Moderna on Thursday requested emergency use authorization of its COVID-19 vaccine for Americans ages 5 and under, a "highly anticipated step" toward protecting the last vulnerable age group in the U.S., The Washington Post reports.
The company's filing will likely push the U.S. Food and Drug Administration to move quickly, "as parents, pediatricians, and politicians have become increasingly impatient about the lack of vaccines and treatments to protect young children," the Post writes.
Moderna hopes a two-shot regimen will sufficiently protect the nation's youngest — though, as was the case with adults, such a regimen only proved modestly effective in preventing illness caused by the Omicron variant, notes both the Post and The Associated Press.
"There is an important unmet medical need here with these youngest kids," Moderna's Chief Medical Officer Dr. Paul Burton told AP. Two low-dose shots "will safely protect them. I think it is likely that over time they will need additional doses. But we're working on that."
Meanwhile, Pfizer is soon expected to announce whether its three-shot regimen effectively protects babies and toddlers, after having been directed to research adding another dose to its initial two.
FDA spokeswoman Stephnie Caccomo told the Post the agency would wait for Moderna's full filing — expected by the second week of May — and "review any [emergency use authorization] request it receives as quickly as possible using a science-based approach."
If/when the FDA clears vaccinations for the youngest age group, CDC recommendations come next.