Pfizer Inc and partner BioNTech have completed the filing with the US drugs regulator seeking authorization for their COVID-19 vaccine in children under 5 years of age.
The filing with the US Food and Drug Administration (FDA), completed on Wednesday, included data showing three lower-dose shots of the vaccine generated a strong immune response in children as young as 6 months of age.
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.
Rival Moderna in March released trial data that showed a two-dose formulation of its vaccine was safe and generated a similar immune response in young children as in adults.
The FDA’s independent advisers will discuss the two applications in a meeting set for June 15.