Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

ClinicalTrials.gov ID

NCT04368728

Acronym / sponsor ID

C4591001

Conditions

SARS-CoV-2 Infection, COVID-19

Keywords

COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine

Phase

Phase 2/3

Study type

Interventional

Recruitment status

Completed

Enrolment

46,969 participants (actual)

Lead sponsor

BioNTech SEIndustry (pharma, biotech, devices)

Collaborators

Pfizer

Study start

29 Apr 2020 (actual)

Primary completion

10 Feb 2023 (actual)

Study completion

10 Feb 2023 (actual)

First posted

30 Apr 2020 (actual)

Results

Posted 25 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Triple blind (participant, care provider, investigator)

Number of arms

20

Who may qualify

Ages

12 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1

   Time frame: Within 7 days after Dose 1

   Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).

2. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 1

   Time frame: Within 7 days after Dose 2

   Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).

3. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 1

   Time frame: Within 7 days after Dose 1

   Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 hours[h]), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).

4. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 1

   Time frame: Within 7 days after Dose 2

   Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).

5. Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1

   Time frame: From Dose 1 to 1 Month After Dose 2

   An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. For BNT162b1 100 mcg, participants received one dose of 100 mcg, followed by one dose of 10 mcg.

6. Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1

   Time frame: From Dose 1 to 6 Months After Dose 2

   An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. For BNT162b1 100 mcg, participants received one dose of 100 mcg, followed by one dose of 10 mcg.

7. Percentage of Participants With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1

   Time frame: 1 Day After Dose 1

   Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : <0.8x lower limit of normal (LLN), Hematocrit : <0.8x LLN, Erythrocytes : <0.8x LLN, Ery. Mean Corpuscular Volume: <0.9x LLN, Ery. Mean Corpuscular Hemoglobin : <0.9x LLN Ery. Mean Corpuscular HGB Concentration : <0.9x LLN, Platelets : <0.5x LLN, Leukocytes : <0.6x LLN, Lymphocytes : <0.8x LLN, Neutrophils : <0.8x LLN, Basophils: >1.2x upper limit of normal (ULN), Eosinophils >1.2x ULN, Monocytes >1.2x ULN. Only parameters with abnormal values were reported in this outcome measure.

8. Percentage of Participants With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1

   Time frame: 7 Days After Dose 1

   Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : <0.8x LLN, Hematocrit : <0.8x LLN, Erythrocytes : <0.8x LLN, Ery. Mean Corpuscular Volume: <0.9x LLN, Ery. Mean Corpuscular Hemoglobin : <0.9x LLN Ery. Mean Corpuscular HGB Concentration : <0.9x LLN, Platelets : <0.5x LLN, Leukocytes : <0.6x LLN, Lymphocytes : <0.8x LLN, Neutrophils : <0.8x LLN, Basophils: >1.2x ULN, Eosinophils >1.2x ULN, Monocytes >1.2x ULN. Only parameters with abnormal values were reported in this outcome measure.

9. Percentage of Participants With Abnormalities in Hematology Parameters Before Dose 2: Phase 1

   Time frame: Before Dose 2

   Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : <0.8x LLN, Hematocrit : <0.8x LLN, Erythrocytes : <0.8x LLN, Ery. Mean Corpuscular Volume: <0.9x LLN, Ery. Mean Corpuscular Hemoglobin : <0.9x LLN Ery. Mean Corpuscular HGB Concentration : <0.9x LLN, Platelets : <0.5x LLN, Leukocytes : <0.6x LLN, Lymphocytes : <0.8x LLN, Neutrophils : <0.8x LLN, Basophils: >1.2x ULN, Eosinophils >1.2x ULN, Monocytes >1.2x ULN. Only parameters with abnormal values were reported in this outcome measure.

10. Percentage of Participants With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1

    Time frame: 7 Days After Dose 2

    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : <0.8x LLN, Hematocrit : <0.8x LLN, Erythrocytes : <0.8x LLN, Ery. Mean Corpuscular Volume: <0.9x LLN, Ery. Mean Corpuscular Hemoglobin : <0.9x LLN Ery. Mean Corpuscular HGB Concentration : <0.9x LLN, Platelets : <0.5x LLN, Leukocytes : <0.6x LLN, Lymphocytes : <0.8x LLN, Neutrophils : <0.8x LLN, Basophils: >1.2x ULN, Eosinophils >1.2x ULN, Monocytes >1.2x ULN. Only parameters with abnormal values were reported in this outcome measure.

11. Percentage of Participants With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1

    Time frame: 1 Day After Dose 1

    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: >1.5x ULN, AST: >3.0x ULN, ALT: >3.0x ULN, ALP: >3.0x ULN, urea nitrogen: >1.3x ULN, creatinine: >1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin.

12. Percentage of Participants With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1

    Time frame: 7 Days After Dose 1

    Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: >1.5x ULN, AST: >3.0x ULN, ALT: >3.0x ULN, ALP: >3.0x ULN, urea nitrogen: >1.3x ULN, creatinine: >1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin.

13. Percentage of Participants With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1

    Time frame: Before Dose 2

    Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: >1.5x ULN, AST: >3.0x ULN, ALT: >3.0x ULN, ALP: >3.0x ULN, urea nitrogen: >1.3x ULN, creatinine: >1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin.

14. Percentage of Participants With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1

    Time frame: 7 Days After Dose 2

    Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: >1.5x ULN, AST: >3.0x ULN, ALT: >3.0x ULN, ALP: >3.0x ULN, urea nitrogen: >1.3x ULN, creatinine: >1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin.

15. Percentage of Participants With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1

    Time frame: 1 Day After Dose 1

    Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: <8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: <8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: <1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: <250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: >5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: <25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: >31; G4: requires dialysis. Only parameters where grade shift was observed were reported.

16. Percentage of Participants With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1

    Time frame: 7 Days After Dose 1

    Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: <8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: <8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: <1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: <250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: >5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: <25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: >31; G4: requires dialysis. Only parameters where grade shift was observed were reported.

17. Percentage of Participants With Grade Shift in Hematology Parameters Before Dose 2: Phase 1

    Time frame: Before Dose 2

    Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: <8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: <8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: <1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: <250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: >5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: <25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: >31; G4: requires dialysis. Only parameters where grade shift was observed were reported.

18. Percentage of Participants With Grade Shift in Hematology Parameters 7 Days After Dose 2: Phase 1

    Time frame: 7 Days After Dose 2

    Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: <8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: <8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: <1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: <250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: >5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: <25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: >31; G4: requires dialysis. Only parameters where grade shift was observed were reported.

19. Percentage of Participants With Grade Shift in Chemistry Parameters 1 Day After Dose 1: Phase 1

    Time frame: 1 Day After Dose 1

    Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(milligram per deciliter [mg/dL]): G1: 23 - 26, G2: 27 - 31, G3: >31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: > 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: >10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: >10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: >1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: >3.0 x ULN. Only parameters where grade shift was observed were reported.

20. Percentage of Participants With Grade Shift in Chemistry Parameters 7 Days After Dose 1: Phase 1

    Time frame: 7 Days After Dose 1

    Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: >31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: > 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: >10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: >10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: >1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: >3.0 x ULN. Only parameters where grade shift was observed were reported.

21. Percentage of Participants With Grade Shift in Chemistry Parameters Before Dose 2: Phase 1

    Time frame: Before Dose 2

    Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: >31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: > 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: >10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: >10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: >1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: >3.0 x ULN. Only parameters where grade shift was observed were reported.

22. Percentage of Participants With Grade Shift in Chemistry Parameters 7 Days After Dose 2: Phase 1

    Time frame: 7 Days After Dose 2

    Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: >31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: > 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: >10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: >10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: >1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: >3.0 x ULN. Only parameters where grade shift was observed were reported.

23. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 2/3

    Time frame: Within 7 Days after Dose 1

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).

24. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 2/3

    Time frame: Within 7 Days after Dose 2

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).

25. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 2/3

    Time frame: Within 7 Days after Dose 1

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).

26. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 2/3

    Time frame: Within 7 Days after Dose 2

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).

27. Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 2/3

    Time frame: From Dose 1 to 1 Month After Dose 2

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded from this analysis.

28. Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 2/3

    Time frame: From Dose 1 to 6 Months After Dose 2

    An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded from this analysis.

29. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 2

    Time frame: Within 7 Days after Dose 1

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).

30. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 2

    Time frame: Within 7 Days after Dose 2

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).

31. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 2

    Time frame: Within 7 Days after Dose 1

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).

32. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 2

    Time frame: Within 7 Days After Dose 2

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).

33. Percentage of Participants Reporting Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2

    Time frame: From Dose 1 to 7 Days After Dose 2

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

34. Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2

    Time frame: From Dose 1 to 7 Days After Dose 2

    A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events.

35. Percentage of Participants With Local Reactions Within 7 Days After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose

    Time frame: Within 7 Days After Booster Dose

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded.

36. Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose

    Time frame: Within 7 Days After Booster Dose

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded.

37. Percentage of Participants Reporting Adverse Events From First Booster Dose to 1 Month After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose

    Time frame: From First Booster Dose to 1 Month After Booster Dose

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded.

38. Percentage of Participants Reporting Serious Adverse Events From First Booster Dose to 6 Months After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose

    Time frame: From First Booster Dose to 6 Months After Booster Dose

    A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded.

39. Percentage of Participants With Local Reactions Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA

    Time frame: Within 7 Days After Booster Dose 1

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded from this analysis.

40. Percentage of Participants With Local Reactions Within 7 Days After Booster Dose 2: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA

    Time frame: Within 7 Days after Booster Dose 2

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded from this analysis.

41. Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA

    Time frame: Within 7 Days After Booster Dose 1

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants excluded.

42. Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 2: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA

    Time frame: Within 7 Days After Booster Dose 2

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants excluded.

43. Percentage of Participants Reporting Adverse Events From First Booster Dose to 1 Month After Second Booster Dose: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA

    Time frame: From First Booster Dose to 1 Month After Second Booster Dose

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded.

44. Percentage of Participants Reporting Serious Adverse Events From First Booster Dose to 5 Months After Second Booster Dose: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA

    Time frame: From First Booster Dose to 5 Months After Second Booster Dose

    An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded.

45. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA

    Time frame: Within 7 Days After Dose 1

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded.

46. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA

    Time frame: Within 7 Days After Dose 2

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded.

47. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA

    Time frame: Within 7 Days After Dose 1

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded.

48. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA

    Time frame: Within 7 Days After Dose 2

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded.

49. Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: BNT162b2-Naïve Participants Who Were Enrolled to Receive BNT162b2SA

    Time frame: From Dose 1 Through 1 Month After Dose 2

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded.

50. Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: BNT162b2-Naïve Participants Who Were Enrolled to Receive BNT162b2SA

    Time frame: From Dose 1 to 6 Months After Dose 2

    A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded.

51. Percentage of Participants With Local Reactions Within 7 Days After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose)

    Time frame: Within 7 days After Booster Dose

    Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded.

52. Percentage of Participants With Systemic Events Within 7 Days After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose)

    Time frame: Within 7 days After Booster Dose

    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded.

53. Percentage of Participants Reporting Adverse Events From Booster Dose to 1 Month After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose)

    Time frame: From Booster Dose to 1 Months After Booster Dose

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded.

54. Percentage of Participants Reporting Serious Adverse Events From Booster Dose to 6 Months After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose)

    Time frame: From Booster Dose to 6 Months after Booster Dose

    A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded.

55. COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants Without Serological or Virological Evidence: Phase 2/3

    Time frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.247, Placebo - 6.003)

    Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, without serological or virological evidence of prior SARS-CoV-2 infection were reported in this outcome measure. HIV positive participants were excluded from this analysis.

56. COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA)

    Time frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.214, Placebo - 2.222)

    Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, without serological or virological evidence of prior SARS-CoV-2 infection (analysis for EUA) were reported in this outcome measure.

57. COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants With or Without Serological or Virological Evidence: Phase 2/3

    Time frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.509, Placebo - 6.274)

    Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, with or without serological or virological evidence of prior SARS-CoV-2 infection were reported in this outcome measure.

58. COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants With or Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA)

    Time frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.332, Placebo - 2.345)

    Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, with or without serological or virological evidence (analysis for EUA) of prior SARS-CoV-2 infection were reported in this outcome measure. HIV positive participants were excluded from this analysis.

59. GMR Based on Geometric Mean Titer (N1a) - Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection (N1a) up to 1 Month After Dose 2: Phase 3

    Time frame: 1 Month After Dose 2

    GMR based on geometric mean titer, comparison of 1 month after dose 2 between vaccine groups: BNT162b2-naive participants without evidence of infection up to 1 month after dose 2 were reported in this outcome measure. HIV positive participants excluded from this analysis.

60. Percentage Difference of Participants Achieving Seroresponse Comparison (N1b) of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection up to 1 Month After Dose 2: Phase 3

    Time frame: 1 Month After Dose 2

    Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the lower limit of quantification (LLOQ), a post vaccination assay result >=4 × LLOQ was considered a seroresponse. HIV positive participants excluded.

61. GMR of Neutralizing Titers (E1a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3

    Time frame: 1 Month After Booster Dose to 1 Month After Dose 2

    GMR based on geometric mean titer, comparison of 1 month after booster dose to 1 month after dose 2 for BNT162b2-experienced participants were reported in this outcome measure. HIV positive participants excluded from this analysis.

62. Percentage Difference of Participants Achieving Seroresponse (E1b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3

    Time frame: 1 Month After Booster Dose to 1 Month After Dose 2

    Percentage difference of participants achieving seroresponse - comparison of 1 month after booster dose to 1 month after Dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 × LLOQ was considered a seroresponse. HIV positive participants excluded.

63. GMR of Neutralizing Titers (E2a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3

    Time frame: 1 Month After Booster Dose to 1 Month After Dose 2

    GMR of neutralizing titers (E2a) for comparison of 1 month after booster dose to 1 month after dose 2: BNT162b2-experienced participants in Phase 3 were reported in this outcome measure. HIV positive participants were excluded from this analysis.

64. Percentage Difference of Participants Achieving Seroresponse (E2b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3

    Time frame: 1 Month After Booster Dose to 1 Month After Dose 2

    Percentage difference of participants achieving seroresponse - comparison of 1 month after booster dose to 1 month after Dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 × LLOQ was considered a seroresponse. HIV positive participants excluded.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 40396505Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
• Derived from this study: PubMed 40237463Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.
• Derived from this study: PubMed 39197299Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.
• Derived from this study: PubMed 38012751Killeen T, Kermer V, Troxler Saxer R. mRNA vaccine development during the COVID-19 pandemic: a retrospective review from the perspective of the Swiss affiliate of a global biopharmaceutical company. J Pharm Policy Pract. 2023 Nov 27;16(1):158. doi: 10.1186/s40545-023-00652-y.
• Derived from this study: PubMed 36055877Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022 Sep 22;40(40):5798-5805. doi: 10.1016/j.vaccine.2022.08.036. Epub 2022 Aug 31.
• Derived from this study: PubMed 35792746Kurhade C, Zou J, Xia H, Liu M, Yang Q, Cutler M, Cooper D, Muik A, Sahin U, Jansen KU, Ren P, Xie X, Swanson KA, Shi PY. Neutralization of Omicron sublineages and Deltacron SARS-CoV-2 by three doses of BNT162b2 vaccine or BA.1 infection. Emerg Microbes Infect. 2022 Dec;11(1):1828-1832. doi: 10.1080/22221751.2022.2099305.
• Derived from this study: PubMed 35739094Kurhade C, Zou J, Xia H, Cai H, Yang Q, Cutler M, Cooper D, Muik A, Jansen KU, Xie X, Swanson KA, Shi PY. Neutralization of Omicron BA.1, BA.2, and BA.3 SARS-CoV-2 by 3 doses of BNT162b2 vaccine. Nat Commun. 2022 Jun 23;13(1):3602. doi: 10.1038/s41467-022-30681-1.
• Derived from this study: PubMed 35472295De Santis F, Gubbiotti S. Borrowing historical information for non-inferiority trials on Covid-19 vaccines. Int J Biostat. 2022 Apr 27;19(1):177-189. doi: 10.1515/ijb-2021-0120. eCollection 2023 May 1.
• Derived from this study: PubMed 35131133Thomas SJ, Perez JL, Lockhart SP, Hariharan S, Kitchin N, Bailey R, Liau K, Lagkadinou E, Tureci O, Sahin U, Xu X, Koury K, Dychter SS, Lu C, Gentile TC, Gruber WC. Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial. Vaccine. 2022 Mar 1;40(10):1483-1492. doi: 10.1016/j.vaccine.2021.12.046. Epub 2021 Dec 24.
• Derived from this study: PubMed 34525277Thomas SJ, Moreira ED Jr, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Polack FP, Zerbini C, Bailey R, Swanson KA, Xu X, Roychoudhury S, Koury K, Bouguermouh S, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Yang Q, Liberator P, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Gruber WC, Jansen KU; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med. 2021 Nov 4;385(19):1761-1773. doi: 10.1056/NEJMoa2110345. Epub 2021 Sep 15.
• Derived from this study: PubMed 34043894Frenck RW Jr, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, Perez JL, Walter EB, Senders S, Bailey R, Swanson KA, Ma H, Xu X, Koury K, Kalina WV, Cooper D, Jennings T, Brandon DM, Thomas SJ, Tureci O, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 Jul 15;385(3):239-250. doi: 10.1056/NEJMoa2107456. Epub 2021 May 27.
• Derived from this study: PubMed 33524990Vogel AB, Kanevsky I, Che Y, Swanson KA, Muik A, Vormehr M, Kranz LM, Walzer KC, Hein S, Guler A, Loschko J, Maddur MS, Ota-Setlik A, Tompkins K, Cole J, Lui BG, Ziegenhals T, Plaschke A, Eisel D, Dany SC, Fesser S, Erbar S, Bates F, Schneider D, Jesionek B, Sanger B, Wallisch AK, Feuchter Y, Junginger H, Krumm SA, Heinen AP, Adams-Quack P, Schlereth J, Schille S, Kroner C, de la Caridad Guimil Garcia R, Hiller T, Fischer L, Sellers RS, Choudhary S, Gonzalez O, Vascotto F, Gutman MR, Fontenot JA, Hall-Ursone S, Brasky K, Griffor MC, Han S, Su AAH, Lees JA, Nedoma NL, Mashalidis EH, Sahasrabudhe PV, Tan CY, Pavliakova D, Singh G, Fontes-Garfias C, Pride M, Scully IL, Ciolino T, Obregon J, Gazi M, Carrion R Jr, Alfson KJ, Kalina WV, Kaushal D, Shi PY, Klamp T, Rosenbaum C, Kuhn AN, Tureci O, Dormitzer PR, Jansen KU, Sahin U. BNT162b vaccines protect rhesus macaques from SARS-CoV-2. Nature. 2021 Apr;592(7853):283-289. doi: 10.1038/s41586-021-03275-y. Epub 2021 Feb 1.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

175 sites in 6 countries: see every site and its status.