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• Posted January 5, 2022

CDC Panel Backs FDA Approval of Boosters for Those Aged 12-15

An advisory panel to the U.S. Centers for Disease Control and Prevention on Wednesday backed the emergency use approval of Pfizer's booster shots for those between the ages of 12 and 17.

The Food and Drug Administration had announced the move on Monday.

In arriving at its decision, the CDC advisory panel pointed to rising COVID hospitalizations among the young as the Omicron variant races across the country.

If the panel's 13-1 vote is endorsed by CDC Director Dr. Rochelle Walensky, as expected, adolescents ages 12 to 15 can get boosters immediately. Teens ages 16 and older were already eligible for booster shots, but the panel strengthened that recommendation.

The panel spent much of its time weighing the risks of the vaccine and its side effects, including a very rare inflammation of the heart seen mostly in young men. But Dr. Camille Kotton, an associate professor at Harvard Medical School who specializes in transplants and immunocompromised patients, emphasized that COVID-19 is a far greater threat to the hearts of vulnerable and immunocompromised youth.

"This is an important thing to think about -- the risk of myocarditis from the disease itself," Kotton said, The New York Times reported.

Though Omicron is generally perceived as causing less severe disease, she noted that with case numbers spiking she's now seeing numerous patients on life support and some have died.

"It's a horrible state of affairs," Kotton said. "The highly infectious nature of Omicron is such that patients who have been incredibly careful the last two years have been getting infected with awful outcomes."

Another pediatric health expert said the parents of vulnerable kids are desperate.

"There are children waiting in the emergency department 18 hours and longer to get into the hospital because we're so full," said Dr. Katherine Poehling, director of pediatric population health at Wake Forest School of Medicine in Winston-Salem, N.C. "We have parents asking us can their children get a booster dose, like older children."

Still, several committee members stressed that getting kids vaccinated should be the priority, since only a small share of younger children are getting vaccinated at all.

"We can't put all of the burden on the people who are willing to get vaccinated," said Lynn Bahta, a committee member who is a registered nurse with the Minnesota Department of Health, the Times reported. "When we have only half our adolescents vaccinated, that adds more burden as well. I am so concerned that the burden of disease prevention is all falling on the vaccinated and them getting the boosters."

The panel vote came as the Omicron variant rages in the United States and kids return to school following the holiday break.

On Tuesday, the CDC backed the emergency use approval of Pfizer's booster shot for high-risk kids between the ages of 5 and 11, along with shortening the time period between a second dose and a booster shot from six months to five months.

Both approvals also came from the FDA on Monday.

If the committee approves the boosters for kids aged 12-15, it would be followed by what is expected to be a quick endorsement from Walensky.

While children are believed to better tolerate infection with COVID-19, in rare cases they can become severely ill and die. As well, the highly contagious Omicron variant of COVID is infecting record numbers of Americans now, putting pressure on hospitals that are already caring for patients infected with the Delta variant, the New York Times reported.

And children are not being spared in the Omicron surge: COVID-19 hospitalizations among the young are surging across the United States just as students return to school.

At least nine states have reported record numbers of COVID-related pediatric hospitalizations: They include Connecticut, Georgia, Illinois, Kentucky, Massachusetts, Maine, Missouri, Ohio and Pennsylvania, as well as Washington, D.C., NBC News reported Monday.

And in more troubling news, the American Academy of Pediatrics on Monday reported a stunning rise in pediatric COVID cases.

"COVID-19 cases among U.S. children have reached the highest case count ever reported since the start of the pandemic," the report said. "For the week ending Dec. 30th, over 325,000 child COVID-19 cases were reported. This number is a 64% increase over the 199,000 added cases reported the week ending Dec. 23rd and an almost doubling of case counts from the two weeks prior."

While serious illness from COVID is still rare for younger children, the sheer number of new cases worries doctors.

"It seems like people have tried to downplay the significance of the disease in children," said Dr. Mark Kline, the physician-in-chief at Children's Hospital New Orleans. "We've spent two years rebutting myths pertaining to COVID and children, that it's 'harmless' for children. It's not."

Kline is not the only pediatric infectious disease doctor who is worried about climbing COVID hospitalizations among children.

"I have never seen an infection sweep an entire country in a matter of a week or two," Dr. David Kimberlin, co-director of the division of pediatric infectious diseases at the University of Alabama at Birmingham, told NBC News. "The rate of cases in my portion of Alabama is like a rocket ship. It reflects how much virus is out there in the community. With that, we're going to see increasing hospitalization numbers."

Dr. Chethan Sathya, a pediatric surgeon at Cohen Children's Medical Center in New York, part of Northwell Health, said that "literally every child" he and his team operated on or was seeing over the last weekend was COVID-positive. Even if their illnesses weren't specific to the coronavirus, they stretched resources nevertheless.

Pfizer boosters had been authorized for people ages 16 and up. The two other COVID vaccines, from Moderna and Johnson & Johnson, are only authorized for adults 18 and up.

About 70% of Americans ages 12 and older are now fully vaccinated, according to the CDC, but about 1.8 million adolescents in the 12- to 15-year-old demographic have already tested positive for the virus.

More information

Visit the U.S. Centers for Disease Control and Prevention for more on COVID vaccines and kids.

SOURCES: U.S. Centers for Disease Control and Prevention, news release, Jan. 4, 2022; New York Times