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pf-07302048 (bnt162b2 rna-based covid-19 vaccine)  (Pfizer Inc)

 
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    Pfizer Inc pf-07302048 (bnt162b2 rna-based covid-19 vaccine)
    Pf 07302048 (Bnt162b2 Rna Based Covid 19 Vaccine), supplied by Pfizer Inc, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
    https://www.bioz.com/product/pf-07302048/bnt162b2/pmc09947923__NEJMoa2211031_protocol-2151-47-65
    Average 90 stars, based on 1 article reviews
    pf-07302048 (bnt162b2 rna-based covid-19 vaccine) - by Bioz Stars, 2026-09
    90/100 stars

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    Related Articles

    Reverse Transcription Polymerase Chain Reaction:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Isolation:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Immunopeptidomics:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Infection:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Sequencing:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Virus:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Vaccines:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    In Vitro:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Variant Assay:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Neutralization:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Activity Assay:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Medications:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Biomarker Discovery:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Pregnancy Test (hCG) Assay:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Injection:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Imaging:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Clinical Proteomics:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    Standard Deviation:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.

    AST Assay:

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 26 of 40

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 8 TABLE OF CONTENTS LIST OF TABLES...................................................................................................................18 1.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: • GMR, estimated by the ratio of the geometric mean of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 in participants ≥2 to <5 years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study • The difference in percentages of participants with seroresponse at 1 month after Dose 3 in participants ≥2 to <5 years of age and at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 99 Phase 2/3 Objectives Estimands Endpoints • In participants ≥6 months to <2 years of age compared to participants 16 to 25 years of age from Phase 2/3 of the C4591001 study.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 168 • Record AEs and SAEs as described in Section 8.3.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 35 of 40 Analysis set: Evaluable immunogenicity population (Section 4).

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 25 At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age.

    Article Title: Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine
    Article Snippet: 09 01 77 e1 9a 43 8a 5b \A pp ro ve d\ A pp ro ve d O n: 2 0- M ay -2 02 2 16 :5 1 (G M T ) Protocol C4591031 – Substudy E (PF-07302048) Statistical Analysis Plan DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022 PFIZER CONFIDENTIAL TMF Doc ID: 98.03 Page 15 of 40 Presence or Absence For each local reaction and any local reaction on any day, Table 5 defines the algorithm to derive the presence of a reaction (yes or no) during the interval within 7 days after the study vaccination.

    Article Title: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
    Article Snippet: 0 9 0 1 7 7 e 1 9 9 9 4 d 0 a 0 \A p p ro v e d \A p p ro v e d O n : 1 0 -M a r- 2 0 2 2 2 0 :2 5 ( G M T ) PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) Protocol C4591007 Final Protocol Amendment 7, 10 Mar 2022 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 167 • If appropriate, discuss contraceptive use as described in Section 5.3.1.



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