FDA Grants Emergency Authorization of Pfizer’s Bivalent COVID-19 Booster in Children Under 5 Years Who Completed Three Monovalent Shots
On Tuesday, the Food and Drug Administration (FDA) announced that it granted an emergency use authorization for Pfizer’s bivalent COVID-19 booster in children under 5 years who had previously received three monovalent shots, despite concerns from well-respected doctors about the dangers of the COVID-shots.
“Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to provide a single booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years of age) at least 2 months after completion of primary vaccination with three doses of the Pfizer-BioNTech COVID-19 Original Vaccine,” according to the company’s release.
“Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner,” the company said.
Under the expanded EUA, the bivalent booster dose may be given to children at least 2 months after they received a third dose of Pfizer’s monovalent vaccine. The FDA said children who have not yet completed their primary series should complete it with a dose of bivalent vaccine and are not eligible for a bivalent booster.
“[This] authorization provides parents and caregivers of children aged 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 bivalent vaccine,” Peter Marks, MD, PhD, director of the FDA’s
Source: The Gateway Pundit