Pfizer-BioNTech LP.8.1-Adapted COVID-19 Vaccine Receives Regulatory Approval in Australia and New Zealand
核心洞察
Pfizer and BioNTech's LP.8.1-adapted COVID-19 (搜索) vaccine has received regulatory approval in both Australia and New Zealand for individuals aged 6 months and older.
The updated vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, which the World Health Organization identified as a COVID-19 (搜索) Variant under Monitoring as of January 24, 2025.
Registration is based on cumulative clinical, non-clinical, and real-world data supporting the safety and efficacy of Pfizer-BioNTech COVID-19 (搜索) vaccines.
Pfizer and BioNTech have achieved regulatory approval for their LP.8.1-adapted COVID-19 (搜索) vaccine in both Australia and New Zealand, marking a significant milestone in the ongoing effort to address evolving SARS-CoV-2 variants. The vaccine, marketed as COMIRNATY LP.8.1 (搜索), has been approved for use in individuals aged 6 months and older in both countries.
Regulatory Approvals and Availability
The LP.8.1-adapted COVID-19 (搜索) vaccine received consent from Medsafe in New Zealand and registration on the Australian Register of Therapeutic Goods (ARTG) in December 2025. In Australia, the vaccine is fully funded by the government for all eligible individuals, though it is not included on the Pharmaceutical Benefits Scheme or National Immunisation Program. In New Zealand, COVID-19 vaccines are provided free of charge for eligible individuals and are available in pharmacies and general practices across the country.
Variant-Adapted Formulation
The updated vaccine formulation specifically targets the SARS-CoV-2 sublineage LP.8.1, following guidance from global and regional health and regulatory bodies to more closely match circulating strains. The World Health Organization identified LP.8.1 as one of the COVID-19 (搜索) Variants under Monitoring (VUM) as of January 24, 2025.
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 (搜索) vaccine for protection against circulating variants.
Dosing and Administration
The vaccine is available in three age-specific formulations:
- 30 micrograms/0.3 mL for individuals 12 years and older
- 10 micrograms/0.3 mL for children aged 5 to 11 years
- 3 micrograms/0.3 mL for children aged 6 months to 4 years
Safety Profile and Regulatory Basis
Registration of the LP.8.1-adapted COVID-19 (搜索) vaccine is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech, including clinical, non-clinical, and real-world data supporting the safety and efficacy of their COVID-19 vaccines.
The safety profile remains consistent with previous COMIRNATY formulations. Registered mRNA COVID-19 (搜索) vaccines show increased risks of myocarditis (搜索) and pericarditis (搜索), particularly within the first week following vaccination, with the observed risk highest in males aged 12 through 17 years. The most commonly reported adverse reactions include pain at the injection site, fatigue, headache, chills, muscle pain, fever, joint pain, injection site swelling, injection site redness, and nausea.
Technology Platform
The COVID-19 (搜索) vaccines by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed collaboratively by both companies. BioNTech serves as the Marketing Authorization Holder for COMIRNATY and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, while holding emergency use authorizations or equivalents in additional jurisdictions.
Clinical Indications
COMIRNATY LP.8.1 (搜索) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19 (搜索)) caused by SARS-CoV-2 in individuals aged 6 months and older. The use of this vaccine should be in accordance with official recommendations from health authorities in each respective country.