The United States Food and Drug Administration (FDA) authorized this Monday the use of the vaccine from the laboratory Pfizer and Bio-N-Tech against covid-19 in children between 12 and 15 years old. In this sense, it is the first vaccine authorized in children under 16 years of age in the United States. Until now, only Pfizer’s vaccine was licensed for ages 16 and over.
“The FDA has determined that the Pfizer-BioNTech covid-19 vaccine has met the legal criteria to amend the EUA (emergency use authorization), and that the known and potential benefits of this vaccine in people older than 12 years exceed those known potential risks, supporting the use of the vaccine, ”the FDA reported.
The decision will allow many students to be enrolled before the start of the next school year, taking advantage of the summer vacation that will begin in the coming weeks.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12-15 years of age is a significant step in the fight against the COVID-19 pandemic,” it said Acting FDA Commissioner Janet Woodcock.
The announcement comes just a month after the company discovered that its two-dose vaccine, which has already been licensed for those over 16, also provides protection in the youngest group of teens.
The American laboratory published in March the preliminary results of a trial between 2,260 volunteers in the United States between the ages of 12 and 15, revealing that there were no cases of covid-19 among adolescents who were fully vaccinated.