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The FDA on Monday gave its nod to Pfizer booster shots for kids ages 12 to 15 as part of a series of new recommendations to combat the highly contagious Omicron variant.
The FDA-approved booster use must now be OK’d by the CDC, which is expected to officially authorize it as early as this week.
The Food and Drug Administration said it backs the emergency use of the booster for the age group after determining its benefits outweighed the risks amid a surge in the COVID-19 Omicron variant.
The agency said its decision was based on “real-world data” provided by the Israeli Ministry of Health from 6,300 individuals within the age range who received a Pfizer booster.
US officials said their review of data revealed “no new safety concerns” regarding the shot. For example, there were no new cases of heart issues such as myocarditis or pericarditis, the FDA said.
The FDA gave the green light to Pfizer booster shots for kids ages 12 to 15.GIL COHEN-MAGEN/AFP via Getty Images
The FDA also recommended shortening the time period that people must wait between their second vaccine dose and their booster, going from six months down to five months.
Additionally, immunocompromised children between ages 5 and 11 were cleared by the FDA to receive a third dose of the vaccine.
The Pfizer shot is given in two doses, with those ages 5 to 11 getting a third of the adult shots each time, as well as when they receive their booster. Anyone 12 and older gets the full amount each time.
Immunocompromised children between ages 5 and 11 were cleared by the FDA to receive a third dose.Jakub Porzycki/NurPhoto via Getty Images
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” acting FDA Commissioner Janet Woodcock said in a statement.
“With the current wave of the Omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing in order to effectively fight COVID-19,” she added.
The FDA announced its latest recommendations amid a nationwide surge in COVID-19 cases driven by the Omicron variant. Public health officials have expressed concern that the variant’s spread could place further strain on hospitals.
The FDA said its decision was based on “real-world data.”JOSEPH PREZIOSO/AFP via Getty Images
Last month, the CDC OK’d Pfizer’s vaccine booster for people ages 16 and 17.
Studies show a booster dose of the Pfizer vaccine “greatly improves an individual’s antibody response to be able to counter the Omicron variant,” according to the FDA.