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ARTGs
346290
Device/Product name
COMIRNATY
Active Ingredient
BNT162b2 (mRNA)
Date of decision
Published
Submission type
New biological entity
ATC codes
J07BX
Decision
Approved for provisional registration
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 COMIRNATY was considered favourable for the therapeutic use approved.
What steps were involved in the decision process

Registration timeline

The following table captures the key steps and dates for this application.

Data were provided as a rolling submission. Under normal circumstances, TGA's assessment (for both provisional and general registration) begins once all information to support registration is available. As part of the Department of Health's response to the pandemic, the TGA has agreed to accept rolling data for COVID-19 vaccines, to enable early evaluation of data as it comes to hand.

Description Date
Designation (Provisional) 14 October 2020
Submission dossier accepted 2 November 2020
Evaluation completed 8 January 2021
Delegate's overall benefit-risk assessment and request for Advisory Committee advice 11 January 2021
Sponsor's pre-Advisory Committee response 13 January 2021
Advisory Committee meeting 15 January 2021
Registration decision (Outcome) 24 January 2021
Completion of administrative activities and registration on ARTG 25 January 2021
Number of working days from submission dossier acceptance to registration decision* 54

*Statutory timeframe for standard applications is 255 working days

Date of entry onto ARTG
Original publication date
Black triangle scheme
As a provisionally registered product, this medicine will remain in the Black Triangle Scheme for the duration of its provisional registration
Dose forms
Concentrated suspension for injection
Strength
30 µg/0.3 mL
Other ingredients
((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315), 2-((polyethylene glycol)-2000)-N,N-ditetradecylacetamide (ALC-0159), distearoylphosphatidylcholine (DSPC), cholesterol, potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dehydrate, sucrose, water for injections. Note: less than 1 mmol potassium per dose, and less than 1 mmol sodium per dose.
Containers
Multi dose vial
Pack sizes
195 vials
Routes of administration
Intramuscular
Dosage

Individuals 16 years of age and older

COMIRNATY is administered intramuscularly after dilution as a course of 2 doses at least 21 days apart.

There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination course. Individuals who have received 1 dose of COMIRNATY should receive a second dose of COMIRNATY to complete the vaccination course.

For further information refer to the Product Information.

Pregnancy category
B1Drugs 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 have not shown 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

COMIRNATY (BNT162b2 mRNA) was provisionally approved for the following therapeutic use:

COMIRNATY (BNT162b2 (mRNA)) COVID-19 vaccine has provisional approval for the indication below:

Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

What is this medicine and how does it work
The nucleoside-modified messenger RNA in COMIRNATY is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 spike (S) antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. COMIRNATY elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute to protection against COVID-19.
What post-market commitments will the sponsor undertake
  • COMIRNATY vaccine is to be included in the Black Triangle Scheme due to provisional approval. The Product Information (PI) and Consumer Medicines Information (CMI) for COMIRNATY vaccine must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
  • The COMIRNATY European Union (EU)-Risk Management Plan (RMP) (version 1.0, dated 21 December 2020; data lock point 17 December 2020), with Australian Specific Annex (version 0.2, dated 17 January 2021), included with submission PM-2020-05461-1-2, 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).

    Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than six calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than six monthly until the period covered by such reports is not less than three years from the date of the approval letter, or the entire period of provisional registration, whichever is longer.

    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agencys 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.

  • Additional to the routine submission of the routine PSURs, expedited monthly, COMIRNATY safety summary reports (including safety data for patients in Australia) are to be provided for the first 6 months post registration, and thereafter at intervals specified by the TGA.
  • Clinical studies

    The following study reports of the two ongoing studies will have to be submitted before a definitive authorisation can be considered:

    • Submit safety analysis at 6 months post Dose 2 from Study C4591001 (Phase II/III) when the analysis is available.
    • Submit the final completed study report for Study C4591001 with 24 months follow up duration when it becomes available.
    • Submit final study reports for Study BNT162-01 once completed, including data on healthy subjects.

    When available, further data relating to vaccine efficacy against asymptomatic disease, vaccine efficacy in immunocompromised subjects, paediatric subjects, pregnant women, lactating mother, and the information relating to post-market safety and effectiveness studies should be provided to the TGA, as separate submissions, to update the PI.

  • Medicine labels
    • Unless otherwise agreed to by the Secretary following an application under Section 9D of the Act, the product must only be supplied with the following labels:
      • The international label, referred to here as the 'US emergency use - 5 doses labels' as follows: A) carton label, B) vial label.
      • The international label, referred to here as the 'US emergency use - 6 doses labels' as follows: A) carton label, B) vial label.
      • The international label, referred to here as the 'Comirnaty-branded - 5 doses labels' as follows: A) carton label, B) vial label.
      • The international label, referred to here as the 'Comirnaty-branded – 6 doses labels' as follows: A) carton label, B) vial label.
    • The sponsor will develop Australian-specific labels for the product, that conform with all relevant Australian labelling requirements, and will take all reasonable steps to implement such labelling before the end of the provisional registration period referred to in subsection 29(3) of the Act (being the period of 2 years starting on the day specified in the ARTG certificate of registration) (noting that, consistent with paragraph 28(5)(aaa) of the Act, changes to such matters as labels that have been agreed to as part of an evaluation under section 25 of the Act may only occur following submission under section 9D of a 'variation' application and approval by the TGA).
    • The sponsor will provide information to the TGA on the proposed strategies and planned timelines for Australian dedicated supplies, as soon as possible. Australian specific labels will be implemented no later than 24 January 2023.
  • Batch Release Testing and Compliance

    It is a condition of registration that all independent manufacturing batches of COMIRNATY (BNT162b2 (mRNA)) COVID-19 vaccine to be supplied in Australia are not released for supply by or on behalf of the sponsor until samples and the manufacturer's release data have been assessed by, and the sponsor has received notification acknowledging authorisation to release from, the Laboratories Branch, TGA.

    In complying with the above, the sponsor must supply the following for each independent batch of the product imported or proposed to be imported into Australia:

    • A completed Request for Release Form, available from vaccines@health.gov.au; and
    • complete summary protocols for manufacture and QC, including all steps in production in the agreed format; and
    • at least 20 (twenty) vials (samples) of each manufacturing batch of BNT162b2(mRNA) COVID-19 vaccine with the Australian labels, PI and packaging (unless an exemption to supply these has been granted) representative of all batches of product proposed to be distributed in Australia; and
    • if the manufacturing batch has been released in Europe or United Kingdom (UK) a copy of the EU Official Control Authority Batch Release (OCABR) certificate (or equivalent from the UK) must also be provided; and
    • any reagents, reference material and standards required to undertake testing as requested by Laboratories Branch, TGA.
  • 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) 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 at Certified product details (CPD) - Biological prescription medicines. 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.

  • Post approval quality commitments

    As a provisionally registered medicine, extensive post-approval commitments are required of the sponsor. The additional requested quality data and notifications to the TGA should be provided as post approval commitments. This includes the following commitments:

    • Commitment is required from the sponsor that they maintain the validity of all manufacturer Good Manufacturing Practice (GMP) clearances for the duration of product supply to Australia. Additionally, that adherence to the conditions of GMP clearance approval is upheld.
    • Additional data should be provided in relation to the reference standards and materials.
    • Additional stability data should be submitted as it becomes available. Once additional data have been submitted to the TGA for evaluation, an extended shelf life and/or change in storage conditions for the DS and/or DP may be considered.
    • The sponsor must inform the TGA of any temperature deviation during shipment and not supply product that has been exposed to a temperature excursion outside of the approved storage conditions of -90°C to -60°C.
    • Additional information should be provided regarding batch analyses.
    • Additional data should be provided in relation to process validation of commercial scale batches.
    • Additional data should be provided for the proposed rapid sterility test.
    • The requested leachables study data should be provided.

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