- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster (fourth) dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years).
The Omicron BA.4/BA.5-adapted bivalent vaccine is currently authorized as the third dose of the three-dose primary series for children in this age group. Authorization of a booster dose would give families the option to further protect their young children against more recently circulating Omicron sublineages.
If the FDA authorizes the bivalent vaccine as a booster (fourth) dose, young children who have completed their primary series - either with three doses of the companies' original vaccine or with two doses of the companies' original and one dose of the bivalent vaccine - would be eligible to receive a 3-µg booster dose of the bivalent vaccine at least two months after the completion of their primary series.
The submission is based on data from substudies within the companies' Phase 1/2/3 study (NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth dose of the bivalent vaccine in children 6 months through 4 years of age. Among a subset of study participants 6 months through 4 years of age (n=60), a fourth dose of the Omicron BA.4/BA.5-adapted bivalent booster elicited a higher Omicron BA.4/BA.5 neutralizing response compared to participants who received three doses of the companies' original vaccine. The safety and tolerability profile of the bivalent vaccine remained similar to that of the original vaccine.1
The companies also plan to submit an application to the European Medicines Agency (EMA) and other regulatory authorities worldwide to extend the Omicron BA.4/BA.5-adapted bivalent vaccine's marketing authorization to include use in children 6 months through 4 years as both primary series and booster (fourth dose) vaccination. In the European Union (EU), the Omicron BA.4/BA.5-adapted bivalent vaccine is currently authorized as a booster dose for ages 5 years and older who have completed at least the primary vaccination course against COVID-19.
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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent are 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 through 11 years of age.
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:
Primary Series
- 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
Pfizer-BioNTech COVID-19 Vaccine, Bivalent is FDA authorized to provide:
Booster Dose
- a single booster dose to individuals 5 through 11 years of age who have completed any authorized or approved monovalent COVID-19 vaccine.
Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent are authorized to provide:
- a 3-dose primary series to individuals 6 months through 4 years of age as follows:
- Dose 1: Pfizer-BioNTech COVID-19 Vaccine
- Dose 2: Pfizer-BioNTech COVID-19 Vaccine
- Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent
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. 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
Tell your vaccination provider about all the vaccine recipient's medical conditions, including if the vaccine recipient:
- has any allergies
- has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- has a fever
- has a bleeding disorder or is on a blood thinner
- is immunocompromised or is on a medicine that affects the immune system
- is pregnant, plans to become pregnant, or is breastfeeding
- has received another COVID-19 vaccine
- has ever fainted in association with an injection
• Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
• The vaccine recipient should not receive Pfizer-BioNTech COVID-19 Vaccine if the vaccine recipient had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine
• There is a remote chance that Pfizer-BioNTech COVID-19 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 the vaccine recipient to stay at the place where the vaccine was administered for monitoring after vaccination. If the vaccine recipient experiences a severe allergic reaction, call 9-1-1 or go to the nearest hospital
Seek medical attention right away if the vaccine recipient has 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 or Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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
- 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. Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask the vaccine recipient to sit or lie down for 15 minutes after receiving the vaccine
• Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine
• Additional side effects include rash, itching, hives, swelling of the face, injection site pain, tiredness, feeling weak or lack of energy, 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 and irritability
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.
• You should always ask your 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. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985
Fact Sheets for individuals 6 months through 11 years of age:
EUA Recipients and Caregivers Fact Sheet (6 months through 4 years of age)
EUA Recipients and Caregivers Fact Sheet (5 through 11 years of age)
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
