Pfizer-BioNTech seeks USFDA authorisation for COVID vaccine for kids under 5 years
No COVID-19 shot is yet approved for children in that age group in most parts of the world.;
New Delhi: 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), 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.
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.
Read also: Pfizer-BioNTech COVID booster authorized in Canada for 16, 17-year-olds
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