Pfizer Inc and its German partner BioNTech SE said on Friday they filed an application to the U.S Food and Drug Administration (FDA) for a full approval of their Omicron-adapted COVID-19 vaccine.
said on Friday they filed an application to the U.S Food and Drug Administration for a full approval of their Omicron-adapted COVID-19 vaccine.
The companies are seeking approval of the updated vaccine both as a primary course and a booster dose for individuals 12 years of age and above.in favor of using the same coronavirus strain for the initial COVID-19 vaccine doses and the boosters to simplify the vaccination regimen in the United States.
If the application is approved, individuals will be able to receive the Omicron-adapted vaccine for their primary dose, rather than using the original vaccine for the primary course before having access to the bivalent vaccine, the company said. The updated vaccine is currently available in the United States under emergency-use authorization as a single booster dose for people aged 5 years and above, and as the third dose in the three-dose primary series for children 6 months through 4 years of age.
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