'It's been difficult waiting': What to know about Moderna's proposed vaccine for kids under 6
Moderna Inc. announced Wednesday it will soon seek federal authorization for its COVID-19 vaccine for kids under age 6, which if granted would close a gap that has existed for months.
The pharmaceutical company said trials showed positive results in protecting babies, toddlers and preschoolers against severe infections and hospitalizations and will apply to the U.S. Food and Drug Administration “in the coming weeks.”
It's welcome news for parents like Rebecca Grant of Palatine.
“My husband and I plan to get our 4-year-old son vaccinated as soon as the vaccine is available for his age group,” she said.
Pfizer Inc.'s COVID-19 vaccine is currently the only one in the U.S. approved for children ages 5 to 11 in November, leaving out the younger cohort.
For families with children not eligible for shots, “it's been difficult waiting,” Grant said. “The starts and stops with the approval process haven't helped. Everyone is ready to go 'back to normal,' but for many like us, that just doesn't feel possible yet.”
She said she's also worried about others in the family.
“My elderly parents help us out with child care, and while they're vaccinated, I'm still concerned about protecting them,” Grant said.
Veteran pediatrician Michael Bauer expects some mixed reactions from families.
“There are those that are chomping at the bit — approximately one-third” of parents, said Bauer, medical director at Northwestern Lake Forest Hospital.
“There's probably going to be 25% to 30% that say no, and some of the in-betweens will say let's wait and see what happens,” he said.
About 11,700 participants from age 6 months to 11 years took part in Moderna's study.
“The safety data that they're submitting is excellent,” Bauer said. “There have been no safety signals identified because, remember, this is the same vaccine that's been given in hundreds of millions of doses now (to adults). It's the same vaccine but a lower amount.
“There's been no deaths, so far no cases of myocarditis or heart inflammation. The real big question comes down to risk versus benefit. There is exceedingly no to low risk with it and a good benefit.”
Moderna and Pfizer's vaccines were developed to combat early strains of COVID-19 that could cause severe illness and complications like pneumonia, and it had high rates of effectiveness. The disease has mutated, with the new omicron variants typically causing milder upper-respiratory infections, experts said.
Against omicron in the studies of children, “Moderna is quoting on average about 40% effectiveness for not getting COVID,” Bauer said.
“More importantly, we expect that same level being much higher for protecting against severe disease, hospitalizations and death. And that's really what we're all about — protecting against that,” he said.
Moderna's doses for young children are about one-quarter of the adult amount with two shots required.
Side effects reported “were pretty mild and minimal. About upward of 15% (participants) had low-grade fevers,” Bauer said.
Across Illinois, about 35% of 5- to 11-year-olds are fully vaccinated compared to over 69% of adults ages 18 to 64. COVID-19 vaccines first arrived in the U.S. in late December 2020.
“What we do know in the long history of giving vaccines is that any safety signals or concerns come up very early, usually within four to six weeks, tops,” Bauer said.
Once Moderna submits its application for emergency authorization to the FDA, it will be reviewed by experts, and the U.S. Centers for Disease Control will also weigh in.
“It's going to be at least a few weeks,” Bauer said. “They'll pore over the data. With infants and children, there's always that extra layer and level of protection and safety. Fortunately, that safety data looks very, very good. It's more about how effective is this vaccine versus how risky.”