Pfizer Inc. (PFE) and BioNTech SE (BNTX) have asked the U.S Food and Drug Administration to approve their COVID-19 vaccine for children age 6 months up to 5 years.
If authorization is granted, the vaccine would be the first COVID-19 vaccine available for pediatric populations under 5 years of age.
The companies expect to complete the emergency use authorization submission in the coming days. The application is for authorization of the first two 3 micro gram doses of a planned three-dose primary series in the age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of the requested EUA, the companies said in a statement.
The FDA's Vaccines and Related Biological Products Advisory Committee will meet on February 15 to discuss the request for emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for the age group.
"Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge..," said Acting FDA Commissioner Janet Woodcock.
The FDA authorized the Pfizer-BioNTech COVID-19 vaccine for use in children 5 through 11 years of age in October 2021 and recently authorized the use of a single booster dose in individuals 12 through 15 years of age and older. The vaccine had been authorized for emergency use in the US since December 2020 for people age 16 and older.
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