Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted 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. Children in this age group can 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 bivalent vaccine to complete the primary series. Vaccine doses can be delivered immediately upon receipt of a recommendation from the U.S. Centers for Disease Control and Prevention ("CDC").
On top of a persistent stream of COVID-19 cases, surging seasonal respiratory illnesses in young children are straining health systems across the U.S., with many states reporting more than 90% of their pediatric hospital beds are occupied.iii Updated COVID-19 vaccines may improve protection against severe illness and hospitalization caused by SARS-CoV-2 in this age group.
"This authorization offers an opportunity for parents to help better protect their young children against COVID-19, including disease caused by Omicron sublineages," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Nearly 40 million Americans have received a booster dose of an updated vaccine. It is critical that we all continue to do our part to help protect ourselves by staying up to date with COVID-19 vaccinations, as recommended by public health authorities, especially now as we plan to gather for the holidays and head into the winter season."
"As the virus evolves it remains our goal to be able to provide access to variant-adapted vaccines against COVID-19 to a broader population," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "With this authorization, the adapted vaccine based on the Omicron sublineages BA.4 and BA.5 can become an important part of the primary vaccination series for young children."
The amendment to the EUA is supported by clinical data from adults who received the Omicron BA.4/BA.5-adapted bivalent vaccine, post-authorization experience with this bivalent vaccine among ages 5 years and older, and post-authorization experience with the original Pfizer-BioNTech COVID-19 Vaccine as a three-dose primary series for children 6 months through 4 years of age. Additional support is provided by clinical data from the companies' Omicron BA.1-adapted bivalent vaccine in adults as well as pre-clinical and manufacturing data from the companies' 3-µg Omicron BA.4/BA.5-adapted bivalent vaccine. 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).
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 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 Wild Type 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 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 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 a primary series with Pfizer-BioNTech 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 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
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
- Dizziness
- 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 (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 (5 through 11 years of age), BIVALENT (Original and Omicron BA.4/BA.5), DILUTE BEFORE USE, Orange Cap
