The U.S. Food and Drug Administration on Friday approved Pfizer BioNTech’s COVID-19 emergency vaccine in children ages 5-11, an important step towards starting vaccination for the age group.

“The FDA has determined that this Pfizer vaccine meets the criteria for emergency approval,” said an FDA press release. “Based on all of the available scientific evidence, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh the known and potential risks in those under the age of 5.

The FDA issued the emergency clearance days after a panel of experts recommended the approval. The dose for children is one third of the recommended dose for people 12 years and over.


The agency cited data showing that despite the lower dose, the vaccine was nearly 91% effective in preventing COVID-19 for the age group.

Experts from the Centers for Disease Control of Prevention will meet next week to consider whether the vaccine is recommended for children and which groups to consider. The approval of the CDC would pave the way for vaccinations to begin.

“As a mother and doctor, I know that parents, carers, school staff and children have been waiting for today’s approval. Vaccinating younger children against COVID-19 will bring us closer to a return to a sense of normalcy, “said Acting FDA Commissioner Janet Woodcock. “Our comprehensive and rigorous evaluation of data on the safety and effectiveness of the vaccine is designed to reassure parents and guardians that this vaccine meets our high standards.”

It is expected that approximately 28 million children will be eligible for the lower dose vaccination, which could require two vaccinations approximately three weeks apart. Earlier this month, the White House announced that approximately 15 million doses of the Pfizer vaccine will be ready to ship within a week of approval.

Federal officials and health experts have touted the vaccine’s approval for children as a critical step in returning to normal school operations and protecting the wider population from infection.

“We are finalizing operations planning to ensure that vaccinations are easily and conveniently available for children ages 5-11,” said Jeff Zients, COVID-19 coordinator for the White House on October 20. “We’ll be ready pending the decision by the FDA and CDC.”


About 8,300 COVID-19 cases affecting children ages 5-11 resulted in hospitalization, according to the CDC.