Vaccination is the most cost effective means to protect yourself against Covid-19

1. Essential Information on Covid-19 vaccination
Developing Vaccine at Pandemic Speed
&
using it to control the pandemic

2. Eradication of Small Pox, Near Elimination of Polio & Neonatal Tetanus & Reduction of Measles have been possible by vaccines
20 additional vaccines have prevented 2 to 3 million deaths annually
Vaccines are considered the
safest & most cost effective
intervention for control of
Covid – 19 disease & to bring
an end to this pandemic by
providing individual protection
& subsequently Herd Immunity

4. Consequence of whole genome of nCoV being
available by 10th Jan 2020
Diagnostics
• Identification of SARS CoV 2
• RT PCR base on N gene
(CDC,USA)
• RT PCR based on E & RdRp
genes by Koch Institute, Berlin
• RT LAMP
• Crispr
Vaccines
• mRNA vaccine design
• DNA vaccine using Viral vector
design
• Both novel approaches had been
tried for HIV & HCV and
• Gene therapy
• Correlates of immunity

5. 103, 989, 900
2, 260, 259
2 %
2021

6. Vaccines
Most cost effective approach
once immune correlates of protection are known
1. Viral culture / Gene sequence
2. Cell line in which it grows (Vero)
3. Immune equivalent of protection
4. Animal model : Syrian Hamster & monkey
5. Method of delivery
6. Clinical Trials: Safety, Immunogenicity Protection
(Efficacy)
7. Manufacturing
8. Logistics of getting it to the end user

8. VACCINE DEVELOPMENT
Failure is the norm

9. • The longitudinal tracking of re-exposure after the disappeared symptoms of the
SARS-CoV-2-infected monkeys :
• weight loss in some monkeys, viral replication mainly in nose, pharynx, lung and
gut, as well as moderate interstitial pneumonia at 7 days post-infection (dpi) were
clearly observed in rhesus monkeys after the primary infection.
• After the symptoms were alleviated and the specific antibody tested positively,
• half of infected monkeys were re-challenged with the same strain
• Neither viral loads in nasopharyngeal and anal swabs along timeline nor viral
replication in all primary tissue compartments at 5 days post-reinfection (dpr) was
found in re-exposed monkeys.
• Monkeys with re-exposure showed no recurrence of COVID-19, similarly to the
infected monkey without re-challenge.
Bao et al: Beijing Key Laboratory for Animal Models of Emerging and Remerging Infectious Diseases

11. Types of Possible vaccines

12. Operation warp speed vaccine candidates
Goal: deliver 300 million doses by Jan 2020
125 potential vaccine candidates
14 candidates in May 2020
progress with 5
Candidate Technology Single Doses Stage Support
Moderna (mRNA 1273) Messenger RNA No Phase 2a 483 million
BioNTech / Fusan /Pfizer Messenger RNA Potentially Phase 1-2 Nil
Merck / International AIDS
vaccine initiative
Recombinant vesicular stomatitis
virus vector
Unknown Preclinical 38 million
J & J Replicative defective human
adenovirus 26 vector
Yes Phase 2a 456 million
Astra Zeneca / Oxford Univ Replication defective simian
adenovirus vector
Yes Phase 2a 1.2 billion
Biomedical Advanced Research & Development Authorities (BARDA) part of HHS

13. mRNA rRNA tRNA
m
Adeno Virus Replication deficient Viral Vector

20. Covid-19 Vaccines in different stages of development
Type of vaccine Preclinical Phase I Phase I/II Phase II Phase II/III Phase III Licensed
Virus Live
attenuated
3 1
Inactivated 11 1 2 1 3 1
Viral vector Replicating 18 1 2 1
Non
replicating
26 6 4 1
Nucleic acid DNA 16 2 5
RNA 29 2 2 1 1 2
Protein
based
Protein
subunit
64 9 5 2 1
Virus like
particle
17 1 1
Not
disclosed
31 3
Total 215 25 17 5 1 10 4*

21. Indian Landscape of Covid-19 vaccines
Product Indian Manufacturer Collaborator Stage
Covishield Serum Institute of India Astra Zeneca /Oxford Licensed
Covaxin Bharat Biotech International ICMR [Phase III] EUA Licensed
ZyCo V-D Cadila Healthcare Dept of Biotechnology Phase II  III
Sputinik V Trial & manufacture in India Dr Reddy’s
Lab; Mankind Pharma for distribution
Gamaleya National Centre,
Russia
III  review
NVX-CoV 2373
Protein subunit
Serum Institute of India Novavax II/III
R Protein Antigen based Biological E MIT, USA I/II
HGCO 19
(mRNA based)
Genova HDT, USA PC
Inactivated rabies
vector platform
Bharat Biotech International Thomas Jefferson Univ,
USA
PC
Vesiculo Vax Platform Aurobindo Pharma Aurovaccine, USA PC

22. MoHFW Covid-19 Vaccines Fact sheet
• Authorized Age Group:
• 18 years and above
• Co-administration of vaccine:
• If required Covid-19 vaccine and other vaccines should be separated by an
interval of at least 14 days
• Interchangeability of Covid-19 Vaccines:
• Not permitted. Second dose should also be of the same Covid-19 vaccine
which was administered as the first dose.*
• [UK is going to initiate Pfizer followed by Oxford & vice versa]
• [Prime with Oxford, boost with Sputnik V as both contain Adenovirus vector]

23. Contraindicated
• Persons with history of:
– Anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine
– Anaphylaxis or allergic reaction to vaccines or injectable therapies,
pharmaceutical products, food-items etc.
• Pregnancy and Lactating women.
MMWR on Pfizer Vaccine

24. Provisional / Temporary contra-indication
• Defer Covid Vaccination for 4-8 weeks after recovery
• 1. Persons having active symptoms of COIVD-19 infection.
• 2. COVID-19 patients who have received monoclonal antibodies or
convalescent plasma
• 3. Acutely unwell and hospitalized (with or without intensive care) patients
due to any illness
• Special Precautions:
• Administer with caution in persons with history of any bleeding or
coagulation disorder.

25. Conditions Not Contraindicated
• Persons with a past history of COVID infection*
• Chronic diseases and morbidities (cardiac, neurological, pulmonary,
metabolic, renal, malignancies)
• Immuno-deficiency, HIV, patients on immune suppression due to any
condition (the response to the COVID-19 vaccines may be less in
these individuals)

26. Approved for use in India

27. Covid 19 vaccines in the pipeline in India
ZyCo V- D of Cadila (DNA vaccine) Sputnik V (Human Adenovirus vaccine) r Protein vaccine of Biological E

28. Information for Healthcare Professional
Covishield
• One Dose = 0.5 ml IM, contains 5 x 1010 viral particles (vp)
• Recombinant, replication-deficient chimpanzee adenovirus vector
encoding SARS CoV 2 Spike (S) glycoprotein, produced in genetically
modified human embryonic kidney (HEK) 293 cells
• Solution is colourless to slightly brown, clear to slightly opaque
• Particle free, pH 6.6
• Donot shake before use
• Two doses of 0.5 ml each IM (preferably Deltoid) , 4 to 12 weeks apart
• Complete vaccination course using same vaccine

29. • Elderly (> 65 yrs); No dosage adjustment required
• Paediatrics : Not approved for children < 18 yrs
• Contraindications: hypersensitivity to active substance or excipients
• Concurrent illness: postpone if there is an acute severe febrile illness
• But, Minor infections, eg. Cold, low grade fever shouldnot delay vaccination
• Thrombocytopenia & coagulation disorders. Give with caution
• Immunocompromised: no data
• Duration & level of protection: not yet established, but > 6 months
• Interchangeability : no data
• Sodium: 1 mmol sodium (23 mg) per dose, essentially sodium free
Information for Healthcare Professional
Covishield

30. • Fertility, pregnancy, lactation
• Pregnancy: limited experience, no direct or indirect harmful effect
• Breast feeding : unknown if vaccine is excreted in human milk
• Fertility : no direct or indirect harmful effect
• Ability to drive & use machines
• No or negligible influence on ability to drive or use machines
Information for Healthcare Professional
Covishield

31. Summary of safety profile
Covishield
• all participants need to be followed up for 12 months
• Interim analysis of pooled data from 4 clinical trials in UK, Brazil &
South Africa
• 23,745 participants >18 yrs, randomised to covid or control vaccine
• 12,021 received at least one dose of Covid 19
• Medium duration of follow up 105 days post dose 1 & 62 days post
dose 2 [ideally one year]
• Age between 18 – 64 yrs 90.3%, >65 9.7%
• White 75.5%; Black 10.1% ; Asians 3.5
• Female 55.8% Male 44.2%

32. • Injection site tenderness > 60 %
• Injection site pain, headache, fatigue > 50 %
• Myalgia, malaise > 40 %
• Pyrexia, chills > 30 %
• Arthralgia, nausea > 20 %
• Most were mild to moderate & resolved within a few days
• By 7th day post dose local reaction in 4% ; systemic reaction 13%
• After Second dose, reactions were milder & less frequent
• Adverse reactions were milder & reported less frequently in older adults (>65)
• Paracetamol took care of most
Summary of safety profile
Covishield

33. Adverse Drug Reactions
Covishield
MedDRA SOC Frequency Adverse Reactions
Blood & lymphatic system Uncommon Lymphadenopathy
Metabolism & nutritional Uncommon Decreased appetite
Nervous system disorder Very common headache
Uncommon dizziness
Gastrointestinal Very common Nausea
Common Vomiting
Uncommon Abdominal pain
Skin & subcutaneous Uncommon Hyperhidrosis, pruritus, rash
Musculoskeletal & connective tissue Very common Myalgia, arthralgia
General disorders & administration site
conditions
Very common Injection site tenderness, pain, warmth, erythema,
pruritus, swelling, bruising, fatigue, pyrexia, chills
Common Injection site induration, influenza like illness
SOC System Organ Class
Very common (> 1/10); Common (>1/100 to <1/10); uncommon (><1/1000 to <1/100); rare (>1/10,000 to <1/1000)

34. Pharmacological Properties
Covishield
• Mechanism of action : Covishield is a monovalent vaccine composed of a
single recombinant replication deficient chimpanzee adenovirus (ChAdOx1)
vector encoding the S glycoprotein of SARS CoV 2.
• Following administration the S glycoprotein of SARS CoV 2 is expressed
locally stimulating neutralizing antibodies and CMI
• Clinical efficacy: all participants need to be followed up for 12 months
• Study enrolment excluded participants with history of anaphylaxis or
angioedema, severe CVS, GIT, Liver, Renal, Metabolic or Neurological
disease
• Two doses were administered but because of logistical constrains interval
between dose 1 and dose 2 ranged from 4 to 26 weeks.
• One group in UK was administered half the standard dose

35. Covishield Efficacy against Covid-19
Population Covishield Vaccine Control Vaccine efficacy
% (CI)
N Number of Covid-19 cases N Number of covid-19 cases
Primary 5,807 5,829
Covid-19 cases 30
(0.52)
101
(1.73)
70.42
(58.84 80.63)
Hospitalization 0 5 (0.09)
Severe disease 0 1 (0.02)
Any dose 10,014 10,000
Covid-19 cases
after dose 1
108
(1.08)
227
(2.27)
52.69
(40.52 62.37)
Hospitalization
after dose 1
2
(0.02)
16
(0.16)
Severe disease
after dose 1
0 2
(0.02)

36. SARS CoV 2 S binding antibody response to Covishield
Population Baseline 28 days after dose 1 28 days after dose 2
GMT
(95% CI)
GMT
(95% CI)
GMT
(95% CI)
Overall N= 882
57.18
(52.8 62.0)
N = 817
8,386.46
(7758.6 9065.1)
N = 819
29,034.74
(22118.2 31086.7)
Dose interval
< 6 weeks (N = 481)
60.51
(54.1 67.7)
(N = 479)
8734.08
(7883.1 9676.9)
(N = 443)
22222.73
(20360.5 24,255.3)
6 – 8 weeks ( N = 137)
58.02
(N = 99)
7295.54
( N= 116)
24363.1
9 – 11 weeks ( N = 110)
48.79
(N = 87)
7492.98
(N = 106)
34754.1
> 12 weeks (N = 154)
52.98
(44.4 63.2)
(N = 152)
8618.17
(7195.4 10322.3)
(N = 154)
63181.59
(55180.1 72343.4)

37. Titre Number
 100 11
91 – 100 7
81 – 90 9
71 – 80 9
61 – 70 11
51 – 60 16
41 – 50 26
31 – 40 41
21 – 30 60
11 – 20 80
>1 251
< 1 1919
TNP 18
Total negative 2271
Total Positive 552
Titre Number
 1000 2
 500 1
> 400 1
300 – 399 17
200 – 299 58
100 – 199 275
80 – 99 103
40 – 79 294
15 – 39 368
12 – 15 58
< 12 1120
< 3.5 1462
TNP 28
Total Negative 2582
Total Positive 1119
Total Antibodies against NCP IgG Antibodies against S1/S2
N = 2841 N = 3787

38. Information for Healthcare Professional
Covaxin
• One Dose = 0.5 ml IM, each vial contains 20 doses
• Shelf life is 6 months, store between 2 and 8 C
• Solution is white translucent
• Shake well before use
• Freeze sensitive, discard if frozen or presence of particulate matter
• Two doses of 0.5 ml each IM (preferably Deltoid) , 4 weeks apart
• Complete vaccination course using same vaccine

39. Covaxin

40. 4 arms, 3 vaccine + 1 control
3ug Algel-IMDG; 6 ug Algel-IMDG; 6Ug Algel; Algel
2 doses IM, 14 days (accelerated schedule)
Primary end points: 1. Reactogencity; 2. Safety
Secondary: 1. Immunogencity
anti spike IgG, Nx, CMI
Results:
Mild reactions, absent in majority, quickly resolved
Less after second dose
Robust immune response comparable to convalescent plasma
No significant difference between 3 & 6 ug Algel-IMDG
Nx antibodies detected
CMI was biased to a Th 1 phenotype
Covaxin

41. • Objective: Immunogenicity & Safety of BBV 152
• 380 healthy children & adults; 2 arms: 3 ug Algel-IMDG & 6 ug Algel-IMDG
• 2 doses IM, 4 weeks apart
• Primary end point: Seroconversion (> 4 fold) based on Nx antibodies (PRNT)
• Secondary end point: Reactogenicity & Safety
• Results:
• PRNT50 seroconvertion of Nx on day 56 in 92.9 & 98.3%
• More Th 1 cytokines
• Reaction was 9.7 % & 10.3%
• Seroconvertion on day 104
• 3 ug Algel-IMDG 73.5% (63.6 81.9%)
• 6 ug Algel-IMDG 81.1% (71.4 88.1%)
• 6 ug Algel 73.1% (62.9 81.8%)
• 6 ug Algel IMDG was selected for Phase III efficacy trials
Covaxin

42. Covaxin

43. Covaxin

44. Covaxin

45. Cell Mediated Immune Response
Covaxin

46. Covaxin

47. Information for Healthcare Professional
Pfizer mRNA Vaccine
• One multidose vial must be diluted before use, 1 vial (0.45 ml) contains 5 doses
30 microgram of BNT 162b2 RNA (embedded in lipid nanoparticles)
• Covid-19 mRNA Vaccine BNT 162b2 is highly purified single stranded, 5’-capped
messenger RNA (mRNA) produced by cell free in vitro transcription from the
corresponding DNA templates, encoding the viral spike (S) protein of SARS CoV -2.
• Pharmaceutical form : concentrate for solution for injection. The vaccine is a
white to off white frozen solution
• Active immunization to prevent Covid-19, in 16 yrs and older
• Two doses of 0.3 ml each IM (preferably Deltoid) , 21 days apart
• Complete vaccination course using same vaccine, no data on interchangeability
• Individuals maynot be maximally protected until atleast 7 days after their second
dose of the vaccine.
• The multidose vial is stored frozen and must be thawed prior to dilution.

53. • Elderly (> 65 yrs); No dosage adjustment required
• Paediatrics : Not approved for children < 16 yrs
• Contraindications: hypersensitivity to active substance or excipients
• Concurrent illness: postpone if there is an acute severe febrile illness
• But, Minor infections, eg. Cold, low grade fever shouldnot delay vaccination
• Thrombocytopenia & coagulation disorders. Give with caution
• Immunocompromised: no data
• Duration & level of protection: not yet established, but > 6 months
• Interchangeability : no data
• Potassium: 1 mmol potassium (39mg) per dose, essentially potassium free,
contains less than 1 mmol sodium (23 mg) per dose, so essentially sodium free
Information for Healthcare Professional
Pfizer mRNA Vaccine

54. • Fertility, pregnancy, lactation
• Pregnancy: limited experience, no direct or indirect harmful effect
• Breast feeding : unknown if vaccine is excreted in human milk
• Fertility : no direct or indirect harmful effect
• Ability to drive & use machines
• No or negligible influence on ability to drive or use machines
Information for Healthcare Professional
Pfizer mRNA Vaccine

55. Summary of safety profile
Pfizer mRNA Vaccine
• all participants need to be followed up for 12 months
• Interim analysis of pooled data from 2 clinical trials in USA, Europe,
Turkey, South Africa & South America.
• Sudy 1 enrolled 60, study 2 enrolled 44,000 participants, 12 yrs &
above; atleast 21,720 participants 16 yrs or older received atleast one
dose; 19,063 of participants evaluated for safety 2 months after
second dose
• 51.5% males; 48.5% females
• White 82.1%; Blacks 9.6%; Hispanics 26.1%; Asian 4.3% ; Native
Americans 0.7%

56. • Injection site tenderness > 80 %
• Injection site pain, headache, fatigue > 50 %
• Myalgia, malaise > 30 %
• chills > 30 %
• Arthralgia, nausea > 20 %
• Pyrexia > 10 %
• Most were mild to moderate & resolved within a few days
• By 7th day post dose local reaction in 4% ; systemic reaction 13%
• After Second dose, reactions were milder & less frequent
• Adverse reactions were milder & reported less frequently in older adults (>65)
Summary of safety profile
Pfizer mRNA Vaccine

57. Adverse Drug Reactions
Pfizer mRNA Vaccine
MedDRA SOC Frequency Adverse Reactions
Blood & lymphatic system Uncommon Lymphadenopathy
Immune system disorders Not known Anaphylaxis, hypersensitivity
Nervous system disorder Very common headache
rare Acute peripheral facial paralysis [4 in vaccine group]
Gastrointestinal common Nausea
Musculoskeletal & connective tissue Very common Myalgia, arthralgia
General disorders & administration site
conditions
Very common Injection site tenderness, pain, warmth, erythema,
pruritus, swelling, bruising, fatigue, pyrexia, chills
Common Injection site induration, influenza like illness
Uncommon Malaise
SOC System Organ Class
Very common (> 1/10); Common (>1/100 to <1/10); uncommon (><1/1000 to <1/100); rare (>1/10,000 to <1/1000)

58. Pharmacological Properties
Pfizer mRNA Vaccine
• Mechanism of action : The nucleoside modified messenger RNA in Covid-
19 mRNA vaccine BNT 162n2 is formulated in lipid nanoparticles, which
enables delivery of the RNA into host cells to allow expression of SARS CoV-
2 S antigen. The vaccine elicits both neutralizing antibodies & cellular
immune responses to the spike (S) antigen
• Clinical efficacy in 16 yrs and older: it is planned to follow up all
participants for 24 months
• Study enrolment excluded participants with history of anaphylaxis or
angioedema, severe CVS, GIT, Liver, Renal, Metabolic or Neurological
disease
• Two doses were administered 21 days apart

59. Pfizer mRNA Vaccine Efficacy against Covid-19
Population Covishield Vaccine Control Vaccine efficacy
% (CI)
N Number of Covid-19 cases N Number of covid-19 cases
Primary 2214 2222
Covid-19 cases 9 172 95
(90.3 97.6)
Participants
> 65 yrs
> 75 yrs
94.7%
66.7 99.9

61. S1 binding IgG
Pfizer mRNA Vaccine
18 – 55 yrs of age 65 – 85 yrs of age

62. 50% Neutralization Titre
Pfizer mRNA Vaccine
18 – 55 yrs 65 – 85 yrs

63. Information for Healthcare Professional
Moderna
• Multidose vial, one vial contains 10 doses
• One dose (0.5 ml) contains 100 microgram of mRNA (embedded in lipid
nanoparticles) to persons 18 yrs or older
• Covid-19 mRNA vaccine is single stranded 5’capped messenger RNA
(mRNA) produced by using cell free in vitro transcription, encoding the pre-
fusion stabilized Spike (S) glycoprotein of SARS CoV-2.
• Phramaceutical form : Dispersion for injection
• White to off white frozen dispersion (pH 7 to 8).
• Vaccine Moderna is a two dose regimen. Each dose is 0.5 ml. second dose
should be administered after 28 days.
• No data on interchangeability

64. • Paediatrics : Not approved for children < 18 yrs
• Contraindications: hypersensitivity to active substance or excipients
• Anaphylaxis has been reported. Close observation for atleast 15 minutes after
vaccination is recommended.
• Donot give second dose to those who experienced severe allergic reaction.
• Anxiety related reaction including vasovagal reactions (syncope),
hyperventilation or stress related reactions may occur.
• Precautions must be in place to prevent injury from fainting.
• Efficacy, safety & immunogenicity have not been assessed in
immunocompromised individuals
• Should be administered with caution in persons with bleeding disorders such
as haemophilia or those on anticoagulant therapy.
Information for Healthcare Professional
Moderna

65. • Postpone in individuals with severe febrile illness
• Protection maynot occur until 14 days after second dose
• Duration of protection is unknown.
• Fertility, pregnancy, lactation
• Pregnancy: limited experience, no direct or indirect harmful effect
• Breast feeding : unknown if vaccine is excreted in human milk
• Fertility : no direct or indirect harmful effect
• Ability to drive & use machines
• No or negligible influence on ability to drive or use machines
Information for Healthcare Professional
Moderna

66. Summary of safety profile
Moderna
• all participants need to be followed up for 12 months
• Interim analysis one phase III trial in USA involving 30,351 individuals
18 years or older
• Mean age 52 yrs (range 18 – 95); 22,831 (75%) of participants were
18 to 64 yrs of age and 7520 (24.8%) were older than 65 yrs.

67. • Injection site pain > 92 %
• fatigue > 70 %
• Headache > 65 %
• Myalgia > 62 %
• Arthralgia > 46 %
• Chills > 46 %
• nausea / vomiting > 23 %
• Most were mild to moderate & resolved within a few days
• Adverse reactions were milder & reported less frequently in older adults (>65)
• Paracetamol took care of most
Summary of safety profile
Moderna

68. Adverse Drug Reactions
Moderna
MedDRA SOC Frequency Adverse Reactions
Blood & lymphatic system Very common Lymphadenopathy
Immune system disorders Not known Anaphylaxis
Not known hypersensitivity
Nervous system disorder Very common Headache
Gastrointestinal Very common Nausea / Vomiting
Skin & subcutaneous common rash
Musculoskeletal & connective tissue Very common Myalgia, arthralgia
General disorders & administration site
conditions
Very common Injection site pain, fatigue, pyrexia, chills
Common Injection site erythema
Injection site urticarial
Injection site rash
SOC System Organ Class
Very common (> 1/10); Common (>1/100 to <1/10); uncommon (><1/1000 to <1/100); rare (>1/10,000 to <1/1000)

69. Pharmacological Properties
Moderna
• Mechanism of action : Covid-19 Vaccine Moderna encodes for the pre-
fusion stabilized Spike protein of SARS CoV-2. After IM injection, cells at the
site take up lipid nanoparticles, effectively delivering the mRNA sequence
into cells for translation into protein. The mRNA delivery system is based
on the principle and observation that cells in vivo can take up mRNA,
translate it, and express viral protein antigen in the desired conformation.
The delivered mRNA doesnot enter the cellular nucleus or interact with the
genome, is nonreplicating and is expressed transiently. Both T cell & B cell
responses are elicited.
• Clinical efficacy: all participants need to be followed up for 12 months
• Subjects were 18 yrs and older. Pre specified cohorts either > 65 or with
comorbidity were included.

70. Moderna Efficacy against Covid-19
Age
group
Moderna Covid-19 vaccine Placebo % Vaccine
Efficacy
(95% CI)
Subjects Covid-19
cases
Incidence
rate per
1000
persons-yrs
Subjects Covid-19
cases
Incidence
rate per
1000
persons-yrs
Overall
( > 18)
14,134 11 3.328 14,073 185 56,510 94.1
(89.3 96.8)
18 –
< 65
10,551 7 2.875 10,521 156 64.625 95.6
(90.6 97.9)
> 65 3, 583 4 4. 595 3,552 29 33.728 86.4
(61.4 95.2)
 65
< 75
2,953 4 5.586 2,864 22 31.744 82.4
(48.9 93.9)
75 630 0 0 688 7 41.968 100

75. Shelf Life
Moderna
• 7 months at –25C to – 15 C
• After thawing
• Shouldnot be refrozen
• May be stored at 2 C to 8 C protected from light for up to 30 days
• Chemical & physical stability of unopened vial after removal from refrigerated
conditions is 12 hours at 8 C to 25 C
• Donot refreeze
• Punctured vial : chemical & physical in use stability is 6 hours at 2 to 25 C

76. Indicators Covishield Covaxin Pfizer Moderna
Type Chimpenzae Adenovirus
with spike DNA of SARS
CoV2
Killed whole cell mRNA of spike protein mRNA of spike protein
No. of doses 10; 5x 1010 viral
particles
20 ; 6 ug in Alum IMDG 5 ; 30 ug of mRNA 10; 100 ug mRNA
Shelf life 6 M 6 M 6 M 7 M
Storage
conditions
2 – 8 C 2 - 8 C --70 C -- 20 C
Physical
appearance
Clear White translucent Frozen White frozen dispersion
Route IM IM IM IM
Dose 0.5 ml 0.5 ml 0.3 ml 0.5 ml
Course 2 doses, 28 days apart 2 doses 28 days apart 2 doses 21 days apart 2 doses 28 days apart
Participants in
clinical trial
23,745
12021 atleast one dose
28,000 underway 44,000; 21720 atleast
one dose; 19,063 two
doses
30,351
Volunteers > 65 9.7% ?? ++ 7520 (24.8%)
Volunteers > 75 0 ?? + 630
Youngest
approved
> 18 > 18 > 12 > 18

77. Indicator Covishield Covaxin Pfizer Moderna
Side effects
Local
Systemic
60 % local tenderness
Headache
9.7 %
10.3 %
80 % local tenderness
A few anaphylaxis
92 % injection site
pain
Bells palsy
Immunogenicity
Anti Spike
PRNT
1st dose: 8386 AU/ml
2nd dose: 29,034 AU/ml
If 12 wks:
63,181 AU/ml
Seroconversion
81.1%
PRNT 98.3%
Th1 response
104 on day 28
103 in 65 to 85 yrs old
PRNT 103 on day 28
RBD ELISA 105 AU/ml
PRNT 1024 on day 42
Efficacy
Vaccinated
Control
70.42 %
30
101
No data in public
domain
95 %
9
172
94.1 %
11
185
Efficacy against
mutant strains
Wild
D614G (Doug)
N501Y (Nelly)
P681H (Pooh)
E484K (Eeek)
++
++
?
?
?
++
++
?
?
?
++
++
?
?
?
++
++
+
+
+
Suitability for India Yes Yes No No

78. Vaccines Near Approval
• 1. Sputnik V [ Viral vector using Human Adenovirus]
• 2. Johnson & Johnsons [single dose]
• 3. Novavax [effective against mutants]

79. Thyrocare Serosurveillance
results after 4,40,196
57
20
20
32
30
Covid 19 antibodies present
9 September
Place Number Tested Positive %
Bihar 47,094 14,982 31.87
Punjab 3,201 957 29.92
Andhra 20,148 6,018 29.91
Telangana 50,471 14,152 28.07
Gujarat 21,462 5,772 26.94
Delhi 18,273 4,697 25.75
Odisha 13,617 3,253 23.93
Chhatisgarh 3,291 775 23.61
West Bengal 39,998 9,177 22.97
Maharashtra 77,795 17,549 22.61
Uttra Pradesh 29,568 6,607 22.38
Madhya Pradesh 12,500 2,663 21.36
Haryana 10,596 1,779 16.83
Uttarakhand 953 129 13.56
Rajasthan 3,653 483 13.33
41
26

82. Implications of the available evidence
These analyses show that higher vaccine efficacy is obtained with a longer interval
between the first and second dose, and that a single dose of vaccine is highly efficacious
in the first 90 days, providing further support for current policy

84. 1. generated an isogenic Y501 SARS-CoV-2 on the genetic
background of the N501 clinical strain USA-WA1/2020,
2. Sera of 20 participants in the previously reported trial,1,2
drawn 2 or 4 weeks after immunization with two 30-μg
doses of BNT162b2 spaced three weeks apart, were
tested for neutralization of N501 and Y501 viruses by a
50% plaque reduction neutralization assay (PRNT50;
Figure 1).
3. The ratio of the 50% neutralization GMT of the sera
against the Y501 virus to that against the N501 virus was
1.46, indicating no reduction in neutralization activity
against the virus bearing the Y501 spike
Pfizer

85. Moderna

86. Next-Gen Vaccine For Covid-19 Mutants Will Be
Ready By Fall, AstraZeneca Says