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US FDA clears Pfizers Covid-19 booster shot for 12- to 15-year-olds

US FDA clears Pfizers Covid-19 booster shot for 12- to 15-year-olds

The US Food and Drug Administration (FDA) on Monday authorized the use of a third dose of the Pfizer and BioNTech COVID-19 vaccine for children aged between 12 and 15 years. The federal health regulator said it is reissuing the Dec 16, 2021 letter of authorization in its entirety with revisions incorporated to amend the EUA for COVID-19 Vaccine, mRNA and Pfizer-BioNTech COVID-19 vaccine to authorize the use of the vaccine as a single booster dose in individuals 12 through 15 years of age. The health regulator also lowered the authorized dosing interval of the homologous booster dose to at least five months after completion of the primary series. The FDA also authorized a third primary series dose of the vaccine administered at least 28 days following the two dose regimen of this vaccine in individuals 5 through 11 years of age who have undergone solid organ transplantation, or 5 through 11 years of age who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Download.

science 2022-01-03 Livemint