Moderna seeks emergency authorization for COVID-19 vaccine in young children
Moderna on Thursday submitted a request to the FDA for emergency use authorization for its COVID-19 vaccine in children 6 months to under 6 years of age.
Why it matters: Young children have been largely unprotected throughout the pandemic. The FDA's approval could ultimately permit them to get a COVID-19 vaccine.
The big picture: Moderna said last month its COVID-19 vaccine for children — which consists of two 25-microgram doses — generated a strong immune response in children ages 6 months to 5 years.
- Efficacy was 43.7% for children ages 6 months to 2 years and 37.5% in children ages 2 to 6, clinical trial data showed.
- "The majority of cases were mild, and no severe COVID-19 disease was observed in either age group," the drugmaker said last month.
Driving the news: "We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers," Moderna CEO Stéphane Bancel said in a statement.
Moderna also said Thursday that it is evaluating booster doses for children, including those ages 6 months to under 6 years.
Go deeper: The high-stakes push to get COVID vaccines to young children