WASHINGTON (AP) – The U.S. Food and Drug Administration plans to authorize the use of Pfizer’s COVID-19 vaccine in children ages 12 to 15 next week, a federal official and a person familiar with the process, which would allow many students to be inoculated before the start of the next school year
The announcement would be made just a month after the company found that its two-dose vaccine, which has already been licensed for ages 16 and older, also provides protection in the youngest group of teens.
The federal official, who spoke on condition of anonymity to reveal the agency’s (FDA) intentions, said the FDA is expected to expand its emergency use authorization for the Pfizer vaccine next. week, and even earlier. The person familiar with the process, who requested anonymity to disclose the internal discussions, confirmed the deadline, adding that the FDA will presumably approve the use of Pfizer’s vaccine in younger children by the end of the year.
The New York Times newspaper was the first to report on the possible authorization.
Pfizer released preliminary results from a trial of 2,260 U.S. volunteers ages 12-15 in late March, revealing no COVID-19 cases among teens who were fully vaccinated, compared with 18 infections in the group. of control.
The children had side effects similar to those developed in young adults, the company said. The main side effects are pain, fever, chills, and fatigue, especially after the second dose. The study will continue to follow participants for another two years to gather additional information on long-term safety and safety.
Pfizer is not the only company looking to extend the age limit for its vaccine. It is expected that by the middle of this year the results of a study in the United States carried out for the Moderna vaccine in volunteers between 12 and 17 years old will be released.