TGA实验室公布Abrysvo、Arexvy与Beyfortus检测结果：所有受检批次符合批准标准

The Therapeutic Goods Administration (TGA) Laboratories Branch has conducted testing on two Respiratory Syncytial Virus (RSV) vaccines and one monoclonal antibody that are supplied in the Australian market. These products are: -

• ABRYSVO recombinant respiratory syncytial virus pre-fusion F protein 120 microgram/0.5 mL bivalent vaccine powder for injection vial + diluent syringe [AUSTR 406624],
• AREXVY Recombinant Respiratory Syncytial Virus pre-fusion F protein vaccine 120 micrograms powder vial and suspension vial suspension for injection [AUSTR 400657], and 
• Beyfortus nirsevimab [AUSTR 397898] 100mg in 1mL solution for injection prefilled syringe and AUSTR [397899] BEYFORTUS nirsevimab 50mg in 0.5mL solution for injection prefilled syringe.

These are the first approved vaccines against RSV in Australia. Abrysvo is now included on the National Immunisation Program (NIP) for pregnant women between 28-36 months gestation. Arexvy is on NIP for older adults aged 60-74 years and people with medical risk conditions.

Beyfortus is the first monoclonal against RSV on the NIP. It is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:

• Neonates and infants born during or entering their first RSV season
• Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. 

Every batch of Abrysvo & Arexvy supplied in Australian is released in Europe based on the Official Control Authority Batch Release (OCABR) process for testing and quality review. Although there is no scientific evidence to suggest that products quality is at a level that would require testing the products are being re-tested to ensure public confidence. The TGA testing of these two vaccines will enable independent data analysis and data trending to monitor batch to batch consistency.  Further the TGA testing would provide a high level of public reassurance of vaccine quality. Unlike vaccines, no external independent test results are supplied for Beyfortus, so our TGA test results provide an independent quality assessment of this product.

The TGA testing has been conducted between September 2024 and July 2026.

Highlights and key insights

The testing project revealed the following findings:

• All Abrysvo batches tested passed the approved specifications for product quality including protein content, purity, potency and endotoxin.
• All Arexvy batches tested passed the approved specifications for product quality including content, purity, potency and endotoxin.
• All Beyfortus batches tested passed the approved specifications for content and purity.

Method

Samples

All new final container batches of Abrysvo and Arexvy submitted for release from September 2024 to June 2026 by the Sponsor were tested. All 5 Batches of Beyfortus supplied in 2025 were also tested, although these were not submitted to TGA for batch release.

Data analysis

The data analysis is done according to the methods described in the test procedures. All test procedures used are either company validated test methods (i.e. ELISA, UV spectroscopy, SE-HPLC, RP-UPLC & SEC-UPLC test methods) or internationally harmonised methods (Endotoxin test: Ph.Eur. 2.6.14, USP <85> & JP 4.01). 

Test methods

Each of the samples received were tested for compliance against TGA approved manufacturer specifications

The samples were tested for purity, content and potency. The following testing methods in the TGA Laboratories quality system were used to analyse the samples:

• BT-IMM03 -11  ABRYSVO ELISA METHOD
• BT-BEE03-2     Endotoxin Routine Assay
• BT-PCR03-19   Pfizer Abrysvo Protein Determination by UV spectroscopy
• BT-BPC03-41   Analysis of RSV Drug Product by Size-Exclusion HPLC (SE-HPLC)
• BT-IMM03-12   AREXVY ELISA Method
• BT-BPC03-42   Determination of Aggregates, Trimers and Other Species in Arexvy RSVPEF3 FC by SEC-UPLC
• BT-BPC03-43   Arexvy RSVPEF3 Content Determination in DS and DP samples by RP-UPLC-FLUO
• CPD Method    D24-4164648 SOP-0104116 v5.0 NIRSEVIMAB HIGH PERFORMANCE SIZE EXCLUSION CHROMATOGRAPHY used for purity (and content)**

Results

All results for potency, protein and purity were within the approved specifications. Results demonstrated batch to-batch consistency (Tabel 1 - Table 3). 

Conclusion

All batches tested were within the approved drug product specifications. No trends were observed across the 8 batches tested for Abrysvo, 16 batches tested for Arexvy and 5 batches of Beyfortus. 

The test results provide public reassurance that the batches supplied for the NIP [Abrysvo, Arexvy and Beyfortus (nirsevimab)] are compliant to the approved product specifications following TGA testing.

References

National Immunisation Program update - RSV vaccine

Respiratory syncytial virus (RSV)