Pfizer Covid Booster Gets CDC Panel’s Backing for Teens’ Use (2)

U.S. public health advisers said vaccinated teens should get a Covid-19 booster shot from Pfizer Inc. and BioNTech SE, an important step in efforts to expand immunizations and keep schools open.

The panel of outside experts convened by the Centers for Disease Control and Prevention voted to 13 to 1 to recommend the booster shot for people ages 12 to 17 who received their second dose at least five months earlier. CDC Director Rochelle Walensky endorsed the recommendation, making it official.

The agency’s Advisory Committee on Immunization Practices met following Monday’s emergency clearance of the third shot by the Food and Drug Administration. Immunization and boosters are gaining importance as the highly transmissible omicron variant has quickly overtaken delta to become the dominant strain in the U.S. While omicron appears to cause less serious disease, the sheer numbers of patients pose a burden to hospitals and health workers.

“It is critical that we protect our children and teens from Covid-19 infection and the complications of severe disease,” Walensky said late Wednesday in a statement. “I encourage all parents to keep their children up to date with CDC’s Covid-19 vaccine recommendations.”

Effect Fading

Research indicates that the effect of the initial two-shot regimen from Pfizer-BioNTech is fading in the face of omicron, and that Covid immunity can be restored with boosters. Parents are keen to give children a shield against disease, especially as students and teachers return to school after the holidays.

Read More: What We Know About the Omicron Variant

It’s the first time the committee considered third shots for kids ages 12 to 15. Boosters have been available to 16- to 17-year-olds since Dec. 9, but the panel’s recommendation beefs up the call for additional shots in that group.

“This is one more tool in our toolbox and if it’s a hammer, we should hit that nail hard,” Oliver Brooks, a panel member who’s also chief medical officer of the Watts HealthCare Corp. in Los Angeles, said in the discussion.

In addition to preventing coronavirus hospitalizations and deaths, two doses of the Pfizer-BioNTech vaccine had a 91% efficacy rate against a severe linked condition called multisystem inflammatory syndrome in children, CDC Epidemic Intelligence Service Officer Sara Oliver said in a presentation. The finding was based on a case-control study that included more than 100 MIS-C patients and 181 hospitalized people ages 12 to 18.

Of 8.6 million U.S. 12- to 15-year-olds who are fully vaccinated, roughly 5 million got the shots more than five months ago and would be immediately eligible for a booster dose.

Needed Tool

During the meeting, experts discussed safety concerns with the shots that include myocarditis, a heart condition mostly seen in younger males who have received messenger RNA vaccines. Myocarditis risk appears to peak at around ages 16 to 17, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said Monday on a press call.

After almost 19 million doses of the Pfizer shot were administered to younger teens as of late December, there were 265 reports of myocarditis, according to CDC data presented at the meeting. The majority of the cases occurred after second doses of the vaccine, and mostly in males. While most of the patients recovered from their symptoms, 8% are still monitored.

Of 47,000 Americans ages 16 to 17 and around 930,000 ages 18 to 24 that received a booster, there have been just 13 preliminary reports of myocarditis following the shot, according to a presentation by CDC epidemiologist John Su.

While the data appear reassuring, it may be premature to determine whether the booster is safe in younger age groups, Sarah Long, a member of the panel, said in the meeting.

“I can see you concluding, for those parents waiting, that there is no worrisome signal, but I think its much too early to say,” said Long, who’s also a professor of pediatrics at Drexel University College of Medicine in Philadelphia.

The committee debated how strong the recommendation should be -- whether to say that teens “may” or “should” receive the booster. Ultimately, most members decided to come out forcefully in favor of the shots across the age group.

“This is the tool we need to use and help our children through this pandemic,” said Katherine Poehling, a pediatrician and epidemiologist at Wake Forest School of Medicine in Winston-Salem, North Carolina.

(Adds CDC endorsement in second and fourth paragraphs.)

--With assistance from Robert Langreth, Celine Castronuovo and Jeannie Baumann.

To contact the reporter on this story:
Fiona Rutherford in New York at frutherford@bloomberg.net

To contact the editors responsible for this story:
Timothy Annett at tannett@bloomberg.net

John Lauerman

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