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COVID-19: FDA Expands Eligibility For Pfizer Booster To Children 5 Through 11

Pfizer COVID-19 vaccine
Pfizer COVID-19 vaccine Photo Credit: Flickr US Secretary of Defense

Federal health officials have granted emergency use authorization for a booster dose of the Pfizer-BioNTech COVID-19 vaccine in children.

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On Tuesday, May 17, the US Food and Drug Administration (FDA) announced that it is expanding eligibility for boosters to include children between the ages of 5 and 11 years old.

That age group will be permitted to receive their booster shot five months after completing their initial COVID-19 vaccination series, officials said.

FDA Commissioner Robert Califf said that while data shows COVID-19 is less severe in children, the vaccine and boosters can help prevent potential long-term effects.

“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,” he said.

“Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe,” he continued.

"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.”

Pfizer had requested the emergency use authorization at the end of April, citing data that found the vaccine was effective in helping fight the Omicron and other wild variants, which led to a surge of new cases in the winter and early spring.

Antibody responses were evaluated in 67 study participants who received a booster dose seven to nine months after completing a two-dose primary series, according to the FDA.

To date, Pfizer said that more than eight million children in that age group have completed the initial vaccination process.

"The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research said.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations.”

According to Pfizer, 4,500 children ages 5 through 11 years of age participated in their trials, which found the vaccine’s efficacy to be above 90 percent.

The decision now falls to the Centers for Disease Control and Prevention (CDC) which will recommend how to use the booster in children.

They are scheduled to meet on Thursday, May 19 to make a decision.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” Marks added.

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