There’s finally some good news for parents waiting to get their infants and toddlers vaccinated against COVID-19.
“I think we’re getting close, but it’s been a frustrating wait for everybody,” Dr. Andrew Pavia, chief of the pediatric infectious diseases division at University of Utah Health and director of hospital epidemiology at Intermountain Primary Children’s Hospital in Salt Lake City, told the Deseret News.
Moderna became the first COVID-19 vaccine manufacturer to seek approval from the federal Food and Drug Administration to give the shots to children as young as 6 months old, filing a request for an emergency use authorization on Thursday.
A fast-tracked effort earlier this year by Pfizer to get similar authorization for using its vaccine in younger children was delayed by the Centers for Disease Control and Prevention when two reduced doses proved less effective than expected. The Utah Department of Health had been expecting to distribute 23,000 scaled-down doses of the Pfizer vaccine in late February.
Now, the soonest shots would be available to the nation’s 18 million infants and toddlers is likely mid-May, but it could take until June if the FDA decides to deal with both the Moderna and Pfizer vaccines at the same time, since Pfizer has yet to submit a new request.
“I think the good news for parents is that we’re in a relative lull right now. So that sense of urgency that we all felt in December and January is a little bit less,” Pavia said, referring to the height of the omicron surge that saw record-breaking case counts in Utah and the rest of the country. “But we need vaccine for children.”
COVD-19 cases are headed up again in Utah, though, as so-called “stealth omicron” and its subvariants continue to spread. Thursday’s weekly update by the Utah Department of Health showed an increase of 1,695 cases and more than a 51% hike in the seven-day average case count since April 21.
The state health department also reported 59 Utahns are currently hospitalized with COVID-19 and seven more Utahns have died from the virus, bringing the state’s death toll to 4,747. Nearly 60% of wastewater treatment sites monitored for the virus are showing increased levels, up from 25% last week.
Pavia said no one knows for sure what the virus will do.
“We’d all like the pandemic to be over and COVID to go away. But the virus doesn’t care what we want. It’s here to stay. I think it’s very likely we’re going to have some more difficult times ahead,” he said. “Parents need to plan. Hopefully, we’ll never see anything like the omicron surge again, but even that’s uncertain.”
The new filing by Moderna is for children under 6 years old. The Moderna vaccine is currently authorized only for adults, but The New York Times reported a company spokeswoman said data would be submitted in about two weeks for authorization for 6- to 11-year-olds and 12- to 17-year-olds.
The FDA may look at all of Moderna’s requests for children and teens as a whole, according to the newspaper, which cited testimony at a Senate hearing Tuesday by Dr. Peter Marks, an FDA director who oversees the safety and effectiveness of vaccines.
Marks told the Senate health committee some requests “are complicated because they are relatively larger, covering larger swaths of the pediatric population than others,” when asked how soon a pediatric vaccine would be ready.
He said a schedule for reviewing the requests will be released soon.
In children 6 months to under 6 years of age, Moderna said a study found two doses — each a quarter of the amount given to adults — produced “a robust neutralizing antibody response,” similar in adult efficacy against the omicron variant as well as “a favorable safety profile.”
“We believe (the vaccine) will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers,” Moderna CEO Stéphane Bancel said in a statement.
Pavia said the limited data Moderna has shared in a news release “looks very good.”
Pfizer, the only vaccine approved for those 5 and older, had been expected to be first in line for approval for younger children, but was slowed by disappointing trial results showing two shots — each just one-tenth of an adult dose — couldn’t produce a strong enough immune response.
A study is underway to determine the difference a third dose makes. The results, once anticipated as soon as mid-April, are now expected this summer. Politico reported last week the Biden administration might hold off on Moderna’s request so both vaccines could be reviewed at the same time.
Politicians and health experts have pushed back on that possibility.
White House press secretary Jen Psaki responded Tuesday by saying she’d “point you to the FDA for their decision-making process.” But Psaki added that as a parent of a child under 5, “I am eager to have vaccines approved and available, and I want to make sure they go through the proper protocols and process.”
Pavia said it’s unclear which way the FDA will go. He said the choice is between making the Moderna vaccine available several weeks sooner, “which I think a lot of parents would find very comforting and important” or waiting so there can be a single set of recommendations “which might be less confusing.”
“As a pediatrician who cares a lot about children and COVID, I think we’ve waited a long time and we should be moving as quickly as we can safely move,” Pavia said.