Thursday, April 14, 2022 - 06:45am
Data from a subanalysis of 30 sera from a Phase 2/3 clinical trial of children 5 through 11 years of age show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine
In the Phase 2/3 clinical trial with 140 children a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine increased neutralizing antibodies by 6-fold against the SARS-CoV-2 wild-type strain in this age group
Companies plan to submit these data to U.S. Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. These data demonstrate an increase in SARS-CoV-2 Omicron variant and wild-type strain neutralizing titers following a booster dose of the Pfizer-BioNTech COVID-19 vaccine compared to two doses. These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group.
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In the Phase 2/3 clinical trial, data were analyzed from 140 children 5 through 11 years of age received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 vaccine 10-µg primary series. Data from a sub analysis of 30 sera from this study indicate that serum antibodies induced by a third dose neutralize the SARS-CoV-2 Omicron variant in this age group, as demonstrated by a 36-fold increase in neutralizing antibody titers compared to levels seen after two doses of the Pfizer-BioNTech COVID-19 Vaccine. A robust response was observed regardless of prior SARS-CoV-2 infection.
Further, immunogenicity data from 140 participants in the Phase 2/3 clinical trial with who had no evidence of prior SARS-CoV-2 infection showed a 6-fold increase (95% CI: 5.0, 7.6) in SARS-CoV-2 wild-type strain–neutralizing geometric mean titers (GMTs) one month after the booster compared to the SARS-CoV-2–neutralizing GMTs one month after the second dose of the Pfizer-BioNTech COVID-19 vaccine, demonstrating a strong immune response in this age group. To date, more than 10,000 children under the age of 12 have participated in clinical trials investigating the Pfizer-BioNTech COVID-19 vaccine, and in this most recent booster data readout (n=401), the vaccine was well tolerated with no new safety signals observed.
Pfizer and BioNTech plan to submit a request for Emergency Use Authorization (EUA) of a booster dose for children ages 5 through 11 in the U.S. in the coming days. The companies also plan to share these data with the European Medicines Agency (EMA) and other regulatory agencies around the world as soon as possible.
A primary series of two 10-µg doses of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA for this age group in October 2021. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
About the Phase 1/2/3 Trial in Children
The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. In December 2021, Pfizer and BioNTech announced the companies would test a third 3 µg dose given at least two months after the second dose in children under age 5 and a third dose of the 10 µg formulation in children 5 to under 12 years of age.
About the Pfizer-BioNTech Laboratory Study
To evaluate the effectiveness of a third 10-µg dose in children 5 through 11 years of age, Pfizer and BioNTech tested a panel of 30 human immune sera obtained from the blood of individuals that received two or three 10-µg doses of the current Pfizer-BioNTech COVID-19 Vaccine, using a live SARS-CoV-2 recombinant virus fluorescent foci reduction neutralization test (FFRNT). Each serum was tested simultaneously for its neutralizing titer against recombinant SARS-CoV-2 (with USA-WA-1/2020 genetic backbone) bearing the wild-type SARS-CoV-2 spike protein and theOmicron spike. The 50% neutralizing geometric mean titer (GMT) against Omicron was 993 (after three doses), compared to 27 after two doses. The neutralizing GMT against the wild-type virus was 2153 (after three doses), compared to 335 after two doses. Further analysis will assess the persistence of neutralizing titers over time after a booster dose of the Pfizer-BioNTech COVID-19 Vaccine against the Omicron and wild-type strains.
U.S. Indication & Authorized Use
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:
Primary Series
a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise
Booster Series
a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
COMIRNATY®INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
COMIRNATY® is administered as a 2-dose primary series
COMIRNATY® AUTHORIZED USES
COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:
Primary Series
a 2-dose primary series to individuals 12 through 15 years of age
a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
Booster Dose
a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
Emergency Use Authorization
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in either individuals 12 years of age and older, or in individuals 5 through 11 years of age, as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
INTERCHANGEABILITY
FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA-authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.
The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age differs from the formulations authorized for individuals 12 years of age and older and should therefore not be used interchangeably. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age should not be used interchangeably with COMIRNATY® (COVID-19 Vaccine, mRNA).