Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the U.S. Food and Drug Administration ("FDA") has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY ® (COVID-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies' Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. This season's vaccine is for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a COVID-19 vaccine may be eligible to receive additional doses.
The KP.2 adaptation is based on guidance from the FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines for use in the U.S. during the 2024-2025 fall and winter season, if feasible. 1 Staying up to date on vaccinations in line with the Centers for Disease Control and Prevention ("CDC") recommendations remains important, particularly in light of COVID-19 cases on the rise again. 2 This season's Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. beginning in the coming days.
The approval is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and effectiveness of the COVID-19 vaccines by Pfizer and BioNTech. The application also included manufacturing and non-clinical data showing that the KP.2-adapted vaccine generates a substantially improved response against currently circulating Omicron JN.1 sublineages, including KP.2, KP.3 and LB.1, compared with the companies' Omicron XBB.1.5 adapted COVID-19 vaccine .3
The COVID-19 vaccines 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 ® (COVID-19 Vaccine, mRNA); COMIRNATY ® Original/Omicron BA.1; COMIRNATY ® Original/Omicron BA.4-5; COMIRNATY ® Omicron XBB.1.5; COMIRNATY ® JN.1; COMIRNATY ® KP.2) in the United States, the European Union, the United Kingdom, 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 AND IMPORTANT SAFETY INFORMATION
INDICATION
COMIRNATY ® (COVID-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (COVID-19).
IMPORTANT SAFETY INFORMATION
- You should NOT get COMIRNATY® (COVID-19 Vaccine, mRNA) if you had a severe allergic reaction to a previous dose of COMIRNATY or any Pfizer-BioNTech COVID-19 vaccine or to any ingredient in these vaccines
- There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of your 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 mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following COMIRNATY have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding heart
- Fainting can happen after getting injectable vaccines including COMIRNATY. Your vaccination provider may ask you to sit or lie down
- People with weakened immune systems may have a reduced immune response to COMIRNATY
- COMIRNATY may not protect all people who receive the vaccine
Before getting COMIRNATY, tell your vaccination provider about all of your medical conditions, including if you:
- have any allergies
- had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
- 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 your 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
Additional side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include:
- Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
- Injection site reactions: pain, swelling, redness, arm pain
- General side effects: tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness
These may not be all the possible side effects of COMIRNATY. Ask your healthcare provider about any side effects that concern you.
You may report side effects to the FDA/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, you can report side effects to Pfizer Inc. at 1-800-438-1985 or www.pfizersafetyreporting.com
Please click here for full Prescribing Information and Patient Information for COMIRNATY. If it is not currently available via these links, it will be visible as soon as possible as we work to finalize the documents. Please check back for the full information shortly.
AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)* is FDA authorized under Emergency Use Authorization (EUA) 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.
*Hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine.
EMERGENCY USE AUTHORIZATION
Emergency uses of COVID-19 vaccines from BioNTech and Pfizer, including Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula), 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. Emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical products under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com .
IMPORTANT SAFETY INFORMATION
- Your child should NOT get Pfizer-BioNTech COVID-19 Vaccine if they had a severe allergic reaction after a previous dose of any Pfizer-BioNTech COVID-19 vaccine 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 one hour after getting a dose of the vaccine. For this reason, the vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Signs of a severe allergic reaction can include:
- difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, or 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 mRNA COVID-19 vaccines. Myocarditis and pericarditis following Pfizer-BioNTech COVID-19 vaccines have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. Seek medical attention right away if your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
- 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. 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
- Pfizer-BioNTech COVID-19 Vaccine may not protect everyone
- Tell your vaccination provider about all of your child's medical conditions, including if your child:
- 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 or is breastfeeding
- has received another COVID-19 vaccine
- has ever fainted in association with an injection
- Side effects that have been reported with Pfizer-BioNTech COVID-19 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/tenderness
- Tiredness
- Headache
- Muscle pain
- Arm pain
- Fainting in association with injection of the vaccine
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- Dizziness
- Irritability
- Febrile seizures (convulsions during a seizure)
These may not be all the possible side effects. Serious and unexpected side effects may occur. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.
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 . Please include "Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) EUA" in the first line of box #18 of the report form.
In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please click here for Pfizer-BioNTech COVID-19 Vaccine Healthcare Providers Fact Sheet and Vaccine Recipient and Caregiver EUA Fact Sheet . If it is not currently available via these links, it will be visible as soon as possible as we work to finalize the documents. Please check back for the full information shortly.
