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COVID-19 Vaccination &
Prevention strategies
Dr. Shinjan Patra
Introduction
ā€¢ COVID-19 has been the cause of distress &
ailment all throughout the globe for last 18
months
ā€¢ Clinical manifestations progressed from
pneumonia to ARDS
Complications
ā€¢ Typically associated with the phenomenon of
Cytokine storm
ā€¢ Lung injury leads to reduced surfactant &
reduced gas exchange in the alveoli
ā€¢ Leads to massive vascular inflammation,
shock, hypotension, disseminated
intravascular coagulation & multi-organ
dysfunction
ā€¢ Vaccination holds the key to tackle his
epidemic
Outline
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending
authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
Early days
ā€¢ Vaccine for an infectious disease never been produced in
less than several years
ā€¢ No vaccine existed for preventing a corona virus infection in
humans
ā€¢ Established body of knowledge about the structure and
function of corona-viruses causing diseases like SARS CoV-1
& MERS
ā€¢ Enabled accelerated development of various vaccine
technologies during early 2020
ā€¢ On 10 January 2020, the SARS-CoV-2 genetic sequence data
shared
ā€¢ By 19 March, the global pharmaceutical industry
announced a major commitment to address COVID-19
Initiation
ā€¢ Since January 2020, vaccine development
expedited via unprecedented collaboration in
the multinational pharmaceutical industry and
between governments
Basic steps
ā€¢ Safety
ā€¢ Targeting vulnerable populations
ā€¢ Need for vaccine efficacy breakthroughs
ā€¢ Duration of vaccination protection
ā€¢ Special delivery systems (such as oral or nasal,
rather than by injection)
ā€¢ Dose regimen
ā€¢ Stability and storage characteristics
ā€¢ Dissemination of the licensed vaccine
Challenges
ā€¢ Urgency compressed schedules that shortened
the standard vaccine development timeline
ā€¢ Compromising safety assurance
ā€¢ Research at universities obstructed by physical
distancing and closing
ā€¢ Virus proved to be a "moving target" of changing
transmission rates across and within countries
ā€¢ Compete for trial participants
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
Authorization
ā€¢ 17 vaccines authorized by at least one
national regulatory authority for public use
RNA vaccines Pfizerā€“BioNTech Viral Vector Vaccines Oxford-AstraZeneca
Moderna Sputnik Light
CVnCoV Sputnik V
Inactivated vaccines BBIBP-CorV Johnson & Johnson
CoronaVac Convidecia
Covaxin Protein subunit
vaccine
EpiVacCorona
WIBP-CorV RBDDimer
CoviVac
Minhai-Kangtai
QazVac
Others in pipeline
ā€¢ 308 vaccine candidates are in various stages of
development
ā€¢ With 73 in clinical research
ļƒ˜24 in Phase I trials
ļƒ˜33 in Phase Iā€“II trials
ļƒ˜16 in Phase III development
First approval
ā€¢ On 2/12/20 UKā€™s Medicines and Healthcare
products Regulatory Agency (MHRA) gave
temporary regulatory approval for the Pfizerā€“
BioNTech vaccine
ā€¢ On 1/01/21, (DCGI) approved emergency use
of the Oxfordā€“AstraZeneca vaccine
(Covishield) in India
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending
authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
Platform & target
ā€¢ Most of the platforms of vaccine candidates in
clinical trials focused on the spike protein and its
variants as the primary antigen
ā€¢ Platform Being developed in 2020 involved
nucleic acid technologies (nucleoside-modified
messenger RNA and DNA), non-replicating viral
vectors, peptides, recombinant proteins, live
attenuated viruses and inactivated viruses
Next generation strategies
ā€¢ Precise targeting of COVID-19 infection
mechanisms
ā€¢ Use a 2P mutation to lock the spike protein
into its prefusion configuration, stimulating an
immune response to the virus before it
attaches to a human cell
RNA vaccine
ā€¢ When introduced into a tissue, acts as mRNA
to cause the cells to build the foreign protein
and stimulate an adaptive immune response
ā€¢ Delivery of mRNA is achieved by a co-
formulation of the molecule into lipid nano-
particles which protect the RNA strands and
help their absorption into the cells
Approval status
ā€¢ First to be approved in US, UK, EU
ā€¢ In January 2021, Pfizerā€“BioNTech and the
Moderna got approval
ā€¢ In February 2021, the CVnCoV RNA vaccine
from CureVac got authorization in EU
ā€¢ Allergic reactions rare
Inactivated virus vaccines
ā€¢ Consist of virus particles that have been
grown in culture and then are killed using a
method such as heat or formaldehyde to lose
disease producing capacity, while still
stimulating an immune response
Adenovirus vector vaccines
ā€¢ Non-replicating viral vector vaccines, using an
adenovirus shell containing DNA that encodes
a SARS-CoV-2 protein
ā€¢ Convidecia and the Johnson & Johnson
COVID-19 vaccine are both one-shot vaccines
which offer less complicated logistics and can
be stored under ordinary refrigeration for
several months
Subunit vaccines
ā€¢ Present one or more antigens without
introducing whole pathogen particles
ā€¢ Antigens involved are often protein subunits,
but can be any molecule that is a fragment of
the pathogen
Other types
ā€¢ In clinical trials include
ļƒ˜Virus-like particle vaccines
ļƒ˜Multiple DNA plasmid vaccines
ļƒ˜Lentivirus vector vaccines
ļƒ˜Conjugate vaccine
ļƒ˜Vesicular stomatitis virus displaying the
SARS-CoV-2 spike protein
Formulation
ā€¢ To enhance immunogenicity
ā€¢ Particularly effective for technologies using
the inactivated virus and recombinant protein-
based or vector-based vaccines
ā€¢ Aluminum salts, the first adjuvant used for
licensed vaccines, the adjuvant of choice in
some 80% vaccines
Outline
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
Efficacy
ā€¢ Not straightforward to compare the efficacies
of the different vaccines because the trials
were run with different populations,
geographies and variants of the virus
Lineage B.1.1.7 (alpha)
ā€¢ Identified in Decā€™20 in UK
ā€¢ Results suggest protection from the Pfizer-
BioNTech and Moderna vaccines
ā€¢ Oxfordā€“AstraZeneca had an efficacy of 42ā€“89%
versus 71ā€“91% against non-B.1.1.7 variants
Wang P, Nair MS, Liu L, Iketani S, Luo Y, Guo Y, et al. (March 2021). "Antibody Resistance of SARS-CoV-2 Variants B.1.351 and B.1.1.7". Nature. 593 (7857):
130ā€“35
Emary KR, Golubchik T, Aley PK, Ariani CV, Angus BJ, Bibi S, et al. (2021). "Efficacy of ChAdOx1 nCoV-19 (AZD1222) Vaccine Against SARS-CoV-2 VOC
202012/01 (B.1.1.7)
Lineage B.1.351 (Beta)
ā€¢ First detected in Decā€™20 in South Africa
ā€¢ Decreased neutralizing activity of Moderna and
Pfizer-BioNTech vaccines
ā€¢ On 1 April 2021, an update on a Pfizer/BioNTech
stated that the vaccine 100% effective
ā€¢ Johnson & Johnson, reported the level of
protection 72% in the United States and 57% in
South Africa
ā€¢ Reduced efficacy of the Oxfordā€“AstraZeneca
Hoffmann M, Arora P, Gross R, Seidel A, Hoernich BF, Hahn AS, et al. (March 2021). "1 SARS-CoV-2 variants B.1.351 and
P.1 escape from neutralizing antibodies". Cell. 184 (9): 2384ā€“2393.e12
Lineage P.1 (Gamma)
ā€¢ Initially identified in Brazil
ā€¢ Seems to partially escape vaccination with the
Pfizer- BioNTech
Hoffmann M, Arora P, Gross R, Seidel A, Hoernich BF, Hahn AS, et al. (March 2021). "1 SARS-CoV-2 variants B.1.351 and P.1 escape from
neutralizing antibodies". Cell. 184 (9): 2384ā€“2393.e12
Lineage B.1.617 (Kappa & Delta)
ā€¢ First discovered in India
ā€¢ Mostly detected after Janā€™21
ā€¢ Spike mutations D111D, G142D,P681R, E484Q
and L452R,the latter two of which may cause it to
easily avoid antibodies
ā€¢ Neutralized by Covaxin
ā€¢ Covishield 60% effective
Principles of epidemiology, Section 8: Concepts of disease occurrence". U.S. Centers for Disease Control and Prevention (CDC). 18 May
2012. Archived from the original on 6 April 2020. Retrieved 6 May 2020.
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending
authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
Oxfordā€“AstraZeneca
(Vaxzevria, Covishield)
Developers Country of
origin
Technology Doses (
Interval)
Storage Pre-marketing study Post-marketing
study
University
of Oxford,
AstraZenec
a, CEPI
US,
Sweden
Adenovirus
vector
2 doses
4ā€“12
weeks
2ā€“8 Ā°C Phase III (30,000)
Interventional;
randomized,
placebo-controlled
study for efficacy,
safety, and
Immunogenicity.
Overall efficacy of
76% after the first
dose and 81% after
a second dose
taken 12 weeks or
more after the
first
Phase IV
(10,000)
Interventional,
Nonrandomized
undergoing
Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. (March 2021). "Single-dose administration and the influence of
the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised
trials". Lancet. 397 (10277): 881ā€“91. doi:10.1016/S0140-6736(21)00432-3
Pfizerā€“BioNTech
Developers Country
of origin
Technology Doses (
Interval)
Storage Pre-marketing
study
Post-marketing
study
BioNTech,
Pfizer
Germany
US
RNA
(modRNA in
lipid
nanoparticles)
2 doses
3ā€“4
weeks
āˆ’70 Ā± 10
Ā°C
Phase III (43,448)
Randomized,
placebo-controlled.
Positive results
from an interim
analysis were
announced on
18/11 2020
and published on
10/12/ 2020
reporting an
overall
efficacy of
95%
Phase IV
(10,000)
Interventional,
Nonrandomized
undergoing
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (December 2020). "Safety and Efficacy of the BNT162b2 mRNA Covid-19
Vaccine". The New England Journal of Medicine. 383 (27): 2603ā€“15. doi:10.1056/NEJMoa2034577
Sputnik V
Developers Country of
origin
Technology Doses (
Interval)
Storage Pre-marketing study Post-
marketing
study
Gamaleya
Research
Institute of
Epidemiology
and
Microbiology
Russia Adenovirus
vector
(recombinant
Ad5 and
Ad26 )
2 doses
3 weeks
ā‰¤āˆ’18 Ā°C Phase III (40,000)
Randomized double
blind,
Placebo controlled
to
evaluate efficacy,
immunogenicity,
and safety.
Interim analysis
from the trial
published in The
Lancet, indicating
91.6% efficacy
without unusual side
effects
Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. (February 2021). "Safety and efficacy of an
rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in
Russia". Lancet. 397 (10275): 671ā€“81. doi:10.1016/S0140-6736(21)00234-8
BBV152 (Covaxin)
Developers Country of
origin
Technology Doses (
Interval)
Storage Pre-marketing study Post-
marketing
study
Bharat
Biotech,
Indian
Council of
Medical
Research
India Inactivated
SARS-CoV-2
(vero cells)
2 doses
4 weeks
2ā€“8 Ā°C Phase III (25,800)
Randomised,
observer-blinded,
Placebo controlled.
Bharat Biotech reported
an interim
efficacy of 78% in
its phase 3 trial
Koshy, Jacob (21 April 2021). "Updated data from Covaxin phase 3 trial shows 78% efficacy". The Hindu. ISSN 0971-751X
Moderna
Developers Country
of origin
Technology Doses (
Interval)
Storage Pre-marketing study Post-
marketing
study
Moderna,
NIAID,
BARDA, CEPI
US RNA
(modRNA in
lipid
nanoparticles)
2 doses
4 weeks
āˆ’20 Ā± 5 Ā°C Phase III (30,000)
Interventional;
randomized, placebo-
controlled
study for efficacy,
safety, and
immunogenicity.
Positive results
from an interim
analysis were
announced on
15/11/2020
and published on
30/12/2020
reporting an overall
efficacy of
94%.
Phase IV
(10,000)
Interventiona
l non-
randomized
undergoing
Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine". National Institutes of Health (NIH). 15 November 2020.
Johnson & Johnson
Developers Country
of origin
Technology Doses (
Interval)
Storage Pre-marketing
study
Post-marketing
study
Janssen
Vaccines
(Johnson &
Johnson),
BIDMC
US
Netherlan
ds
Adenovirus
vector
(recombina
nt
Ad26)
Single dose 2ā€“8 Ā°C Phase III (40,000)
Randomized,
double-blinded,
placebo-controlled
Positive results
from an interim
analysis were
announced on
29/1/2021. An
efficacy
of 66% against mild
and moderate
symptoms, and
85% against severe
symptoms
Janssen COVID-19 Vaccine ā€“ ad26.cov2.s injection, suspension". DailyMed. U.S. National Institutes of Health. Retrieved 15 March 2021.
CoronaVac
Develope
rs
Countr
y of
origin
Technology Doses (
Interval)
Storage Pre-marketing study Post-
marketing
study
Sinovac China Inactivated
SARS-CoV-2
(vero cells)
2 doses
2ā€“3 weeks
2ā€“8 Ā°C Phase III (33,620)
Double-blind,
randomized, Placebo
controlled
to evaluate efficacy
and safety.
Final Phase III
results from various parts of
globe reported efficacy
below 70% but more
effective in
preventing severe
cases
"Estudo clƭnico que comprova maior eficƔcia da Coronavac Ʃ enviado para Lancet". CNN Brasil (in Portuguese). Retrieved 18 April 2021
Other approved vaccines
Vaccine Developers/Country Remarks/Usage/Efficacy
Sputnik Light Russia On emergency use; undergoing phase III trial
WIBP-CorV China Phase III trial showed 72.3% efficacy
EpiVacCorona Russia On emergency use; undergoing phase III trial
QazCovid-in Kazakhstan On emergency use; undergoing phase III trial
Minhai COVID-
19 vaccine
China On emergency use; undergoing phase III trial
CoviVac Russia 2 doses only 2 weeks apart; undergoing
phase III trial
EpiVacCorona Russia On both full time & emergency use; Phase III
trail reports pending
RBD-Dimer China Only vaccine to have 3 doses; Phase III trials
reports pending
Approved COVID-19 vaccines in Phase
Iā€“III trials
Vaccine Developer
s/Country
Type Trial phase Emergency use
Authorisation
Novovax US Subunit Undergoing phase III US EU NZ Aus
Sanofi-GSK UK France Subunit Undergoing phase III US EU Canada
Cure-Vac Germany RNA Undergoing phase III EU
CoVLP Canada Subunit Undergoing phase III Canada
SOBERANA 02 Cuba Subunit Undergoing phase III Cuba
VLA2001 France Subunit Phase III trial started EU
Other vaccines awaiting emergency
use authorization
Vaccine Developers/Country Type Trial phase
ZyCoV-D India Subunit III
COVIran Barakat Iran Subunit III
CIGB-66 Cuba Subunits III
Nanocovax Vietnam Subunit II
Bio E COVID-19 India US Subunit II
UB-612 Brazil Subunit II
GRAd-COV2 Italy Adenovirus vector II
MVC-COV1901 Taiwan Subunit II
COVAX-19 Australia Subunit II
AG0302 Japan DNA plasmid II
IIBR-100 Israel Vesicular
stomatitis virus
Pre-clinical
HGC019 India US RNA Pre-clinical
BBV154 India Adenovirus vector Pre-clinical
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending
authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
Distribution
ā€¢ 1.9 billion COVID-19 vaccine doses administered
worldwide
ā€¢ Licensed vaccines should be available and
affordable for people at the frontline of
healthcare and having the greatest need
ā€¢ Several companies plan to initially manufacture a
vaccine at artificially low pricing, then increase
prices for profitability later if annual vaccinations
are needed and as countries build stock for future
needs
Inequality concerns
ā€¢ WHO, CEPI, and GAVI have expressed concerns
that affluent countries should not receive priority
access to the global supply of eventual COVID-19
vaccines
ā€¢ Although 9 percent of the world's population
lives in the 29 poorest countries, these countries
received only 0.3% of all vaccines administered
ā€¢ Brazil vaccinated twice more white than black
people and noticed the fact that the mortality of
is higher in the black population
Misinformation & hesitancy
ā€¢ Anti-vaccination activists and other people
spread a variety of rumors, including
overblown claims about side effects
Encouragement by public figures
ā€¢ Current and former heads of state and
government ministers have released photographs
of their vaccinations, encouraging others to be
vaccinated including Joe Biden, Barack Obama,
Narendra Modi, the Dalai Lama, Justin Trudeau,
Kyriakos Mitsotakis, Zdravko Marić, Olivier VĆ©ran
ā€¢ Many musicians, actors,TV personalities, athletes
also encouraged
Adverse events
ā€¢ Injection-site events mainly grade 1 or 2 in
severity
ā€¢ Lasted a mean of 2.6 and 3.2 days after the
first and second doses respectively
ā€¢ M/C pain after injection > 80%
ā€¢ Rest fever, headache, fatigue, myalgia,
arthralgia, nausea, vomiting ; severe grade
rarely
ā€¢ Hypersensitivity reaction rarely crosses 1%
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
Initiation
ā€¢ As of early May 2020, there were over 30
vaccine candidates in development in India,
many of which were already in pre-clinical
trials
Serum Institute of India & Covishield
ā€¢ World's largest vaccine maker
ā€¢ In Febā€™2020, SII had begun animal trials of
vaccine candidates
ā€¢ In Augā€™2020, SII received approvals for phase 2
and phase 3 trials of its version of a vaccine
being developed by AstraZeneca and the
University of Oxford's
ā€¢ Planned to manufacture 1.5 and 2.5 billion
doses per-year
Bharat Biotech & Covaxin
ā€¢ ICMR partnered with Bharat Biotech in May 2020
to develop a COVID vaccine entirely within India
ā€¢ In June 2020,received DCGI approval to begin
phase 1 and phase 2 trials on its vaccine
ā€¢ On 3 March 2021, Bharat Biotech reported that
Covaxin showed an efficacy of 78% in its phase 3
trial
ā€¢ Expanded its production capabilities for Covaxin
to 700 million doses per-year
Covaxin showed 81% efficacy in third phase trials, says Bharat Biotech" (https://scroll.in/latest/ 988469/covaxin-showed-81-efficacy-in-third-
phase-trials-says-bharat-biotech). Scroll.in. 3 March 2021. Retrieved 4 March 2021.
Cadila Healthcare
ā€¢ Began vaccine development in March 2020
ā€¢ Including a viral vector vaccine and a DNA
plasmid vaccine
ā€¢ In mid-July 2020 held early human trials of its
vaccine candidate ZyCoVD
ā€¢ Received approval for phase 3 trials in January
2021
ā€¢ Expecting to receive emergency authorization
shortly
Dr Reddyā€™s
ā€¢ Partnered with the Russian Direct Investment
Fund (RDIF) to conduct phase 3 trials of the
Sputnik V vaccine
ā€¢ Also working with the RDIF on approval of
"Sputnik Light"ā€”a regiment of Sputnik V
consisting only of the first dose
Launching vaccination programme
ā€¢ On 1/01/21, the DCGI approved emergency use
of the Covishield
ā€¢ On the following day, the Covaxin also approved
ā€¢ Standard emergency use authorization to Covaxin
later on in Marchā€™21
ā€¢ On 12 April, the DCGI approved Russia's Sputnik V
vaccine for emergency use
ā€¢ Began its vaccination program on 16th January
operating 3,006 vaccination centers on the onset
ā€¢ Concerns about low turnout, due to a safety
concerns
Second phase
ā€¢ From 1st march covering all residents over 60
ā€¢ Between the ages of 45 and 60 with one or more
qualifying co-morbidities
ā€¢ Any health care or frontline worker that did not
receive a dose during phase 1
ā€¢ From 1 April, eligibility extended to all residents
over 45
ā€¢ PM called for a four-day ā€œTeeka Utsav" from 11 to
14 April to encourage vaccination
Third phase
ā€¢ From 1st may
ā€¢ Eligibility to all residents over the age of 18
ā€¢ On 25 May, India exceeded 200 million vaccine
doses administered
Vaccine Maitri
ā€¢ Humanitarian initiative from Janā€™21
ā€¢ Aims to leverage the country's pharmaceutical
industry to export Indian-manufactured
vaccines to other countries
ā€¢ Had donated over 64.5 million vaccines to 85
countries
ā€¢ Canada, Bahrain, Brazil, South Africa,
Argentina, Iran notable recipients
ā€¢ WHO heaped praise for this great effort
State wise dataā€™s
ā€¢ Gujarat, Karnataka, Maharasthra, Rajasthan,
Uttar Pradesh & West Bengal are the states
with more than 10 million jabs
ā€¢ Tripura & Ladakh have vaccinated more than
itā€™s 15% of the populations
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
ā€¢ Super-spreading events
ā€¢ Transmission of infection in Quarantine hotels
ā€¢ Infection from Asymptomatic & pre-
symptomatic individuals
ā€¢ More indoor transmission than outdoor
transmission
ā€¢ Nosocomial infection despite adequate
personal protection
ā€¢ Viable SARS-CoV-2 detection in the air; stayed
infectious in the air for up to 3 h with a half-life of 1Ā·1 h
ā€¢ Identified in air filters and building ducts in hospitals
ā€¢ Transmission between caged animals connected only
through air duct
ā€¢ No strong or consistent evidence to refute the
hypothesis of airborne SARS-CoV-2 transmission
ā€¢ Limited evidence to support other dominant routes of
transmission: respiratory droplet or fomite
Lednicky JA, Lauzard M, Fan ZH, et al. Viable SARS-CoV-2 in the air of a hospital room with COVID-19 patients. Int J Infect Dis 2020; 100: 476ā€“82.
Modes of prevention
ā€¢ Hand hygiene
ā€¢ Respiratory hygiene
ā€¢ Social Distancing
ā€¢ High risk group
Home quarantine rules
ā€¢ Stay in well-ventilated room
ā€¢ Restrict movement
ā€¢ Using separate bathroom
ā€¢ Follow respiratory hygiene/hand hygiene specially if
symptomatic
ā€¢ Avoid visitors in house
ā€¢ Household members use separate bathroom &
bedroom
ā€¢ Avoid sharing household items
ā€¢ To remain free from any kinds of rumour & stigma
ā€¢ Planning & development
ā€¢ Current scenario
ā€¢ Vaccine types & mechanisms
ā€¢ Efficacy & action against variants
ā€¢ Chief vaccines & trial results
ā€¢ Other approved vaccines & vaccines pending authorization
ā€¢ Distribution & inequality concerns
ā€¢ Indiaā€™s vaccine development & distribution
ā€¢ General prevention strategies
ā€¢ Hospital preparedness
Components
How Should U.S. Hospitals Prepare for Coronavirus Disease 2019 (COVID-19)? Ann Intern Med. Published online March 11,
2020. doi:10.7326/M20-0907
Preparing for Triage
ā€¢ At healthcare facility entrance to direct patients to
ā€“ Telemedicine facility
ā€“ Those with fever and respiratory symptoms like cough or
breathing difficulty ā€“ immediately proceed to triage or
registration desk
ā€¢ Additional symptoms to consider
ā€“ Chills
ā€“ Repeated shaking with chills
ā€“ Muscle pain
ā€“ Headache
ā€“ Sore throat
ā€“ New loss of taste or smell
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
Protecting the healthcare personnel
ā€¢ Install physical barriers (e.g. glass/plastic
screens) at registration desk with 1 m at-least
distance
ā€¢ Identify isolation rooms or separate well-
ventilated rooms for suspected patients
ā€¢ Provide masks/ face covers for all patients
visiting the HCF
ā€¢ Convenient access to hand hygiene products
ā€¢ Should wear gowns, gloves, face mask, and
eye protection
ā€¢ Only doing emergency procedures
ā€¢ Mandatory telemedicine facilities
Sample visual alerts to post at facility
entry
Airborne Infection Control: Ventilation
Fans in isolation wards ā€“ key factors
ā€¢ Cool ambient temperature
through dissipation of
radiant heat
ā€¢ Provide directionality in
order to improve
ventilation
ā€¢ Direction of fans should
deflect air away from
health care workers
How to ensure surgeons safety
ā€¢ Elective surgeries should be postponed
ā€¢ Take precautions when performing Aerosol-
Generating Procedures (AGPs)
ā€¢ Operating rooms should be allocated and
signs posted on the doors to minimize staff
exposure
ā€¢ If no general anesthesia:
ā€“ Patient should continue to wear the surgical
mask
ā€¢ If general anesthesia used:
ā€“ Place a HEPA filter between the Y-piece of the
breathing circuit and the patient's mask,
endotracheal tube or laryngeal mask airway
ā€“ If available, use a closed suction system during
airway suctioning
https://journals.lww.com/annalsofsurgery/Documents/Managing%20COVID%20in%20Surgical%20Systems%20v2.pdf
https://www.asahq.org/about-asa/governance-and-committees/asa-committees/committee-on-occupational-health/coronavirus
https://doi.org/10.1007/s12630-020-01617-4
Take home messages
ā€¢ COVID vaccination is one of the greatest & fastest scientific
discovery of mankind
ā€¢ India didnā€™t lag behind in technological expertise to build a
top quality vaccine indigenously
ā€¢ US EU nations have vaccinated in pretty organized manner
ā€¢ India had started vaccination in a quite efficient manner
but anti-vaccination campaigning dampened the spirit
initially
ā€¢ The second wave & appearance of variants have compelled
citizens to take jabs currently
ā€¢ Prevention strategies should be very proper in health care
settings
ā€¢ Telemedicine facilities needs to be encouraged
Thank youā€¦ā€¦ā€¦
Hand hygiene
DO
ā€¢ Hand washing with soaps &
water for at-least 40 sec or
using alcohol based
handrubs
ā€¢ Especially after you have
been in a public place, or
after blowing your nose,
coughing, or sneezing
ā€¢ Of your hands and rub them
together until they feel dry
DONT
Touch your eyes, nose, and
mouth with unwashed
hands
touch surfaces like door knobs
and door bells, elevator
buttons,handrails, support
handles, chair backs, atm ,
mobiles
Respiratory hygiene
Do
ā€¢ Use handkerchief/tissue
while coughing/sneezing
ā€¢ Throw the tissue
immediately in dustbin
ā€¢ Cover sneeze into bent
upper arm
ā€¢ Wash hands immediately
DONT
ā€¢ Spit in open
ā€¢ Use other ways of covering
face
Social distancing
Do
ā€¢ STAY AT HOME UNLESS
ABSOLUTELY NECESSARY
ā€¢ KEEP A DISTANCE OF AT
LEAST ONE METER
BETWEEN YOURSELF AND
ANOTHER PERSON
Dont
ā€¢ DO NOT HOLD EVENTS
WHEREPEOPLE HAVE TO
GATHER (EVEN IF IT IS A
CORNER MEETING WITH
THREE OR FOUR FRIENDS, OR
AN EVENING CHAT ON THE
CHAUPAL)
ā€¢ ā€¢DO NOT GO TO CROWDED
PLACES LIKE MARKETS,
SHOPPING, MELAS, PARTIES
ā€¢ ā€¢DO NOT USE PUBLIC
TRANSPORT
ZyCoV-D vaccine
ā€¢ DNA vaccine
ā€¢ Plasmid expressing SARS-CoV2 protein
ā€¢ First of its kind
ā€¢ On its way to becoming the 1st DNA vaccine to
get approval
ā€¢ 1st vaccine to get authorization between age
group 12-18
Vaccines approved below 18 yrs of age
ā€¢ Pfizer approved for age 12-16
ā€¢ Pfizer/Moderna/Novavax/Johnson undergoing
trial for children from 6 months to 11 years
ā€¢ Covaxin undertaking trial in children
ā€¢ Bharat biotechā€™s nasal vaccine incorporated
children
Clotting abnormalities in OA vaccines
ā€¢ Blood coagulation with thrombocytopenia to be listed
as very rare S/E of Vaxzevria
ā€¢ Generally occurring within 2 weeks
ā€¢ Mostly in women < 60 years
ā€¢ Among 20 million vaccination, only 25 cases reported
ā€¢ Examples: CVT/splanchnic venous thrombosis
ā€¢ Pathology similar to HIT
ā€¢ Possibly antibody developing against P4
ā€¢ All cases notified from Europe only; notably UK
ā€¢ Benefit outweighs risk

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COVID vaccination and prevention strategies

  • 1. COVID-19 Vaccination & Prevention strategies Dr. Shinjan Patra
  • 2. Introduction ā€¢ COVID-19 has been the cause of distress & ailment all throughout the globe for last 18 months ā€¢ Clinical manifestations progressed from pneumonia to ARDS
  • 3. Complications ā€¢ Typically associated with the phenomenon of Cytokine storm ā€¢ Lung injury leads to reduced surfactant & reduced gas exchange in the alveoli ā€¢ Leads to massive vascular inflammation, shock, hypotension, disseminated intravascular coagulation & multi-organ dysfunction ā€¢ Vaccination holds the key to tackle his epidemic
  • 4. Outline ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 5. Early days ā€¢ Vaccine for an infectious disease never been produced in less than several years ā€¢ No vaccine existed for preventing a corona virus infection in humans ā€¢ Established body of knowledge about the structure and function of corona-viruses causing diseases like SARS CoV-1 & MERS ā€¢ Enabled accelerated development of various vaccine technologies during early 2020 ā€¢ On 10 January 2020, the SARS-CoV-2 genetic sequence data shared ā€¢ By 19 March, the global pharmaceutical industry announced a major commitment to address COVID-19
  • 6. Initiation ā€¢ Since January 2020, vaccine development expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments
  • 7. Basic steps ā€¢ Safety ā€¢ Targeting vulnerable populations ā€¢ Need for vaccine efficacy breakthroughs ā€¢ Duration of vaccination protection ā€¢ Special delivery systems (such as oral or nasal, rather than by injection) ā€¢ Dose regimen ā€¢ Stability and storage characteristics ā€¢ Dissemination of the licensed vaccine
  • 8. Challenges ā€¢ Urgency compressed schedules that shortened the standard vaccine development timeline ā€¢ Compromising safety assurance ā€¢ Research at universities obstructed by physical distancing and closing ā€¢ Virus proved to be a "moving target" of changing transmission rates across and within countries ā€¢ Compete for trial participants
  • 9. ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 10. Authorization ā€¢ 17 vaccines authorized by at least one national regulatory authority for public use RNA vaccines Pfizerā€“BioNTech Viral Vector Vaccines Oxford-AstraZeneca Moderna Sputnik Light CVnCoV Sputnik V Inactivated vaccines BBIBP-CorV Johnson & Johnson CoronaVac Convidecia Covaxin Protein subunit vaccine EpiVacCorona WIBP-CorV RBDDimer CoviVac Minhai-Kangtai QazVac
  • 11. Others in pipeline ā€¢ 308 vaccine candidates are in various stages of development ā€¢ With 73 in clinical research ļƒ˜24 in Phase I trials ļƒ˜33 in Phase Iā€“II trials ļƒ˜16 in Phase III development
  • 12. First approval ā€¢ On 2/12/20 UKā€™s Medicines and Healthcare products Regulatory Agency (MHRA) gave temporary regulatory approval for the Pfizerā€“ BioNTech vaccine ā€¢ On 1/01/21, (DCGI) approved emergency use of the Oxfordā€“AstraZeneca vaccine (Covishield) in India
  • 13. ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 14. Platform & target ā€¢ Most of the platforms of vaccine candidates in clinical trials focused on the spike protein and its variants as the primary antigen ā€¢ Platform Being developed in 2020 involved nucleic acid technologies (nucleoside-modified messenger RNA and DNA), non-replicating viral vectors, peptides, recombinant proteins, live attenuated viruses and inactivated viruses
  • 15.
  • 16. Next generation strategies ā€¢ Precise targeting of COVID-19 infection mechanisms ā€¢ Use a 2P mutation to lock the spike protein into its prefusion configuration, stimulating an immune response to the virus before it attaches to a human cell
  • 17. RNA vaccine ā€¢ When introduced into a tissue, acts as mRNA to cause the cells to build the foreign protein and stimulate an adaptive immune response ā€¢ Delivery of mRNA is achieved by a co- formulation of the molecule into lipid nano- particles which protect the RNA strands and help their absorption into the cells
  • 18. Approval status ā€¢ First to be approved in US, UK, EU ā€¢ In January 2021, Pfizerā€“BioNTech and the Moderna got approval ā€¢ In February 2021, the CVnCoV RNA vaccine from CureVac got authorization in EU ā€¢ Allergic reactions rare
  • 19. Inactivated virus vaccines ā€¢ Consist of virus particles that have been grown in culture and then are killed using a method such as heat or formaldehyde to lose disease producing capacity, while still stimulating an immune response
  • 20. Adenovirus vector vaccines ā€¢ Non-replicating viral vector vaccines, using an adenovirus shell containing DNA that encodes a SARS-CoV-2 protein ā€¢ Convidecia and the Johnson & Johnson COVID-19 vaccine are both one-shot vaccines which offer less complicated logistics and can be stored under ordinary refrigeration for several months
  • 21. Subunit vaccines ā€¢ Present one or more antigens without introducing whole pathogen particles ā€¢ Antigens involved are often protein subunits, but can be any molecule that is a fragment of the pathogen
  • 22. Other types ā€¢ In clinical trials include ļƒ˜Virus-like particle vaccines ļƒ˜Multiple DNA plasmid vaccines ļƒ˜Lentivirus vector vaccines ļƒ˜Conjugate vaccine ļƒ˜Vesicular stomatitis virus displaying the SARS-CoV-2 spike protein
  • 23. Formulation ā€¢ To enhance immunogenicity ā€¢ Particularly effective for technologies using the inactivated virus and recombinant protein- based or vector-based vaccines ā€¢ Aluminum salts, the first adjuvant used for licensed vaccines, the adjuvant of choice in some 80% vaccines
  • 24. Outline ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 25. Efficacy ā€¢ Not straightforward to compare the efficacies of the different vaccines because the trials were run with different populations, geographies and variants of the virus
  • 26.
  • 27. Lineage B.1.1.7 (alpha) ā€¢ Identified in Decā€™20 in UK ā€¢ Results suggest protection from the Pfizer- BioNTech and Moderna vaccines ā€¢ Oxfordā€“AstraZeneca had an efficacy of 42ā€“89% versus 71ā€“91% against non-B.1.1.7 variants Wang P, Nair MS, Liu L, Iketani S, Luo Y, Guo Y, et al. (March 2021). "Antibody Resistance of SARS-CoV-2 Variants B.1.351 and B.1.1.7". Nature. 593 (7857): 130ā€“35 Emary KR, Golubchik T, Aley PK, Ariani CV, Angus BJ, Bibi S, et al. (2021). "Efficacy of ChAdOx1 nCoV-19 (AZD1222) Vaccine Against SARS-CoV-2 VOC 202012/01 (B.1.1.7)
  • 28. Lineage B.1.351 (Beta) ā€¢ First detected in Decā€™20 in South Africa ā€¢ Decreased neutralizing activity of Moderna and Pfizer-BioNTech vaccines ā€¢ On 1 April 2021, an update on a Pfizer/BioNTech stated that the vaccine 100% effective ā€¢ Johnson & Johnson, reported the level of protection 72% in the United States and 57% in South Africa ā€¢ Reduced efficacy of the Oxfordā€“AstraZeneca Hoffmann M, Arora P, Gross R, Seidel A, Hoernich BF, Hahn AS, et al. (March 2021). "1 SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies". Cell. 184 (9): 2384ā€“2393.e12
  • 29. Lineage P.1 (Gamma) ā€¢ Initially identified in Brazil ā€¢ Seems to partially escape vaccination with the Pfizer- BioNTech Hoffmann M, Arora P, Gross R, Seidel A, Hoernich BF, Hahn AS, et al. (March 2021). "1 SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies". Cell. 184 (9): 2384ā€“2393.e12
  • 30. Lineage B.1.617 (Kappa & Delta) ā€¢ First discovered in India ā€¢ Mostly detected after Janā€™21 ā€¢ Spike mutations D111D, G142D,P681R, E484Q and L452R,the latter two of which may cause it to easily avoid antibodies ā€¢ Neutralized by Covaxin ā€¢ Covishield 60% effective Principles of epidemiology, Section 8: Concepts of disease occurrence". U.S. Centers for Disease Control and Prevention (CDC). 18 May 2012. Archived from the original on 6 April 2020. Retrieved 6 May 2020.
  • 31. ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 32. Oxfordā€“AstraZeneca (Vaxzevria, Covishield) Developers Country of origin Technology Doses ( Interval) Storage Pre-marketing study Post-marketing study University of Oxford, AstraZenec a, CEPI US, Sweden Adenovirus vector 2 doses 4ā€“12 weeks 2ā€“8 Ā°C Phase III (30,000) Interventional; randomized, placebo-controlled study for efficacy, safety, and Immunogenicity. Overall efficacy of 76% after the first dose and 81% after a second dose taken 12 weeks or more after the first Phase IV (10,000) Interventional, Nonrandomized undergoing Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. (March 2021). "Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials". Lancet. 397 (10277): 881ā€“91. doi:10.1016/S0140-6736(21)00432-3
  • 33. Pfizerā€“BioNTech Developers Country of origin Technology Doses ( Interval) Storage Pre-marketing study Post-marketing study BioNTech, Pfizer Germany US RNA (modRNA in lipid nanoparticles) 2 doses 3ā€“4 weeks āˆ’70 Ā± 10 Ā°C Phase III (43,448) Randomized, placebo-controlled. Positive results from an interim analysis were announced on 18/11 2020 and published on 10/12/ 2020 reporting an overall efficacy of 95% Phase IV (10,000) Interventional, Nonrandomized undergoing Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (December 2020). "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine". The New England Journal of Medicine. 383 (27): 2603ā€“15. doi:10.1056/NEJMoa2034577
  • 34. Sputnik V Developers Country of origin Technology Doses ( Interval) Storage Pre-marketing study Post- marketing study Gamaleya Research Institute of Epidemiology and Microbiology Russia Adenovirus vector (recombinant Ad5 and Ad26 ) 2 doses 3 weeks ā‰¤āˆ’18 Ā°C Phase III (40,000) Randomized double blind, Placebo controlled to evaluate efficacy, immunogenicity, and safety. Interim analysis from the trial published in The Lancet, indicating 91.6% efficacy without unusual side effects Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. (February 2021). "Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia". Lancet. 397 (10275): 671ā€“81. doi:10.1016/S0140-6736(21)00234-8
  • 35. BBV152 (Covaxin) Developers Country of origin Technology Doses ( Interval) Storage Pre-marketing study Post- marketing study Bharat Biotech, Indian Council of Medical Research India Inactivated SARS-CoV-2 (vero cells) 2 doses 4 weeks 2ā€“8 Ā°C Phase III (25,800) Randomised, observer-blinded, Placebo controlled. Bharat Biotech reported an interim efficacy of 78% in its phase 3 trial Koshy, Jacob (21 April 2021). "Updated data from Covaxin phase 3 trial shows 78% efficacy". The Hindu. ISSN 0971-751X
  • 36. Moderna Developers Country of origin Technology Doses ( Interval) Storage Pre-marketing study Post- marketing study Moderna, NIAID, BARDA, CEPI US RNA (modRNA in lipid nanoparticles) 2 doses 4 weeks āˆ’20 Ā± 5 Ā°C Phase III (30,000) Interventional; randomized, placebo- controlled study for efficacy, safety, and immunogenicity. Positive results from an interim analysis were announced on 15/11/2020 and published on 30/12/2020 reporting an overall efficacy of 94%. Phase IV (10,000) Interventiona l non- randomized undergoing Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine". National Institutes of Health (NIH). 15 November 2020.
  • 37. Johnson & Johnson Developers Country of origin Technology Doses ( Interval) Storage Pre-marketing study Post-marketing study Janssen Vaccines (Johnson & Johnson), BIDMC US Netherlan ds Adenovirus vector (recombina nt Ad26) Single dose 2ā€“8 Ā°C Phase III (40,000) Randomized, double-blinded, placebo-controlled Positive results from an interim analysis were announced on 29/1/2021. An efficacy of 66% against mild and moderate symptoms, and 85% against severe symptoms Janssen COVID-19 Vaccine ā€“ ad26.cov2.s injection, suspension". DailyMed. U.S. National Institutes of Health. Retrieved 15 March 2021.
  • 38. CoronaVac Develope rs Countr y of origin Technology Doses ( Interval) Storage Pre-marketing study Post- marketing study Sinovac China Inactivated SARS-CoV-2 (vero cells) 2 doses 2ā€“3 weeks 2ā€“8 Ā°C Phase III (33,620) Double-blind, randomized, Placebo controlled to evaluate efficacy and safety. Final Phase III results from various parts of globe reported efficacy below 70% but more effective in preventing severe cases "Estudo clĆ­nico que comprova maior eficĆ”cia da Coronavac Ć© enviado para Lancet". CNN Brasil (in Portuguese). Retrieved 18 April 2021
  • 39. Other approved vaccines Vaccine Developers/Country Remarks/Usage/Efficacy Sputnik Light Russia On emergency use; undergoing phase III trial WIBP-CorV China Phase III trial showed 72.3% efficacy EpiVacCorona Russia On emergency use; undergoing phase III trial QazCovid-in Kazakhstan On emergency use; undergoing phase III trial Minhai COVID- 19 vaccine China On emergency use; undergoing phase III trial CoviVac Russia 2 doses only 2 weeks apart; undergoing phase III trial EpiVacCorona Russia On both full time & emergency use; Phase III trail reports pending RBD-Dimer China Only vaccine to have 3 doses; Phase III trials reports pending
  • 40. Approved COVID-19 vaccines in Phase Iā€“III trials Vaccine Developer s/Country Type Trial phase Emergency use Authorisation Novovax US Subunit Undergoing phase III US EU NZ Aus Sanofi-GSK UK France Subunit Undergoing phase III US EU Canada Cure-Vac Germany RNA Undergoing phase III EU CoVLP Canada Subunit Undergoing phase III Canada SOBERANA 02 Cuba Subunit Undergoing phase III Cuba VLA2001 France Subunit Phase III trial started EU
  • 41. Other vaccines awaiting emergency use authorization Vaccine Developers/Country Type Trial phase ZyCoV-D India Subunit III COVIran Barakat Iran Subunit III CIGB-66 Cuba Subunits III Nanocovax Vietnam Subunit II Bio E COVID-19 India US Subunit II UB-612 Brazil Subunit II GRAd-COV2 Italy Adenovirus vector II MVC-COV1901 Taiwan Subunit II COVAX-19 Australia Subunit II AG0302 Japan DNA plasmid II IIBR-100 Israel Vesicular stomatitis virus Pre-clinical HGC019 India US RNA Pre-clinical BBV154 India Adenovirus vector Pre-clinical
  • 42. ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 43. Distribution ā€¢ 1.9 billion COVID-19 vaccine doses administered worldwide ā€¢ Licensed vaccines should be available and affordable for people at the frontline of healthcare and having the greatest need ā€¢ Several companies plan to initially manufacture a vaccine at artificially low pricing, then increase prices for profitability later if annual vaccinations are needed and as countries build stock for future needs
  • 44.
  • 45. Inequality concerns ā€¢ WHO, CEPI, and GAVI have expressed concerns that affluent countries should not receive priority access to the global supply of eventual COVID-19 vaccines ā€¢ Although 9 percent of the world's population lives in the 29 poorest countries, these countries received only 0.3% of all vaccines administered ā€¢ Brazil vaccinated twice more white than black people and noticed the fact that the mortality of is higher in the black population
  • 46. Misinformation & hesitancy ā€¢ Anti-vaccination activists and other people spread a variety of rumors, including overblown claims about side effects
  • 47. Encouragement by public figures ā€¢ Current and former heads of state and government ministers have released photographs of their vaccinations, encouraging others to be vaccinated including Joe Biden, Barack Obama, Narendra Modi, the Dalai Lama, Justin Trudeau, Kyriakos Mitsotakis, Zdravko Marić, Olivier VĆ©ran ā€¢ Many musicians, actors,TV personalities, athletes also encouraged
  • 48. Adverse events ā€¢ Injection-site events mainly grade 1 or 2 in severity ā€¢ Lasted a mean of 2.6 and 3.2 days after the first and second doses respectively ā€¢ M/C pain after injection > 80% ā€¢ Rest fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting ; severe grade rarely ā€¢ Hypersensitivity reaction rarely crosses 1%
  • 49. ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 50. Initiation ā€¢ As of early May 2020, there were over 30 vaccine candidates in development in India, many of which were already in pre-clinical trials
  • 51. Serum Institute of India & Covishield ā€¢ World's largest vaccine maker ā€¢ In Febā€™2020, SII had begun animal trials of vaccine candidates ā€¢ In Augā€™2020, SII received approvals for phase 2 and phase 3 trials of its version of a vaccine being developed by AstraZeneca and the University of Oxford's ā€¢ Planned to manufacture 1.5 and 2.5 billion doses per-year
  • 52. Bharat Biotech & Covaxin ā€¢ ICMR partnered with Bharat Biotech in May 2020 to develop a COVID vaccine entirely within India ā€¢ In June 2020,received DCGI approval to begin phase 1 and phase 2 trials on its vaccine ā€¢ On 3 March 2021, Bharat Biotech reported that Covaxin showed an efficacy of 78% in its phase 3 trial ā€¢ Expanded its production capabilities for Covaxin to 700 million doses per-year Covaxin showed 81% efficacy in third phase trials, says Bharat Biotech" (https://scroll.in/latest/ 988469/covaxin-showed-81-efficacy-in-third- phase-trials-says-bharat-biotech). Scroll.in. 3 March 2021. Retrieved 4 March 2021.
  • 53. Cadila Healthcare ā€¢ Began vaccine development in March 2020 ā€¢ Including a viral vector vaccine and a DNA plasmid vaccine ā€¢ In mid-July 2020 held early human trials of its vaccine candidate ZyCoVD ā€¢ Received approval for phase 3 trials in January 2021 ā€¢ Expecting to receive emergency authorization shortly
  • 54. Dr Reddyā€™s ā€¢ Partnered with the Russian Direct Investment Fund (RDIF) to conduct phase 3 trials of the Sputnik V vaccine ā€¢ Also working with the RDIF on approval of "Sputnik Light"ā€”a regiment of Sputnik V consisting only of the first dose
  • 55. Launching vaccination programme ā€¢ On 1/01/21, the DCGI approved emergency use of the Covishield ā€¢ On the following day, the Covaxin also approved ā€¢ Standard emergency use authorization to Covaxin later on in Marchā€™21 ā€¢ On 12 April, the DCGI approved Russia's Sputnik V vaccine for emergency use ā€¢ Began its vaccination program on 16th January operating 3,006 vaccination centers on the onset ā€¢ Concerns about low turnout, due to a safety concerns
  • 56. Second phase ā€¢ From 1st march covering all residents over 60 ā€¢ Between the ages of 45 and 60 with one or more qualifying co-morbidities ā€¢ Any health care or frontline worker that did not receive a dose during phase 1 ā€¢ From 1 April, eligibility extended to all residents over 45 ā€¢ PM called for a four-day ā€œTeeka Utsav" from 11 to 14 April to encourage vaccination
  • 57. Third phase ā€¢ From 1st may ā€¢ Eligibility to all residents over the age of 18 ā€¢ On 25 May, India exceeded 200 million vaccine doses administered
  • 58. Vaccine Maitri ā€¢ Humanitarian initiative from Janā€™21 ā€¢ Aims to leverage the country's pharmaceutical industry to export Indian-manufactured vaccines to other countries ā€¢ Had donated over 64.5 million vaccines to 85 countries ā€¢ Canada, Bahrain, Brazil, South Africa, Argentina, Iran notable recipients ā€¢ WHO heaped praise for this great effort
  • 59. State wise dataā€™s ā€¢ Gujarat, Karnataka, Maharasthra, Rajasthan, Uttar Pradesh & West Bengal are the states with more than 10 million jabs ā€¢ Tripura & Ladakh have vaccinated more than itā€™s 15% of the populations
  • 60. ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 61.
  • 62. ā€¢ Super-spreading events ā€¢ Transmission of infection in Quarantine hotels ā€¢ Infection from Asymptomatic & pre- symptomatic individuals ā€¢ More indoor transmission than outdoor transmission ā€¢ Nosocomial infection despite adequate personal protection
  • 63. ā€¢ Viable SARS-CoV-2 detection in the air; stayed infectious in the air for up to 3 h with a half-life of 1Ā·1 h ā€¢ Identified in air filters and building ducts in hospitals ā€¢ Transmission between caged animals connected only through air duct ā€¢ No strong or consistent evidence to refute the hypothesis of airborne SARS-CoV-2 transmission ā€¢ Limited evidence to support other dominant routes of transmission: respiratory droplet or fomite Lednicky JA, Lauzard M, Fan ZH, et al. Viable SARS-CoV-2 in the air of a hospital room with COVID-19 patients. Int J Infect Dis 2020; 100: 476ā€“82.
  • 64. Modes of prevention ā€¢ Hand hygiene ā€¢ Respiratory hygiene ā€¢ Social Distancing ā€¢ High risk group
  • 65. Home quarantine rules ā€¢ Stay in well-ventilated room ā€¢ Restrict movement ā€¢ Using separate bathroom ā€¢ Follow respiratory hygiene/hand hygiene specially if symptomatic ā€¢ Avoid visitors in house ā€¢ Household members use separate bathroom & bedroom ā€¢ Avoid sharing household items ā€¢ To remain free from any kinds of rumour & stigma
  • 66. ā€¢ Planning & development ā€¢ Current scenario ā€¢ Vaccine types & mechanisms ā€¢ Efficacy & action against variants ā€¢ Chief vaccines & trial results ā€¢ Other approved vaccines & vaccines pending authorization ā€¢ Distribution & inequality concerns ā€¢ Indiaā€™s vaccine development & distribution ā€¢ General prevention strategies ā€¢ Hospital preparedness
  • 67. Components How Should U.S. Hospitals Prepare for Coronavirus Disease 2019 (COVID-19)? Ann Intern Med. Published online March 11, 2020. doi:10.7326/M20-0907
  • 68. Preparing for Triage ā€¢ At healthcare facility entrance to direct patients to ā€“ Telemedicine facility ā€“ Those with fever and respiratory symptoms like cough or breathing difficulty ā€“ immediately proceed to triage or registration desk ā€¢ Additional symptoms to consider ā€“ Chills ā€“ Repeated shaking with chills ā€“ Muscle pain ā€“ Headache ā€“ Sore throat ā€“ New loss of taste or smell https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
  • 69. Protecting the healthcare personnel ā€¢ Install physical barriers (e.g. glass/plastic screens) at registration desk with 1 m at-least distance ā€¢ Identify isolation rooms or separate well- ventilated rooms for suspected patients ā€¢ Provide masks/ face covers for all patients visiting the HCF ā€¢ Convenient access to hand hygiene products ā€¢ Should wear gowns, gloves, face mask, and eye protection ā€¢ Only doing emergency procedures ā€¢ Mandatory telemedicine facilities
  • 70. Sample visual alerts to post at facility entry
  • 72. Fans in isolation wards ā€“ key factors ā€¢ Cool ambient temperature through dissipation of radiant heat ā€¢ Provide directionality in order to improve ventilation ā€¢ Direction of fans should deflect air away from health care workers
  • 73. How to ensure surgeons safety ā€¢ Elective surgeries should be postponed ā€¢ Take precautions when performing Aerosol- Generating Procedures (AGPs) ā€¢ Operating rooms should be allocated and signs posted on the doors to minimize staff exposure ā€¢ If no general anesthesia: ā€“ Patient should continue to wear the surgical mask ā€¢ If general anesthesia used: ā€“ Place a HEPA filter between the Y-piece of the breathing circuit and the patient's mask, endotracheal tube or laryngeal mask airway ā€“ If available, use a closed suction system during airway suctioning https://journals.lww.com/annalsofsurgery/Documents/Managing%20COVID%20in%20Surgical%20Systems%20v2.pdf https://www.asahq.org/about-asa/governance-and-committees/asa-committees/committee-on-occupational-health/coronavirus https://doi.org/10.1007/s12630-020-01617-4
  • 74. Take home messages ā€¢ COVID vaccination is one of the greatest & fastest scientific discovery of mankind ā€¢ India didnā€™t lag behind in technological expertise to build a top quality vaccine indigenously ā€¢ US EU nations have vaccinated in pretty organized manner ā€¢ India had started vaccination in a quite efficient manner but anti-vaccination campaigning dampened the spirit initially ā€¢ The second wave & appearance of variants have compelled citizens to take jabs currently ā€¢ Prevention strategies should be very proper in health care settings ā€¢ Telemedicine facilities needs to be encouraged
  • 76.
  • 77. Hand hygiene DO ā€¢ Hand washing with soaps & water for at-least 40 sec or using alcohol based handrubs ā€¢ Especially after you have been in a public place, or after blowing your nose, coughing, or sneezing ā€¢ Of your hands and rub them together until they feel dry DONT Touch your eyes, nose, and mouth with unwashed hands touch surfaces like door knobs and door bells, elevator buttons,handrails, support handles, chair backs, atm , mobiles
  • 78. Respiratory hygiene Do ā€¢ Use handkerchief/tissue while coughing/sneezing ā€¢ Throw the tissue immediately in dustbin ā€¢ Cover sneeze into bent upper arm ā€¢ Wash hands immediately DONT ā€¢ Spit in open ā€¢ Use other ways of covering face
  • 79. Social distancing Do ā€¢ STAY AT HOME UNLESS ABSOLUTELY NECESSARY ā€¢ KEEP A DISTANCE OF AT LEAST ONE METER BETWEEN YOURSELF AND ANOTHER PERSON Dont ā€¢ DO NOT HOLD EVENTS WHEREPEOPLE HAVE TO GATHER (EVEN IF IT IS A CORNER MEETING WITH THREE OR FOUR FRIENDS, OR AN EVENING CHAT ON THE CHAUPAL) ā€¢ ā€¢DO NOT GO TO CROWDED PLACES LIKE MARKETS, SHOPPING, MELAS, PARTIES ā€¢ ā€¢DO NOT USE PUBLIC TRANSPORT
  • 80. ZyCoV-D vaccine ā€¢ DNA vaccine ā€¢ Plasmid expressing SARS-CoV2 protein ā€¢ First of its kind ā€¢ On its way to becoming the 1st DNA vaccine to get approval ā€¢ 1st vaccine to get authorization between age group 12-18
  • 81. Vaccines approved below 18 yrs of age ā€¢ Pfizer approved for age 12-16 ā€¢ Pfizer/Moderna/Novavax/Johnson undergoing trial for children from 6 months to 11 years ā€¢ Covaxin undertaking trial in children ā€¢ Bharat biotechā€™s nasal vaccine incorporated children
  • 82. Clotting abnormalities in OA vaccines ā€¢ Blood coagulation with thrombocytopenia to be listed as very rare S/E of Vaxzevria ā€¢ Generally occurring within 2 weeks ā€¢ Mostly in women < 60 years ā€¢ Among 20 million vaccination, only 25 cases reported ā€¢ Examples: CVT/splanchnic venous thrombosis ā€¢ Pathology similar to HIT ā€¢ Possibly antibody developing against P4 ā€¢ All cases notified from Europe only; notably UK ā€¢ Benefit outweighs risk