On Thursday, vaccine manufacturer Moderna sought emergency use authorization for its COVID-19 vaccine for newborns, toddlers, and young children. It is an anticipated step toward making doses available to the youngest group of citizens in the U.S.
“There is an important unmet medical need here with these youngest kids,” said Moderna’s chief medical officer, Dr. Paul Burton, to The Associated Press.
He added his belief that two kid-sized doses of the vaccine “will safely protect” children, but perhaps only temporarily.
“I think it is likely that over time they will need additional doses,” Burton said. “But we’re working on that.”
Per The New York Times, there are roughly 18 million children under the age of 6 in the U.S., the only population group not yet eligible for vaccination.
Politicians such as Maryland Governor Larry Hogan have asked the Food and Drug Administration (FDA) why it cannot move more quickly.
Colorado Governor Jared Polis also called for “more urgency and action” regarding a vaccine for younger children.
Stephanie Caccomo, an FDA spokesperson, said the agency would not be able to issue an approval without a complete filing, and it was impossible to foresee how long the data would be reviewed.
She wrote in an email that the government “will review any [emergency use authorization] request it receives as quickly as possible using a science-based approach.”
Aside from Moderna, other manufacturers are also competing to release a vaccine for young children. Pfizer is expected to announce whether three of its smaller-dose shots are adequate for young children, months after the disappointing finding that two doses were not strong enough for younger kids.
Dr. Peter Marks, FDA’s vaccination commissioner, said the agency would “move quickly without sacrificing [its] standards” to determine whether the vaccine manufacturer’s tot-sized doses are “safe and effective.”
“It’s critically important that we have the proper evaluation so that parents will have trust in any vaccines that we authorize,” he added.
If the FDA approves vaccinations for small children, the CDC will determine if they are for all children or those at higher risk of COVID-19.
