Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. The Committee has also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection.
The European Commission (EC) will review the CHMP's recommendation and is expected to make a final decision soon. Following a decision from the EC, the updated vaccine will be ready to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase.2
"This season's vaccine is ready to ship as soon as the final regulatory decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises," said Albert Bourla, Chairman and Chief Executive Officer at Pfizer. "It's been nearly a year since many citizens in the European Union were vaccinated against COVID-19 and the updated formulation provides the opportunity for them to receive a vaccine more closely matched to current sublineages."
"As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain committed to providing COVID-19 vaccines that are better matched to relevant circulating variants or sublineages to people worldwide, to support vaccinations in the upcoming fall and winter season," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally. The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalization."
The CHMP's recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech. Further, the application included pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple XBB sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Additional pre-clinical data demonstrate that serum antibodies induced by the updated COVID-19 vaccine, when compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, also effectively neutralize the globally dominant and recently WHO-designated variant of interest EG.5.1 (Eris).3
Pfizer and BioNTech have also filed an application with the U.S. Food and Drug Administration (FDA) requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older. A decision is expected in the coming days. The companies have submitted data for the updated COVID-19 vaccine to other regulatory authorities around the world.
The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron BA.1; COMIRNATY 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.
INDICATION & AUTHORIZED USE
AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.
EMERGENCY USE AUTHORIZATION
Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. The emergency use of this product is 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
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
- A person should NOT get Pfizer-BioNTech COVID-19 Vaccine, Bivalent if they have had a severe allergic reaction after a previous dose of Pfizer-BioNTech COVID-19 Vaccine*, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY® (COVID-19 Vaccine, mRNA) or to any ingredients in these vaccines.
- There is a remote chance that the vaccine 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 Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine, or COMIRNATY (COVID-19 Vaccine, mRNA). 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. Seek medical attention right away if the vaccine recipient has any of the following symptoms:
- Chest pain
- Shortness of breath or difficulty breathing
- Feelings of having a fast-beating, fluttering, or pounding heart
Additional symptoms, particularly in children, may include:
- Fainting
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Persistent vomiting
- Persistent pain in the abdomen
- Unusual and persistent cool, pale skin
- Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine, Bivalent. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination
- People with weakened immune systems may have a reduced immune response to Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Side effects that have been reported with Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine, or COMIRNATY (COVID-19 Vaccine, mRNA) 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/tenderness
- 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
- Dizziness
- Irritability
These may not be all the possible side effects of these vaccines. 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
Please click for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vaccination Provider and Recipient and Caregiver EUA Fact Sheets
*The Original Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use in the United States.
