- Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have completed a submission to the FDA requesting Emergency Use Authorization for an omicron BA.4/BA.5-adapted COVID-19 booster dose for 12 years of age and older.
- Pending authorization, the omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.
- Rolling submission for omicron BA.4/BA.5-adapted bivalent vaccine to be completed with the European Medicines Agency in the coming days.
- Related: Canada OKs Pfizer COVID-19 Booster For Kids Aged 5-11 Years.
- Preclinical data showed that a booster dose of Pfizer and BioNTech’s omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against BA.1, BA.2, and BA.4/BA.5 variants and the original strain.
- A clinical study investigating the safety, tolerability, and immunogenicity of the omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month.
- The companies previously announced data from a Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate.
- The companies submitted an application for the omicron BA.1-adapted bivalent COVID-19 vaccine in July.
- Price Action: PFE shares are down 0.24% at $49.03, and BNTX stock is up 0.39% at $148.50 on the last check Monday.
- Photo by Spencer Davis from Pixabay
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