- LP.8.1-adapted COVID-19 vaccine is now registered on the Australian Register of Therapeutic Goods (ARTG) for use in individuals 6 months of age and older.1
- The COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with global and regional health and regulatory bodies’ guidance to more closely match circulating strains.2
- Supply of the LP.8.1-adapted vaccine is available to ensure availability of the vaccine aligns with anticipated seasonal spike in infections across Australia.
SYDNEY, AUSTRALIA and MAINZ, GERMANY, 10 DECEMBER 2025 — Pfizer Australia and BioNTech SE (Nasdaq: BNTX, “BioNTech”) welcomed the Australian Register of Therapeutic Goods registration of the companies’ LP.8.1-adapted COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in individuals 6 months and older,1 available in Australia from December 2025.
COVID-19 vaccines have been updated, as recommended by independent global and regional health and regulatory bodies, to target contemporary circulating SARS-CoV-2 sublineages causing COVID-19 disease.2
The LP.8.1 sublineage selection is based on guidance from global and regional health and regulatory bodies, which stated that LP.8.1 is the preferred sublineage of a monovalent JN.1-lineage-based COVID-19 vaccine for protection against the circulating variants.
The World Health Organization identified LP.8.1 as one of the COVID-19 Variants under Monitoring (VUM), as of 24 January 2025.3
Registration of the LP.8.1-adapted COVID-19 vaccine is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical, and real-world data supporting the safety and efficacy of Pfizer and BioNTech COVID-19 vaccines.
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 authorisations or equivalents in other countries.
The use of this vaccine should be in accordance with official recommendations. Comirnaty is fully funded* by the Australian Government for all Australians. It is not included on the Pharmaceutical Benefits Scheme (PBS) and is not listed under the National Immunisation Program (NIP).
*For individuals aged 6 months and older. Standard doctor or pharmacy fees may apply.
Medicine classification: Prescription medicine
The name of the active ingredient and quantity: SARS-CoV-2 spike protein (mRNA) LP.8.1
30 micrograms/0.3 mL (12 years and older),
10 micrograms/0.3 mL (5 to 11 years) and
3 micrograms/0.3 mL (6 months to 4 years)
Therapeutic Indications:
COMIRNATY LP.8.1 (SARS-CoV-2 spike protein (mRNA) LP.8.1):
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-Cov-2, in individuals 6 month and older. The use of this vaccine should be in accordance with official recommendations.
IMPORTANT SAFETY INFORMATION
You must NOT receive COMIRNATY® LP.8.1 if you have had a severe allergic reaction to any ingredient of the vaccine.
• 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 or your child experience a severe allergic reaction, call 000 or go to the nearest Accident and Emergency Department. Signs of a severe allergic reaction can include:
o difficulty breathing,
o swelling of the face and throat,
o a fast heartbeat,
o a bad rash all over the body,
o dizziness and weakness.
• Registered mRNA COVID-19 vaccines show increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart), particularly within the first week following vaccination. For COMIRNATY, the observed risk is highest in males 12 through 17 years of age.
Seek medical attention right away if you have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
o chest pain
o shortness of breath
o feelings of having a fast-beating, fluttering, or pounding heart
Additional symptoms, particularly in children, may include:
o Fainting
o Unusual and persistent fatigue or lack of energy
o Persistent vomiting
o Persistent pain in the abdomen
o Unusual and persistent cool, pale skin
• Fainting can happen after getting injectable vaccines including COMIRNATY LP.8.1. Your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine
• People with weakened immune systems may have a reduced immune response to the vaccine
• COMIRNATY LP.8.1 may not protect all vaccine recipients
Tell your vaccination provider about all your medical conditions, including if you:
o have any allergies
o have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
o have a fever
o have a bleeding disorder or are on a blood thinner
o are immunocompromised or are on a medicine that affects the immune system
o are pregnant, plan to become pregnant, or are breastfeeding
o have received another COVID-19 vaccine less than six months prior
o have ever fainted in association with an injection.
The most commonly reported adverse reactions after a dose of COMIRNATY were pain at the injection site, fatigue, headache, chills, muscle pain, fever, joint pain, injection site swelling, injection site redness and nausea.
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.
You can report vaccine side effects to:
• your health professional
• your state or territory health department
• 1300 MEDICINE adverse medicine events line – 1300 633 424 or www.1300medicine.com.au
• The TGA- http://www.tga.gov.au/safety/reporting-problems
If you wish to report an adverse event related to a Pfizer product, you can report online at: https://www.pfizersafetyreporting.com/ Alternatively you can email us at: [email protected]
Please click here for the full Consumer Medicine Information.
About Pfizer: Breakthroughs That Change Patients’ Lives®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at: www.Pfizer.com. To learn more, please visit us at: www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
About BioNTech:
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.
For more information, please visit www.BioNTech.com.
Contacts
Pfizer:
Pfizer Australia & New Zealand Media Relations:
[email protected]
BioNTech:
Media Relations
Jasmina Alatovic
[email protected]
Investor Relations
Douglas Maffei, Ph.D.
[email protected]
References
- Therapeutic Goods Administration. (n.d.). COMIRNATY LP.8.1 (SARS-CoV-2 spike protein (mRNA) LP.8.1) COVID-19 Vaccine 10 micrograms/0.3 mL suspension for injection vial (ARTG ID 506526). Accessed December 2025. https://www.tga.gov.au/resources/artg/506526
- FDA. COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025. Available at: https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025. Updated: May 22, 2025. Accessed December 2025.
- World Health Organization. (2025, February 3). Initial risk evaluation of LP.8.1: WHO TAG-VE risk evaluation for SARS-CoV-2 variant under monitoring: LP.8.1 [PDF]. World Health Organization. https://cdn.who.int/media/docs/default-source/documents/epp/tracking-sars-cov-2/03022025_lp.8.1_ire.pdf?sfvrsn=b89f0899_4&download=true
- Australian Government Department of Health and Aged Care. (2025, May 20). About the National COVID-19 Vaccine Program. Accessed December 2025. https://www.health.gov.au/our-work/covid-19-vaccines/about-rollout
© 2025. Pfizer Australia Ltd. Sydney, Australia. All rights reserved. Pfizer Medical Information: 1800 675 229. PP-CMR-AUS-0474 12/25.
