Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision. An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years will be submitted to the European Medicines Agency (EMA) in the coming days.

The companies have also initiated a Phase 1/2/3 study NCT05543616 (C4591048) to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age. This pediatric study is consistent with regulatory guidance and follows a previous Phase 1/2/3 trial involving these age groups that demonstrated the original Pfizer-BioNTech COVID-19 Vaccine is well-tolerated and offers a high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent.

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 for BNT162b2 (COMIRNATY®) 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. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

About the Study

The Phase 1/2/3 pediatric clinical study will have four substudies examining different bivalent vaccine dosing regimens, dose levels and ages, including:

  • Substudy A (Ages 6 through 23 months who are COVID-19 vaccine-naïve): Phase 1 dose-finding study will evaluate 3-µg, 6-µg, and 10-µg dose levels of the bivalent vaccine. Based on Phase 1, Participants in the Phase 2/3 will receive the selected dose as a three-dose primary series, followed by a booster dose.
  • Substudy B (Ages 6 months through 4 years who had previously received 2-3 doses of original COVID-19 vaccine): Those who have received two doses of the original COVID-19 vaccine prior to enrollment will receive both a third and fourth 3-µg dose of the bivalent vaccine. Those who have previously received three doses of the original vaccine will receive a 3-µg booster (fourth) dose of the bivalent vaccine.
  • Substudy C (Ages 6 months through 4 years who had previously received 3 doses of original COVID-19 vaccine): Phase 1 dose-finding study will evaluate 6-µg and 10-µg dose levels of the bivalent vaccine for a fourth dose. Based on Phase 1, Phase 2/3 will receive the selected dose as a fourth dose.
  • Substudy D (Ages 5 through 11 years who had previously received 2-3 doses of original COVID-19 vaccine): Participants will receive the bivalent vaccine as either a third or fourth 10-µg booster dose.

U.S. INDICATION & AUTHORIZED USE

PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) AUTHORIZED USES

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 12 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.

COMIRNATY® AUTHORIZED USES

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 through 11 years of age
  • a third primary series dose to individuals 5 years through 11 years of age with certain kinds of immunocompromise

Booster

  • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine

EMERGENCY USE AUTHORIZATION

Emergency uses of the original and bivalent 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 6 months of age and older (original vaccine)
  • individuals 12 years of age and older (bivalent vaccine)

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
  • COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) may not protect all vaccine recipients.
  • You should not receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) if you have had a severe allergic reaction to after a previous dose of COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID 19 Vaccine or had a severe allergic reaction to any ingredient in these vaccines
  • There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 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 the first week following receipt of the second primary series dose or first booster dose, with most booster doses administered at least 5 months after completing primary vaccination. 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

Click for Fact Sheets and Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5):

EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)

EUA Fact Sheet for Vaccination Providers (12 Years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap

Click for Fact Sheets and Prescribing Information for individuals 5 years of age and older:

Recipients and Caregivers Fact Sheet (6 months through 4 years of age)

Recipients and Caregivers Fact Sheet (5 through 11 years of age)

Recipients and Caregivers Fact Sheet (12 years of age and older)

COMIRNATY® Full Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap

COMIRNATY® Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap

EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap

EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap

EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap

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