Pfizer Inc and partner BioNTech have completed the filing with the U.S. drugs regulator seeking authorization for their COVID-19 vaccine in children under 5 years of age.
The filing with the U.S. Food and Drug Administration (FDA), whose independent advisers will discuss the two applications in a meeting set for June 15, was completed on Wednesday.
No COVID-19 shot is yet approved for children in that age group in most parts of the world. It remains unclear how many parents will get their young ones vaccinated as demand has been low in kids aged 5 to 11.
Pfizer and BioNTech on May 23 said their trial showed a 3 microgram version of the vaccine generated a similar immune response in under 5-year-olds as two doses of 30 micrograms each in 16 to 25-year-olds in an earlier trial.
Reporting from Reuters.
