Pfizer: Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster in European Union

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a 30-µg booster dose of their Omicron BA.1 Bivalent COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.1 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

The Omicron BA.1-adapted 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.1 subvariant. Apart from the addition of the mRNA sequence of the BA.1 spike protein, all other components of the vaccine remain unchanged.

“As we face another autumn living with COVID-19, our Omicron BA.1-adapted bivalent vaccine presents EU residents, care providers and public health authorities with an immediate avenue to begin boosting immunity against Omicron, pending authorization,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “This BA.1-adapted bivalent vaccine was clinically shown to have a favorable safety profile with immunogenicity against both wild-type and Omicron strains and may serve as a key component of vaccination strategies for the coming months.”

“Today’s positive opinion by the committee confirms that immunogenicity and safety goals of variant-adapted mRNA vaccines can be met. Compared to a booster dose of our COVID-19 vaccine, which is currently approved for use in the EU, the bivalent vaccine with mRNA encoding the wild-type and the BA.1 spike proteins provides higher neutralizing antibody titers against the Omicron BA.1 and BA.4/BA.5 sublineages,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In addition, a booster dose of our Omicron BA.1-adapted bivalent vaccine is anticipated to preserve and expand the breadth of B and T-cell responses with the aim to provide broader immunity against COVID-19 caused by SARS-CoV-2, including Omicron sublineages.”

Today’s recommendation follows guidance from the EMA, World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities (ICMRA) to advance a bivalent vaccine candidate, with the goal of making an Omicron-adapted vaccine available to European Union (EU) member states as soon as possible.

The CHMP recommendation is based on previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial of participants 56 years of age and older who received a 30-µg booster dose of the Omicron BA.1-adapted bivalent vaccine. In this study, a booster dose of the Omicron BA.1-adapted bivalent vaccine (n=178) elicited a superior immune response against Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine (n=163) as demonstrated by an approximately 9-fold improvement in neutralizing titers. In additional analyses of a SARS-CoV-2 live virus neutralization assay tested on sera from participants in this trial, neutralization titers improved by approximately 4-fold for BA.4/BA.5 (n=100). The BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile.

If an authorization is granted, COMIRNATY® Original/Omicron BA.1 15/15 ug doses will be available within the coming days to all 27 EU member states supporting the start of the European vaccination campaigns. Local supply may vary based on individual country government requests.

The companies have also filed an application to the EMA for a booster dose of an Omicron BA.4/BA.5-adapted COVID-19 bivalent vaccine to allow for flexible vaccination strategies. This application is currently under review. An Omicron-adapted vaccine based on the BA.4/BA.5 subvariant was authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022.

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, 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
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.