WASHINGTON – US health officials on Friday confirmed that data provided by drugmaker Moderna on the efficacy of its COVID-19 vaccine among very young children was accurate, ahead of a decision next week whether to give children two vaccinations against the virus. be authorized. six months to five years.
The Food and Drug Administration (FDA), which independently analyzed data from clinical trials conducted by Moderna, said the vaccine’s efficacy against symptomatic cases of COVID-19 ranges from six months to less than two years of age. 51 percent of children and 37 percent of children. At the age of two to five years.
These figures are lower than those recorded during clinical trials on adults, but that’s only because the trials were conducted during a wave involving the Omicron version for very young children, according to the FDA.
The FDA stated, “Although VE (vaccine efficacy) … is lower than that observed in significant adult or older pediatric studies in children aged six months to five years, it is comparable to the real-world vaccine effectiveness seen against Omicron in adults.” corresponds to.” in a statement.
Even though Moderna’s vaccine has proven less effective against the Omicron variant, it is very good at protecting against severe cases of the disease, the FDA reported.
That’s why the FDA concluded that Moderna Data “supports the administration of the vaccine in two doses of 100 micrograms each in adolescents 12 to 17 years of age,” 50 micrograms for children six to 11 years of age and six months of age. 25 micrograms in children. five years.
In the United States, Moderna’s vaccine is currently only authorized for people 18 years of age and older.
The latest document, which spans more than 100 pages and is published by the US agency, will serve as the basis for authority discussions next week.
An advisory committee of experts should meet in two days to study and recommend the vaccine as well as Pfizer’s authorization request.
The FDA is expected to publish its independent analysis of data from Pfizer early next week.
Pfizer has filed an application for authorization for children aged six months to four years, although its vaccine will be administered in three doses.
