What is efficacy in the context of vaccines?
Efficacy refers to how much protection a vaccine gives for a particular disease and clinical outcome compared to placebo in an ideal situation (i.e. clinical trial) over a specified time period.
This measurement is typically assessed during clinical trials.
What does effectiveness measure in vaccines?
Effectiveness measures how much protection a vaccine provides for a particular disease and clinical outcome in a real-world setting over a specified time period.
This is crucial for understanding a vaccine’s performance outside of controlled trial conditions.
Define immunogenicity.
Immunogenicity is a measure of how much a vaccine stimulates the immune system, including antibody titres, neutralising antibody titres, seroconversion, and T cell function.
This is an important factor in determining a vaccine’s potential to provide protection.
What factors are considered for duration of protection?
Duration of protection includes durability of immune response and waning effectiveness, which are important for booster recommendations.
Understanding these factors helps in planning vaccination schedules.
What does storage and handling of vaccines involve?
Storage and handling involves temperature requirements, route of administration, and specific steps such as reconstitution, multi-dose vials, paracetamol/ibuprofen, and aftercare.
Proper handling is essential to maintain vaccine efficacy.
What is AEFI?
AEFI stands for adverse event following immunisation, which refers to an untoward medical occurrence that follows immunisation and does not necessarily have a causal relationship with the vaccine.
Examples include unintended signs, abnormal laboratory findings, symptoms, or diseases.
Define AESI.
AESI is an adverse event of special interest, such as those related to COVID-19, and includes specific monitoring frameworks like the Brighton collaboration.
This classification helps in monitoring vaccine safety.
List the data sources used for vaccine safety.
Data sources include:
* Clinical trials
* Pre-licensure studies
* Post-licensure studies
* Post-marketing studies
* Phase IV studies
* Surveillance
* Regulatory data
* Real-world evidence
These sources provide essential information for assessing vaccine safety.
Outline the safety timeline for vaccines.
The safety timeline includes:
* Animal studies
* Regulatory approval
* Factory and distribution (quality controls)
* Recommendations for clinical use
* Supporting activities (education)
* Vaccination at the clinic
* Monitoring adverse events
* Patient and public care
This timeline ensures comprehensive safety oversight.
What is the purpose of safety surveillance in vaccines?
Safety surveillance is conducted to monitor adverse events and includes systems like TGA, passive surveillance, active surveillance (e.g., AusVaxSafety), and clinical longitudinal studies.
This ongoing monitoring is crucial for timely identification of potential safety issues.
