Pfizer and BioNTech are seeking an Emergency Use Authorization for their COVID-19 vaccine to include children 6 months through 4 years of age.
Pfizer and BioNTech recently initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include children 6 months through 4 years of age, in response to growing numbers of pediatric COVID-19 cases.
Since the COVID-19 pandemic began, more than 10.6 million children have tested positive for the virus in the United States, 1.6 million of whom are younger than 4 years of age. Furthermore, reported COVID-19 cases and related hospitalizations among young children have spiked dramatically during the omicron variant surge.
The EUA amendment request is based on the totality of data about the safety, tolerability, immunogenicity, and available efficacy of 2 doses of the Pfizer-BioNTech COVID-19 vaccine.