US health officials, who are due to decide next week on the authorization of two vaccines against Covid-19 in babies, confirmed on Friday the efficacy data previously provided by Moderna for children from 6 months to 5 years old.
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The United States Medicines Agency (FDA), which independently analyzed data from clinical trials conducted by Moderna, in turn reported efficacy against symptomatic cases of 51% in babies from 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 under 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, the Moderna data “supports the administration” of the vaccine in two doses, at the rate of 100 micrograms per shot 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.
In the United States, Moderna's vaccine is currently only licensed for people 18 years of age and older.
This long document of more than a hundred pages published by the American agency should serve as a basis for discussions next week.
An advisory committee of experts must meet over two days to study the request for authorization of this vaccine, as well as that of Pfizer, and make its recommendation.
The FDA is expected to publish its independent analysis of data from Pfizer early next week, which has filed an application for authorization for children aged 6 months to 4 years, this time with a three-dose vaccine.