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Vaxchora
Sponsor
Device/Product name
Vaxchora
Active Ingredient
Vibrio cholerae
Date of decision
Published
Submission type
New Biological Entity
ATC codes
J07AE02
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 Vaxchora was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 11 July 2022 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 24 June 2023 |
| Advisory Committee meeting | 2 August 2023 |
| Registration decision (Outcome) | 4 September 2023 |
| Completion of administrative activities and registration on ARTG | 6 September 2023 |
| Number of working days from submission dossier acceptance to registration decision* | 209 |
*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 for suspension
Strength
4 x 10^8 to 2 x 10^9 colony forming units (CFU)
Other ingredients
Buffer: Sodium bicarbonate, sodium carbonate, ascorbic acid, lactose
Active ingredient: Sucrose, hydrolysed casein, ascorbic acid, lactose
Containers
Sachet
Pack sizes
One box containing 2 sachets
Routes of administration
Oral
Dosage
A single oral dose should be administered at least 10 days prior to potential exposure to cholera.
For further information refer to the Product Information.
Pregnancy category
B2
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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 only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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
Vaxchora (vibrio cholerae) was approved for the following therapeutic use:
Vaxchora vaccine is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older travelling to cholera-affected countries.
Vaxchora vaccine should be used in accordance with official recommendations.
The vaccine should not replace standard preventive hygiene measures.
What is this medicine and how does it work
Vaxchora vaccine contains live attenuated cholera bacteria (V. cholerae O1 classical Inaba strain CVD 103-HgR). CVD 103-HgR was constructed from the serogroup O1 classical Inaba strain 569B by deleting the catalytic domain sequence of both copies of the ctxA gene, which prevents the synthesis of the toxic subunit A of cholera toxin, thus preventing synthesis of active cholera toxin (CT). This attenuated strain remains able to synthesise the immunogenic non-toxic B subunit of CT (encoded by the ctxB gene). In addition, a marker was inserted into the hemolysin gene locus (hlyA) to enable differentiation of the vaccine strain from wild type V. cholerae O1. CVD 103-HgR elicits a local intestinal and serum antibody response which recognizes native cholera toxin and wild type V. cholerae. Due to the inability of CVD 103-HgR to synthesise active cholera toxin subunit A, diarrheal disease normally associated with V. cholerae infection is absent.
Vaxchora vaccine replicates in the gastrointestinal tract of the recipient and induces serum vibriocidal antibody and memory B cell responses. Immune mechanisms conferring protection against cholera following receipt of Vaxchora vaccine have not been determined, however, rises in serum vibriocidal antibody 10 days after vaccination with Vaxchora vaccine were associated with protection in a human challenge study.
Vaxchora vaccine replicates in the gastrointestinal tract of the recipient and induces serum vibriocidal antibody and memory B cell responses. Immune mechanisms conferring protection against cholera following receipt of Vaxchora vaccine have not been determined, however, rises in serum vibriocidal antibody 10 days after vaccination with Vaxchora vaccine were associated with protection in a human challenge study.
What post-market commitments will the sponsor undertake
- Vaxchora (vibrio cholerae) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Vaxchora must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Vaxchora EU [European Union]-Risk Management Plan (RMP) (version 3.1 dated 14 April 2022, data lock point 10 December 2021), with Australia Specific Annex (version 1.1, dated10 January 2023), included with submission PM-2021-04064-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on good pharmacovigilance practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- Batch Release Testing and Compliance
It is a condition of registration that all independent batches of Vaxchora vaccine imported into Australia are not released for sale until samples and the manufacturer’s release data have been assessed and you have received notification acknowledging release from the Laboratories Branch, TGA.
For each independent batch of the product imported into Australia, the sponsor must supply the following:
- A completed Request for Release Form. The template is available from vaccines@health.gov.au.
- Complete summary protocols for manufacture and QC, including all steps in production in the agreed format.
- At least 5 samples of each manufacturing batch of Vaxchora with the Australian approved labels, PI and packaging representative of all batches of product seeking distribution in Australia.
- At least 1 sample of any further consignments of a manufacturing batch of Vaxchora vaccine with the Australian approved labels, PI and packaging. Further consignments cover batches previously supplied to TGA for the purposes of batch release testing but are seeking to be supplied again.
- If the manufacturing batch has been released in Europe or United Kingdom a copy of the EU Official Control Authority Batch Release (OCABR) certificate (or equivalent from the UK) must be provided.
- Any reagents, reference material and standards required to undertake testing, as requested by Laboratories Branch, TGA.
Sponsors must provide all requested samples and data in sufficient time (at least 5 business days) prior to any distribution date to allow the TGA to perform testing and review. Distribution of each batch of vaccine is conditional upon fulfilment of these conditions and receipt of a letter from the Laboratories Branch acknowledging release.
Samples and data should be forwarded to the Biotherapeutics Section, Laboratories Branch before release of each batch and with sufficient lead time to allow for Laboratories Branch testing. The address for courier delivery is:
ATTN: Batch Release Coordinator,
Biotherapeutics Section,
TGA Laboratories Branch,
1 Tindal Lane
Canberra Airport, ACT 2609.
The shipments (including reagents) to TGA are the responsibility of the Australian sponsor/agent who will be required to facilitate the import and customs clearance process.
- Certified Product Details
An electronic copy of the Certified Product Details (CPD) as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) https://www.tga.gov.au/guidance-7-certified-product-details should be provided upon registration of the therapeutic good. In addition, an updated CPD, for the above products incorporating the approved changes is to be provided within one month of the date of approval letter. A template for preparation of CPD for biological prescription medicines and Vaccines can be obtained from the TGA website [https://www.tga.gov.au/form/certified-product-details-cpd-biological-pr…]. The CPD should be sent as a single bookmarked PDF document to Vaccines@health.gov.au as soon as possible after registration/approval of the product or any subsequent changes as indicated above.
More 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.