Pfizer and BioNTech Report New Data on Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Improved Immune Response Against Emerging Omicron Sublineages
- Category: Vaccines
- Published on Friday, 18 November 2022 10:00
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- One month after a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, neutralizing antibody titers against emerging Omicron sublineages increased 3.2- to 4.8-fold compared to the companies’ original COVID-19 vaccine
- Neutralizing antibody titers against Omicron sublineages BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 increased 4.8- to 11.1-fold from pre-booster levels, following a 30-µg booster dose of the bivalent vaccine
- Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data, while the emerging BQ.1.1 sublineage accounts for nearly 25% of cases and is increasing globally
NEW YORK, NY, USA and MAINZ, Germany I November 18, 2022 I Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an analysis examining the immune response induced by their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine [Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)] against newer Omicron sublineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1. These data, posted on the preprint server bioRxiv, indicate that the companies’ bivalent vaccine elicits a greater increase in neutralizing antibody titers than the companies’ original COVID-19 vaccine against these emerging Omicron sublineages. Based on these findings, the Omicron BA.4/BA.5-adapted bivalent booster may help to provide improved protection against COVID-19 due to Omicron BA.4 and BA.5 sublineages as well as new sublineages that continue to increase in prevalence.
Neutralization data were generated using a nonvalidated fluorescent focus reduction neutralization test (FFRNT) one month after administration of a 30-µg booster (fourth) dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine or the original COVID-19 vaccine in adults aged 55 and older (approximately 40/vaccine group). Sera were equally stratified by prior SARS-CoV-2 infection. Results showed the bivalent vaccine booster elicited a greater rise in neutralizing antibody titers for all tested Omicron sublineages compared to the original vaccine, regardless of prior SARS-CoV-2 infection status.
Following a booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, neutralizing antibodies against BA.4.6 increased 11.1-fold (95% CI: 7.1, 17.3), while neutralizing antibodies against BA.2.75.2, BQ.1.1, and XBB.1 increased by 6.7-fold (95% CI: 4.4,10.2), 8.7-fold (95% CI: 5.7, 13.3), and 4.8-fold (95% CI: 3.3, 6.9), respectively. By comparison, the neutralizing antibody titers against BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 following a booster dose of the companies’ original COVID-19 vaccine increased 2.3-fold (95% CI: 1.9, 2.8), 2.1-fold (95% CI: 1.7, 2.5), 1.8-fold, (95% CI: 1.6, 2.2), and 1.5-fold (95% CI: 1.3, 1.8), respectively. Overall, the bivalent booster generated a greater increase in neutralizing antibodies against emerging Omicron sublineages than the original Pfizer-BioNTech COVID-19 vaccine.
These results are similar to recent clinical data showing the Omicron BA.4/BA.5-adapted bivalent booster evokes a 13-fold increase in BA.4/BA.5 neutralizing titers from pre-booster levels in individuals 55 years and older, resulting in a 4-fold higher BA.4/BA.5 response than the companies’ original COVID-19 vaccine.
A booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) for ages 5 years and older and has been granted marketing authorization in the EU by the European Commission for ages 5 years and older.
The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
U.S. INDICATION & AUTHORIZED USE
Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized under Emergency Use Authorization (EUA) for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either:
- completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or
- receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus
COMIRNATY® (COVID-19 Vaccine, mRNA)
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 12 years of age and older.
COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA-authorized under Emergency Use Authorization (EUA) to provide:
- a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise
Pfizer-BioNTech Covid-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide:
- a 3-dose primary series to individuals 6 months through 4 years of age
- 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
EMERGENCY USE AUTHORIZATION
Emergency uses of the vaccines 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 individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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.
COMIRNATY® Full Prescribing Information and EUA Fact Sheets for Vaccination Providers and Recipients and Caregivers Fact Sheets:
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