CDC Gives Nod To Pfizer Boosters For 12- to 15-Year-Olds Amid Omicron Surge
January 6, 2022
January 4, 2022
The Food and Drug Administration on Monday expanded eligibility for Pfizer and BioNTech booster shots to children ages 12 to 15 years old, as school restarts after winter break amid a surge of Covid infections across the U.S.
The FDA also shortened the time between the second Pfizer dose and the booster shot to five months, down from six months. People who received the two-dose Moderna vaccine are still supposed to get their booster at least six months after the second shot, while those who received Johnson & Johnson as their primary vaccine are eligible for a booster at least two months after their first shot.
“We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations,” Bourla said.
The FDA said no new safety concerns had emerged after evaluating real-world data from Israel on 6,300 kids ages 12 through 15 who received a Pfizer booster dose. There were no new cases in this age group of myocarditis or pericarditis, rare conditions in which heart tissue is inflamed or swells, respectively.
“In the setting of a tremendous number of omicron and delta cases in this country, the potential benefits of getting vaccinated in this age range outweigh that risk,” Marks said during a press briefing Monday.
The FDA said peer-reviewed data from multiple laboratories demonstrate that Pfizer booster doses greatly improve an individual’s antibody response to the omicron variant. Allowing people to get booster shots a month sooner may provide better protection faster as omicron rapidly spreads, the agency said.
Children ages 5 to 11 who have undergone organ transplants or have conditions that compromise their immune systems at a similar level may not respond adequately to two shots, according to the FDA. A third dose would give children in this age group the maximum benefit from vaccination, the agency said.
The FDA made clear that kids ages 5 to 11 with normal immune systems do not need a third vaccine dose right now, but it will review emerging data and update its authorization if third shots are needed broadly for that age group.
February 2, 2022
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