Booster doses are currently not part of the marketing authorisation of COVID-19 vaccines and have not yet been subject to a scientific assessment by EMA in the absence of sufficient data
The approval is highly anticipated after the drugmaker said in March the vaccine was found to be safe, effective and produced a robust antibody responses in 12- to 15-year-olds in a clinical trial.
The vaccine has already been cleared in the United States for those aged 16 and above.
The request made to the US Food and Drug Administration is not due to any new safety issues, but in response to the new variants in the country that could be resistant to bamlanivimab when used alone, the drugmaker said in a statement.
Hospitals with bamlanivimab supply should now order etesevimab to pair with it, Lilly said.