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FDA Confirms Effectiveness of Moderna's Vaccine in Babies

U.S. health officials, who are set to decide next week whether to authorize two COVID-19 vaccines in babies, on Friday confirmed efficacy data previously provided by Moderna for children 6 months to 5 years.

The U.S. Drug Administration (FDA), which independently analyzed data from clinical trials conducted by Moderna, in turn reported efficacy against symptomatic cases of 51% in babies 6 months to less than 2 years old. , and 37% in children aged 2 to 5 years.

If these figures are lower than those noted during clinical trials on adults, it is because only the trials for these very young children were conducted during the wave linked to the Omicron variant, according to the FDA.

"Although the efficacy of the vaccine […] in children 6 months to 5 years of age is lower than that observed in studies in adults and older children, it is consistent with the efficacy observed against Omicron in adults in real-life conditions,” the FDA said.

However, Moderna's vaccine in adults, even with reduced effectiveness against Omicron, remains very effective in protecting against severe cases of the disease, she pointed out.

Thus, Moderna's data "support the administration" of the vaccine in two doses, at a rate of 100 micrograms per injection in adolescents aged 12 to 17, 50 micrograms for 6-11 year olds, and 25 micrograms in children from 6 months to 5 years, the FDA concluded.

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