Pfizer Applies for FDA Approval for Coronavirus Vaccine for Children

A student at Carlin Springs Elementary School receives an H1N1 flu vaccination January 7, 2010 in Arlington, Virginia. The US Centers for Disease Control reported in December that at least 60 million people in the US have been vaccinated against swine flu, with children being twice as likely as adults …
MANDEL NGAN/AFP via Getty Images

Pfizer announced Thursday it applied to the Food and Drug Administration (FDA) for approval of its vaccine for 5-11-year-olds — a significant move, as no coronavirus vaccine has been approved for children younger than 12.

The FDA advisory committee is expected to discuss Pfizer’s application on October 26.

The application comes on the heels of Pfizer’s announcement last month, reporting its vaccine to be effective for kids in the younger age bracket:

For elementary school-aged kids, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.

The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said.

Children generally do not get severely ill with COVID-19 as much as older people do, but there were still almost 175,000 cases among children in the week ending Sept. 30, according to the American Academy of Pediatrics (AAP).

According to the American Academy of Pediatrics (AAP), less than two percent of coronavirus cases among children result in hospitalization.

In September, Fauci predicted that vaccines for children would likely be available by Halloween.

“I think there’s a really good chance it will be before Halloween,” he said during an appearance on MSNBC. “I believe there’s a reasonably good chance that it will be.”

The White House chief medical adviser added he would be in favor of mandating the vaccine for children, contending such requirements are “nothing new.”

A local health worker administers a vaccine at a local health center at the financial district of Makati, east of Manila, Philippines, Friday, Sept. 12, 2014. The World Health Organization and the British government are working with the Philippine Department of Health, UNICEF and a host of other partners to help deliver a month-long campaign to immunize children against Measles, Rubella, commonly known as German measles, and Polio which aims to immunize 13 million children nationwide. (AP Photo/Bullit Marquez)

AP Photo/Bullit Marquez

“When you hear, ‘would I be in favor of mandating?’ in fact, I would be. But that gets taken out of context like I’m trying to impose some novel, new restriction on somebody, of taking away their rights,” he said.

“Look at what’s been going on for decades in schools — the requirement for vaccination,” he added.


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