№ lp_1_2_49184
File format: docx Character count: 55228 File size: 462 KB
Year: 2021
Region / City: Australia
Topic: Pneumococcal vaccine submission
Document type: Submission for listing on the National Immunisation Program
Author: Merck Sharp & Dohme (Australia) Pty Ltd
Target audience: Health professionals, regulatory bodies, policy makers
Period of validity: Ongoing
Approval date: 16 July 2021 (FDA approval), 14 October 2021 (EMA recommendation)
Date of changes: Not specified
Context: A clinical submission for the inclusion of a 15-valent pneumococcal conjugate vaccine (PCV15) on the National Immunisation Program for adults at risk of pneumococcal disease.
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
PNEUMOCOCCAL CONJUGATE VACCINE, 15 VALENT ADSORBED 0.5 mL pre-filled syringe, VAXNEUVANCE®, Merck Sharp & Dohme (Australia) Pty Ltd.
Year: 2023
Region / city: Australia
Topic: Pneumococcal vaccination
Document type: Submission
Agency / organization: Australian Technical Advisory Group on Immunisation (ATAGI)
Author: Merck Sharp & Dohme (Australia) Pty Ltd
Target audience: Healthcare professionals involved in immunization
Period of validity: Not specified
Approval date: Expected by 30 April 2023
Date of changes: 9 February 2023
PNEUMOCOCCAL CONJUGATE VACCINE, 15 VALENT ADSORBED 0.5 mL pre-filled syringe, VAXNEUVANCE®, Merck Sharp & Dohme (Australia) Pty Ltd.
Year: 2023
Region / city: Australia
Topic: Pneumococcal vaccination
Document type: Submission
Agency / organization: Australian Technical Advisory Group on Immunisation (ATAGI)
Author: Merck Sharp & Dohme (Australia) Pty Ltd
Target audience: Healthcare professionals involved in immunization
Period of validity: Not specified
Approval date: Expected by 30 April 2023
Date of changes: 9 February 2023
Pneumococcal polysaccharide conjugate vaccine (adsorbed) Patient Group Direction (PGD)
Year: 2025
Region / city: England
Topic: Immunization
Document type: Patient Group Direction (PGD)
Organization / institution: UK Health Security Agency (UKHSA)
Author: Suki Hunjunt, Professor Shamez Ladhani, David Green
Target audience: Healthcare professionals involved in immunization
Period of validity: From 5 January 2026 to 5 January 2029
Approval date: 5 January 2026
Amendment date: 2 June 2025, 16 December 2025
Description: A document detailing the administration guidelines for the pneumococcal polysaccharide conjugate vaccine (PCV13, PCV15) for children under 2 years old in the UK.
Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) (PCV20) Patient Group Direction (PGD)
Year: 2025
Region / city: England
Topic: Immunization
Document type: Patient Group Direction (PGD)
Authoring body: UK Health Security Agency (UKHSA)
Target audience: Healthcare professionals involved in immunization programs
Period of validity: 17 December 2025 - 17 December 2028
Approval date: 9 December 2025
Review date: 17 July 2028
Expiry date: 17 December 2028
Pneumococcal polysaccharide vaccine (PPV23) Patient Group Direction, version 5.00
Publications gateway number: GOV-16528
Reference number: PPV23 PGD
Version: 5.00
Valid from: 1 September 2024
Review date: 1 September 2026
Expiry date: 1 March 2027
Vaccine: 23-valent pneumococcal polysaccharide vaccine (PPV23)
Programme: National immunisation programme against pneumococcal disease
Target population: Individuals aged 65 years and over and individuals aged 2 years and over in clinical risk groups
Geographical scope: England
Legal framework: Human Medicines Regulations 2012, Schedule 16 Part 2
Issuing organisation: UK Health Security Agency
Developing body: Immunisation and Vaccine Preventable Diseases Division, UK Health Security Agency
Authors: Christina Wilson; Professor Shamez Ladhani; David Green
Approval status: Ratified by the UKHSA Medicines Governance Committee
Document type: Patient Group Direction
MENINGOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE SEROGROUPS A, C, W-135 and Y
Year: 2017
Region / city: Australia
Theme: Meningococcal Vaccination
Document Type: Application for Vaccine Listing
Organization / institution: National Immunization Program (NIP)
Author: Pfizer Australia Pty Ltd
Target Audience: Health professionals, adolescents, school-based vaccination program administrators
Validity Period: Not specified
Approval Date: 29 August 2013
Amendment Date: Not specified
Note: Contextual description
PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE, 13-VALENT ADSORBED
Year: 2016
Region / City: Australia
Theme: Pneumococcal disease prevention
Document Type: Submission
Organization / Institution: Pfizer Australia Pty Ltd
Author: Pfizer Australia Pty Ltd
Target Audience: Healthcare professionals, policymakers, public health authorities
Period of Validity: Not specified
Approval Date: Not specified
Date of Changes: Not specified
Topics: VALENT Vaxneuvance polysaccharide