June 10, 2022 – 16:06
Moderna data “support application” of serial vaccine of two 25-microgram doses in children 6 months to 5 years, FDA concluded
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WASHINGTON – The federal health authorities of the United States, which will decide next week whether to authorize the use in babies of two vaccines against COVID-19, confirmed on Friday the efficacy data previously provided by the laboratory Modern for immunization of children from 6 months to 5 years.
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The United States Food and Drug Administration (FDA), which independently analyzed data from clinical trials conducted by Moderna, reported efficacy against symptomatic cases of 51% in infants 6 months to 2 years of age, and 37% in children 2 to 5 years of age.
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“Although the efficacy of vaccine (…) in children 6 months to 5 years of age is lower than that observed in studies in adults and older children, consistent with the efficacy observed against the (variant) omicron in adults,” the FDA stated.
However, Moderna’s adult vaccine, even with reduced effectiveness against omicron, is still very effective in protecting against severe cases of the disease, he noted.
Moderna data “supports application” of the vaccine in a two-dose series, at a rate of 100 micrograms per injection in adolescents 12 to 17 years old, 50 micrograms in children 6 to 11 years old, and 25 micrograms in children 6 months of age to 5 years, the FDA concluded.
In the United States, Moderna’s vaccine is currently only licensed for people 18 and older.
This long document, of more than a hundred pages, published by the FDA will serve as the basis for the discussions that will be held next week by an expert consultation committee, which will study the authorization of the Moderna vaccine and another made by the pharmaceutical company. also American Pfizer.
– FUENTE: With information from AFP–
