, anti-infective vaccines are typically given to healthy children and people on the basis that it will not make them sick or that it will reduce the risk of premature death. Because vaccines need to be preserved, properly stored and kept free of other contamination before it reaches many distribution sites, other ingredients are added to the mix. And some people, especially those with weakened immune systems, may have severe/life-threatening allergies to additives or a contaminated batch.
So, one in a million complications/deaths is one in a million too many. To this end, I have compiled a summary culled from various sources, to foster a positive dialogue towards improvements.
Vaccines are designed to elicit an immune response against the particular microbe or bits of the microbe from which the vaccine is made. This idea dates back several centuries, when British surgeon, Edward Jenner developed the first vaccine against a lethal infectious disease, small pox. Between the 18th century and now, more than 65 products have been approved which, together with public health and other developments, have contributed to the tapering and, in some cases, eradication of infectious diseases that used to kill millions. The problem is that the design is based on the physical attributes of the microbe. So, one person might be infected with virus x, which mutates rapidly to become 10 or more different strains. So, between approval and reaching the public, effectiveness may drop or wane over time. The sheer logistics of designing a trial means that follow-up periods are not long enough to account for every possible safety issue. Nevertheless, they remain our go-to defense for lethal infections, such as Ebola, and ones that reduce productivity. In other cases, timely inoculations may protect against the risk of developing specific cancers later in life. They have also contributed to the fact that most people are not at home sick with polio or some of the other ancient plagues.
However, anti-infective vaccines are typically given to healthy children and people on the basis that it will not make them sick or that it will reduce the risk of premature death. Because vaccines need to be preserved, properly stored and kept free of other contamination before it reaches many distribution sites, other ingredients are added to the mix. And some people, especially those with weakened immune systems, may have severe/life-threatening allergies to additives or a contaminated batch.
So, one in a million complications/deaths is one in a million too many. To this end, I have compiled a summary culled from various sources, to foster a positive dialogue towards improvements.
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease.Vaccine contains certain agents that not only resembles a disease-causing microorganism but it also stimulates body’s immune system recognize the foreign agents.Vaccines can be prophylactic or therapeutic.
The administration of vaccines is called vaccination.
British physician Edward Jenner, who in 1796 used the cowpox virus (Latin variola vaccinia) to confer protection against smallpox. In 1885 the French microbiologist Louis Pasteur and Emile Roux developed the first vaccine against rabies.
There are several types of vaccines like Whole-Organism vaccine, recombinant vaccine,dna vaccine, multivalent subunit vaccines etc.
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...
A vaccine is a biological agent that provides active acquired immunity to a particular disease. A vaccine usually contains an agent that resembles a disease-causing microorganism. Learn more about vaccine technology at https://www.creative-biolabs.com/vaccine/vaccine-technology.htm
Prevention is better than any cure. Smallpox has been eradicated. Polio is largely controlled. Hepatitis A&B now largely preventable. Measles and rubella are targeted for elimination.
What is a vaccine? How are they developed and implemented? What is the public health effectiveness? What vaccines are in use? Learn the answers to these questions and so much more in this free report: Vaccine Fact Book 2013.
Most developments in biotechnology originated for their potential applications in health care.
Contributions of biotechnology are more frequent, more notable and more rewarding in health sector.
A brief presentation on fish vaccination and its application particularly in Bangladesh. The overall process is described in a nutshell here. The types, procedure of formation, regulation, licensing and use are among them.
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease.Vaccine contains certain agents that not only resembles a disease-causing microorganism but it also stimulates body’s immune system recognize the foreign agents.Vaccines can be prophylactic or therapeutic.
The administration of vaccines is called vaccination.
British physician Edward Jenner, who in 1796 used the cowpox virus (Latin variola vaccinia) to confer protection against smallpox. In 1885 the French microbiologist Louis Pasteur and Emile Roux developed the first vaccine against rabies.
There are several types of vaccines like Whole-Organism vaccine, recombinant vaccine,dna vaccine, multivalent subunit vaccines etc.
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...
A vaccine is a biological agent that provides active acquired immunity to a particular disease. A vaccine usually contains an agent that resembles a disease-causing microorganism. Learn more about vaccine technology at https://www.creative-biolabs.com/vaccine/vaccine-technology.htm
Prevention is better than any cure. Smallpox has been eradicated. Polio is largely controlled. Hepatitis A&B now largely preventable. Measles and rubella are targeted for elimination.
What is a vaccine? How are they developed and implemented? What is the public health effectiveness? What vaccines are in use? Learn the answers to these questions and so much more in this free report: Vaccine Fact Book 2013.
Most developments in biotechnology originated for their potential applications in health care.
Contributions of biotechnology are more frequent, more notable and more rewarding in health sector.
A brief presentation on fish vaccination and its application particularly in Bangladesh. The overall process is described in a nutshell here. The types, procedure of formation, regulation, licensing and use are among them.
Immunization, or immunisation, is the process by which an individual's immune system becomes fortified against an infectious agent (known as the immunogen).
This slideshow was created by April Finnen of Dynport Vaccine Company LLC of Frederick, Maryland and was shared with me for the purposes of my column on Examiner.com.
vaccine is a biological preparation that provides active acquired immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future.
HISTORY OF VACCINES-
EDWARD JENNER conduct experiments in 1796 that lead to the creation of the first smallpox vaccine for prevention of smallpox.
A vaccine for RABIES is developed by LOUIS PASTEUR .
Vaccine for COLERA and TYPHOID were developed in 1896 and PLAGE vaccine in 1887.
The first DIPHTHERIA vaccine is developed in about 1913 by EMIL ADOLPH BEHRING,WILLIAM HALLOCK PARK.
The whole cell PERTUSIS vaccines are developed in 1914.
A TETANUS vaccine is developed in 1927.
Toxoid vaccines are vaccines that are made from the toxins (harmful chemicals) from bacteria. There are some bacteria that cause disease through releasing a protein called a toxin. Scientists can inactivate these toxins in the lab using a chemical called formalin (a solution of formaldehyde) and sterilized water, which are completely safe to use in small quantities in the human body. Once the toxin is inactivated, it’s called a toxoid, and it can no longer cause harm. The body learns how to fight off the bacteria’s natural toxin once exposed to the toxoid through producing antibodies that bind into the toxin like keys into a lock
Similar to Vaccines and their clinical phase(1,2,3) (20)
- 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
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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.
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Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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!
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.
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
1. Types of Vaccines and their Clinical Trials (Phase 1,2,3)
Introduction
Itis suspension of weakened, killed, or fragmented microorganisms or toxins
or of antibodies or lymphocytes that primarily used to preventdisease.
Vaccine can provideactive immunity against a harmfulagent by stimulating
the immune systemto fight against the infectious agents.
IMMUNIZATION
Itis the process by which a person is made immune or resistant to an
infectious disease, typically by administrating a vaccine. Vaccine stimulates the
body own immune systemto protect the person against subsequentinfection
or disease.
HISTORYOF VACCINES
The first vaccinewas introduced by Edward Jenner in 1796, used cowpoxvirus
to protection against smallpox virus, which is a related virus in humans.
In 1881 Louis Pasteur demonstrated immunization against anthraxby
injecting sheep with a preparation containing attenuated forms of the bacillus
that causes the disease. Four years later he developed a protective suspension
against rabies.
After Pasteur’s time, a widespread and intensive search for new vaccines was
conducted, and vaccines against both bacteria and viruses wereproduced, as
well as vaccines against venoms and other toxins. Through vaccination,
smallpox was eradicated worldwideby 1980, and polio cases declined by 99
percent.
TYPES OF VACCINES
1. Live-attenuated vaccines
Live vaccines use a weakened (or attenuated) form of the germ that causes a
disease.
Because these vaccines are so similar to the natural infection that they help
prevent, they create a strong and long-lasting immune response. Just1 or 2
2. doses of mostlive vaccines can give you a lifetime of protection against a germ
and the disease it causes.
LIMITATION
Because they contain a small amount of the weakened live virus, somepeople
should talk to their health careprovider before receiving them, such as people
with weakened immune systems, long-term health problems, or people who
had an organ transplant.
They need to be kept cool, so they don’t travel well. That means they cannot
be used in countries with limited access to refrigerators.
These used against the Smallpox, Chickenpox.
2. Inactivated vaccines
Inactivated vaccines use the killed version of the germ that causes a disease.
Inactivated vaccines usually don’t provideimmunity that is as strong as live
vaccines. So you may need several doses over time in order to get ongoing
immunity against diseases.
These used against the Hepatitis A, Polio, Rabies.
3. Toxoid Vaccines
Toxoid vaccines use a toxin made by the germ that causes a disease. They
create immunity to the parts of the germ that causea diseaseinstead of the
germ itself. That means the immune responseis targeted to the toxin instead
of the whole germ.
Like some other types of vaccines, you may need booster shots to get ongoing
protection against diseases.
These used against the Tetanus.
4. Subunit, recombinant, polysaccharide, and conjugatevaccines
Subunit, recombinant, polysaccharide, and conjugatevaccines usespecific
pieces of the germ like its protein, sugar, or capsid.
Because these vaccines use only specific pieces of the germ, they give a very
strong immune responsethat is targeted to key parts of the germ. They can
also be used on almost everyonewho needs them, including people with
weakened immune systems and long-term health problems
3. LIMITATION
These vaccines may need booster shots to get ongoing protection against
diseases.
These used against the Hepatitis B,
Futureof Vaccines
1. DNA Vaccines
2. Recombinant Vector Vaccines
These vaccines are experimental Vaccines Still in experiment stages and
severaltypes are being tested in humans like Influenza vaccines (DNA Vaccine)
and DPT(Recombinant vaccine).
CLINICAL TRAILS
The World Health Organization has made certain guideline and requirements
that has to be full filled in evaluation of vaccines that is good manufacturing
practice for pharmaceutical preparations, good manufacturing practice for
biological products, regulation and licensing of biological products in countries
with newly developing regulatory authorities and guidelines for national
authorities on quality assurancefor biological products.
REGULATIONOF VACCINES
Itis divided into three stages
1 Development Stage (it consists of two parts, preclinical research and
development, and clinical research and development.)
2. Licensure
3. Post licensure
4. Preclinical Research
Preclinical research and development are carried out in the laboratory using in-
vitro techniques or, when necessary, in-vivo techniques in animals. The data
frompreclinical and laboratory research includedetails of the development
and production of a vaccine together with reports of control testing, which
should be adequate to justify subsequentclinical studies in humans.
Phases of Clinical Trials
Clinical trials in humans are classified into three phases: phase1, phase 2 and
phase3.
This is in addition to ethical clearance which is required for clinical trials in all
countries. All studies of human subjects requireproper ethical review.
PHASE1
In Phase1 clinical studies carry out initial testing of a vaccine in small numbers
(e.g. 20) of healthy adults, to test the properties of a vaccine, its tolerability,
and, if appropriate, clinical laboratory and pharmacologicalparameters. Phase
1 studies are primarily concerned with safety.
PHASE2
In Phase2 studies involve larger numbers of subjects and are intended to
providepreliminary information about a vaccine’s ability to produceits desired
effect (usually immunogenicity) in the target population and its general safety.
To fully assess theprotective efficacy and safety of a vaccine,
PHASE3
In phase3 clinical trial is the pivotal study on which the decision on whether to
grant the licence is based and sufficient data haveto be obtained to
demonstratethat a new productis safeand effective for the purposeintended.
By the beginning of the phase3 stage of development, a vaccineshould have
been fully characterized and the final manufacturing process, specifications
and batch release testing procedures should havebeen established. An
application for marketauthorization may be submitted to a national regulatory
authority on the basis of the data from phase 3 testing and if approved, the
vaccine then becomes commercially available in that particular country.
5. If a productcontains or consists of genetically modified organisms an
environmental risk assessmentshould also be undertaken and approved by the
appropriateagency.
The structureof the clinical development programmemustbe tailored to the
type of vaccine and the antigenic content. For example, the clinical evaluation
of a vaccine that contains only novel antigen(s) may of necessity be very
different fromthat of a vaccinethat contains one or more previously evaluated
antigens. Such factors also influence whether clinical protection trials will be
required, whether or not they arefeasible, or whether an approvalmay
reasonably be based on immunogenicity data. In all instances, it is the
obligation of the applicant to justify the content and structureof the clinical
development programme. Pre-submission meetings with regulatory authorities
may assistin ensuring that the content of the final data package is likely to be
acceptable.
Reference
World Health Organization
Submitted by
Vivek Singh