Moderna to ask FDA to authorize Covid-19 vaccine in children 6 months to 6 years

Moderna to ask FDA to authorize Covid-19 vaccine in children 6 months to 6 years Moderna announced it will ask the FDA to authorize its Covid-19 vaccine for emergency use in children aged 6 months to 6 years, a group for which there are currently no authorized Covid vaccines. Helen Branswell STAT

Moderna announced Wednesday that it will ask the Food and Drug Administration to authorize its Covid-19 vaccine for emergency use in children aged 6 months to 6 years, a group for which there are currently no authorized Covid vaccines.

The company’s announcement came as it released interim data from two clinical trials of its vaccine in children under 6 years of age. Moderna said the studies — in children aged 6 months to 23 months and 2 to 6 years — showed the vaccine generated similar immune responses as those seen in adults aged 18 to 25 who received two doses of Moderna’s adult Covid vaccine.

“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,” Moderna CEO Stéphane Bancel said in a statement.

However, the two-dose vaccine was less effective at preventing symptomatic infection — meaning that subjects had symptoms and then a positive Covid test — than vaccines have been in previous trials. In children 6 months to 2 years cases of Covid were decreased 43.7%; they were decreased by 37.5% in the 2 to under 6 years age group. Moderna said that the efficacy was on par with what would be expected of a two-dose vaccine against the Omicron variant, which predominated during the trial. The Omicron variant contains mutations that allow it to evade immunity built up by both vaccination and prior infection.

“A [vaccine efficacy] of 40% with adequate safety data could be very meaningful, especially to at higher risk individuals,” said Luciana Borio, a former FDA acting chief scientist who is now a partner at Arch Venture Partners. One possibility, she said, would be to authorize the vaccine and recommend it for children with underlying medical conditions. But, she said, the FDA should hold an advisory committee to review the data first. ...