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JUST IN: FDA Authorizes COVID-19 Booster Dose for Children Ages 5 to 11


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As expected, the Food and Drug Administration has authorized a COVID-19 booster dose for children ages 5 to 11.

Per the FDA:

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Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”  

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On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. Today’s action expands the use of a single booster dose of the vaccine for administration to individuals 5 through 11 years age at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older.

NBC News reported:

The booster shot is 10 micrograms, the same dosage as the primary series for the age group and a third of the dosage given to people ages 12 and up.

The FDA’s decision will now go to the Centers for Disease Control and Prevention, which will make a recommendation about how the boosters should be used for the age group.

The CDC’s independent group of advisers, known as the Advisory Committee on Immunization Practices, is expected to discuss the booster during a scheduled meeting Thursday. CDC Director Dr. Rochelle Walensky is expected to issue a final recommendation following that meeting. Shots could begin as early as Friday.

Less than a third of the 28 million 5 -to-11-year-old children in the United States have received two doses of a Covid vaccine, according to data from the CDC.



 

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