The FDA granted emergency use authorization days after a panel of experts recommended its approval.
The US Food and Drug Administration on Friday approved the Pfizer-BioNTech COVID-19 vaccine for emergency use in children aged 5 to 11, a significant step toward introducing vaccination for that age group.
“The FDA has determined that this Pfizer vaccine meets the criteria for the Emergency Use Authorization,” the FDA said. Press release. “Based on the totality of the available scientific evidence, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in persons less than 5 years of age outweigh the known and potential risks.
The FDA granted emergency use authorization days after a panel of experts recommended its approval. The dosage size for children is one-third of the recommended dosage for those 12 years of age and older.
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The agency cited data showing the vaccine was about 91% effective in preventing COVID-19 for the age group, despite the smaller dose.
Experts from the Centers for Disease Control and Prevention will meet next week to consider whether to recommend the vaccine for children and which groups should be eligible. The CDC’s approval will clear the way for vaccinations to begin.
“As a mother and a physician, I know that parents, caregivers, school staff and children await today’s authorization. Vaccination of young children against COVID-19 gives us a sense of normalcy. will bring us closer to returning in the U.S.,” said Acting FDA Commissioner Janet Woodcock. “Our comprehensive and rigorous evaluation of data related to vaccine safety and effectiveness will help reassure parents and guardians that this vaccine meets our high standards.”
About 28 million children are expected to be eligible for low-dose vaccination, which may require two shots spaced approximately three weeks apart. Earlier this month, the White House said about 15 million doses of the Pfizer vaccine are ready for shipment within a week of approval.
Federal officials and health experts have touted the approval of the vaccine for children as an important step toward returning to normal operations in schools and protecting the wider population from infection.
“We are completing an operational plan to ensure vaccination is available, easy and convenient for children ages 5 to 11,” White House COVID-19 coordinator Jeff Gents said on October 20. FDA and CDC Decisions.”
According to the CDC, about 8,300 COVID-19 cases affecting children between the ages of 5 and 11 required hospitalization.