WHAT YOU NEED TO KNOW:
- Moderna filed for emergency use authorization for its COVID-19 vaccine for young children.
- Moderna said that its COVID-19 vaccine generated a strong immune response in kids ages 6 months to 5 years.
- Young kids have been largely unprotected throughout the pandemic.
Moderna filed for emergency use authorization for its COVID-19 vaccine for children under the age of 6. If approved, this would be the first vaccine against the virus available for those under 5 years old.
Pfizer and BioNTech’s COVID-19 vaccine was authorized for children 5 and older. Their trial results for 2- to 4-year-olds revealed weaker immune response than in adults. This prompted the study to be extended to test a third dose.
“This does represent an important area of unmet need,” Moderna Chief Medical Officer Paul Burton said in an interview. “There’s no other vaccine, no other therapy, that these little kids can have,” Burton said. “If they do judge the data to be sufficient, I think from a public health perspective, offering it to these children as quickly as possible is the best thing.”
Last month, Moderna released its trial data showing that its COVID-19 vaccine was safe. It generated a similar immune response in young children as for adults, which was the objective of the study.
Moderna said two doses were around 37% effective in preventing infections in 2- to 5-year-olds and 51% effective for children ages 6 months to 2 years.
Burton did not give a time frame for when the U.S. FDA was expected to consider the authorization request.
Dr. Anthony Fauci suggested in a CNN interview last week that the FDA hopes to review data from the Pfizer/BioNTech vaccine in the age group alongside the Moderna data.
In the U.S., only 28% of children in the 5 to 11 age group are fully vaccinated. Children who were infected with COVID-19 often have milder symptoms than adults.
According to data released by the CDC on Tuesday, 75% of U.S. children had evidence of prior COVID infection in their blood, much of which occurred during the Omicron surge from December through February.
Burton is still recommending that children be vaccinated against the virus.
“COVID is a bad disease. These variants now are highly transmissible,” he said.
“I do believe that getting vaccinated now should protect these kids: protect them against severe disease, hospitalization, protect them against the long-term effects of COVID. So it makes sense to get vaccinated,” Burton added.