Pfizer, BioNTech ask FDA to approve use of vaccine in children ages 12 to 15

National News

(NEXSTAR) – Pfizer and BioNTech requested Friday that the U.S. Food and Drug Administration grant emergency use approval to start administering the COVID-19 vaccine to children ages 12 to 15.

The companies said in a news release that they plan to request the same authorization – which could help children return to classrooms sooner – from other regulatory authorities around the world this week.

The company said that children in that age range who are participating in vaccine trials have tolerated the first injection well, showing side effects similar to those in the 16- to 25-year-old age group. While Pfizer says the vaccine has so far been effective in younger children, the FDA has not yet reviewed those results.

Pfizer and BioNTech will continue to monitor the trial participants for two years after their second dose, according to the release.

The vaccine, BNT162b2, was developed by Pfizer and BioNTech using BioNTech’s proprietary mRNA technology. The FDA gave it emergency use approval, but it has not been approved or licensed the vaccine.

“These submissions represent a critical step in Pfizer’s and BioNTech’s ongoing efforts to support
governments in broadening global vaccination efforts,” the release states. “The companies look forward to working closely with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory authorities as part of the companies’ efforts to expand emergency or conditional authorization of their COVID-19 vaccine in 12- to 15-year-olds as quickly as possible.”

According to Dr. James B. Wood, with the Indiana University School of Medicine, kids under the age of 12 who contract COVID-19 tend to have mild illness or no symptoms, but they still face risks and should be vaccinated. At least 226 children in the U.S. have died and thousands more have been hospitalized during the pandemic, Wood said.

At least one Centers for Disease Control and Prevention review found that there was no appreciable uptick in COVID cases if schools followed policies to mitigate the spread of the virus. Researchers have yet to determine how likely children are to pass the virus from a school setting to an adult, however.

Wood recommends that schools continue to follow their social distancing and mask policies until the greater community achieves herd immunity.

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