What needs to be in place to give a vaccine?
WHO BB
Funding
Legal and regulatory approvals
M - Vaccine production and supply; transportation; cold-chain
I - Recommendations/guidelines,
S - Program planning and coordination, vaccination facilities, follow-up after vaccination
H - vaccination providers and support staff.
What is one important document related to the immunisation landscape in Australia?
National Immunisation Strategy for Australia 2019-2024
What are other important documents in the immunisation landscape?
- National Immunisation Strategy for Australia 2019-2024
- National Partnership on Essential Vaccines
- National Preventive Health Strategy 2021-30
- National Aboriginal and Torres Strait Islander Health Plan 2021-31
- National Framework for Communicable Disease Control
- COVID-19 Outbreak Response Plan
- National Medicines Policy 2022
- Therapeutic Goods Act 1989
- Australian Immunisation Register Act 2015
- International Health Regulations
- Immunisation Agenda 2030
Describe the national immunisation landscape stakeholders (see image).
- Government policy - CDNA, JICs, PBAC, ATAGI
- Research and innovation - pharma, PBAC, ATAGI, NCIRS
- Implementation partners - NIC, S/T gov, GPs + HCWs, AIR
- Evaluation and Safety - NCIRS, pharma, TGA, AusVaxSafety
What does GRADE stand for?
Grade of Recommendations, Assessment, Development and Evaluations
What is the purpose of GRADE?
Systematic assessment of quality of evidence available to inform recommendations
Which organization routinely uses GRADE?
ATAGI
What are primary course doses?
Initial doses of a vaccine administered to establish immunity
What are boosters in vaccination?
Additional doses given to enhance or prolong the immune response
What are special circumstances in vaccination?
Conditions like outbreaks or specific events that may alter vaccination strategies
What are catch-up schedules?
Schedules for individuals who missed one or more doses of vaccine
What are catch-up programs?
Programs for population groups, introducing new vaccines to specific age groups that missed out
What is TGA registration?
The process by which vaccines are registered in Australia
Who is responsible for initiating the application for TGA registration?
The pharmaceutical company
What is the Black Triangle Scheme?
Enhanced safety monitoring requirement for all newly registered products for the first 5 years after registration
What documents are required for registered pharmaceuticals?
- Australian Public Assessment Report (AusPAR)
- Product Information (PI)
- Consumer Medicines Information
Pharma companies required to provide these when applying for registratio
How can unregistered products be accessed?
At population level under special exemption or individual level through TGA importation schemes on doctor’s advice
What can jurisdictions choose to fund regarding vaccines?
Additional vaccine doses not covered by the NIP or populations not covered
What is the process for national funding under NIP?
TGA Registration > PBAC recommendation > Price agreement > Government approval > Listing on determination > Vaccine procurement
What does PBAC assess?
Cost-effectiveness, clinical effectiveness (ATAGI advice) and makes recommendations
What does ATAGI do?
Makes recommendations documented in the AIH
What is the AIH?
Officially endorsed vaccination guidelines
What is assessed when guidelines and recommendations are made?
- GRADE evidence
- Eligible population
- Primary course doses
- Boosters
- Special circumstances
- What to do when errors / complications occur
- Timing considerations - dosing intervals; catch-up programs/schedules; PEP/PrEP; coadminstration;
