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Official notice inviting eligible individuals and organisations to submit written evidence and expert input for a focused investigation on myocarditis linked to the Novavax COVID-19 vaccine under specific legislative provisions and statements of principles.
Year:
2026
Organization:
Repatriation Medical Authority
Subject:
Myocarditis associated with Novavax COVID-19 vaccine
Type of document:
Official notice / investigation announcement
Target audience:
Veterans, Australian mariners, members of the Forces, members of Peacekeeping Forces, dependants, relevant experts
Submission deadline:
27 January 2026
First meeting date:
3 February 2026
Contact information:
GPO Box 1014, Brisbane, Qld 4001; Telephone: (07) 3815 9404; Email: [email protected]
Authority chairperson:
Professor Terence Campbell AM
Date of issue:
19 December 2025
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Year:
2024
Region / city:
Victoria, Australia
Topic:
Myocarditis, COVID-19 vaccine
Document type:
Research article
Organization / institution:
SAEFVIC, Murdoch Children’s Research Institute, University of Melbourne
Author:
Dr. Kevin M Slater, Prof. Jim P Buttery, Prof. Nigel W Crawford, A/Prof. Daryl R Cheng
Target audience:
Medical professionals, researchers, healthcare policymakers
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Context:
A research article comparing diagnostic criteria for myocarditis following COVID-19 vaccination based on different international frameworks.
Year:
2024
Country:
Aotearoa New Zealand
Topic:
Long-term health outcomes of myocarditis and pericarditis following COVID-19 vaccination
Document type:
Research report
Study type:
Observational survey study
Commissioning body:
Medsafe, New Zealand Medicines and Medical Devices Safety Authority
Conducting organisation:
Health New Zealand | Te Whatu Ora
Funding body:
Medsafe
Collaborating organisations:
Centre for Adverse Reactions Monitoring (CARM); Reach Aotearoa; Ministry of Health | Manatū Hauora
Study population:
Individuals aged 12 years and older diagnosed with myocarditis and/or pericarditis after receiving at least one dose of Comirnaty, and their healthcare providers
Data collection period:
30 March 2022 – 1 October 2022
Geographical scope:
Nationwide
Sample size:
298 participants; 161 healthcare provider surveys
Ethics approval:
Obtained
Conflict of interest:
None declared
Period covered:
Post-vaccination outcomes at least 90 days after diagnosis
Note:
Year
Topic:
Vaccination Consent
Document Type:
Consent Form
Target Audience:
Patients, Healthcare Providers
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.
Year:
2025
Region / City:
London
Topic:
Neonatal BCG vaccination program
Document Type:
Protocol
Organization / Institution:
NHSE
Author:
Alice Waters
Target Audience:
Healthcare professionals involved in neonatal care and immunization
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
September 2025
Year:
2023
Region / City:
N/A
Subject:
Vaccination
Document Type:
Medical Guidelines
Organization / Institution:
Merck
Author:
N/A
Target Audience:
Healthcare professionals
Effective Period:
N/A
Approval Date:
07/13/2015
Revision Dates:
07/13/2015, 11/15/2015, 06/2016, 04/2023, 08/2024
Year:
2025
Region / city:
United Kingdom
Subject:
COVID-19 vaccination
Document type:
Protocol
Institution:
UK Health Security Agency (UKHSA)
Author:
UK Health Security Agency (UKHSA)
Target audience:
Healthcare providers involved in COVID-19 vaccination
Period of validity:
1 October 2025 – 31 January 2026
Approval date:
12 September 2025
Note:
Revision history
Year:
2025
Region / city:
[insert local health board name]
Theme:
Vaccination
Document type:
Patient Group Direction (PGD)
Authorising organisation:
NHS Wales
Target audience:
Healthcare professionals (Registered)
Period of validity:
01 September 2025 - 31 March 2026
Approval date:
07 August 2025
Amendment date:
30 June 2025
Review date:
01 July 2026
Expiry date:
31 March 2026
Year:
2025
Region / city:
England
Topic:
Influenza immunisation
Document type:
Patient Group Direction (PGD)
Organisation:
UK Health Security Agency (UKHSA)
Author:
Christina Wilson, Jamie Lopez-Bernal, Greta Hayward
Target audience:
Healthcare practitioners, NHS organisations
Period of validity:
From 1 September 2025 to 1 April 2026
Approval date:
3 July 2025
Revision history:
Updated annually, latest update 9 July 2025
Reference no:
HPV (GBMSM) PGD
Version no:
v5.0
Valid from:
1 September 2025
Review date:
1 April 2028
Expiry date:
1 September 2028
Author:
Suki Hunjunt, Sharif Ismail, David Green
Region / city:
England
Target audience:
Healthcare practitioners administering HPV vaccine to GBMSM
Type of document:
Patient Group Direction
Organisation:
UK Health Security Agency (UKHSA)
Date of approval:
17 July 2025
Date of modifications:
16 July 2025
Context:
A formal Patient Group Direction for the administration of HPV vaccine to GBMSM, detailing legal, clinical, and procedural requirements for healthcare practitioners in England.
Reference no:
Hib/MenC PGD
Version no:
v6.0
Valid from:
1 July 2025
Expiry date:
30 April 2026
Authorising organisations:
UK Health Security Agency (UKHSA)
Target audience:
Registered healthcare practitioners
Responsible body:
UKHSA
Note:
Amendment history
v1.0 and v2.0:
See previous versions of this PGD template for details (19 January 2016 to 23 April 2018)
v3.0:
PHE Hib/MenC PGD amended to: include vaccination of individuals for the prevention of secondary cases of meningococcal group C disease (24 April 2018)
v4.0:
PHE Hib/MenC PGD amended to: remove reference to individuals with an underlying medical condition (5 March 2020)
v5.0:
UKHSA Hib/MenC PGD amended to: include minor rewording of standard text, layout and formatting changes (4 May 2022)
v6.0:
UKHSA Hib/MenC PGD amended to: include minor rewording, updated references, and changes to the childhood immunisation schedule (2 June 2025)
Developed by:
Christina Wilson (Lead Pharmacist), Professor Shamez Ladhani (Paediatric Infectious Diseases Consultant), David Green (Nurse Consultant for Immunisation Programmes)
Peer-reviewed by:
UKHSA Immunisations PGD Expert Panel
Date approved:
2 June 2025
Year:
2025
Region / city:
Global
Topic:
Vaccine Policy, Maternal Health, Group B Streptococcus
Document type:
WHO Guidance
Institution:
World Health Organization (WHO)
Author:
WHO ECVP
Target audience:
Policymakers, Vaccine Developers, Public Health Authorities
Period of validity:
Ongoing
Approval date:
March 11, 2025
Date of changes:
Not specified
Year:
2025
Region:
England
Subject:
Hepatitis B vaccination for renal patients
Document Type:
Patient Group Direction (PGD)
Authorising Organisation:
UK Health Security Agency (UKHSA)
Target Audience:
Registered healthcare professionals
Period of Validity:
28 February 2025 - 28 February 2028
Approval Date:
28 February 2025
Amendment Date:
21 February 2025
Year:
2024
Region / city:
England
Topic:
Vaccination
Document type:
Patient Group Direction
Organization:
UK Health Security Agency (UKHSA)
Author:
Christina Wilson, Dr. Mary Ramsay, David Green
Target audience:
Registered healthcare practitioners
Period of validity:
10 October 2024 - 30 April 2027
Approval date:
4 October 2024
Amendments date:
9 October 2024
Year:
2018
Region / City:
Oregon
Theme:
Vaccine Replacement, Immunization Policy
Document Type:
Policy
Organization:
Oregon Immunization Program (OIP)
Target Audience:
VFC program organizations, Healthcare providers
Period of Action:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Document type:
Regulatory template appendix
Subject:
Quality information summary for finished pharmaceutical products and vaccines
Procedure:
Reference SRA collaborative procedure
Regulatory framework:
WHO Guidelines on submission of documentation for prequalification
Issuing organization:
World Health Organization
Series:
WHO Technical Report Series
Series number:
No. 1010
Year:
2018
Scope:
Pharmaceutical products and vaccines approved by stringent regulatory authorities
Intended use:
National registration under the SRA collaborative procedure
Confidentiality status:
Includes confidential quality information
Approval basis:
Information as approved by the reference SRA
Change management:
Revision required upon approved variations affecting QIS-SRA (crp)
Year:
2021
Region / City:
United States
Topic:
COVID-19 Vaccine, Long Term Care, Health and Safety Regulations
Document Type:
Guide
Organization:
Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC)
Author:
Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC)
Target Audience:
Long Term Care Facility Leaders, Healthcare Providers, Staff
Period of Action:
2021
Approval Date:
November 2021
Date of Last Revision:
October 26, 2022