FDA approves booster dose of Pfizer COVID-19 vaccine for children 5 to 11 years of age

Pfizer COVID-19 booster vaccine for children

This Tuesday, the U.S. Food and Drug Administration. The FDA amended the emergency use authorization for the Pfizer COVID-19 booster for children, authorizing the use of a single booster dose to be administered to persons 5 to 11 years of age at least five months after completion of a two-dose primary series.

"While it has largely been that COVID-19 is less serious in children than in adults, the omicron wave has resulted in more children becoming ill and being hospitalized. Children may also experience longer-term effects, even after having a mild illness," said FDA Commissioner Robert M. Califf.

In that regard, he noted that vaccination remains the most effective way to prevent COVID-19 and its serious consequences. "It is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 vaccine and has not yet received their primary series, vaccinating them can help protect them from the potentially serious consequences that can occur."

On January 3 of this year, the FDA authorized the use of a single booster dose of Pfizer-BioNTech COVID-19 vaccine to be administered to persons 12 to 15 years of age after completion of primary vaccination with Pfizer-BioNTech COVID-19 vaccine. 

Today's action expands the use of a Pfizer COVID-19 booster for children for administration to persons 5 to 11 years of age at least five months after completion of a primary series of Pfizer-BioNTech COVID-19 vaccine. 

"The Pfizer-BioNTech COVID-19 vaccine is effective in helping to prevent the most serious consequences of COVID-19 in people 5 years of age and older," said Peter Marks, director of the Center for Biologics Evaluation and Research. 

He added that, since licensure of the vaccine for children under 5 years of age in October 2021, emerging data suggest that COVID-19 vaccine efficacy declines after the second dose of vaccine in all licensed populations. 

The FDA has determined that the known and potential benefits of a single booster dose of Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years of age at least five months after completion of a primary series outweigh its known and potential risks, while it may help provide continued protection against disease in this age group and older.

FDA Safety Assessment for booster dose of Pfizer COVID-19 vaccine for children

The safety of a single booster dose of Pfizer COVID-19 vaccine for children was evaluated in approximately 400 children who received an extra dose at least five months - range 5 to 9 months - after completion of a two-dose primary series.

The most frequently reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, chills and fever.

It should be noted that the reinforcement was only authorized for Pfizer.

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