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Drugs / BNT162b2 Bivalent (original/Omicron BA.4/BA.5)

Follow last change Nov 2024 re-read 3 minutes ago

BNT162b2 Bivalent (original/Omicron BA.4/BA.5)

Developed for: COVID-19
Investigated by: BioNTech SE · Pfizer

Trials 1

today NCT05541861 · Ph 1

2023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1	NCT05541861	Nov 2022 → Nov 2024	COVID-19	BioNTech SE	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 5

Date	Issuer	Release
2023-02-24	Pfizer	Regulatory Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine for Ages 12 Years and Older as Primary Series or Booster pfizer.com ↗ As EUA is not meant to be a long-term status, this sBLA is the next step toward full regulatory approval of the bivalent vaccine.
2022-12-05	Pfizer	Regulatory Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years pfizer.com ↗
2022-12-05	BioNTech SE	Regulatory Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years biontech.com ↗
2022-11-18	BioNTech SE	Results Pfizer and BioNTech Report New Data on Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Improved Immune Response Against Emerging Omicron Sublineages biontech.com ↗ One month after a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, neutralizing antibody titers against emerging Omicron sublineages increased 3.2- to 4.8-fold compared to the companies’ original COVID-19 vaccine
2022-11-10	Pfizer	Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Children 5 Through 11 Years of Age in European Union pfizer.com ↗ The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

All press releases naming this drug 5 releases

Date	Issuer	Release
2023-02-24	Pfizer	Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine for Ages 12 Years and Older as Primary Series or Booster pfizer.com ↗
2022-12-05	Pfizer	Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years pfizer.com ↗
2022-12-05	BioNTech SE	Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years biontech.com ↗
2022-11-18	BioNTech SE	Pfizer and BioNTech Report New Data on Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Improved Immune Response Against Emerging Omicron Sublineages biontech.com ↗
2022-11-10	Pfizer	Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Children 5 Through 11 Years of Age in European Union pfizer.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

Field	Value	Cited text
Known as	BNT162b2 Bivalent (original/Omicron BA.4/BA.5)	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05541861 ↗
Route	Intramuscular	“administered as intramuscular injection.” NCT05541861 ↗