Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and older. An application for an Omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to FDA in early October. The companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children 6 months through 4 years of age.
The Omicron BA.4 and BA.5 subvariants together are the prevalent variants of concern in the U.S., prompting the FDA to instruct manufacturers to develop a variant-adapted vaccine that also addresses the spike protein of the Omicron BA.4/BA.5 subvariants. Pfizer and BioNTech's bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2, which is present in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Because the Omicron BA.4 and BA.5 subvariants contain identical spike protein amino acid sequences, both can be targeted at once with a single mRNA strand. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.
"As we head into the fall and winter season, with the potential for greater SARS-CoV-2 spread in schools and at work, it is important to stay up to date with vaccines as a first line of defense against COVID-19 illness," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We are thrilled by today's news, another important milestone in our ongoing efforts to provide protection against this virus."
"With today's approval, a vaccine will shortly become available that addresses the currently prevalent Omicron sublineages with the aim of preserving protection against COVID-19," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "In less than three months, we were able to develop and manufacture an Omicron BA.4/BA.5-adapted vaccine. This milestone further underlines the strength of rapidly adaptable mRNA vaccines against the this continuously evolving virus."
The authorization of the bivalent COVID-19 vaccine is based on clinical data from Pfizer and BioNTech's Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech's Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies' current COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus.
The companies will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government. Booster vaccinations for individuals 12 years of age and older are anticipated to start subject to and after the Centers for Disease Control and Prevention (CDC) endorse a potential recommendation by the Advisory Committee on Immunization Practices (ACIP). Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government's commitment to free access to COVID-19 vaccines.
Pfizer and BioNTech have submitted data on their Omicron-adapted bivalent vaccines to the European Medicines Agency (EMA) and other regulatory authorities around the world.
As a result of this authorization, Pfizer and BioNTech will file a new supplemental Biologics Application (sBLA) for the Omicron BA.4/BA.5 bivalent booster vaccine and therefore withdraw the sBLA for a booster dose of the Original Pfizer-BioNTech COVID-19 Monovalent Vaccine for individuals 16 and older. The Original Pfizer-BioNTech COVID-19 Vaccine will remain available as a booster for those 5 through 11 years of age and as a primary series for those 6 months of age and older.
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.
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 underEmergency 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 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 (Pfizer-BioNTech COVID-19 Vaccine)
- individuals 12 years of age and older (Pfizer-BioNTech COVID-19 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
