covid19_mrna_vaccines_phase_3__wide.pptx

COVID-19 mRNA Vaccines
David H. Spach, MD
Professor of Medicine
Division of Infectious Diseases
University of Washington
Last Updated: January 31, 2021
mRNA-1273 and BNT162b2: Phase 3 Data
Sarah McGuffin, MD
Senior Fellow
Division of Infectious Diseases
University of Washington

Safety and Efficacy of BNT162b2 mRNA Covid-19 Vaccine
Published Data —Placebo-controlled, observer-blinded trial
Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Background
• BNT162b2 is a lipid nanoparticle– formulated nucleoside-modified RNA
encoding the SARS-CoV-2 full-length spike protein, modified by two proline
mutations to lock the protein in the prefusion conformation.

Study Design
Study Design
• Background: Phase 2/3 multinational, placebo-controlled, observer-blinded, BNT162b2 COVID-
19 vaccine safety and efficacy trial conducted between July 27, 2020 and November 14, 2020
• Location: Global (United States, Argentina, Brazil, South Africa, Germany, Turkey)
• Inclusion Criteria (n = 43,448)
- Age ≥16 years
- Healthy or with stable chronic medical conditions
• Exclusion Criteria
- History of Covid-19 infection
- Treatment with immunosuppressive therapy, diagnosis of immunocompromising condition
• Primary Endpoints
- Efficacy against confirmed Covid-19 at least 7 days after the second dose
- Solicited local or systemic adverse effects within 7 days of vaccination
- Unsolicited adverse events through 1 months after the second dose
- Unsolicited serious adverse events through 6 months after the second dose

Study Design
BNT162b2 30 μg (0.3 mL volume per dose), 2 IM doses, 21 days apart
Saline placebo, 2 IM doses, 21 days apart
or
Study Participant Groups

Baseline Characteristics: Gender Distribution for ALL Participants
50.6% 49.4%
Male Female

Baseline Characteristics: Age Distribution for ALL Participants
57.8% 42.2%
16-55 Years >55 Years

Baseline Characteristics, by Study Group
Baseline Characteristics
BNT162b2
(N=18,860)
Placebo
(N=18,846)
Male, n (%) 9,639 (51.1) 9,436 (50.1)
Female, n (%) 9,221 (48.9) 9,410 (49.9)
Race or ethnic group — no. (%)†
White 15,636 (82.9) 15,630 (82.9)
Black or African American 1,729 (9.2) 1,763 (9.4)
Asian 801 (4.2) 807 (4.3)
Native American or Alaska Native 102 (0.5) 99 (0.5)
Native Hawaiian or other Pacific Islander 50 (0.3) 26 (0.1)
Multiracial 449 (2.4) 406 (2.2)
Not reported 93 (0.5) 115 (0.6)
Hispanic or Latinx 5,266 (27.9) 5,277 (28.0)
Country— no. (%)
Argentina 2,883 (15.3) 2,881 (15.3)
Brazil 1,145 (6.1) 1,139 (6.0)
South Africa 372 (2.0) 372 (2.0)
United States 14,460 (76.6) 14,454 (76.7)
† Race or ethnic group was reported by the participants.

Baseline Characteristics, by Study Group
BNT162b2
(N=18,860)
Placebo
(N=18,846)
Age group — no. (%)
16–55 years 10,889 (57.7) 10,896 (57.8)
>55 years 7,971 (42.3) 7,950 (42.2)
Age at vaccination — years
Median 52.0 52.0
Range 16–89 16–91
Body-mass index (BMI)
≥30.0: obese 6,556 (34.8) 6,662 (35.3)

Outcomes Efficacy against Covid-19 ≥7 days after Second Dose*
Efficacy End Point BNT162b2 Placebo
Vaccine Efficacy, %
(95% Credible
Interval)‡
No. of Cases
Surveillance Time
(n)†
No. of Cases
Surveillance Time
(n)†
(N=18,198) (N=18,325)
Covid-19 occurrence ≥7 days
after second dose in participants
without evidence of existing or
prior SARS-CoV-2 infection
8 2.214 (17,411) 162 2.222 (17,511) 95.0 (90.3–97.6)
(N=19,965) (N=20,172)
Covid-19 occurrence ≥7 days
after second dose in participants
with and those without evidence
of prior SARS-CoV-2 infection
9 2.332 (18,559) 169 2.345 (18,708) 94.6 (89.9–97.3)
* The total population was 40,137. The total population without evidence of baseline infection was 36,523
† The surveillance time is the total time in 1,000 person-years for the given end point across all participants within each group at risk for the end point.
‡ Calculated with the use of a beta-binomial model with prior beta (0.700102, 1) adjusted for the surveillance time.

Vaccine Efficacy Overall and by Subgroups
Efficacy End Point
Subgroup
BNT162b2
(N=18,198)
Placebo
(N=18,325)
Vaccine Efficacy, %
(95% CI)†
No. of Cases
Surveillance time
(No. at Risk)*
No. of Cases
Surveillance time
(No. at Risk)*
Overall 8 2.214 (17,411) 162 2.222 (17,511) 95.0 (90.0–97.9)
Age group
16 to 55 years 5 1.234 (9,897) 114 1.239 (9,955) 95.6 (89.4–98.6)
>55 years 3 0.980 (7,500) 48 0.983 (7,543) 93.7 (80.6–98.8)
≥65 years 1 0.508 (3,848) 19 0.511 (3,880) 94.7 (66.7–99.9)
≥75 years 0 0.102 (774) 5 0.106 (785) 100.0 (−13.1–100.0)
Sex
Male 3 1.124 (8,875) 81 1.108 (8762) 96.4 (88.9–99.3)
Female 5 1.090 (8,536) 81 1.114 (8,749) 93.7 (84.7–98.0)
* The surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.
† The confidence interval (CI) for vaccine efficacy is derived according to the Clopper–Pearson method, adjusted for surveillance time.

Participants with Covid-19 After Second Dose
*Covid-19 at Least 7 Days after Second Dose of BNT162b Vaccine or Placebo
8
162
0
50
100
150
200
BNT162b2 Vaccine Placebo
Symptomatic
Covid-19
Infection
Vaccine Efficacy 95.0%
*Participants who had no evidence of existing or prior SARS-CoV-2 infection.

Participants with Covid-19 After First Dose
Covid-19 After First Dose of BNT162b Vaccine or Placebo
50
1
275
9
0
50
100
150
200
250
300
Symptomactic Covid-19 Severe Covid-19
Number
of
Participants BNT162b2 Vaccine Placebo

Vaccine Efficacy by Age Groups
5 3 1 0
114
48
19
5
0
25
50
75
100
125
16-55 Years >55 Years ≥65 Years ≥75 Years
Participants
with
Symptomatic
Covid-19
Age Group
BNT162b-2 Vaccine Placebo

Covid-19 During Study, Modified Intention-to-Treat Analysis
172
21
82
9
2
39
0 50 100 150 200 250
≥7 Days after Dose 2
Dose 2 to 7 Days after Dose 2
After Dose 1 to before Dose 2
Participants with Symptomatic Covid-19
BNT162b2 Vaccine
Placebo

Vaccine Efficacy Throughout Study, Modified-Intention-to-Treat Analysis
94.8
90.5
52.4
0 20 40 60 80 100
≥7 Days after Dose 2
After Dose 1 to before Dose 2
Vaccine Efficacy (%)

Local and Systemic Reactions Reported with 7 Days of Injection
Event BNT162b2 Placebo BNT162b2 Placebo
Age 16-55 years Age 16-55 years Age > 55 years Age > 55 years
Pain at injection site <7 days
After first dose 83% 14% 71% 9%
After second dose 78% 12% 66% 8%
Fatigue
Headache
Fever (≥38°C)
Use of antipyretic or analgesic

Results: Adverse Events
Adverse Event BNT162b2 (Na=21621) Placebo (Nb=21631)
Nb (%) Nb (%)
Any Event 5770 (26.7) 2638 (12.2)
Relatedc 4484 (20.7) 1095 (5.1)
Severe 240 (1.1) 139 (0.6)
Life-threatening 21 (0.1) 24 (0.1)
Any serious adverse event 126 (0.6) 111 (0.5)
Relatedc 4 (0.0) 0
Severe 71 (0.3) 68 (0.3)
Any adverse event leading to withdrawal 37 (0.2) 30 (0.1)
Relatedc 16 (0.1) 9 (0.0)
Severe 13 (0.1) 9 (0.0)
Death 2 (0.0) 4 (0.0)
aN = number of participants in the specified group. This value is the denominator for the percentage calculations.
bN = number of participants reporting ≥1 occurrence of the specified event category.
For ‘any event’, n = the number of participants reporting ≥1 occurrence of any event.
c Assessed by the investigator as related to investigational product.

Outcomes Vaccine Efficacy Overall and by Subgroup
Efficacy End Point
Subgroup
BNT162b2
(N=18,198)
Placebo
(N=18,325)
Vaccine Efficacy, %
(95% CI)†
No. of Cases
Surveillance time
(No. at Risk)*
No. of Cases
Surveillance time
(No. at Risk)*
Race or ethnic group‡
White 7 1.889 (14,504) 146 1.903 (14,670) 95.2 (89.8–98.1)
Black or African American 0 0.165 (1,502) 7 0.164 (1,486) 100.0 (31.2–100.0)
All others 1 0.160 (1,405) 9 0.155 (1,355) 89.3 (22.6–99.8)
Hispanic or Latinx 3 0.605 (4,764) 53 0.600 (4,746) 94.4 (82.7–98.9)
Non-Hispanic, non-Latinx 5 1.596 (12,548) 109 1.608 (12,661 95.4 (88.9–98.5)
Country
Argentina 1 0.351 (2,545) 35 0.346 (2,521 97.2 (83.3–99.9)
Brazil 1 0.119 (1,129 8 0.117 (1,121) 87.7 (8.1–99.7)
United States 6 1.732 (13,359) 119 1.747 (13,506) 94.9 (88.6–98.2)
* The surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.
† The confidence interval (CI) for vaccine efficacy is derived according to the Clopper–Pearson method, adjusted for surveillance time.
‡ Race or ethnic group was reported by the participants. “All others” included the following categories: American Indian or Alaska Native, Asian, Native Hawaiian or other Pacific
Islander, multiracial, and not reported.

Additional notes
• The cumulative incidence of Covid-19 cases over time among placebo and vaccine recipients begins to
diverge by 12 days after the first dose, 7 days after the estimated median viral incubation period of 5 days
• In the interval between the first and second doses, the observed vaccine efficacy against Covid-19 was
52%
- Some protection occurs as soon as 12 days after first dose
• Of the 10 cases of severe Covid-19 disease, only 1 was in vaccine group
- Provides preliminary evidence of vaccine-mediated protection against severe disease
- Provides preliminary evidence to alleviate concerns over vaccine-mediated disease enhancement

Study Limitations
• Median follow-up time of 2 months after the second dose limits probability of detecting
less common adverse events reliably
• Assessment of long-term vaccine safety and efficacy cannot be conducted in the context
of maintaining a placebo group for the planned follow-up period of 2 years after the
second dose
• Study did not address whether vaccine prevents:
- Asymptomatic Covid-19 infection
- Covid-19 in younger adolescents, children, pregnant women, and
immunocompromised individuals

Authors’ Conclusions
Conclusions: “A two-dose regimen of BNT162b2 conferred 95%
protection against Covid-19 in persons 16 years of age or older.
Safety over a median of 2 months was similar to that of other viral
vaccines.”

Efficacy and Safety of mRNA-1273 SARS-CoV-2 Vaccine
COVE Study
Published Data —Randomized, placebo-controlled, observer-blinded trial
Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
Background
• mRNA-1273 is a lipid-nanoparticle (LNP)-encapsulated mRNA vaccine expressing the
prefusion-stabilized spike glycoprotein

Study Design
Study Design
• Background: Phase 3 randomized, placebo-controlled, observer-blinded, mRNA-1273 COVID-19
vaccine safety and efficacy trial between July 27 and October 23, 2020 in the United States
• Inclusion Criteria (n = 30,420)
- Age ≥18 years
- At locations or circumstances putting the participant at an appreciable risk of SARS-CoV-2
infection and/or high risk of severe Covid-19
• Exclusion Criteria
- Known history of SARS-CoV-2 infection
- Pregnant or breastfeeding
- Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections
• Primary Endpoints
- Solicited and unsolicited local and systemic adverse events
- Prevention of symptomatic Covid-19 at least 14 days after the second injection
• Secondary Endpoints
- Prevention of severe Covid-19
- Efficacy of vaccine at preventing Covid-19 after a single dose
• Follow-up Time period: median follow-up duration ≥2 months after completing two-dose regimen

Study Design
Risk factors for Severe Covid-19 Illness
Participants who were younger than 65 years of age were categorized as at risk for severe
Covid-19 illness if they had at least one of the following:
• Chronic lung disease or moderate to severe asthma
• Significant cardiac disease
• Severe obesity (body mass index ≥40 kg/m2 )
• Diabetes
• Liver disease
• HIV infection

Study Design
mRNA-1273 100 μg (0.5 mL), 2 IM doses, 28 days apart
(n = 15,181)
Saline placebo, 2 IM doses, 28 days apart
(n = 15,170)
or
Study Participant Groups

Baseline Characteristics: Gender Distribution for ALL Participants
52.7% 47.3%
Male Female

Baseline Characteristics: Age Distribution for ALL Participants
24.8%
58.6%
16.7%
Age ≥65 Years
Age <65 Years,
not at risk for severe COVID-19
Age <65 Years,
at risk for severe COVID-19

Baseline Characteristics, by Group
Placebo
(N=15,170)
mRNA-1273
(N=15,181)
Sex — no. of participants (%)
Male 8,062 (53.1) 7,923 (52.2)
Female 7,108 (46.9) 7,258 (47.8)
Mean age (range) — years 51.3 (18–95) 51.4 (18–95)
Age category and risk for severe Covid-19 — no. (%)
18 to <65 years, not at risk 8,886 (58.6) 8,888 (58.5)
18 to <65 years, at risk 2,535 (16.7) 2,530 (16.7)
≥65 years 3,749 (24.7) 3,763 (24.8)
Risk factor for severe Covid-19 — no. of participants (%)
Chronic lung disease 744 (4.9) 710 (4.7)
Significant cardiac disease 744 (4.9) 752 (5.0)
Severe obesity 1,021 (6.7) 1,025 (6.8)
Diabetes 1,440 (9.5) 1,4 1,435 (9.5)
Liver disease 96 (0.6) 10 100 (0.7)
HIV infection 87 (0.6) 92 (0.6)
BMI, mean ± SD 29.3± 6.7 29.3±6.9

Placebo
(N=15,170)
mRNA-1273
(N=15,181)
Hispanic or Latino ethnicity — no. of participants (%)‡
Hispanic or Latino 3,114 (20.5) 3,121 (20.6)
Not Hispanic or Latino 11,917 (78.6) 11,918 (78.5)
Not reported and unknown 139 (0.9) 142 (0.9)
Race or ethnic group — no. of participants (%)‡
White 11,995 (79.1) 12,029 (79.2)
Black or African American 1,527 (10.1) 1,563 (10.3)
Asian 731 (4.8) 651 (4.3)
American Indian or Alaska Native 121 (0.8) 112 (0.7)
Native Hawaiian or other Pacific Islander 32 (0.2) 35 (0.2)
Multiracial 321 (2.1) 315 (2.1)
Other 316 (2.1) 321 (2.1)
Not reported and unknown 127 (0.8) 155 (1.0)
‡ Race or ethnic group was reported by the participant. Participants could be included in more than one category.

Baseline Characteristics Placebo
(N=15,170)
mRNA-1273
(N=15,181)
Baseline SARS-CoV-2 status — no. of participants (%)§
Negative 14,598 (96.2) 14,550 (95.8)
Positive 337 (2.2) 343 (2.3)
Missing data 235 (1.5) 288 (1.9)
Baseline RT-PCR test — no. of participants (%)
Negative 14,923 (98.4) 14,917 (98.3)
Positive 95 (0.6) 87 (0.6)
Missing data 152 (1.0) 177 (1.2)
Baseline binding antibody anti–SARS-CoV-2 assay —
no. of participants (%)
Negative 14,726 (97.1) 14,690 (96.8)
Positive 303 (2.0) 305 (2.0)
Missing data 141 (0.9) 186 (1.2)
§Baseline SARS-CoV-2 status was positive if there was immunologic or virologic evidence of previous illness with Covid-19, as
defined by a positive RT-PCR test or a positive binding antibody against SARS-CoV-2 at day 1.

Vaccine Efficacy
11
0
185
30
0
50
100
150
200
250
Symptomactic Covid-19 Severe Covid-19
Number
of
Participants
mRNA-1273 Vaccine Placebo
Vaccine Efficacy 94.1%

Incidence Rate and Vaccine Efficacy, Based on Type of Analysis
3.3 5.6
56.5
79.8
0
20
40
60
80
100
120
Per-Protocol Analysis Modified Intention-to-Treat Analysis
Incidence
Rate
per
1,000
Person-Years
Vaccine Efficacy 94.1% Vaccine Efficacy 93.0%

Incidence Rate and Vaccine Efficacy, Based on Age Group
7 4
156
29
0
50
100
150
200
≥18 to <65 Years ≥65 Years
Participants
with
Symptomatic
Covid-19
Age Group
Vaccine Efficacy 95.6% Vaccine Efficacy 86.4%

Vaccine Efficacy During Study, Modified Intention-to-Treat Analysis
204
19
35
11
12
0
2
5
0 50 100 150 200 250
Starting 14 Days after Dose 2
14 Days after Dose 1 to Dose 2
Randomization to 14 Days after Dose 1
Participants with Symptomatic Covid-19
mRNA-1273 Vaccine
Placebo

Vaccine Efficacy
Endpoint
Placebo
(N=14,073)
mRNA-1273
(N=14,073)
Vaccine
Efficacy*
Cases of Symptomatic Covid-19
Number (95% CI) 185 11
94.1%
(89.3-96.8, p<.001)
Incidence per1000 person-years (95% CI) 56.5
(48.7-65.3)
3.3
(1.7 to 6.0)
Secondary end point
Cases of severe Covid-19, n 30 0 100%
*Vaccine efficacy defined as 1 minus the hazard ratio (mRNA vs placebo)

Vaccine Efficacy– Subgroup analysis
Subgroup
Placebo
(N=14,073)
no. of events/total no.
mRNA-1273
(N=14,134)
no. of events/total no.
Vaccine efficacy
(95% CI)
All patients 185/14,073 11/14,134 94.1 (89.3–96.8)
Age
≥18 to <65 years 156/10,521 7/10,551 95.6 (90.6–97.9)
>65 years 29/3552 4/3583 86.4 (61.4–95.2)
Age, risk for severe Covid-19
18 to <65 years, not at risk 121/8403 5/8396 95.9 (90.0–98.3)
18 to <65 years, at risk 35/2118 2/2155 94.4 (76.9–98.7
≥65 years 29/3552 4/3583 86.4 (61.4–95.2)
Sex
Male 87/7462 4/7366 95.4 (87.4–98.3)
Female 98/6611 7/6768 93.1 (85.2–96.8)
At risk for severe Covid-19
Yes 43/3167 4/3206 90.9 (74.7–96.7)
No 142/10,906 7/10,928 95.1 (89.6–97.7)
Race and ethnic group
White 144/8916 10/9023 93.2 (87.1–96.4)
Communities of color 41/5132 1/5088 97.5 (82.2–99.7)

Injection-Site Adverse Events
84.2
88.6
19.8 18.8
0
20
40
60
80
100
After First Dose After Second Dose
Participants
(%)
Adverse Events at Injection-Site

Safety, Localized Adverse Events (1)
Localized Adverse Events Grade 1 Grade 2 Grade 3
Any local adverse event, %
Placebo, dose 1 18.7 0.5 0.5
Placebo, dose 2 17.7 0.6 0.5
mRNA-1273, dose 1 70.8 9.9 3.5
mRNA-1273, dose 2 59.8 21.9 7.0
Pain
Placebo, dose 1 16.8 0.4 0.4
Placebo, dose 2 16.3 0.4 0.3
mRNA-1273, dose 1 72.5 8.5 2.7
mRNA-1273, dose 2 64.7 19.4 4.1
Erythema
Placebo, dose 1 0.3 <0.1 <0.1
Placebo, dose 2 0.3 <0.1 0.1
mRNA-1273, dose 1 1.8 0.8 0.3
mRNA-1273, dose 2 3.0 3.6 2.0

Safety, Localized Adverse Events (2)
Localized Adverse Events Grade 1 Grade 2 Grade 3
Swelling
Placebo, dose 1 0.3 <0.1 <0.1
Placebo, dose 2 0.2 <0.1 <0.1
mRNA-1273, dose 1 4.0 1.6 0.5
mRNA-1273, dose 2 6.1 4.4 1.7
Lymphadenopathy
Placebo, dose 1 4.4 0.2 0.2
mRNA-1273, dose 1 9.2 0.7 0.3
mRNA-1273, dose 2 11.8 1.9 0.5

Systemic Adverse Events
54.9
79.4
42.2
36.5
0
20
40
60
80
100
After First Dose After Second Dose
Participants
(%)
Systemic Adverse Events

Safety: Systemic Adverse Events (1)
Systemic Adverse Events Grade 1 Grade 2 Grade 3
Any systemic adverse event, % participants
Placebo, dose 1 28.7 11.5 2.0
Placebo, dose 2 24.2 10.4 1.9
mRNA-1273, dose 1 35.4 16.5 2.9
mRNA-1273, dose 2 25.4 38.1 15.8
Fever
Placebo, dose 1 0.2 <0.1 <0.1
Placebo, dose 2 0.2 <0.1 <0.1
mRNA-1273, dose 1 0.5 0.2 <0.1
mRNA-1273, dose 2 9.3 4.8 1.4
Headache
Placebo, dose 1 21.8 3.5 1.3
Placebo, dose 2 18.8 3.5 1.1
mRNA-1273, dose 1 26.1 4.8 1.8
mRNA-1273, dose 2 32.7 21.4 4.5

Fatigue
Placebo, dose 1 17.9 8.7 0.7
Placebo, dose 2 15.0 7.7 0.7
mRNA-1273, dose 1 23.7 12.4 1.0
mRNA-1273, dose 2 23.4 32.2 9.7
Myalgia
Placebo, dose 1 10.3 3.0 0.3
mRNA-1273, dose 1 16.1 6.0 0.6
mRNA-1273, dose 2 22.1 26.9 9.0
Arthralgia
mRNA-1273, dose 1 12.2 4.0 0.4
mRNA-1273, dose 2 19.1 18.5 5.2

Nausea or vomiting
Placebo, dose 1 5.9 1.1 <0.1
Placebo, dose 2 5.2 1.1 <0.1
mRNA-1273, dose 1 6.9 1.3 <0.1
mRNA-1273, dose 2 14.2 4.6 0.1
Chills
Placebo, dose 1 4.7 1.0 <0.1
mRNA-1273, dose 1 6.2 1.9 0.2
mRNA-1273, dose 2 19.8 23.1 1.3

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine: Additional notes
• Fewer occurrences of symptomatic SARS-CoV-2 infection were noted after a singe dose of mRNA-1273,
though the trial was not designed to evaluate the efficacy of a single dose
• The magnitude of mRNA-1273 vaccine efficacy at preventing symptomatic SARS-CoV-2 infection is higher
than the efficacy observed for vaccines for respiratory viruses (e.g. 59% efficacy seen for inactivated
influenza vaccine)
• No evidence in the short term of enhanced respiratory disease after infection

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine: Limitations
• Short duration of safety and efficacy follow-up
• Lack of an identified correlate of protection
• Insufficient data to assess the incidence of asymptomatic or subclinical infection and viral shedding after
infection
• Pregnant women and children were excluded from this trial

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine: Authors’ Conclusions
Conclusions: “The mRNA-1273 vaccine showed 94.1% efficacy at
preventing Covid-19 illness, including severe disease. Aside from
transient local and systemic reactions, no safety concerns were
identified.”

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