Moderna Asks FDA To Authorize COVID Vaccine For Children Under 5
CAMBRIDGE, MA — On Thursday, Cambridge-based Moderna said it will ask the Food and Drug Administration to authorize a low-dose version of the COVID-19 vaccine for children ages 6 months to five years.
The request will go directly to the FDA, which is expected to make a decision by June.
Moderna's vaccine for children will be a smaller dose — only about a quarter of what adults receive. Officials say children will receive two 25-microgram doses four weeks apart.
Currently, children under 5 are the only age group ineligible to receive a COVID-19 vaccine in the country. Pfizer-BioNTech's vaccine is available to anyone as young as 5, but Moderna and Johnson & Johnson's vaccines are only available to adults.
Health experts say young children are part of the COVID-19 chain of transmission, and getting shots in their arms will help reduce coronavirus rates in Massachusetts and elsewhere around the country.
A Centers for Disease Control and Prevention study published in March shows that during the omicron surge, children under 5 were hospitalized at a rate about five times higher than they were during the delta surge.
Moderna said early data showed that two weeks after getting the two shots, 6,900 children enrolled in its study showed youngsters developed virus-fighting antibody levels as strong as young adults getting its full-strength shots, the company said in a news release.
Moderna said the only side effects were mild fevers similar to those associated with other common pediatric vaccines.
Another concern is that a large majority of children under the age of 11 have already been infected with COVID-19. Before the omicron surge in December, only 44 percent of children 11 and younger had been affected, but now the CDC estimates that at least 75 percent of children in that age group have been infected.
And Anthony Fauci, the nation's top infectious disease expert, said that the United States is now "out of the full-blown, explosive pandemic phase."
Vaccinating the nation's youngest children "has been somewhat of a moving target over the last couple of months," Dr. Bill Muller of Northwestern University, an investigator in Moderna's pediatric studies, said in an interview with The Associated Press. "There's still, I think, a lingering urgency to try to get that done as soon as possible."
In February, Moderna competitor Pfizer paused its application seeking emergency authorization to offer toddler-sized doses to children under 5. The FDA said at the time it wanted more data on the efficacy of a three-dose series of the vaccine for children ages 6 months to 4 years. A third dose "may provide a higher level of protection in this age group," the company said in a statement.
Moderna Asks FDA To Authorize COVID Vaccine For Children Under 5 originally appeared on the Cambridge Patch
