Moderna announced Wednesday that it’s ready to ask the Food and Drug Administration for emergency authorization to begin administering the COVID-19 vaccine to children under 6 years old after testing a lower-dosage shot on about 6,700 participants.
Two doses of the shot — a quarter of the full dose for adults — was about 44% effective for those 6 months to 2 years and 37.5% effective for those ages 2 to 6, according to Moderna.
The pediatric doses “showed a robust neutralizing antibody response,” similar to that for adults, the company said. For those who did catch COVID-19 after the shot, the majority of cases were mild, and no severe disease was reported in either group.
Both age groups tolerated the shots, primarily reporting “mild to moderate” symptoms. Only 0.2% in each age group showed fevers over 40 degrees Celsius, or about 104 degrees Fahrenheit. No deaths, myocarditis, pericarditis or multisystem inflammatory syndrome were reported.
“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants six months of age through older adults,” Stéphane Bancel, CEO of Moderna, said in a statement.
“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… We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages.”
Currently, only the Pfizer vaccine is available for children under the age of 12. Even that shot is not approved for those under 5.
Moderna has also submitted for emergency use authorization for a two-dose shot for kids between the ages of 6 and 12, which has already been approved in Australia, Canada and the European Union. The company is also updating a similar request for the 12-17 cohort, which was put on hold after the FDA expressed concerns about a rare side effect of myocarditis.
While not there yet, Moderna is “preparing to evaluate” the efficacy and need for a booster shot for all adolescents.
Pfizer has also asked for emergency use authorization for its vaccine for kids under 5, but put a hold on the request last month, saying it will wait for its data on a three-dose series of the vaccine. Data on the third shot is expected in early April.