US Food and Drug Administration scientists said in a new analysis of data released Friday that Moderna’s coronavirus vaccine is safe and effective for young children and infants. At a meeting next week, the FDA’s external advisers will review that information and decide whether to approve the company’s vaccine for babies and children under five.
Children under five are still the only people in the United States who are not eligible for a coronavirus vaccine.
In April, Moderna submitted an emergency use authorization request to the FDA for the vaccination of children aged 6 months to less than 6 years.
Pfizer and BioNTech are also seeking emergency use authorization for their coronavirus vaccine for children. Next Monday, outside FDA advisers will review the vaccine from Pfizer and BioNTech.
On June 17 and 18, the CDC’s advisory committee will meet to approve the vaccines developed by the companies.
The Biden administration announced this week that it had made 10 million doses of the COVID-19 vaccine available for young children and newborns, anticipating clearance approval. The first assays should be available by June 21.
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The Food and Drug Administration (FDA), which independently reviewed data from Moderna’s clinical studies, found that the vaccine’s effectiveness against symptomatic cases of Covid-19 was 51% in babies aged six months. under two years of age and 37% in children aged two to five years.
According to the FDA, the statistics are lower than those found in adult clinical trials because the trials for very young children were conducted during a wave related to the Omicron variation.
“Although the VE (vaccine effectiveness)…in children six months to five years of age is lower than that observed in the pivotal studies in adults or older children, it is very consistent with the observed real-world vaccine efficacy against Omicron in adults,” the FDA said in a statement.
Despite Moderna’s vaccine being less effective against the Omicron variety, the FDA noted that it is still quite effective against severe cases of the disease.
Accordingly, the FDA determined that Moderna’s data “supports the administration” of the vaccine in two doses of 100 micrograms each in adolescents ages 12 to 17, 50 micrograms in children ages six to 11, and 25 micrograms in six-month-old toddlers. at five years old.
Moderna’s vaccination is currently only available to people age 18 and older in the United States.
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Post expires at 5:26am on Tuesday June 21st, 2022