NEW YORK and MAINZ, GERMANY, NOVEMBER 18, 2022 - 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)
AUTHORIZED USE
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)
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 12 years of age and older.
AUTHORIZED USE
COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA-authorized under Emergency Use Authorization (EUA) to provide:
Primary Series
- a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise
Pfizer-BioNTech Covid-19 Vaccine
AUTHORIZED USES
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide:
Primary Series
- 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.
IMPORTANT SAFETY INFORMATION
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine
Tell your vaccination provider about all of your medical conditions, including if you:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the immune system
- are pregnant, plan to become pregnant, or are breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
- The vaccine may not protect everyone
- You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccines
- There is a remote chance that these vaccines could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital
- Seek medical attention right away if you have any of the following symptoms: difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY® (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low
Side effects that have been reported with these vaccines include:
- Severe allergic reactions
- Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Injection site pain
- Tiredness
- Headache
- Muscle pain
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- Arm pain
- Fainting in association with injection of the vaccine
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Unusual and persistent cool, pale skin
These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.
Individuals should always ask their healthcare providers for medical advice about adverse events.
Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html. In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
COMIRNATY® Full Prescribing Information and EUA Fact Sheets for Vaccination Providers and Recipients and Caregivers Fact Sheets:
COMIRNATY® Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)
EUA Fact Sheet for Recipients and Caregivers (5 through 11 years of age)
EUA Fact Sheet for Recipients and Caregivers (6 months through 4 years of age)
