Pfizer-BioNTech’s COMIRNATY Gets FDA Nod for COVID-19 Vaccine

• The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains¹
• Shipping of the LP.8.1-adapted vaccine will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY^® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.²

The FDA approval is based on the cumulative body of evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, including clinical trial data supporting the approval for children 5 through 11 years of age. The application also included data from pre-clinical models showing that the LP.8.1-adapted monovalent COVID-19 vaccine generates improved immune responses against multiple circulating SARS-CoV-2 sublineages, including XFG, NB.1.8.1, and other contemporary sublineages, compared to the companies’ JN.1- and KP.2-adapted monovalent COVID-19 vaccines.³

The LP.8.1 sublineage selection is based on guidance from the FDA, which stated that LP.8.1 is the preferred sublineage of a monovalent JN.1-lineage-based COVID-19 vaccine for use in the U.S. beginning in fall 2025.¹ 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. in the coming days.

To date, 5 billion doses have been distributed globally of the Pfizer-BioNTech COVID-19 vaccine, which continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as by clinical, non-clinical, pharmacovigilance, and manufacturing data.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 in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in other countries.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

COMIRNATY (COVID-19 VACCINE, mRNA) is a vaccine to protect against coronavirus disease 2019 (COVID-19).

COMIRNATY is for people who are:

• 65 years of age and older, or
• 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

IMPORTANT SAFETY INFORMATION

• You or your child should NOT get COMIRNATY ® (COVID-19 Vaccine, mRNA) if you or your child had a severe allergic reaction after 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, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. 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
  • 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 administration of mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. In most of these people, symptoms began within a week following vaccination. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the COMIRNATY, 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
  • Additional symptoms, particularly in children, may include:
    • Fainting
    • 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 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
• Vaccination with COMIRNATY may not protect all people who receive the vaccine

Before getting COMIRNATY, tell your vaccination provider about all of your or your child’s medical conditions, including if you or your child:

• 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, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness
• Febrile seizures (convulsions during a fever) in children 5 through 11 years of age

These may not be all the possible side effects of COMIRNATY. Ask your or your child’s healthcare provider about any side effects that concern you.

You may report side effects to 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 details are not currently available via this link, it will be visible as soon as possible as we work to finalize the document. Please check back for the full information shortly.