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Abrysvo (RSV vaccine)
Australian Prescription Medicine Decision Summary
Sponsor
Device/Product name
Abrysvo
Active Ingredient
Recombinant respiratory syncytial virus (RSV) pre-fusion F protein bivalent vaccine
Date of decision
Published
Submission type
New biological entity
ATC codes
J07BX05
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of ABRYSVO was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
This submission was evaluated under the standard prescription medicines registration process
The following table summarises the key steps and dates for this application:
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced | 1 May 2023 |
Evaluation completed | 30 November 2023 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice, | 2 January 2024 |
Sponsor’s pre-Advisory Committee response | 16 January 2024 |
Advisory Committee meeting | 31 January 2024 |
Registration decision (Outcome) | 20 March 2024 |
Completion of administrative activities and registration on ARTG | 21 March 2024 |
Number of working days from submission dossier acceptance to registration decision* | 197 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
Powder and diluent for solution for injection.
Strength
After reconstitution, 1 dose (0.5 mL) contains:
Respiratory syncytial virus (RSV) subgroup A stabilised prefusion F protein 60 micrograms
Respiratory syncytial virus (RSV) subgroup B stabilised prefusion F protein 60 micrograms.
Respiratory syncytial virus (RSV) subgroup A stabilised prefusion F protein 60 micrograms
Respiratory syncytial virus (RSV) subgroup B stabilised prefusion F protein 60 micrograms.
Other ingredients
Trometamol
Trometamol hydrochloride
Sucrose
Mannitol
Polysorbate 80
Sodium chloride
- Hydrochloric acid (for pH adjustment)
Containers
Vial containing lyophilised vaccine.
Pack sizes
Carton containing:
One vial of powder for injection, 1 pre-filled syringe of diluent, 1 vial adapter.
Five vials of powder for injection, 5 pre-filled syringes of diluent, 5 vial adapters.
Ten vials of powder for injection, 10 pre-filled syringes of diluent, 10 vial adapters.
One vial of powder for injection, 1 pre-filled syringe of diluent, 1 vial adapter.
Five vials of powder for injection, 5 pre-filled syringes of diluent, 5 vial adapters.
Ten vials of powder for injection, 10 pre-filled syringes of diluent, 10 vial adapters.
Routes of administration
Intramuscular injection only, preferably in the deltoid region of the upper arm.
Dosage
ABRYSVO is administered as a single dose (0.5 mL). For further information refer to the Product Information document
Pregnancy category
A
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
ABRYSVO (recombinant respiratory syncytial virus pre-fusion F protein bivalent vaccine) was approved for the following therapeutic use:
- Active immunisation of pregnant women between 24-36 weeks of gestation for prevention of lower respiratory tract disease caused by RSV in infants from birth through 6 months of age.
- Active immunisation of individuals 60 years of age and above for prevention of lower respiratory tract disease caused by respiratory syncytial virus RSV.
What is this medicine and how does it work
Abrysvo is a vaccine that confers protection from lower respiratory tract disease caused by RSV. The vaccine contains two proteins found on the surface of the virus. Following injection of the vaccine, these proteins are recognised by cells of the immune system. This allows antibodies against these proteins to be generated, which can then neutralise the virus if a subsequent RSV infection occurs. High neutralising anti-RSV antibody levels in the blood are associated with reduced risk of disease.
This approval extended eligibility for the vaccine to pregnant women and individuals 60 years of age and above. In both of these groups, the vaccine works by inducing an immune response against the virus. i.e, the production of neutralising antibodies that target the RSV virus. In pregnant individuals, the anti-RSV antibodies generated also protect the developing baby through transfer of these antibodies to the baby via the placenta.
This approval extended eligibility for the vaccine to pregnant women and individuals 60 years of age and above. In both of these groups, the vaccine works by inducing an immune response against the virus. i.e, the production of neutralising antibodies that target the RSV virus. In pregnant individuals, the anti-RSV antibodies generated also protect the developing baby through transfer of these antibodies to the baby via the placenta.
What post-market commitments will the sponsor undertake
ABRYSVO is to be included in the Black Triangle Scheme. The PI and CMI for ABRYSVO must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date of first supply of the product. The black triangle reminds health professionals and consumers to report suspected adverse events related to new medicines, or those being used in new ways.
The ABRYSVO risk management plan (RMP) implemented in Australia. An obligatory component of RMPs is routine pharmacovigilance, including the submission of periodic safety update reports (PSURs). Batches of ABRYSVO will not be released for sale until samples and the manufacturer’s release data have been assessed by the TGA. The sponsor will also provide the TGA with a copy of the product’s Certified Product Details (CPD) upon registration. The CPD is a summary of the formulation, quality control and shelf life for a prescription medicine.
Further information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.