Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT162b1 · 2 trials · 3 indications
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Solicited local AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by United States (US) Food and Drug Administration (FDA) criteria along with the 14-day period AE assessment as graded by National Medical Products Administration (NMPA) criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The "solicited" AEs were pre-defined and listed in the subjects' diaries. All the solicited local AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo).
Solicited systemic AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by US FDA criteria along with the 14-day period AE assessment as graded by NMPA criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The "solicited" AEs were pre-defined and listed in the subjects' diaries. Except for 1 event (myalgia) occurred in 10 µg group and 1 event (diarrhea) occurred in placebo group, all the solicited systemic AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo). All the solicited systemic AEs occurred within 14 days after vaccination were related to investigational vaccine (or placebo), except for 1 event (myalgia) occurred in placebo group and 2 events (both diarrhea; 1 event occurred in 30 µg group, 1 event occurred in placebo group).
AEs occurred during the 21-day period after dose 1 were also referred as "unsolicited" AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.
AEs occurred during the 28-day period after dose 2 were also referred as "unsolicited" AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.
| Arm | Type | Description |
|---|---|---|
| 10 µg dose, 18-55 years of age (2 doses) | EXPERIMENTAL | - |
| 20 µg dose, 18-55 years of age (2 doses) | EXPERIMENTAL | - |
| 30 µg dose, 18-55 years of age (2 doses) | EXPERIMENTAL | - |
| 10 µg dose, 65-85 years of age (2 doses) | EXPERIMENTAL | - |
| 20 µg dose, 65-85 years of age (2 doses) | EXPERIMENTAL | - |
| 30 µg dose, 65-85 years of age (2 doses) | EXPERIMENTAL | - |
| 30 µg dose, ≥12 years of age (2 doses) | EXPERIMENTAL | - |
| Placebo, 18-55 years of age | PLACEBO_COMPARATOR | - |
| Placebo, 65-85 years of age | PLACEBO_COMPARATOR | - |
| Placebo, ≥12 years of age | PLACEBO_COMPARATOR | - |
| 100 µg dose, 18-55 years of age (2 doses) | EXPERIMENTAL | - |
| Vaccination of Placebo recipients with BNT162b2 - Stage 1 | OTHER | Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study. |
| Vaccination of placebo recipients with BNT162b2 - Stage 2 | OTHER | Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. |
| Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg | EXPERIMENTAL | - |
| Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg | EXPERIMENTAL | - |
| Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg | EXPERIMENTAL | - |
| Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg | EXPERIMENTAL | - |
| Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg | EXPERIMENTAL | - |
| Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg | EXPERIMENTAL | - |
| Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg | EXPERIMENTAL | - |
| Low-dose, 18-55 years of age | EXPERIMENTAL | - |
| High-dose, 18-55 years of age | EXPERIMENTAL | - |
| Low-dose, 65-85 years of age | EXPERIMENTAL | - |
| High-dose, 65-85 years of age | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BNT162b1 | BIOLOGICAL | Intramuscular injection |
| BNT162b2 | BIOLOGICAL | Intramuscular injection |
| Placebo | OTHER | Intramuscular injection |
| BNT162b2SA | BIOLOGICAL | Intramuscular injection |
Inclusion Criteria: • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a ...
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BNT162b1 is an investigational mRNA vaccine candidate being studied for the prevention of SARS-CoV-2 infection and COVID-19. It is in clinical development for use in healthy individuals, including those aged 12 years and older, to generate an immune response against the virus.
BNT162b1 is an mRNA-based vaccine that encodes the receptor-binding domain of the SARS-CoV-2 spike protein. It is designed to elicit an immune response against the virus that causes COVID-19, though specific molecular target details are not provided.
BNT162b1 is being developed by BioNTech SE, a biotechnology company traded on the Nasdaq under the ticker BNTX. The vaccine candidate is part of BioNTech's COVID-19 vaccine program and has been studied in clinical trials.
BNT162b1 has completed Phase 1 and Phase 2 clinical trials. It is an investigational vaccine candidate and is not FDA approved. The trials have been completed, and the vaccine is no longer in active clinical development.
BNT162b1 was studied in two completed clinical trials. NCT04368728 was a Phase 2 study with 46,969 participants across multiple countries, and NCT04523571 was a Phase 1 study with 144 participants in China. Both trials evaluated safety and immunogenicity.
BNT162b1 is a distinct vaccine candidate from BNT162b2. While both are mRNA vaccines developed by BioNTech for COVID-19, BNT162b1 encodes the receptor-binding domain, whereas BNT162b2 encodes the full spike protein. BNT162b2 is the authorized vaccine, while BNT162b1 remains investigational.