New Delhi: 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 full approval of their Omicron-adapted COVID-19 vaccine.
The companies are seeking approval for the updated vaccine both as a primary and a booster dose for individuals 12 years and above.
Advisers to the FDA in January had unanimously voted 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 updated vaccine as their primary dose, rather than using the original vaccine for the primary doses before having access to the updated version for boosters, the company said.