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Moderna Seeking FDA Authorization for COVID Vaccine in Children as Young as Six Months

Moderna's CEO said there is a 'need for a vaccine against COVID-19 in infants and young children,' prompting their request for approval

Moderna plans to seek authorization to give a pediatric, low-dose COVID-19 vaccine to children ages six months to under six years of age.

The pharmaceutical giant is planning to submit its request to the Food and Drug Administration (FDA) “in the coming weeks” in order to receive authorization for a two-dose, 25 microgram-each shot. 

According to Moderna, the pediatric dose is 25% of adults’ first two doses.

“Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,” the company’s CEO Stéphane Bancel said in the statement.

Approximately 6,900 children were part of the drug trials. According to Moderna, most side effects were “mild or moderate,” and no cases of a rare heart condition called myocarditis were reported.

In their trials, Moderna found that protection against infection from the omicron variant of the coronavirus was low. For children ages six months to 2 years, efficacy was 43.7%, and in children ages 2 to 6, it was only 37.5%. There were no cases of severe illness, hospitalization, or death for those vaccinated in the trial.

Given the lower efficacy, Dr. Jesse Goodman of Georgetown University, former FDA chief scientist, said it’s hard to predict what action the FDA will take.

“FDA could decide the data are sufficient for emergency authorization given that there is not another vaccine available at present for this age group,” he said. “However, kids this age, if otherwise healthy and without other medical issues, are usually at low risk of complications of Covid so how widely the vaccine would be used or recommended is unclear.”

In a recent report from the Centers for Disease Control and Prevention during the late December surge of the Omicron variant, hospitalization rates for infants and children up to age 4 was roughly five times greater than the rate during the peak of the Delta variant last summer and fall.

The youngest age at which the COVID-19 vaccine is currently available is five. Children ages 5 to 11 are currently eligible for Pfizer’s pediatric vaccine. However, research shows efficacy rates in children dropped significantly after about seven weeks.

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