Efficacy & Safety of BNT162b2 booster - C4591031 2 month ...

1 Breakthroughs that change patients livesEfficacy & Safety of BNT162b2 booster -C45910312 month interim analysisJohn L. Perez, MD, MBA, MAPfizer, Vice PresidentVaccine Clinical Research & Development19 November 20212 Worldwide Research, Development and Medical Recruited approximately 10,000 participants 16 years of age who completed a 2 dose primaryseries of BNT162b230 g in Study C4591001 randomized at a 1:1 ratio into Study C4591031to receive either a booster dose of BNT162b230 g or a placebo dose at least 6 months after the second dose. Randomization was stratified by age, such that approximately 60% of participants enrolled wouldbe 16 to 55 years of age and approximately 40% of participants >55 years of age.

2 Assessments include Safety evaluations of adverse events and COVID-19 case surveillance forbooster Efficacy estimation after the booster dose. Reactogenicity data were not collected in this study but booster reactogenicity was reported from study1001 Study Design C45910313 Worldwide Research, Development and MedicalBNT162b2 (30 g)(N=5081)n (%)Placebo(N=5044)n (%)Total(N=10125)n (%)SexMale2457 ( )2518 ( )4975 ( )Female2624 ( )2526 ( )5150 ( )RaceWhite3997 ( )4002 ( )7999 ( )Black or African American472 ( )460 ( )932 ( )American Indian or Alaska native86 ( )91 ( )177 ( )Asian288 ( )269 ( )557 ( )Native Hawaiian or other Pacific Islander8 ( )11 ( )19 ( )Multiracial207 ( )196 ( )403 ( )Not reported23 ( )15 ( )38 ( )EthnicityHispanic/Latino760 ( )748 ( )1508 ( )Non-Hispanic/non-Latino4309 ( )4288 ( )8597 ( )

3 Not reported12 ( )8 ( )20 ( )CountryBrazil580 ( )584 ( )1164 ( )South Africa134 ( )134 ( )268 ( )USA4367 ( )4326 ( )8693 ( )Demographic characteristics ( Safety population) 1/2 Representative participants enrolled from the landmark C4591001 study4 Worldwide Research, Development and MedicalBNT162b2 (30 g)(N=5081)n (%)Placebo(N=5044)n (%)Total(N=10125)n (%)Age group(at vaccination)16-55 Years2823 ( )2797 ( )5620 ( )>55 Years2258 ( )2247 ( )4505 ( )16-17 Years46 ( )44 ( )90 ( )18-55 Years2777 ( )2753 ( )5530 ( )56-64 Years1083 ( )1059 ( )2142 ( )65+ Years1175 ( )1188 ( )2363 ( )Age at vaccination(years)Mean (SD) ( ) ( ) ( ) , max(16, 86)(16, 87)(16, 87)BaselineSARS-CoV-2statusPositive284 ( )261 ( )545 ( )Negative4789 ( )4775 ( )9564 ( )Unknown8 ( )8 ( )16 ( )Demographic characteristics ( Safety population) 2/2 Representative participants enrolled from the landmark C4591001 study5 Worldwide Research, Development and MedicalBNT162b2 (30 g)(N=5088)n (%)Placebo(N=5048)n (%)Randomized5088 ( )5048 ( )Not vaccinated6 ( )5 ( )Received booster vaccination5082 ( )5043 ( )Time from Dose 2 of BNT162b2 (received in Study C4591001) to booster vaccination.

4 <6 Months14 ( )6 ( ) 6 Months to <8 Months752 ( )732 ( ) 8 Months to <10 Months819 ( )833 ( ) 10 Months to <12 Months3321 ( )3298 ( ) 12 Months176 ( )174 ( )Mean (SD) ( ) ( ) , max( , )( , )Vaccine administration timing (All randomized )Majority of booster doses administered 10-12 months after dose 26 Worldwide Research, Development and MedicalBNT162b2 (30 g)(N=5081)n (%)Placebo(N=5044)n (%)Total(N=10125)n (%)Participants (%) with length of blinded follow-up of:<2 Months99 ( )204 ( )303 ( ) 2 Months to <4 Months4982 ( )4840 ( )9822 ( )Mean (SD) ( ) ( ) ( ) , max( , )( , )( , )Blinded follow-up time after booster vaccination ( Safety population)Prespecified analysis 2 months after last participant enrolledBreakthroughs that change patients livesSafety8 Worldwide Research, Development and MedicalSummary of Reactogenicity of a booster Dose Grade 3 BNT162b2 (30 g)N=289n% (95%CI)Any grade 3 reactogenicity event19 ( , )Local ( , )Injection site ( , )Injection site redness00% ( , )Injection site ( , ( , ) ( , )Vomiting00% ( , )Diarrhea00% ( , )Headache31% ( , ) ( , )Chills31% ( , )Muscle ( , ))

5 Joint ( , )9 Worldwide Research, Development and MedicalOverall adverse events from booster dose to 1 month after booster doseAEs more frequent in BNT162b2 group due to already known eventsAny AERelated AEAny SAER elated SAEW ithdrawal due to of subjects (%)Reporting at least 1 AEBNT162b2(N=5055)Placebo(N=5020)10 Worldwide Research, Development and MedicalAdverse Events 1% by System Organ Class From booster Vaccination to 1 month Post booster Dose Blinded Follow-up Period020406080100 Gastrointestinal disorders5 Blood and lymphaticsystem disorders4 Nervous system disorders3 Musculoskeletal and connective tissue disorders2 General disorders and administration site conditions1 Any adverse of Subjects Reporting 1% AEBNT162b2 30 g(N=5055)Placebo(N=5020) reflect local reactions at the injection site and systemic reactions of fever, fatigue and reflects myalgia and reflects = (compared to after the second dose from Study C4591001)5.

6 Predominantly reflects nausea and diarrhea11 Worldwide Research, Development and MedicalOverall adverse events from booster dose to cut-off date (5-Oct-2021)( Safety population)Very few additional AEs identified beyond 1 month after boosterAny AERelated AEAny SAER elated SAEW ithdrawal due to of subjects (%)Reporting at least 1 AEBNT162b2(N=5055)Placebo(N=5020)** 1 non-related death occurred 53 days after a placebo injection12 Worldwide Research, Development and MedicalAdverse Events 1% by System Organ Class From booster Vaccination to CutoffDate Blinded Follow-up Period020406080100 Gastrointestinal disorders5 Blood and lymphaticsystem disorders4 Nervous system disorders3 Musculoskeletal and connective tissue disorders2 General disorders and administration site conditions1 Any adverse of Subjects Reporting 1% AEBNT162b2 30 g(N=5055)Placebo(N=5020)

7 Reflect local reactions at the injection site and systemic reactions of fever, fatigue and reflects myalgia and reflects = (compared to after the second dose from Study C4591001)4. Predominantly reflects nausea and diarrhea13 Worldwide Research, Development and MedicalSerious Adverse Events By System Organ Class from booster Vaccination to CutoffDate Blinded Follow-up PeriodBNT162b2(N=5055)n (%)Placebo(N=5020) n (%)Any event16 ( )24 ( )Cardiac disorders2 ( )3 ( )Gastrointestinal disorders1 ( )0 General disorders and administration site conditions02 ( )Infections and infestations4 ( )4 ( )Injury, poisoning and procedural complications1 ( )2 ( )Investigations2 ( )0 Musculoskeletal and connective tissue disorders1 ( )1 ( )Neoplasms benign, malignant and unspecified2 ( )5 ( )Nervous system disorders3 ( )2 ( )

8 Pregnancy, puerperium and perinatal conditions01 ( )Psychiatric disorders1 ( )0 Renal and urinary disorders1 ( )0 Reproductive system and breast disorders01 ( )Respiratory, thoracic and mediastinal disorders06 ( )Vascular disorders01 ( )14 Worldwide Research, Development and MedicalBNT162b2recipients: Young adult male with PMHof postural orthostatic tachycardia syndrome and orthostatic hypotension,developed tachycardia 8 days after booster vaccination, was moderate in nature and resolved 2 days later. Female > 55 years with Gilbert s syndrome developed moderate hepatic enzyme increase (transientelevated liver enzymes) that occurred 5 days after booster vaccination and resolved 37 days later.

9 Shestarted taking Tylenol (500mgq 6 PRN) for diverticulitis that started 2 days before the booster dose. 18-55 y/o female developed mild hepatic enzyme increase (transient elevated liver enzymes) that occurred49 days after booster vaccination and was ongoing at the time of data cut off. Now thought to be secondaryto recipients: > 55 year old female with DM, HTN, obesity, prior smoking, supraventricular tachycardia (SVT), and heartfailure developed acute myocardial infarction (acute non-ST elevation MI) that occurred 9 days afterplacebo, was life threatening in nature and resolved 4 days later Young adult male with SVT, developed chest pain of unknown origin that occurred 6 days after placebo, wassevere in nature and resolved without treatment 1 day later.

10 Troponin & ECG Serious Adverse Events from booster Vaccination to CutoffDateBreakthroughs that change patients livesEfficacy16 Worldwide Research, Development and MedicalRelative Vaccine Efficacy during blinded follow-up periodBooster dose was highly effective against symptomatic COVID-19 BNT162b2 (30 g)N=4695 PlaceboN=4671 Efficacy EndpointnSurveillance Time (n)nSurveillance Time (n)RVE(%)(95% CI)First COVID-19 occurrence from 7 days after booster vaccination to <2 months after booster (4659) (4614) ( , )Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpointRVE= relative vaccine Efficacy of the BNT162b2 booster group relative to the placebo group (nonbooster)Subjects WITHOUT Evidence of Infection Prior to 7 days after Dose 217 Worldwide Research, Development and MedicalVaccine Efficacy during blinded follow-up period (Evaluable Efficacy population) booster dose was highly effective against symptomatic COVID-19 BNT162b2 (30 g)N=4993 PlaceboN=4952 Efficacy EndpointnSurveillance Time (n)nSurveillance Time (n)RVE(%)(95% CI)