Moderna to seek regulatory nod for low dose COVID-19 shot in kids after positive data
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Announcing positive interim results from a trial involving children aged 6 months to 6 years, Moderna (NASDAQ:MRNA) said on Wednesday that the company would seek regulatory authorization in the coming weeks for its COVID-19 vaccine at 25 Î¼g as a two-dose regimen for the age group.
According to the data from the Phase 2/3 KidCOVE study, the mRNA-based vaccine showed a robust neutralizing antibody response and favorable safety profile in children 6 months to under 2 years and 2 years to under 6 years of age, the company said.
In both age groups, two doses of 25 Âµg led to a similar level of immune response to the 100 Âµg two-dose primary series in adults ages 18 to 25 years.
During the Omicron wave, there was a statistically significant, but lower efficacy against COVID-19 infection in line with adult data. Studies are underway for a booster dose of the vaccine mRNA-1273 and its bivalent booster candidate mRNA-1273.214 to introduce a booster shot for all pediatric populations, Moderna (MRNA) said.
"Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,â Chief Executive StÃ©phane Bancel said.
In the U.S., the company has also started filing for emergency use authorization of the vaccine in children aged 6 to 11 years. It is also updating the EUA submission for adolescents aged 12 to 17 years with additional data.
Moderna (MRNA) COVID-19 vaccine, branded as Spikevax, is approved in the U.S. at 100 Î¼g dose for those aged 18 years and older.
Read: Last month, the U.S. Food and Drug Administration (FDA) delayed a review of the COVID-19 vaccine developed by rival Pfizer (PFE) and BioNTech (BNTX) for children under the age of 5after the companies decided to extend the rolling submission citing the need for more data.