Safety and Efficacy of BNT162b2 mRNA Covid-19 Vaccine Phase 3 Data

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Phase 3 data of the BNT162b2 mRNA Covid-19 vaccine, including study design, participant groups, primary endpoints, and key findings regarding safety and efficacy. The vaccine demonstrated efficacy against confirmed Covid-19, with reported local and systemic adverse effects within a specified timeframe post-vaccination. The study, conducted in multiple countries, involved individuals aged 16 years and above, either healthy or with stable chronic medical conditions, excluding those with a history of Covid-19 infection or certain immunocompromising conditions. Notable features of the vaccine formulation were lipid nanoparticles and nucleoside-modified RNA encoding the spike protein of SARS-CoV-2.

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

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

  3. 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. Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  4. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine 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 Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  5. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Study Design Study Participant Groups BNT162b2 30 g (0.3 mL volume per dose), 2 IM doses, 21 days apart or Saline placebo, 2 IM doses, 21 days apart Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  6. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Baseline Characteristics: Gender Distribution for ALL Participants Male Female 50.6% 49.4% Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  7. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Baseline Characteristics: Age Distribution for ALL Participants 16-55 Years >55 Years 42.2% 57.8% Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  8. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Baseline Characteristics, by Study Group BNT162b2 (N=18,860) 9,639 (51.1) 9,221 (48.9) Placebo (N=18,846) 9,436 (50.1) 9,410 (49.9) Baseline Characteristics Male, n (%) Female, n (%) Race or ethnic group no. (%) White Black or African American Asian Native American or Alaska Native Native Hawaiian or other Pacific Islander Multiracial Not reported Hispanic or Latinx Country no. (%) Argentina Brazil South Africa United States 15,636 (82.9) 1,729 (9.2) 801 (4.2) 102 (0.5) 50 (0.3) 449 (2.4) 93 (0.5) 5,266 (27.9) 15,630 (82.9) 1,763 (9.4) 807 (4.3) 99 (0.5) 26 (0.1) 406 (2.2) 115 (0.6) 5,277 (28.0) 2,883 (15.3) 1,145 (6.1) 372 (2.0) 14,460 (76.6) 2,881 (15.3) 1,139 (6.0) 372 (2.0) 14,454 (76.7) Race or ethnic group was reported by the participants. Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  9. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Baseline Characteristics, by Study Group BNT162b2 (N=18,860) Placebo (N=18,846) Baseline Characteristics 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) Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  10. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Outcomes Efficacy against Covid-19 7 days after Second Dose* Vaccine Efficacy, % (95% Credible Interval) Efficacy End Point BNT162b2 Placebo Surveillance Time (n) Surveillance Time (n) No. of Cases No. of Cases (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. Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  11. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Vaccine Efficacy Overall and by Subgroups Efficacy End Point Subgroup BNT162b2 (N=18,198) Placebo (N=18,325) Vaccine Efficacy, % (95% CI) Surveillance time (No. at Risk)* Surveillance time (No. at Risk)* No. of Cases No. of Cases 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. Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  12. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Participants with Covid-19 After Second Dose *Covid-19 at Least 7 Days after Second Dose of BNT162b Vaccine or Placebo 200 Vaccine Efficacy 95.0% Symptomatic Covid-19 Infection 162 150 100 50 8 0 BNT162b2 Vaccine Placebo *Participants who had no evidence of existing or prior SARS-CoV-2 infection. Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  13. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Participants with Covid-19 After First Dose Covid-19 After First Dose of BNT162b Vaccine or Placebo BNT162b2 Vaccine Placebo 300 275 250 Number of Participants 200 150 100 50 50 9 1 0 Symptomactic Covid-19 Severe Covid-19 Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  14. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Vaccine Efficacy by Age Groups BNT162b-2 Vaccine Placebo 125 Participants with Symptomatic Covid-19 114 100 75 48 50 19 25 5 5 3 1 0 0 16-55 Years >55 Years 65 Years 75 Years Age Group Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  15. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Covid-19 During Study, Modified Intention-to-Treat Analysis BNT162b2 Vaccine 39 After Dose 1 to before Dose 2 Placebo 82 2 Dose 2 to 7 Days after Dose 2 21 9 7 Days after Dose 2 172 0 50 100 150 200 250 Participants with Symptomatic Covid-19 Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  16. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Vaccine Efficacy Throughout Study, Modified-Intention-to-Treat Analysis After Dose 1 to before Dose 2 52.4 Dose 2 to 7 Days after Dose 2 90.5 7 Days after Dose 2 94.8 0 20 40 60 80 100 Vaccine Efficacy (%) Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  17. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Local and Systemic Reactions Reported with 7 Days of Injection Placebo BNT162b2 Event Placebo BNT162b2 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 After first dose 47% 33% 34% 23% After second dose 59% 23% 51% 17% Headache After first dose 42% 34% 25% 18% After second dose 52% 24% 39% 14% Fever ( 38 C) After first dose 4% 1% 1% 0% After second dose 16% 0% 11% 0% Use of antipyretic or analgesic After first dose 28% 14% 20% 12% After second dose 45% 13% 38% 10% Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  18. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Results: Adverse Events Placebo (Nb=21631) BNT162b2 (Na=21621) Adverse Event 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) Life-threatening 21 (0.1) 23 (0.1) 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) Life-threatening 3 (0.0) 6 (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. Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  19. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Outcomes Vaccine Efficacy Overall and by Subgroup Efficacy End Point Subgroup BNT162b2 (N=18,198) Placebo (N=18,325) Vaccine Efficacy, % (95% CI) Surveillance time (No. at Risk)* Surveillance time (No. at Risk)* No. of Cases No. of Cases 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. Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  20. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine 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 Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  21. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine 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 Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

  22. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine 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. Source: Polack FP, et al. N Engl J Med. 2020;383:2603-15.

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

  24. 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 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  25. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine 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 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  26. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine 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 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  27. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Study Design Study Participant Groups mRNA-1273 100 g (0.5 mL), 2 IM doses, 28 days apart (n = 15,181) or Saline placebo, 2 IM doses, 28 days apart (n = 15,170) Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  28. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Baseline Characteristics: Gender Distribution for ALL Participants Male Female 52.7% 47.3% Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  29. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Baseline Characteristics: Age Distribution for ALL Participants Age <65 Years, not at risk for severe COVID-19 58.6% 16.7% 24.8% Age <65 Years, at risk for severe COVID-19 Age 65 Years

  30. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Baseline Characteristics, by Group Placebo (N=15,170) mRNA-1273 (N=15,181) Baseline Characteristics 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 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  31. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Baseline Characteristics, by Group Placebo (N=15,170) mRNA-1273 (N=15,181) Baseline Characteristics 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. Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  32. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Baseline Characteristics, by Group Placebo (N=15,170) mRNA-1273 (N=15,181) Baseline Characteristics 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. Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  33. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Vaccine Efficacy mRNA-1273 Vaccine Placebo 250 Vaccine Efficacy 94.1% Number of Participants 200 185 150 100 50 30 11 0 0 Symptomactic Covid-19 Severe Covid-19 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  34. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Incidence Rate and Vaccine Efficacy, Based on Type of Analysis mRNA-1273 Vaccine Placebo 120 Incidence Rate per 1,000 Person-Years Vaccine Efficacy 94.1% Vaccine Efficacy 93.0% 100 79.8 80 56.5 60 40 20 5.6 3.3 0 Per-Protocol Analysis Modified Intention-to-Treat Analysis Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  35. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Incidence Rate and Vaccine Efficacy, Based on Age Group mRNA-1273 Vaccine Placebo 200 Participants with Symptomatic Covid-19 Vaccine Efficacy 95.6% Vaccine Efficacy 86.4% 156 150 100 50 29 7 4 0 18 to <65 Years 65 Years Age Group Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  36. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Vaccine Efficacy During Study, Modified Intention-to-Treat Analysis mRNA-1273 Vaccine 5 Randomization to 14 Days after Dose 1 11 Placebo 2 14 Days after Dose 1 to Dose 2 35 0 Dose 2 to 14 Days after Dose 2 19 12 Starting 14 Days after Dose 2 204 0 50 100 150 200 250 Participants with Symptomatic Covid-19 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  37. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Vaccine Efficacy Vaccine Efficacy* Placebo (N=14,073) mRNA-1273 (N=14,073) Endpoint Cases of Symptomatic Covid-19 94.1% Number (95% CI) 185 11 (89.3-96.8, p<.001) 56.5 3.3 Incidence per1000 person-years (95% CI) (48.7-65.3) (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) Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  38. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Vaccine Efficacy Subgroup analysis Placebo (N=14,073) no. of events/total no. 185/14,073 mRNA-1273 (N=14,134) no. of events/total no. 11/14,134 Vaccine efficacy (95% CI) Subgroup All patients Age 18 to <65 years >65 years Age, risk for severe Covid-19 18 to <65 years, not at risk 18 to <65 years, at risk 65 years Sex Male Female At risk for severe Covid-19 Yes No Race and ethnic group White Communities of color 94.1 (89.3 96.8) 156/10,521 29/3552 7/10,551 4/3583 95.6 (90.6 97.9) 86.4 (61.4 95.2) 121/8403 35/2118 29/3552 5/8396 2/2155 4/3583 95.9 (90.0 98.3) 94.4 (76.9 98.7 86.4 (61.4 95.2) 87/7462 98/6611 4/7366 7/6768 95.4 (87.4 98.3) 93.1 (85.2 96.8) 43/3167 142/10,906 4/3206 7/10,928 90.9 (74.7 96.7) 95.1 (89.6 97.7) 144/8916 41/5132 10/9023 1/5088 93.2 (87.1 96.4) 97.5 (82.2 99.7) Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  39. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Injection-Site Adverse Events mRNA-1273 Vaccine Placebo 100 88.6 84.2 80 Participants (%) 60 40 19.8 18.8 20 0 After First Dose After Second Dose Adverse Events at Injection-Site Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  40. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine 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 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  41. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine 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 Placebo, dose 2 3.6 0.2 0.1 mRNA-1273, dose 1 9.2 0.7 0.3 mRNA-1273, dose 2 11.8 1.9 0.5 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  42. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Systemic Adverse Events mRNA-1273 Vaccine Placebo 100 79.4 80 Participants (%) 54.9 60 42.2 36.5 40 20 0 After First Dose After Second Dose Systemic Adverse Events Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  43. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine 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 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  44. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Safety: Systemic Adverse Events (2) Systemic Adverse Events Grade 1 Grade 2 Grade 3 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 Placebo, dose 2 8.9 3.1 0.4 mRNA-1273, dose 1 16.1 6.0 0.6 mRNA-1273, dose 2 22.1 26.9 9.0 Arthralgia Placebo, dose 1 8.9 2.7 0.2 Placebo, dose 2 7.8 2.6 0.3 mRNA-1273, dose 1 12.2 4.0 0.4 mRNA-1273, dose 2 19.1 18.5 5.2 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  45. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Safety: Systemic Adverse Events (3) Systemic Adverse Events Grade 1 Grade 2 Grade 3 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 Placebo, dose 2 4.3 1.1 0.1 mRNA-1273, dose 1 6.2 1.9 0.2 mRNA-1273, dose 2 19.8 23.1 1.3 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  46. 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 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  47. 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 Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

  48. 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. Source: Baden LR, et al. N Engl J Med. 2020 Dec 30. DOI: 10.1056/NEJMoa2035389

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