FDA Expands Pfizer Booster Eligibility to Kids Ages 12 to 15, Authorizes Third Shots at 5 Months

• The Food and Drug Administration on Monday expanded eligibility for Pfizer and BioNTech booster shots to children ages 12 to 15 years old.
• The FDA also shortened the time between the second Pfizer dose and the booster shot to five months, down from six months.
• The agency also authorized a third vaccine dose as part of the primary series of shots for children ages 5 through 11 who have compromised immune systems.
• New Covid infections have hit a pandemic high in the U.S. as the highly contagious omicron variant has supplanted delta as the dominant strain.

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.

The agency also authorized a third vaccine dose as part of the primary series of shots for children ages 5 through 11 who have compromised immune systems.

Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention, has encouraged everyone who is eligible to receive a booster dose. The CDC still has to sign off on expanded eligibility for 12- to 15-year-old kids, and its expert advisory panel will meet on Wednesday.

"The recent rise in COVID-19 cases is concerning to all and today's decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic," Pfizer CEO Albert Bourla said in a statement.

"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.

Dr. Peter Marks, who oversees vaccine safety for the FDA, said myocarditis primarily affects males ages 16 to 17, though men as old as 30 have also had the condition. Marks said it is a relatively uncommon side effect of the vaccine and 98% of cases have been mild, with a median hospitalization stay of one day. Patients generally have not had long-lasting effects, Marks said.

"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 demonstrates 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.

New Covid infections have hit a pandemic high in the U.S. as the highly contagious omicron variant has supplanted delta as the dominant strain. The U.S. reported a seven-day average of 404,000 new cases as of Sunday, an increase of 104% compared with the week prior, according to a CNBC analysis of data compiled by Johns Hopkins University.

Elected officials are determined to avoid school closures, and studies from the United Kingdom have shown that booster shots significantly increase an individual's protection against infection from omicron. Two doses of Pfizer's vaccine still protect against severe disease from omicron, but the original series of shots are much less effective at preventing infection from the new variant.

More than 65% of people ages 5 and older are fully vaccinated in the U.S., according to CDC data. Children under 5 years of age are not yet eligible for vaccination.

A growing body of data from the U.K. and South Africa indicates that omicron results in hospitalization less often than the delta variant, though researchers and public health officials have cautioned that it is still too early to draw broad conclusions about the strain's severity.

Children are generally at lower risk of developing severe disease from Covid, though pediatric hospital admissions are increasing in the U.S.