Moderna Asks FDA to Authorize COVID-19 Vaccine for Kids Under 6

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Moderna asked the Food and Drug Administration (FDA) Thursday for emergency use authorization of its COVID-19 vaccine in children ages 6 months to under 6 years.

The company recently reported that its vaccine for children generated a strong immune response in children ages 6 months to 5 years during clinical trials. Trial data reportedly showed that vaccine efficacy was 43.7% in children ages 6 months to 2 years and 37.5% in children ages 2 to 6. The company said that "no severe COVID-19 disease was observed in either age group" during the trials. 

Kids under the age of 6 are the last age group in the U.S. without access to a COVID-19 vaccine. Pfizer's vaccine is available for everyone ages 5 and older; Moderna is authorized for people ages 17 and up. In February, the FDA delayed a meeting on Pfizer's vaccine for children under 5, citing a desire to review more data.

Moderna's request was highlighted more by left- and center-rated news sources, and less by right-rated outlets. Some reports from the right mentioned concerns about vaccine side effects in kids and teens; few reports from the left and center did. Reports from the left and center more often focused on Moderna's clinical trial data and mentioned public health concerns for kids who aren't yet eligible to receive a COVID-19 vaccine. 

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Moderna is seeking emergency use authorization from the US Food and Drug Administration for its Covid-19 vaccine for children 6 months through 5 years of age, the company said Thursday.

"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," Stéphane Bancel, chief executive officer of Moderna, said in a news release.

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.

Moderna asked Food and Drug Administration (FDA) regulators on Thursday to authorize its COVID-19 vaccine for emergency use in children under 6 years of age. 

The biotech company said the shot was about 51% effective against the virus for kids under 2 years old and about 37% effective in kids ages 2 to 5.

It added that similar requests are underway with international regulatory authorities, noting that the requests are based on a 25-microgram two-dose primary series of the vaccine.