Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have announced results from a Phase 2/3 trial of a 10 µg booster (third) dose of COVID-19 vaccine in children aged 5-11 years.
The data demonstrate an increase in omicron variant and wild-type strain neutralizing titers following a booster dose compared to two doses, reinforcing the potential in maintaining high levels of protection against the virus in this age group.
In the Phase 2/3 trial, data comes from 140 children 5 through 11 years who received a booster dose approximately 6 months after the second dose of the 10 µg primary series.
Related: Pfizer/BioNTech's COVID- Vaccine Cuts Hospitalization Risk In Kids Aged 5-11 Years: Reuters.
Data from a subanalysis of 30 sera indicate that serum antibodies induced by a third dose neutralize the omicron variant. It demonstrated a 36-fold increase in neutralizing antibody titers compared to levels seen after two vaccine doses.
Further, immunogenicity data from the 140 participants who had no evidence of prior infection showed a 6-fold increase in wild-type strain–neutralizing geometric mean titers one month after the booster compared to one month after the second dose.
Pfizer and BioNTech plan to submit a request for Emergency Use Authorization (EUA) for a booster dose for children ages 5 through 11 in the U.S. in the coming days.
Price Action: PFE shares are down 0.15% at $53.02, BNTX stock is down 0.45% at $178.58 during premarket trading.
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