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Device/Product name
Prevenar 20
Active Ingredient
Pneumococcal purified capsular polysaccharides
Date of decision
Published
Submission type
New biological entity
ATC codes
J07AL02
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 Prevenar 20 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

30 November 2021

First round evaluation completed

2 May 2022

Sponsor provides responses on questions raised in first round evaluation

1 July 2022

Second round evaluation completed

5 September 2022

Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice

14 September 2022

Sponsor’s pre-Advisory Committee response

21 September 2022

Advisory Committee meeting

5 October 2022

Registration decision (Outcome)

30 November 2022

Completion of administrative activities and registration on ARTG

2 December 2022

Number of working days from submission dossier acceptance to registration decision*

204

*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
Suspension for injection
Strength
Each 0.5 mL dose contains 46.2 micrograms of total pneumococcal polysaccharides.
Each dose is comprised of 2.2 micrograms each of the pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F and 4.4 micrograms of serotype 6B.
Other ingredients

Aluminium phosphate, sodium chloride, succinic acid, polysorbate 80 and water for injection

Containers
Prefilled syringe
Pack sizes
1 and 10
Routes of administration
Intramuscular
Dosage

Prevenar 20 is to be administered as a single dose to adults 18 years of age and older. For further information refer to the Product Information.

Pregnancy category
B1
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 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

Prevenar 20 (pneumococcal purified capsular polysaccharides) was approved for the following therapeutic use:

Active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.

Prevenar 20 may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.

Prevenar 20 should be used in accordance with official recommendations.

What is this medicine and how does it work
Prevenar 20 contains 20 pneumococcal capsular polysaccharides all conjugated to a cross reacting material CRM197 carrier protein, which modifies the immune response to the polysaccharide from a T-cell independent response to a T-cell dependent response. The T-cell dependent response leads to both an enhanced antibody response and generation of memory B-cells, allowing for an anamnestic (booster) response on re-exposure to the bacteria.
Vaccination with Prevenar 20 induces serum antibody production and immunologic memory against the serotypes contained within the vaccine.
Protection against pneumococcal disease is conferred mainly by opsonophagocytic killing of Streptococcus pneumoniae. Prevenar 20 generates functional antibodies as measured by opsonophagocytic activity (OPA). An opsonic antibody titre that is predictive of protection against invasive pneumococcal disease or pneumococcal pneumonia has not been established.
What post-market commitments will the sponsor undertake
  • Prevenar 20 (pneumococcal capsular polysaccharides vaccine) is to be included in the Black Triangle Scheme. The PI [product information] and CMI [Consumer Medicines Information] for Prevenar 20 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 Prevenar 20 EU-Risk Management Plan (RMP) (version 0.2, dated 1 September 2021, data lock point 4 June 2020), with Australia specific annex (version 1.0, dated 4 October 2021), included with submission PM-2021-04721-1-2, to be revised to the satisfaction of 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.

  • For all injectable products the Product Information must be included with the product as a package insert.

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