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Why So Many Vaccines in Development
1.
2.
3. Why are there so many vaccines in development?
Typically, many vaccine candidates will be evaluated before any are found to be both safe and effective.
For example, of all the vaccines that are studied in the lab and laboratory animals, roughly 7 out of every
100 will be considered good enough to move into clinical trials in humans.
Of the vaccines that do make it to clinical trials, just one in five is successful.
Having lots of different vaccines in development increases the chances that there will be one or more
successful vaccines that will be shown to be safe and effective for the intended prioritized populations.
4. Why do we need a vaccine?
The vast majority of
people are still
vulnerable to
coronavirus.
It's only the current
restrictions that are
preventing more
people from dying.
Vaccines teach our bodies
to fight the infection by
stopping us from catching
coronavirus, or at least
making Covid less deadly.
Having a vaccine,
alongside better
treatments, is "the"
exit strategy.
5. Who will get the vaccine first?
This depends on where
Covid is spreading when
the vaccine becomes
available and in which
groups each is most
effective.
Older care home
residents, HCW, and
the over-80s. top the
priority list
Age is, by far,
Covid's biggest risk
factor.
1
2 3
10. Each country has their own
national regulatory authorities
(NRA) responsible for approving
for new drugs in their country.
There are several NRAs that
are particularly relevant,
among them the US-American
FDA and the European EMA.
We signify a COVID-19
vaccine as approved if
one of these bodies
approves a vaccine.
Approval
11. To be displayed as
approved a vaccine
needs to be either
approved by:
The European Medicines Agency Cleared for emergency use by
12. Vaccine Candidate Approved by on notes
BioNTech-Pfizer FDA 2020-12-12 for emergency use
Moderna FDA 2020-12-19 for emergency use
13. Given the urgent need,
some vaccine developers
have compressed the
clinical process for SARS-
CoV-2 by running trial
phases simultaneously.
14. Assignment of clinical
phases
There are five phases of
clinical trials: Phase I,
Phase I/II, Phase II,
Phase II/III, Phase III.
If a vaccine is in a dual
phase like Phase I/II or
in Phase II/III it is tested
there simultaneously,
but for analysis assigned
to the higher phase:
a vaccine candidate
in Phase I/II is assigned
to Phase II, whereas a
vaccine candidate tested
in Phase II/III it is
assigned to Phase III.
Beyond these dual phases, vaccine
candidates can be in different clinical trial
phases at the same time (e.g. Phase
I and Phase III) with different trial
parameters (age, pre-existing
conditions). If that is the case for a
candidate, it is shown in both phases.
15.
16. Normal duration for vaccines production 10 -15 years.
Least duration for mumps vaccines was 4 years.
For covid -19 vaccines nearly less than 1 year.
WHY WE ARE AFRAID?
17.
18.
19.
20.
21.
22. • A live-attenuated vaccine uses a living but weakened version of
the virus or one that’s very similar.
• The measles, mumps and rubella (MMR) vaccine and the
chickenpox and shingles vaccine are examples of this type of
vaccine.
• This approach uses similar technology to the inactivated
vaccine and can be manufactured at scale.
• However, vaccines like this may not be suitable for people with
compromised immune systems.
Live-attenuated
vaccine
23.
24.
25. All about COVAXIN (Bharat Biotech’s Covid-19 vaccine)
COVAXINTM is developed in tie-up with the Indian Council of Medical Research
(ICMR), National Institute of Virology (NIV).
Bharat Biotech’s Covid-19 vaccine has been cleared in the clinical trial mode, which
means the consent of participants has to be taken.
The indigenous, inactivated vaccine is developed and manufactured in Bharat
Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.
India authorized vaccines for emergency use on Jan. 3, despite a lack of published
Phase 3 data showing the vaccine is safe and effective.
COVAXIN
26. Prompting an Immune Response
Because the coronaviruses in Covaxin are dead, they can be injected into the arm
without causing Covid-19.
Once inside the body, some of the inactivated viruses are swallowed up by a type of
immune cell called an antigen-presenting cell.
The antigen-presenting cell tears the coronavirus apart and displays some of its
fragments on its surface.
A so-called helper T cell may detect the fragment. If the fragment fits into one of its
surface proteins, the T cell becomes activated and can help recruit other immune
cells to respond to the vaccine.
27.
28. Viral vector vaccine
This type of vaccine uses a safe virus to deliver specific sub-
parts – called proteins – of the germ of interest so that it can
trigger an immune response without causing disease.
To do this, the instructions for making particular parts of the
pathogen of interest are inserted into a safe virus.
The safe virus then serves as a platform or vector to deliver
the protein into the body.
The protein triggers the immune response. The Ebola vaccine
is a viral vector vaccine and this type can be developed
rapidly.
29. Oxford researchers developed the vaccine by genetically engineering an adenovirus
that normally infects chimpanzees.
Unlike the Pfizer-BioNTech and Moderna vaccines, which are RNA based, the Oxford
vaccine uses double-stranded DNA.
The Oxford-AstraZeneca vaccine is more rugged than those developed by Pfizer and
Moderna. That’s because DNA is not as fragile as RNA, and the adenovirus’s tough
protein coat helps protect the genetic material inside.
30.
31.
32.
33. Covishield
Covishield is a highly effective vaccine against novel coronavirus.
India has approved Covishield by the Serum Institute of India.
Covishield vaccine doses will be given 4-6 weeks apart, Bharat Biotech’s Covaxin
should be taken three weeks apart.
Participants’ enrollment and vaccination of Phase II/III Human Clinical Trial has also
been completed.
STORAGE: Stable in refrigerator for at least 6 months
34.
35. A nucleic acid vaccine delivers a specific set of instructions to our cells, either as DNA or
mRNA, for them to make the specific protein that we want our immune system to recognize
and respond to.
The nucleic acid approach is a new way of developing vaccines.
Before the COVID-19 pandemic, none had yet been through the full approvals process for use
in humans, though some DNA vaccines, including for particular cancers, were undergoing
human trials.
Because of the pandemic, research in this area has progressed very fast and some mRNA
vaccines for COVID-19 are getting emergency use authorization, which means they can now be
given to people beyond using them only in clinical trials.
DNA is first turned into messenger RNA, which is then used as the blueprint to make specific
proteins.
36.
37.
38.
39. All about Pfizer/BioNtech vaccine
UK became the first country to approve the Pfizer/BioNTech coronavirus vaccine on 2
December.
The vaccine is said to be 95% effective.
Pfizer will be given in two doses, three weeks apart.
Pfizer must be stored at a temperature of around -70C.
The vaccine will be transported packed in dry ice.
Once the vaccine is delivered, it can be stored for up to five days in a fridge between
2C and 8C.
Who is allowed who’s not?
Anyone with a history of anaphylaxis to a vaccine, medicine or food should not get
the Pfizer vaccine.
40. Vaccine: Pfizer-BioNTech COVID-19 Vaccine
Diluent: 0.9% sodium chloride (normal saline, preservative-free)
Vaccine MUST be mixed with diluent before administration.
Multidose vial: Up to 6 doses per vial
Dosage: 0.3 mL
Age Indications:
16 years of age and older
Schedule:
2-dose series separated by 21 days)
A series started with COVID-19 vaccine (Pfizer) should be completed with this product.
Administer:
Intramuscular (IM) injection in the deltoid muscle
41.
42. General Information:
Multidose vial: 10 doses per vial
Dosage: 0.5 mL
Do NOT mix with a diluent.
Discard vial when there is not enough vaccine to obtain a
complete dose.
Do NOT combine residual vaccine from multiple vials to obtain a
dose.
Age Indications:
18 years of age and older
Schedule:
2-dose series separated by 28 days
A series started with COVID-19 vaccine (Moderna) should be
completed with this product.
Administer:
Intramuscular (IM) injection in the deltoid muscle.
43. Modena's Covid-19 vaccine candidate is the most advanced and uses synthetic
Ribonucleic acid that uses genetic code from the coronavirus to produce human cells
to generate spike protein found on the outside of the virus.
Moderna is said to be 94.5% effective.
The vaccine will be given in two doses, four weeks apart.
It is easy to store Moderna because it stays stable at -20C for up to six months.
Expecting the medicine to be ready for use and available, many airlines and logistics
firms have already started working on the transfer of coronavirus vaccine as it
requires special conditions.
44.
45. A subunit vaccine is one that only uses the very specific parts (the
subunits) of a virus or bacterium that the immune system needs to
recognize.
It doesn't contain the whole microbe or use a safe virus as a vector.
The subunits may be proteins or sugars.
Most of the vaccines on the childhood schedule are subunit vaccines,
protecting people from diseases such as whooping cough, tetanus,
diphtheria and meningococcal meningitis.
46.
47. The strongest immune
responses, come from
vaccines that contain a live
version of what they’re trying
to protect against.
Because there’s so much we
don’t know about SARS-CoV-
2, putting a live version of the
virus into a vaccine can be
risky.
Safer methods – such as
getting the body to make just
the virus’s spike proteins, or
delivering a dead version of
the virus – will lead to a
weaker response that fades
over time.
But boosters can top this up.
1 2
3 4
49. Key overall IPC principles for COVID-19 vaccine
deployment
Standard precautions to be applied during any vaccination activity are also valid for COVID-19
vaccine delivery, considering that the population to be vaccinated consists of individuals not
presenting signs and symptoms of infection.
However, additional IPC precautions are necessary in the context of the COVID-19 pandemic to
reduce the risk of SARS-CoV-2 transmission (e.g. mask use).
It is critical to provide health workers with specific training of Infection prevention and control (IPC)
principles and procedures for COVID-19 vaccination activities .
50. Staff Appoint a facility IPC focal point for the planning, deployment and monitoring of the vaccination
activities.
Identify an adequate number of vaccinators to ensure there is sufficient staff and time to support correct
implementation of the IPC practices required to safely administer the vaccine.
Identify trained staff to deliver IPC training to those involved in vaccination activities (including
managers, logisticians, vaccinators, cleaners and health workers dedicated to screening) and to provide
information for clients to be vaccinated.
Identify health workers for the supervision of vaccination activities and define a monitoring and
evaluation process of IPC practices, including providing feedback to vaccinators and other staff as
required.
Key overall IPC principles for COVID-19 vaccine
deployment
51. Guidance Develop local IPC guidance and standard operating procedures for COVID-19 vaccination,
outlining the following:
• screening policies for COVID-19 signs and symptoms of staff and individuals arriving for vaccination
with clear exclusion criteria;
• key IPC measures to be taken by anyone in the vaccination area or clinic
• key IPC measures for safely administering COVID-19 vaccines;
• cleaning and disinfection of the environment;
• appropriate waste management also considering the increase of waste associated with COVID-19
vaccination activities, including environmentally friendly treatment methodologies and solutions to
minimize both general and medical waste at point of use, segregation, disposal and collection;
Key overall IPC principles for COVID-19 vaccine
deployment
52. visual reminders emphasizing:
Hand hygiene.
Safe injection practices.
Safe use of medical masks.
Respiratory hygiene.
And other IPC measures.
training materials for relevant staff and educational and informational
materials for the public.
Key overall IPC principles for COVID-19 vaccine
deployment
53. Assess the layout of the building or area identified for vaccination delivery and
ensure that the following features are in place to support appropriate IPC
implementation:
Clearly marked one-way foot traffic flow with clear entry and exit areas
through the vaccination clinic; these should be separated when the vaccination
area or clinic is located in a health care facility.
Adequate screening area (ideally, private spaces) at the entry where people
are assessed, including questioning for signs and symptoms of COVID-19 and
other criteria for inclusion.
54. Sufficient space to allow at least 1 meter physical distance between
all individuals including between health workers at all stations (at the
entrance, at the screening stages, while waiting to be vaccinated and
during the observation period post vaccination) and between staff.
Adequate ventilation (mechanical, natural or hybrid) of all areas,
including the screening, waiting, post-vaccination observation, and
vaccination areas; if a mechanical ventilation system is operating in
these areas, the ventilation rate should be 6 air changes per hour or
according to national or local requirements.
55. *Medically equipped post-vaccination observation area for dealing with possible vaccine adverse
reactions.
*Adequate number of hand hygiene stations in strategic areas to support appropriate hand
hygiene for the public and staff (i.e., at the entrance and exit areas, in the waiting areas, and in
each vaccination station).
*Signage/posters to include reminders about:
1-Reporting COVID-19 signs and symptoms.
2-Mask wearing.
3-Hand and respiratory hygiene.…
4-Physical distancing (e.g. floor markings, seating arrangements, tape, ropes, and cones.
56. Adequate space for vaccine storage and preparation (e.g. clean and hygienic
environment, adequate ventilation and equipment to adhere to specific
COVID-19 vaccine cold chain requirements.
Vaccination stations a least 1 meter apart (ideally with installation of physical
barriers between vaccination stations).
Adequate cleanability of screening areas, vaccination stations, waiting areas
(e.g. removal of items that cannot be readily decontaminated and minimizing
clutter to aid effective cleaning).
Appropriate waste management system including safe disposal of waste (such
as vials and masks) and sharps at each vaccination station.
57. Ensure continuous and sufficient availability of the following:
1- Adequate supplies of medical masks for health workers and for individuals to be
vaccinated who may not have a mask.
2- Sufficient supplies of other personal protective equipment (PPE), including eye
protection, gloves and gowns, in case it is required for health workers’ protection when
dealing with vaccine adverse events, to prevent exposure of non-intact skin to blood or
body fluids or if a suspected case of COVID-19 is identified during the screening process.
3- Other supplies: …
soap, clean water, and tissue.
58. IPC
Alcohol-based hand rub products.
Thermo-scans for temperature screening.…
Tissues.
Waste bins/waste bags.
Safety boxes, preferably puncture- and leak-proof.
Cleaning and disinfection equipment and products.
Visual reminders and signage/floor markers; …
physical barriers to aid spatial
separation.
Identify suitable areas for supply storage.
59. Operational phase
Use a daily checklist to monitor and ensure that the IPC and other safety measures are adhered to:
Screen all staff for signs and symptoms of COVID-19 at the start of the shift.
Screen all individuals arriving for vaccination for COVID-19 signs and symptoms.
Implement a robust scheduling process for vaccination appointments to avoid overcrowding and
facilitate physical distancing and adherence to IPC practices.
Limit the number of people accompanying individuals coming for vaccination to one person and only for
those needing assistance.
Ensure infrastructure described above is always is in place to support adequate implementation of IPC
measures.
Consider organizing a regular staff safety huddle (a short multidisciplinary briefing) to enhance
teamwork (including daily check-in, discussing monitoring data, agreeing actions and improving
situational awareness of safety concerns).
60. Key IPC measures to be implemented
Hand hygiene
All staff should wash their
hands with soap and
water on arrival at the
start of the shift and when
leaving.
Clients to be vaccinated
should be encouraged to
perform hand hygiene on
arrival and when leaving.
Functioning hand hygiene
stations should be
available at the entrance
and exit areas and at each
vaccination station.
61. Operational phase
Vaccinators should always perform hand hygiene :
Before putting on and removing PPE (e.g. mask).
Before preparing the vaccine and between each vaccine administration preferably
using alcohol-based hand rubs, which have advantages for logistics, efficacy and
tolerability.
Gloves are not required and, if used, do not replace the need for performing hand
hygiene between each vaccine administration and for other indications.
Applying alcohol-based hand rubs on gloved hands is strongly discouraged.
If gloves are used, they should be removed, hand hygiene performed and a new
pair of gloves donned between vaccines.
63. PPE
Select PPE (e.g. mask, eye protection, gloves, gowns) based on risk
assessment as part of standard precautions.
In the context of the COVID-19 pandemic, staff administering the vaccine
should wear a medical mask, and the individual being vaccinated should wear
a medical or a non-medical/fabric mask .
For screening activities and vaccine administration, PPE additional to mask use
is not indicated, since there is no splash or body fluid exposure risk during an
intramuscular injection.
Gloves are not indicated for intramuscular or intradermic injections.
Single-use gloves are indicated if there is any skin breakdown.
64. Injection safety
Injection safety Procure and use prequalified (or equivalent) safety-engineered injection devices (auto
disabled syringes, ideally with a sharps injury protection feature) if possible.
If these are not available, sterile single-use syringes and needles should be used.
Perform hand hygiene before preparing injection material.
Prevent contamination of the vials by wiping the access diaphragm (septum) with 70% alcohol (isopropyl
alcohol or ethanol) on a swab or cotton wool ball before piercing the vial and allow to air dry.
Pierce the septum with a sterile needle every time it is used.
If multidose vials are used, ensure measures to avoid contamination are consistently implemented.
A sterile needle should be used every time the septum of a multi dose vial is pierced.
Never leave a needle in the stopper of the vial.
Label the multidose vial with the date it was first used and discard at the required time .
Discard the multidose vial immediately if sterility is questioned or compromised or if it is not properly
labeled with the original entry date.
65. Injection safety
Follow any additional injection safety practices and specific instructions
provided by the manufacturer in the vaccine product information for
preserving, reconstituting and administering the vaccine.
For skin preparation at the site of injection, clean visibly dirty skin with water,
and if recommended by national or local policies, disinfect with a 60–70%
alcohol-based solution.
Ensure the alcohol is dry on the skin prior to injecting the vaccine.
66. Environmental cleaning and disinfection and waste
management
Prepare each injection in a clean, designated area.
Perform regular environmental cleaning and disinfection of the areas and site
where the vaccination is administered at least twice daily, with special
attention to high-touch surfaces, using procedures recommended in the
context of COVID-19.
Discard used syringes as a single unit into a sharps container immediately. To
minimize
67. Environmental cleaning and disinfection and
waste management
Sharps waste at the point of use, use needle or hub cutter tools.
Collect used syringes and needles at the point of use in an enclosed sharps
container that is puncture and leak-proof, and seal once ¾ full.
Seal full sharps containers and store in a secure area in preparation for
transport and final disposal.
After closing and sealing sharps containers, secure and dispose of as soon as
possible.
Do not open, empty, re-use, or sell.
Manage sharps waste in an efficient, safe and environmentally friendly way.
70. Tying together negative messaging
to pop culture can be especially
memorable and drive people to
share because the meme is funny, or
sticky (memorable)."
71.
72.
73.
74.
75.
76.
77.
78. Without a vaccine, there
will be many more
infections and therefore
deaths before enough
people are immune to stop
the spread( This is known
as herd immunity ).
For every person who dies,
there are others who live
through it but undergo
intensive medical care, and
those who suffer long
lasting disease effect.
Trusted Messengers, Trusted Messages': How To
Overcome Vaccine Hesitancy
79. This can contribute to a health
service overburdened with
Covid patients, competing with
a hospital's limited resources
to treat patients with other
illnesses and injuries.
The worst part of the pandemic,
the reason for lockdown, is
because the health service would
be overwhelmed. Vulnerable
groups like the old and sick in
care homes have a much higher
chance of getting severely ill if
they catch the virus".