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Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
Any event 66 (5.8) (4.5, 7.4) 57 (10.6) (8.2, 13.6) 66 (5.8) (4.5, 7.4) 45 (8.0) (5.9, 10.6)
BLOOD AND LYMPHATIC SYSTEM DISORDERS 9 (0.8) (0.4, 1.5) 1 (0.2) (0.0, 1.0) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Lymphadenopathy 9 (0.8) (0.4, 1.5) 1 (0.2) (0.0, 1.0) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
CARDIAC DISORDERS 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Tachycardia 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
EAR AND LABYRINTH DISORDERS 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Ear pain 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Cerumen impaction 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
EYE DISORDERS 1 (0.1) (0.0, 0.5) 1 (0.2) (0.0, 1.0) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Eye pain 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Eyelid rash 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Ocular hyperaemia 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Retinal haemorrhage 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
GASTROINTESTINAL DISORDERS 14 (1.2) (0.7, 2.1) 4 (0.7) (0.2, 1.9) 3 (0.3) (0.1, 0.8) 5 (0.9) (0.3, 2.1)
Nausea 5 (0.4) (0.1, 1.0) 2 (0.4) (0.0, 1.3) 1 (0.1) (0.0, 0.5) 2 (0.4) (0.0, 1.3)
Diarrhoea 3 (0.3) (0.1, 0.8) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 2 (0.4) (0.0, 1.3)
Abdominal pain 2 (0.2) (0.0, 0.6) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Aphthous ulcer 1 (0.1) (0.0, 0.5) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220983
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
Lip swelling 1 (0.1) (0.0, 0.5) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Vomiting 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Gastritis 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Mouth swelling 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Oral mucosal blistering 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Rectal prolapse 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Toothache 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
GENERAL DISORDERS AND ADMINISTRATION SITE
CONDITIONS 16 (1.4) (0.8, 2.3) 21 (3.9) (2.4, 5.9) 11 (1.0) (0.5, 1.7) 10 (1.8) (0.9, 3.3)
Injection site pain 7 (0.6) (0.2, 1.3) 10 (1.9) (0.9, 3.4) 7 (0.6) (0.2, 1.3) 2 (0.4) (0.0, 1.3)
Fatigue 7 (0.6) (0.2, 1.3) 7 (1.3) (0.5, 2.7) 4 (0.4) (0.1, 0.9) 3 (0.5) (0.1, 1.6)
Pyrexia 5 (0.4) (0.1, 1.0) 7 (1.3) (0.5, 2.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Chills 1 (0.1) (0.0, 0.5) 2 (0.4) (0.0, 1.3) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Injection site erythema 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 2 (0.4) (0.0, 1.3)
Injection site swelling 1 (0.1) (0.0, 0.5) 2 (0.4) (0.0, 1.3) 0 (0.0, 0.3) 0 (0.0, 0.7)
Oedema peripheral 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 1 (0.2) (0.0, 1.0)
Pain 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Chest pain 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Injection site bruising 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Injection site discomfort 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220984
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
Injection site hyperaesthesia 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Nodule 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Peripheral swelling 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Vessel puncture site pain 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
IMMUNE SYSTEM DISORDERS 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Food allergy 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
INFECTIONS AND INFESTATIONS 7 (0.6) (0.2, 1.3) 4 (0.7) (0.2, 1.9) 6 (0.5) (0.2, 1.2) 12 (2.1) (1.1, 3.7)
Ear infection 3 (0.3) (0.1, 0.8) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Conjunctivitis 0 (0.0, 0.3) 0 (0.0, 0.7) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Otitis externa 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Otitis media 1 (0.1) (0.0, 0.5) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Sinusitis 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 2 (0.4) (0.0, 1.3)
Tonsillitis 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 2 (0.4) (0.0, 1.3)
Vulvovaginal mycotic infection 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Body tinea 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Candida infection 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Cellulitis 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Cystitis 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Folliculitis 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220985
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
Genital herpes 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Genital herpes simplex 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Impetigo 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Infectious mononucleosis 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Oral fungal infection 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Pharyngitis streptococcal 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Pilonidal cyst 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Subcutaneous abscess 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Tinea capitis 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Tinea infection 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Urinary tract infection 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Vulval abscess 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
INJURY, POISONING AND PROCEDURAL COMPLICATIONS 8 (0.7) (0.3, 1.4) 3 (0.6) (0.1, 1.6) 10 (0.9) (0.4, 1.6) 6 (1.1) (0.4, 2.3)
Ligament sprain 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 2 (0.2) (0.0, 0.6) 2 (0.4) (0.0, 1.3)
Concussion 3 (0.3) (0.1, 0.8) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Accident 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Clavicle fracture 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Contusion 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Exposure during pregnancy 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 2 (0.4) (0.0, 1.3)
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220986
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
Fall 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Muscle strain 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Procedural pain 0 (0.0, 0.3) 0 (0.0, 0.7) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Tooth fracture 0 (0.0, 0.3) 0 (0.0, 0.7) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Fibula fracture 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Foot fracture 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Hand fracture 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Humerus fracture 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Joint dislocation 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Lip injury 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Meniscus injury 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Patella fracture 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Radius fracture 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Road traffic accident 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
INVESTIGATIONS 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Electrocardiogram QT prolonged 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
METABOLISM AND NUTRITION DISORDERS 0 (0.0, 0.3) 2 (0.4) (0.0, 1.3) 0 (0.0, 0.3) 0 (0.0, 0.7)
Decreased appetite 0 (0.0, 0.3) 2 (0.4) (0.0, 1.3) 0 (0.0, 0.3) 0 (0.0, 0.7)
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220987
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
MUSCULOSKELETAL AND CONNECTIVE TISSUE
DISORDERS 9 (0.8) (0.4, 1.5) 12 (2.2) (1.2, 3.9) 8 (0.7) (0.3, 1.4) 8 (1.4) (0.6, 2.8)
Arthralgia 2 (0.2) (0.0, 0.6) 3 (0.6) (0.1, 1.6) 3 (0.3) (0.1, 0.8) 4 (0.7) (0.2, 1.8)
Myalgia 3 (0.3) (0.1, 0.8) 6 (1.1) (0.4, 2.4) 2 (0.2) (0.0, 0.6) 1 (0.2) (0.0, 1.0)
Back pain 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Pain in extremity 1 (0.1) (0.0, 0.5) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Arthropathy 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Joint swelling 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Limb mass 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Mobility decreased 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Musculoskeletal chest pain 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Musculoskeletal discomfort 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Neck pain 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Osteochondrosis 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Plantar fasciitis 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Spinal disorder 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Torticollis 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED
(INCL CYSTS AND POLYPS) 0 (0.0, 0.3) 0 (0.0, 0.7) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Fibroadenoma of breast 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220988
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
Skin papilloma 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
NERVOUS SYSTEM DISORDERS 11 (1.0) (0.5, 1.7) 13 (2.4) (1.3, 4.1) 7 (0.6) (0.2, 1.3) 7 (1.2) (0.5, 2.6)
Headache 5 (0.4) (0.1, 1.0) 11 (2.1) (1.0, 3.6) 4 (0.4) (0.1, 0.9) 5 (0.9) (0.3, 2.1)
Dizziness 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 2 (0.4) (0.0, 1.3)
Migraine 2 (0.2) (0.0, 0.6) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Presyncope 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Burning sensation 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Paraesthesia 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
PSYCHIATRIC DISORDERS 4 (0.4) (0.1, 0.9) 5 (0.9) (0.3, 2.2) 5 (0.4) (0.1, 1.0) 1 (0.2) (0.0, 1.0)
Anxiety 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 2 (0.2) (0.0, 0.6) 1 (0.2) (0.0, 1.0)
Depression 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Attention deficit hyperactivity disorder 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Depressed mood 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Disorientation 1 (0.1) (0.0, 0.5) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Generalised anxiety disorder 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Sleep terror 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Tic 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
REPRODUCTIVE SYSTEM AND BREAST DISORDERS 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Cervical dysplasia 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220989
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 2 (0.2) (0.0, 0.6) 1 (0.2) (0.0, 1.0) 4 (0.4) (0.1, 0.9) 4 (0.7) (0.2, 1.8)
Rhinorrhoea 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 4 (0.4) (0.1, 0.9) 0 (0.0, 0.7)
Oropharyngeal pain 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 3 (0.5) (0.1, 1.6)
Asthma 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Nasal congestion 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 0 (0.0, 0.3) 0 (0.0, 0.7)
Reflux laryngitis 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS 6 (0.5) (0.2, 1.2) 5 (0.9) (0.3, 2.2) 13 (1.2) (0.6, 2.0) 2 (0.4) (0.0, 1.3)
Rash 2 (0.2) (0.0, 0.6) 3 (0.6) (0.1, 1.6) 4 (0.4) (0.1, 0.9) 0 (0.0, 0.7)
Urticaria 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7) 4 (0.4) (0.1, 0.9) 0 (0.0, 0.7)
Acne 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7) 2 (0.2) (0.0, 0.6) 0 (0.0, 0.7)
Dermatitis contact 1 (0.1) (0.0, 0.5) 1 (0.2) (0.0, 1.0) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Macule 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Pityriasis rosea 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Rash erythematous 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Rash maculo -papular 0 (0.0, 0.3) 0 (0.0, 0.7) 1 (0.1) (0.0, 0.5) 0 (0.0, 0.7)
Seborrhoeic dermatitis 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
SURGICAL AND MEDICAL PROCEDURES 0 (0.0, 0.3) 2 (0.4) (0.0, 1.3) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
Sclerotherapy 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Tooth extraction 0 (0.0, 0.3) 0 (0.0, 0.7) 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0)
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220990
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by
System Organ Class and Preferred Term –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n
Vaccine Group (as Administered)
BNT162b2 (30 μg)
Placebo
12-15 Years
(Na=1131) 16-25 Years
(Na=536) 12-15 Years
(Na=1129) 16-25 Years
(Na=561)
System Organ Class
Preferred Term nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc) nb (%) (95% CIc)
Wisdom teeth removal 0 (0.0, 0.3) 1 (0.2) (0.0, 1.0) 0 (0.0, 0.3) 0 (0.0, 0.7)
Note: MedDRA (v23.1) coding dictionary applied.
Note: Adverse events that occurred on the day of or after subjects were unblinded are excluded from this summary.
Note: This table includes all subjects 12 through 15 years of age (all of whom are in the reactogenicity subset) and the subs et of subjects 1 6 through 25 years of
age who received an electronic diary (e -diary).
a. N = number of subjects in the specified group. This value is the denominator for the percentage calculations.
b. n = Number of subjects reporting at least 1 occurrence of the specified event. For "any event," n = number of subjects reporting at least 1 occurrence of
any event.
c. Exact 2 -sided CI based on the Clopper and Pearson method.
PFIZER CONFIDENTIAL SDTM Creation: . (.) Source Data: adae Table Generation: 04APR20 21 (13:23)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA_RR/adae_s130_1md2_soc_nsae_ped_ saf
090177e198c3844b\Final\Final On: 03-Dec-2021 01:39 (GMT)
FDA-CBER-2022-5812-0220991