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#accelerateism FDA Authorizes Pfizer Booster For Children 12 To 15 Years Old - Health - Nairaland

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#accelerateism FDA Authorizes Pfizer Booster For Children 12 To 15 Years Old by Uasldas: 10:16am On Jan 25, 2022
On Monday, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization for Pfizer's new crown vaccine booster shot, officially including 12 to 15-year-old children in the United States.

At the same time, the FDA also shortened the interval between booster shots for people over 12 years old from "6 months after the first injection" to "5 months after the first injection"; and authorized certain immunocompromised 5 to 11 years old. Children get the third dose of the new crown vaccine.

"During the COVID-19 pandemic, the FDA's need to adapt rapidly to the evolving virus means making informed decisions using the best science available," FDA Acting Commissioner Janet Woodcock said in a statement. , while taking into account the health and safety of the American public. In the current wave of transmission of the Omicron variant strain, we must continue to take effective preventive measures, including vaccination and booster shots, wearing masks and maintaining social distancing.”

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said that the agency's update to expand the scope of the vaccine's authorization is based on a review of clinical trial data submitted by Ruihui and real country data in Israel, as well as multiple laboratory tests. Decisions made by peer review.

"Based on the FDA's assessment of currently available data, the current authorized vaccine booster dose may help provide better protection against Delta and Omicron variant strains," Marks said. Considering that the Omicron variant strain appears to be resistant to the current vaccine standard dose The levels of antibodies produced are more resistant, and the FDA has expanded the scope of booster shots and shortened the interval between doses to help protect the youngest and most vulnerable populations."

According to the U.S. Centers for Disease Control and Prevention (CDC), half of the nation’s 12- to 15-year-olds (about 8.7 million) are now fully vaccinated, and 5 million of them have been 5 months away from their first vaccination, which means that They are now eligible for booster shots.

According to the regulations, the FDA's authorization also needs to be approved by the CDC before it can take effect. CDC Director Rochelle Walensky is expected to approve the authorization this week.

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