FDA panel endorses Pfizer’s COVID-19 vaccine for children 5-11

WASHINGTON - The U.S. Food and Drug Administration’s panel of experts on Tuesday endorsed the Pfizer-BioNTech COVID-19 vaccine for kids ages 5 to 11, a key step in making the shots more widely available for younger children. 

The FDA’s Vaccines and Related Biological Products Advisory Committee voted to expand Pfizer’s emergency use authorization for the roughly 28 million younger children in the U.S., to be administered as just a third of the dose given to teens and adults.

Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.

If the FDA authorizes the kid-size doses, there’s still another step: Next week, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots and which youngsters should get them.

Children could begin vaccinations early next month, with the first kids in line to be fully protected by Christmas.

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While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness -- including over 8,300 hospitalizations, about a third requiring intensive care, and nearly 100 deaths, FDA vaccine chief Dr. Peter Marks told the advisory panel.

Also, "infections have caused many school closures and disrupted the education and socialization of children," Marks said.

"I want to acknowledge the fact that there are strong feelings" among the public for and against child vaccinations, Marks added, noting that the discussion would be on scientific data "not about vaccine mandates, which are left to other entities outside of FDA."

Last week, the FDA said the smaller doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues.

Pfizer’s study tracked 2,268 children ages 5 to 11 who got two shots three weeks apart of either a placebo or the kid dose. Vaccinated youngsters developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots.

So far, 16 kids given placebo shots developed symptomatic COVID-19 compared to three vaccinated youngsters, meaning the vaccine was nearly 91% effective. Most of the study data was collected in the U.S. during August and September as the delta variant surged.

FILE - A healthcare worker administers a dose of a Pfizer-BioNTech Covid-19 vaccine to a child at a pediatrician's office in Bingham Farms, Michigan, on May 19, 2021. Photographer: Emily Elconin/Bloomberg via Getty Images

There were no severe illnesses reported among any of the young study participants, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.

The study isn’t large enough to detect any extremely rare side effects, such as heart inflammation that occasionally occurs after the second dose, mostly in young men and teen boys.

The FDA analysis calculated that in most scenarios of the continuing pandemic, the vaccine would prevent roughly 200 to 250 COVID-19 hospitalizations for every 1 million kids vaccinated, with about 58 hospitalizations for heart inflammation. The side effect risk is based on levels in teens, and Pfizer expects it to be far lower in youngsters getting the kid-size dose.

Meanwhile, Moderna’s COVID-19 vaccine was also shown to generate a "robust" neutralizing antibody response in children ages 6 to 11, the company said Monday in a statement. Moderna said it plans to seek authorization from the FDA for the age group soon.

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Moderna shared interim data from its Phase 2/3 study, which showed that two smaller doses of its COVID-19 vaccine given 28 days apart were generally well-tolerated in more than 4,750 children. The participants in the trial were given 50 micrograms of vaccine, which is just half the dose given to adults.

One month after the second dose, participants in Moderna’s trial had antibody levels that were 1.5 times higher than those observed in young adults, the company said.

Moderna said the majority of the side effects in the trial, which had a total of 4,753 participants, were mild or moderate. The most common side effects were fatigue, headache, fever and pain at the injection site.

Both Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.

More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.

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This story was reported from Los Angeles. Kelly Hayes and the Associated Press contributed.