Modnera
The company's emergency use authorization (EUA) submission comes after results from a Phase 2/3 clinical trial showed the vaccine was 51% effective against infection from the Omicron variant in children under 2-years-old and 37% effective for children between the ages of 2- to 5-years old, according to Moderna.
The request is based on a 25 microgram two-dose vaccination series of the biotech's current-generation COVID vaccine. For comparison, adults receive two 100 microgram doses in their primary vaccine series.
"There is an important unmet medical need here with these youngest kids," Dr. Paul Burton, chief medical officer at Moderna, told The Associated Press. This two smaller two-dose series "will safely protect them. I think it's likely that over time they will need additional doses. But we're working on that."
Burton said the 40% to 50% vaccine effectiveness range for infants and young children is similar to the two-dose protection offered to adults against Omicron, CNBC reports. Moderna's current COVID vaccine was developed to produce antibodies against the original SARS-CoV-2 virus by blocking its spike protein from infecting healthy human cells. Since then, the virus has had many variants, including Omicron, which has more than 30 mutations to its spike protein, making the company's vaccine less effective at preventing infection.
However, Burton told CNBC that Moderna's vaccine still provides protection against severe illness for the youngest Americans, similar to how the current vaccine holds up against Omicron in adults. Burton said adults have about 1,000 units of antibodies following their two shot regimen, which children in the company's latest study had a range of 1,400 to 1,800 units after the same primary series, CNBC reports.
"What we know is that those level of antibody will translate into very high protection against severe disease and hospitalization," Burton told CNBC.
Rivals Pfizer
