The 36-fold increase in Omicron neutralizing titers in children between 5-11 years old is providing data for the companies to be able to file for an FDA EUA in this age group.
The Pfizer-BioNTech COVID-19 vaccine is reported to have shown a 36-fold increase in Omicron neutralizing titers following a third dose of their COVID-19 vaccine.
Specifically, 140 children who were between 5-11 years of age received the third dose of the vaccine 6 months after the second shot of the Pfizer-BioNTech COVID-19 vaccine. The companies report a sub analysis of 30 sera from this study indicated that serum antibodies induced by the booster (third dose) neutralized the Omicron variant with a 36-fold increase in neutralizing antibody titers compared to levels seen after 2 doses of their vaccine. The companies said a robust response was observed regardless of prior COVID-19 infection.
On the strength of this data, the companies are planning to file for a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for their booster dose for children 5-11 years old. Pfizer and BioNTech are also planning to share this data with the European federal agency as well as other countries.
Last October, the FDA approved an EUA for the Pfizer-BioNTech COVID-19 vaccine for 5 to 11 year olds in a primary 2-dose series.