Pfizer requests FDA clearance for its COVID-19 vaccine in kids ages 12 to 15
NEW YORK - Pfizer-BioNTech on Friday requested to expand the emergency use of its COVID-19 vaccine in the United States for older children ages 12 to 15.
The request asks the U.S. Food and Drug Administration to amend its Emergency Use Authorization, which was originally granted in December for people ages 16 and older.
"Pending regulatory decision, our hope is to make this vaccine available to the 12-15-year-old age group before the start of the 2021 school year," Pfizer said in a statement.
Pfizer, which developed the two-dose vaccine with its German partner BioNTech, said it plans to submit a similar request to European regulators and other health officials worldwide in the coming days.
FILE - A nurse prepares a dose of the Pfizer/BioNTech Covid-19 vaccine on April 9, 2021. (Photo by LOIC VENANCE/AFP via Getty Images)
Last week, Pfizer said Phase 3 clinical trials found its COVID-19 vaccine was safe and 100% effective among this age group. The preliminary data showed there were no cases among the fully vaccinated adolescents compared to 18 among those given dummy shots.
The study involved 2,260 U.S. volunteers ages 12 to 15 and has not yet been peer-reviewed.
Overall, kids develop serious illness or die from COVID-19 at much lower rates than adults, but they do still get sick and can still spread the virus.
Children make up roughly 13% of COVID-19 cases that have been documented in the U.S. At least 268 have died from COVID-19 in the U.S. alone and more than 13,500 have been hospitalized, according to figures shared by the American Academy of Pediatrics.
Some have also gotten MIS-C, a rare inflammatory syndrome in children linked to COVID-19.
In the ongoing mass vaccination campaign, the U.S. is vaccinating roughly 3 million people a day. One-third of American adults have received at least one dose of a COVID-19 vaccine, U.S. data shows. But experts say getting children inoculated will be crucial to ending the pandemic and ultimately returning to some kind of normalcy.
Adding cause for concern is a more contagious coronavirus variant first identified in the U.K., known as B.1.1.7, that has become the dominant strain in the U.S. Health officials say the three currently approved vaccines work well against the B. 1.1.7. variant — appears to infect children more easily than previous strains.
"Please understand, this B.1.1.7 variant is a brand new ballgame," Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy, said Sunday on "Meet the Press."
"Unlike the previous strains of the virus, we didn't see children under eighth grade get infected often, or they were not frequently very ill. They didn't transmit to the rest of the community," Osterholm added. "That's why I was one of those people very strongly supporting reopening in-class learning. B.1.1.7 turns that on its head."
Both Pfizer and Moderna are also studying their shots in children under 12 — including babies as young as 6 months. Johnson & Johnson, the third vaccine currently being administered in the U.S., also recently began testing its shot in older children and teenagers.
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This story was reported from Cincinnati.