Moderna expects to have new data to share about how well its mRNA vaccine works in kids very soon. And with the spread of the omicron variant and rise in pediatric COVID-19 cases in the U.S., parents are anxious to see it.
"For the 2- to 5-year-olds, we have completed a study in that age group," Dr. Paul Burton, Moderna's chief medical officer, told TODAY. "That study is fully enrolled and should complete and we should have data in the next month or so," he said. "We'll then take those data to the FDA and other regulators around the world."
That prediction is similar to one from Dr. Anthony Fauci, White House chief medical advisor. “My hope is that it’s going to be within the next month or so and not much later than that," Fauci told Blue Star Families last week. Moderna previously announced in a Jan. 12 statement to investors that it expected to have clinical trial data for this age group in March.
The company's two-dose mRNA vaccine has an emergency use authorization from the Food and Drug Administration for use in adults age 18 and older. Moderna submitted data to the FDA from clinical trials involving adolescents between the ages of 12 and 17. But regulators wanted to see more data about the potential risk for vaccine-related myocarditis, a rare type of heart inflammation, in this age group before giving their authorization.
"The FDA is doing a very thorough review; we would want and expect nothing else," Burton said. "We'll keep working with them. We would be hopeful that in either late this quarter or early next quarter we might be able to see an approval here in the United States."
Burton also noted that the vaccine is available for 12- to 17-year-olds in other countries already. And a recent JAMA study showed the risk of myocarditis after getting an mRNA vaccine is elevated, but overall still quite low — and much lower than the risk of heart inflammation associated with a COVID-19 infection. Myocarditis after a vaccine in these cases is also typically treatable, "relatively mild and short-lived," Burton said.
Adults receive two initial doses of 100 micrograms of the Moderna vaccine. For kids in the 2- to 5-year-old group, each dose is only 25 micrograms, Burton said.
After Pfizer's clinical trials in younger kids showed disappointing results with a two-dose regimen of 3 micrograms per shot, the company announced it would be adding a third dose to its trial. But Burton said he doesn't expect Moderna to do the same because its dose is so much higher than the one Pfizer is using.
"Right now, I would predict that a two-dose regimen is will be sufficient," he said, adding that we'll know more in a month when the trial data are available.
Last fall, the company announced favorable data for its vaccine in 6- to 11-year-olds and decided to evaluate the potential for lower doses in this age group in early December, the company told TODAY in a statement.
Regarding children younger than 2, Burton said "it's clearly an area that we would predict we need to get vaccinated. It's certainly under careful consideration and we will be moving there in the near future."