Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bivalent BNT162b2 3 microgram dose · 1 trial · 3 indications
Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries
Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
as elicited by investigational site staff
as elicited by investigational site staff
Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries
Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
as elicited by investigational site staff
as elicited by investigational site staff
As measured at the central laboratory
As measured at the central laboratory
As measured at the central laboratory
As measured at the central laboratory
Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries
Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
as elicited by investigational site staff
as elicited by investigational site staff
As measured at the central laboratory
As measured at the central laboratory
Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries
Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
as elicited by investigational site staff
as elicited by investigational site staff
As measured at the central laboratory
As measured at the central laboratory
As measured at the central laboratory
pain at the injection site, redness, and swelling as self-reported on electronic diaries
fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
as elicited by investigational site staff
as elicited by investigational site staff
As measured at the central laboratory
As measured at the central laboratory
pain at the injection site, redness, and swelling as self-reported on electronic diaries
fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
as elicited by investigational site staff
as elicited by investigational site staff
As measured at the central laboratory
As measured at the central laboratory
| Arm | Type | Description |
|---|---|---|
| 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) | EXPERIMENTAL | Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 |
| 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) | EXPERIMENTAL | Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 |
| 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) | EXPERIMENTAL | Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 |
| 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule | EXPERIMENTAL | Injection in the muscle at 0- and 8-weeks |
| 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule | EXPERIMENTAL | Injection in the muscle at 0- and 8-weeks |
| 3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1) | EXPERIMENTAL | Injection in the muscle, 2 doses 2 months apart |
| 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 10 microgram dose, 5 to <12 Years (Substudy D, Group 1) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 10 microgram dose, 5 to <12 Years (Substudy D, Group 2) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 10 microgram dose, 5 to <12 Years (Substudy D, Group 3) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) | EXPERIMENTAL | Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 |
| 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) | EXPERIMENTAL | Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 |
| 10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) | EXPERIMENTAL | Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 |
| 6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule | EXPERIMENTAL | Injection in the muscle at 0-, 3-, and 11-weeks |
| 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2) | EXPERIMENTAL | Injection in the muscle, 1 dose |
| 10 microgram dose, 6 months to <2 years (Substudy A Phase 2/3, Group 6) - 0/8 week schedule | EXPERIMENTAL | Injection in the muscle at 0- and 8-weeks |
| Name | Type | Description |
|---|---|---|
| Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose | BIOLOGICAL | Injection in the muscle |
| Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose | BIOLOGICAL | Injection in the muscle |
| Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose | BIOLOGICAL | Injection in the muscle |
| Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose | BIOLOGICAL | Injection in the muscle |
| Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose | BIOLOGICAL | Injection in the muscle |
| Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose | BIOLOGICAL | injection in the muscle |
| Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose | BIOLOGICAL | Injection in the muscle |
Substudy A Inclusion Criteria: * Phase 1: Healthy male or female participants ≥6 months to \<4 years 3 months of age, at the time of randomization. * Phase 2/3: Healthy male or female participants ≥6 months to \<5 years of age at the time of randomization/enrollment. Exclusion Criteria: * Previo...
Bivalent BNT162b2 3 microgram dose is an investigational COVID-19 vaccine candidate developed by BioNTech SE. It is designed to protect against SARS-CoV-2 and was studied in healthy children. The 3 microgram dose refers to the amount of mRNA in each dose. It is not yet approved and remains in clinical development.
Bivalent BNT162b2 3 microgram dose is being studied for the prevention of COVID-19 caused by SARS-CoV-2. The Phase 3 trial enrolled healthy children to evaluate the vaccine candidate. It targets the original SARS-CoV-2 strain and the Omicron BA.4/BA.5 variants.
Bivalent BNT162b2 3 microgram dose is developed by BioNTech SE, which trades on the Nasdaq under the ticker BNTX. BioNTech is the sponsor of the clinical trial evaluating this vaccine candidate.
Bivalent BNT162b2 3 microgram dose is in Phase 3 clinical development. The trial has been completed, and the vaccine candidate is not approved. It remains investigational.
Bivalent BNT162b2 3 microgram dose was evaluated in a single Phase 3 trial, NCT05543616, titled "A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children." The trial enrolled 4,338 participants across the United States, Brazil, Mexico, Puerto Rico, and South Africa, and is now completed.