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

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization.

If authorized, children in this age group would receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine. An application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years is under discussion with the European Medicines Agency (EMA).

The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized as a booster dose for ages 5 years and older in the U.S. and European Union (EU).

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 (Original) 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:

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

EUA Fact Sheet for Vaccination Providers (5 through 11 Years), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Orange Cap

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 (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 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)

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