Pfizer requests FDA approval for vaccination of children aged 12 to 15 years
Pfizer on Friday asked to extend the use of its Covid-19 vaccine for children between the ages of 12 and 15.
The application asks the Food and Drug Administration to amend the emergency use authorization, which was issued by the FDA early last year for people 16 years and older.
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Last week, Pfizer-BioNTech said its phase 3 clinical trials showed that its vaccine was safe and 100% effective for 12- to 15-year-olds, although the findings were not reviewed by peers.
“It is hoped to start vaccinating these people before the start of the next school year,” chief executive Albert Bourla said in a statement when the results were released.
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“Immunization of our youth is the next step in seeing how we can survive this epidemic,” said Drs. Buddy Creech, pediatric infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tennessee.
“By extending the age at which we can receive the vaccine, we can continue our efforts to protect those most at risk: the elderly as well as the elderly and the youth with lower health conditions,” said Creech, who was not involved in the Pfizer study.
The FDA review process will probably take a few weeks, as long as the information looks good and is consistent with what was seen in adults, said Dr. Jesse Goodman, director of the Center for Medical Product Access, Safety and Stewardship at Georgetown University and former FDA scientist scientist.
Norman Baylor, president and chief executive officer of Biologics Consulting and former director of the FDA’s Office of Research and Revision, agreed.
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The FDA does not need to consult with its independent advisory body before amending Pfizer EUA, although it may decide to do so with the intention of making it more public, Baylor said.
One-third of Americans have received at least one dose of the Covid-19 vaccine, according to the NBC News database. In order to vaccinate everyone, however, vaccines must be approved by children.
Pfizer also learns how effective the vaccine is for children aged 6 to 11 years. The first measurements in that trial were made in March.
Pfizer vaccine is the only one now approved for young people 16 years of age and older; other vaccines available in the U.S., from Moderna and Johnson & Johnson, for people 18 years of age and older. In December, Moderna began testing mRNA vaccines for teens between the ages of 12 and 18. She is also learning her vaccine for children aged 6 to 11 years.
Pfizer’s request comes as Covid-19 infections among young people and children are fueling outbreaks in other provinces. In Michigan, for example, crime rates for children aged 10 to 19 are very high, according to the Michigan Department of Health and Human Services.