The safety and immunogenicity of a booster dose (third dose) of Comirnaty in individuals 65 years of age and older is based on safety and immunogenicity data in adults 18 to 55 years of age. [...] However, it should be pointed out that most of these sequences are from the USA (72.2%) and the UK (7.3%), while, as of late February 2023, other countries show a genome prevalence of no more than 20%.11 As reflected in the figures above, after the derivation of XBB.1.5 from its predecessor, the COVID-19 cases in the US increased from 1% to 40% with rapid transmission due to XBB.1.5. [...] In the northeastern US states, more than 70% of the cases are caused by XBB.1.5 whereas only 5–6% of the cases were from XBB.1.5 in the Upper Midwest US.14 In Texas, the gateway US state to Mexico and Latin America, just under 20% of the cases were from XBB.1.5.15,16 Table 2 shows country-specific epidemiology data across the globe for the outbreak of COVID-19 Omicron subvariant XBB.1.5.15 Page 31. [...] In the ECDC’s TESSy database, COVID-19 case-based data, including age and gender, are available for over 80% of the official number of cases reported by ECDC epidemic intelligence17 enabling estimates of age and gender distribution representative of the European population. [...] The median age of the cases was 32 years (range 2 to 95) and 433 (55%) were male.27 In one US-based study, the mean age and gender distribution of persons infected with the Omicron variant of the COVID 19 virus was similar to that of persons infected with prior strains; the study, conducted using electronic health records from a large community health system, examined the outcomes of patients admi.
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Table of Contents
- TITLE PAGE 1
- TABLE OF CONTENTS 9
- LIST OF TABLES 11
- Table 1. Incidence, Prevalence, And Mortality Of COVID-19 As Of 23 November 2023 26
- Table 2. Country-Specific Epidemiology Data Across The Globe For The Outbreak Of COVID-19 Omicron Subvariant XBB.1.5 32
- Table 3. Distribution Of Cases (N=94,447,829) By Age, Sex, Race, And Cross-Tabulated Age And Sex -- United States As Of 28 December 2022 33
- Table 4. Distribution Of Deaths (N=937,757) By Age, Sex, Race, And Cross-Tabulated Age And Sex -- United States As Of 28 December 2022 34
- Table 5. COVID-19 Incidence And Rate Ratios, By Age Group Among Persons Aged <25 Years Across Three Periods Of 2020 In 16 U.S. Jurisdictions 39
- Table 6. Demographics Of 135,794 US Individuals Under Age 25 Tested For COVID-19 By 08 September 2020 40
- Table 7. Risk For COVID-19 Infection, Hospitalization, And Death In US By Age Group And By Race/Ethnicity As Of 28 December 2022 42
- Table 8. Hazard Ratios And 95% Confidence Intervals For COVID-19-Related Death 45
- Table 9. Drugs Or Non-Vaccine Biologics With Emergency Use Authorization Or Full Approval From The FDA 49
- Table 10. Signs And Symptoms Among 291 Paediatric (Age <18 Years) And 10,944 Adult (Age 18–64 Years) Patientsa With Laboratory Confirmed COVID-19 — United States, February 12–April 2, 2020 52
- Table 11. Factors Associated With Severe Disease In Those With COVID-19 55
- Table 12. Preconditions Among COVID-19 Patients In EU/EEA, By Severity Of Disease. Case-Based Data From Tessy Reported 12 August 2021 65
- Table 13. Comorbidities In Individuals Tested For COVID-19 In The Providence St. Joseph Health System – States Of California, Oregon, And Washington, 01 March–31 December 2020 66
- Table 14. Prevalence (%) Of Most Common Comorbid Conditions Among Patient Hospitalized For COVID-19 In A Single Health Care System From March 5th, 2020, To February 5th, 2022, By Predominant Variant At The Time Of Admission 69
- Table 15. Key Safety Findings And Relevance To Human Usage 73
- Table 16. Exposure To Study Vaccine (C4591031 Substudy E) – Sentinel And Expanded Cohorts – Participants >55 Years Of Age 79
- Table 17. Exposure To Study Vaccine By Age Group (C4591031 Substudy E) – Sentinel And Expanded Cohorts – Participants >55 Years Of Age 80
- Table 18. Exposure To Study Vaccine By Dose And Gender (C4591031 Substudy E) – Sentinel And Expanded Cohorts – Participants >55 Years Of Age 81
- Table 19. Exposure To Study Vaccine By Dose, Age Group And Gender (C4591031 Substudy E) – Sentinel And Expanded Cohorts – Participants >55 Years Of Age 82
- Table 20. Exposure To BNT162b2 By Race/Ethnic Origin (C4591031 Substudy E) – Sentinel And Expanded Cohorts – Participants >55 Years Of Age 83
- Table 21. Exposure To Study Vaccine By Special Population (C4591031 Substudy E) – Sentinel And Expanded Cohorts – Participants >55 Years Of Age 84
- Table 22. Exposure To Study Vaccine By Age Group (C4591031 Substudy D) – Cohort 2 85
- Table 23. Exposure To Study Vaccine By Age Group And Gender (C4591031 Substudy D) – Cohort 2 86
- Table 24. Exposure To BNT162b2 By Race/Ethnic Origin (C4591031 Substudy D) – Cohort 2 87
- Table 25. Exposure To Study Vaccine By Special Population (C4591031 Substudy D) – Cohort 2 88
- Table 26. Exposure To BNT162b2 By Age Group (C4591031 Substudy C) 89
- Table 27. Exposure To BNT162b2 By Age Group And Gender (C4591031 Substudy C) 89
- Table 28. Exposure To BNT162b2 By Age Group And Race/Ethnic Origin (C4591031 Substudy C) 90
- Table 29. Exposure To BNT162b2 By Special Population (C4591031 Substudy C) Age Group: 12-17 91
- Table 30. Exposure To BNT162b2 Bivalent (WT/OMI BA.4/BA.5) (C4591044) – Cohort 2 And Cohort 3 Combined 91
- Table 31. Exposure To BNT162b2 Bivalent (WT/OMI BA.4/BA.5) By Sex (C4591044) – Cohort 2 And Cohort 3 Combined 92
- Table 32. Exposure To BNT162b2 Bivalent (WT/OMI BA.4/BA.5) By Age Group And Sex (C4591044) – Cohort 2 And Cohort 3 Combined 92
- Table 33. Exposure To BNT162b2 Bivalent (WT/OMI BA.4/BA.5) By Race/Ethnic Origin (C4591044) – Cohort 2 And Cohort 3 Combined 94
- Table 34. Exposure To BNT162b2 Bivalent (WT/OMI BA.4/BA.5) By Special Population (C4591044) – Cohort 2 And Cohort 3 Combined Age Group: 12-17 95
- Table 35. Exposure To BNT162b2 Bivalent (WT/OMI BA.4/BA.5) By Special Population (C4591044) – Cohort 2 And Cohort 3 Combined Age Group: 18+ 96
- Table 36. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA.5) 3 μG By Age Group (C4591048 Subset Of Substudy B Group 2) 97
- Table 37. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA.5) 3 μG By Age Group, And Gender (C4591048 Subset Of Substudy B Group 2) 97
- Table 38. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA.5) 3 μG By Age Group, And Race/Ethnic Origin (C4591048 Subset Of Substudy B Group 2) 98
- Table 39. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA.5) 3 μG By Special Population (C4591048 Subset Of Substudy B Group 2) – ≥6 Months To <2 Years Of Age 99
- Table 40. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA.5) 3 μg By Special Population (C4591048 Subset Of Substudy B Group 2) – ≥2 To <5 Years Of Age 100
- Table 41. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA.5) 10 µg (C4591048 Substudy D Group 2) 100
- Table 42. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA.5) 10 μg By Sex (C4591048 Substudy D Group 2) 101
- Table 43. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA.5) 10μg By Race/Ethnic Origin (C4591048 Substudy D Group 2) 101
- Table 44. Exposure To Bivalent BNT162b2 (Original/Omi BA.4/BA 102
- Table 45. Exposure Of Special Populations Included Or Not In Clinical Trial Development Programmes 106
- Table 46. Cumulative Estimated Shipped Doses Of BNT162b2 Original By Region Worldwide And Age Group 113
- Table 47. Cumulative Estimated Shipped Doses Of BNT162b2 Bivalent Omi BA.1 By Region Worldwide And Age Group 114
- Table 48. Cumulative Estimated Shipped Doses Of BNT162b2 Omi Bivalent BA.4/BA.5 By Region Worldwide And Age Group 114
- Table 49. Cumulative Administered Doses Of BNT162b2 Original And BNT162b2 Bivalent Omi BA.4/BA.5 Vaccine – License Partner Data 115
- Table 50. EU/EEA – Cumulative Number Of BNT162b2 Original And BNT162b2 Bivalent Omi Vaccines Administered Doses By Age Group 116
- Table 51. EU/EEA – Cumulative Number Of Original Administered Doses By Age Group 116
- Table 52. EU/EEA – Cumulative Number Of Bivalent Omi BA.1 Administered Doses By Age Group 117
- Table 53. EU/EEA – Cumulative Number Of Bivalent Omi BA.4/BA.5 Administered Doses By Age Group 117
- Table 54. EU/EEA – Cumulative Number Of Bivalent Omi Administered Doses By Age Group 118
- Table 55. Japan - Cumulative Number Of Original And Bivalent Omi Administered Doses (1St And 2nd) 119
- Table 56. Japan - Cumulative Number Of Original And Bivalent Omi Administered Doses (3rd Through 6th) 119
- Table 57. Summary Of Safety Concerns 121
- Table 58. Myocarditis And Pericarditis 131
- Table 59. Use In Pregnancy And While Breast Feeding 140
- Table 60. Use In Immunocompromised Patients 140
- Table 61. Use In Frail Patients With Co-Morbidities (e.g., Chronic Obstructive Pulmonary Disease (COPD), Diabetes, Chronic Neurological Disease, Cardiovascular Disorders) 140
- Table 62. Use In Patients With Autoimmune Or Inflammatory Disorders 140
- Table 63. Long Term Safety Data 141
- Table 64. Summary Of Safety Concerns 141
- Table 65. Vaccine Presentation Characteristics - 12 Years And Older 144
- Table 66. Vaccine Presentation Characteristics - 5 Through 11 Years 146
- Table 67. Vaccine Presentation Characteristics - 6 Months Through 4 Years 147
- Table 68. Additional Pharmacovigilance Activities 155
- Table 69. On-Going And Planned Additional Pharmacovigilance Activities 171
- Table 70. Description Of Routine Risk Minimisation Measures By Safety Concern 180
- Table 71. Additional Risk Minimisation Measures For The Important Identified Risk Of Myocarditis And Pericarditis 182
- Table 72. Summary Table Of Pharmacovigilance Activities And Risk Minimisation Activities By Safety Concern 183
- Table 73. List Of Important Risks And Missing Information 187
- Table 74. Important Identified Risk: Myocarditis And Pericarditis 187
- Table 75. Missing Information: Use In Pregnancy And While Breast Feeding 188
- Table 76. Missing Information: Use In Immunocompromised Patients 188
- Table 77. Missing Information: Use In Frail Patients With Co-Morbidities (Eg. Chronic Obstructive Pulmonary Disease (COPD), Diabetes, Chronic Neurological Disease, Cardiovascular Disorders) 188
- Table 78. Missing Information: Use In Patients With Autoimmune Or Inflammatory Disorders 189
- Table 79. Missing Information: Long Term Safety Data 189
- LIST OF FIGURES 15
- Figure 1. Variant Proportions For All SARS-CoV-2 Specimens Sequenced By The CDC During The Week Ending 11 November 2023 And Since The Week Ending 23 July 2023. 28
- Figure 2. SARS-CoV-2 Virus Characterisation Using Erviss Database – Weekly Variant Detection By Country (EU-27 & United Kingdom) (Week 33-Week 48 2023) 29
- Figure 3. Daily New Confirmed COVID-19 Cases Per Million People: Before & After XBB.1.5 Recognition 30
- Figure 4. Age-Sex Distribution Of COVID-19 Cases As Different Levels Of Severity, Pooled Data For EU/EEA Countries. Case-Based Data From Tessy Produced On 04 November 2021 33
- Figure 5. COVID-19-Associated US Hospital Admissions By Age, March 2020 - December 2022 34
- Figure 6. COVID-19-Associated US Hospital Admissions By Sex, March 2020 - August 2022 35
- LIST OF ABBREVIATIONS 6
- PART I. PRODUCT(S) OVERVIEW 16
- PART II. SAFETY SPECIFICATION 25
- Module SI. Epidemiology Of The Indication(s) And Target Population (s) 25
- Module SII. Non-Clinical Part Of The Safety Specification 70
- Module SIII. Clinical Trial Exposure 74
- Participants >55 Years Of Age (C4591031 Substudy E) 79
- Participants ≥18 To ≤55 Years Of Age C4591031 Substudy D 85
- Participants 12 To 17 Years Of Age C4591031 Substudy C 89
- Participants Aged 12 Years And Older (Study C4591044 - Cohort 2/Cohort 3) 91
- Participants Aged 6 Months To <2 Years And ≥ 2 To < 5 Years (Study C4591048 – Substudy B, Group 2) 96
- Participants Aged 5 Years To <12 Years (Study C4591048 – Substudy D Group 2) 100
- Module SIV. Populations Not Studied In Clinical Trials 103
- SIV.1. Exclusion Criteria In Pivotal Clinical Studies Within The Development Programme 103
- SIV.2. Limitations To Detect Adverse Reactions In Clinical Trial Development Programmes 105
- SIV.3. Limitations In Respect To Populations Typically Under-Represented In Clinical Trial Development Programmes 105
- Module SV. Post-Authorisation Experience 112
- SV.1. Post-Authorisation Exposure 112
- SV.1.1. Method Used To Calculate Exposure 120
- SV.1.2. Exposure 120
- Module SVI. Additional EU Requirements For The Safety Specification 120
- Module SVII. Identified And Potential Risks 120
- SVII.1. Identification Of Safety Concerns In The Initial RMP Submission 120
- SVII.1.1. Risks Not Considered Important For Inclusion In The List Of Safety Concerns In The RMP 121
- SVII.1.2. Risks Considered Important For Inclusion In The List Of Safety Concerns In The RMP 128
- SVII.2. New Safety Concerns And Reclassification With A Submission Of An Updated RMP 130
- SVII.3. Details Of Important Identified Risks, Important Potential Risks, And Missing Information 130
- SVII.3.1. Presentation Of Important Identified Risks And Important Potential Risks 130
- SVII.3.1.1. Important Identified Risk: Myocarditis And Pericarditis 130
- SVII.3.1.2. Important Potential Risk: 139
- SVII.3.2. Presentation Of The Missing Information 140
- Module SVIII. Summary Of The Safety Concerns 141
- PART III. PHARMACOVIGILANCE PLAN (INCLUDING POST-AUTHORISATION SAFETY STUDIES) 142
- III.1. Routine Pharmacovigilance Activities 142
- III.2. Additional Pharmacovigilance Activities 150
- III.3. Summary Table Of Additional Pharmacovigilance Activities 170
- III.3.1. On-Going And Planned Additional Pharmacovigilance Activities 170
- PART IV. PLANS FOR POST AUTHORISATION EFFICACY STUDIES 179
- PART V. RISK MINIMISATION MEASURES (INCLUDING EVALUATION OF THE EFFECTIVENESS OF RISK MINIMISATION ACTIVITIES) 180
- V.1. Routine Risk Minimisation Measures 180
- V.2. Additional Risk Minimisation Measures 181
- V.3. Summary Of Risk Minimisation Measures 183
- PART VI. SUMMARY OF THE RISK MANAGEMENT PLAN 185
- I. The Medicine And What It Is Used For 185
- II. Risks Associated With The Medicine And Activities To Minimise Or Further Characterise The Risks 186
- II.A List Of Important Risks And Missing Information 186
- II.B Summary Of Important Risks 187
- II.C Post-Authorisation Development Plan 189
- II.C.1 Studies Which Are Conditions Of The Marketing Authorisation 189
- II.C.2 Other Studies In Post-Authorisation Development Plan 189
- PART VII. ANNEXES TO THE RISK MANAGEMENT PLAN 191
- REFERENCES 192
- ANNEX 4 – SPECIFIC ADVERSE DRUG REACTION FOLLOW- UP FORMS 207
- ANNEX 6 – DETAILS OF PROPOSED ADDITIONAL RISK MINIMISATION ACTIVITIES (IF APPLICABLE) 212
