FDA Authorizes Pfizer's COVID-19 Vaccine for Children 5-11

Brenda Goodman, MA

October 29, 2021

The US Food and Drug Administration (FDA) has authorized Pfizer’s vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week.

The move brings families with young children a step closer to resuming their normal activities, and should help further slow transmission of the SARS-CoV-2 virus in the United States.

States have already placed their orders for initial doses of the vaccines. The FDA authorization of the shots triggers the shipments of millions of doses to pediatricians, family practice physicians, children's hospitals, community health centers, and pharmacies.

Next, a panel of experts advising the Centers for Disease Control and Prevention (CDC) known as the Advisory Committee on Immunization Practices, or ACIP, will meet on Tuesday to vote on recommendations for use of the vaccine.

As soon as the CDC director signs off on those recommendations, children can get the shots, perhaps as early as next Wednesday. 

Pfizer's vaccine for children is 10 micrograms, or one third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. 

In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3100 children. 

In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children. There are about 28 million children in the US between the ages of 5 and 12.

"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," said Acting FDA Commissioner Janet Woodcock, MD, in a news release.

"Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards," she said.

Manufacturing Change

Since the start of the pandemic, there have been at least 1.9 million cases of COVID-19 in children ages 5 through 11. At least one third of the children who have been hospitalized for the infection have had no underlying medical conditions.

The FDA also approved a manufacturing change to the vaccine, to allow the company to switch the buffering solution that controls its Ph. The new buffer is called tromethamine, or tris. 

It has been used as buffer in other vaccines, and does not affect the safety profile of the shots, said Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research.

The change makes the vaccine more stable at refrigerator temperatures for longer periods of time, he said during a press briefing.

"If I had a child in this age group, I would not hesitate, for a second, to give my child one of these vaccines," Marks said.

He said the companies are still studying the use of the vaccines in even younger children, and that COVID-19 vaccines are still a few months away for children in the under-5 age group.


FDA, News Release, October 29, 2021

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