Pfizer-BioNTech Booster Dose Demonstrates Protection Against Omicron in Pediatric Population

The 36-fold increase in Omicron neutralizing titers in children aged 5-11 years provides the companies with data to be able to apply for an FDA-EUA in this age group.

2 companies’ COVID-19 vaccine has reportedly shown a 36-fold increase in Omicron neutralizing titers after a third dose of the Pfizer-BioNTech COVID-19 vaccine.

Specifically, 140 children between the ages of 5 and 11 received the third dose of the vaccine 6 months after the second injection of the Pfizer-BioNTech COVID-19 vaccine. serum antibodies induced by the booster (third dose) neutralized the Omicron variant with a 36-fold increase in neutralizing antibody titers compared to the levels observed after 2 doses of their vaccine. The companies said a robust response was observed regardless of previous COVID-19 infection.

Based on this data, the companies plan to file an application with the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for their booster dose for children ages 5-11. Pfizer and BioNTech also plan to share this data with the European Federal Agency and with 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 series of 2 doses.