Pfizer and BioNTech Report EUA Submission to the US FDA for Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children Aged 5-11 Years
Shots:
- The EUA submission was based on the safety and immunogenicity data from the Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from Omicron BA.4/BA.5-adapted bivalent vaccine
- The companies will also submit an application to EMA to extend the marketing authorization of Omicron BA.4/BA.5-adapted bivalent vaccine in the EU in children aged 5-11yrs. in the coming days
- Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is being studied in the P-I/II/III study to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens in children aged 6mos. to 11yrs.
Ref: Globenewswire | Image: Pfizer
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