The US Food and Drug Administration (FDA) on Monday approved the use of the third dose of the Pfizer and BioNTech COVID-19 vaccines for children aged 12 to 15 years.
The federal health regulator said it is releasing the letter of authorization in full dated December 16, 2021, amending the EUA for the COVID-19 vaccine, mRNA and Pfizer-BioNtech COVID-19 vaccine, with amendments in order to authorize the use of the vaccine. Single booster dose in persons 12 to 15 years of age.
The health regulator reduced the authorized dosing interval of homologous booster doses to at least five months after completion of the primary series.
The FDA has authorized a third primary series dose of vaccine administered at least 28 days following a two-dose regimen of this vaccine in individuals 5 to 11 years of age who have had a solid organ transplant, or 5 to 11 years of age. have been diagnosed at an age with conditions that are considered to have an equivalent level of immunocompromise.
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