COVID-19: vaccine safety surveillance and response to adverse events following immunisation in NSW - RACGP Presentation Monday 18 January 2020 Dr ...
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
COVID-19: vaccine safety
surveillance and
response to adverse
events following
immunisation in NSW
RACGP Presentation
Monday 18 January 2020
Dr Kerry Chant, Chief Health Officer
1
COVID-19 Vaccine Approval and Post Marketing Surveillance
► All vaccines must pass stringent evaluation process before they are approved
► Only vaccines whose benefits outweigh the risks are registered by the Therapeutic Goods Administration
(TGA)
► Provisional registration is based on a number of factors including:
► the safety, quality and effectiveness of the vaccine has been satisfactorily established for its intended use
► ongoing submission of comprehensive clinical data, stability data and other information before the provisional
registration ends (initial period 2 years).
► The Therapeutic Goods Administration (TGA):
► assesses all COVID-19 vaccines before they can be used in Australia.
► continues to monitor and evaluate the safety of vaccines once they are registered in collaboration with state
and territory health departments
► national vaccine safety monitoring system can rapidly detect, investigate and respond to any emerging safety
issues identified for COVID-19 vaccines.
2Detect rare, late-onset or unexpected adverse events that
may not be detected in pre-licensure vaccine trials.
NSW ► Passive surveillance
► AEFI are a notifiable condition under the NSW
Vaccine Public Health Act (2010) and must be reported to the
Public Health Unit.
Safety
Surveillance ► Active surveillance
► AusVaxSafety will send an automated SMS or email
Systems (via Vaxtracker or SmartVax) to a person who
received the vaccine to monitor for AEFIs.
► Public Health Rapid, Emergency, Disease and
Syndromic Surveillance (PHREDSS) will provide
real-time public health syndromic surveillance to
identify changes in trends of ED presentations of
specific AEFIs.
3SmartVax
► How it works
► SmartVax software installed and runs in the background of your practice software, no
interaction or management required.
► SMS sent to patients 3 to 5 days after their vaccination
► Patients that accept initiation complete a survey if they have experienced an adverse event
► GPs are notified via their practice software inbox of any medically attended adverse events.
► Patient records can then be updated and additional care arranged if needed.
► Data is sent to AusVaxSafety to analyse and report de-identified data to all states, territories
and the Therapeutic Goods Administration (TGA).
► GPs have access to summary reaction report
► To sign up visit http://www.smartvax.com.au/contact-smartvax/
4When to report an adverse event following immunisation (AEFI)
► Report all uncommon, serious or unexpected AEFI or any event felt to be
clinically significant following vaccination.
An Adverse Event Following
► An AEFI is considered serious if it: Immunisation (AEFI) is any
► *results in death untoward medical event that
occurs after a vaccination has
► is life threatening
been given which may be related
► requires hospitalisation to the vaccine itself or to its
► results in persistent or significant disability or incapacity handling or administration. A
► results in a congenital anomaly/birth defect conclusion regarding a causal
relationship with the vaccine is not
► does not fit in with the common reactions for that vaccine outlined in the necessary to suspect or report an
product information. AEFI.
► Any medical event that requires intervention to prevent one of the
outcomes above may also be considered serious
► *Deaths occurring within 6 weeks of vaccination where it is plausible that
vaccination contributed to, or caused the conditions causing death. This
timeframe is a guide only, if a death occurs outside this timeframe and meets
criteria for a serious AEFI it should still be reported.
5How to report an AEFI
► Sign up to the AusVaxSafety
Program via SmartVax
► To report a suspected AEFI,
please download the National
Adverse Events Following
Immunisation (AEFI)
Reporting Form and contact
your local Public Health Unit on
1300 066 055.
► https://www.tga.gov.au/sites/d
efault/files/national-adverse-
events-following-
immunisation-aefi-reporting-
form.pdf
► Provide any relevant medical
reports and investigations for
serious AEFI
6Obtaining clinical advice
► Public Health Unit
► Guidance can be sought through the local Public Health Unit on 1300 066 055 during business hours on whether an
event is notifiable and for general immunisation advice
► NSW Immunisation Specialist Service
► Clinicians can contact the Immunisation Advice Line for specialist immunisation advice during business hours on
1800 679 477
► Should further immunisation specialist consultation or assessment be required, individuals can be referred to the
appropriate services in consultation with the NSW Immunisation Specialist Service.
► Centralised COVID-19 safety hotline for patients
► A centralised hotline will be established for patients with vaccine safety concerns
7Communicating risk - Key messages
► Healthcare professionals play an important role in facilitating vaccine uptake, communication is key:
► Acknowledge and empathise with the persons concerns
► Build trust and rapport
► Engage in active listening
► The risk of COVID-19 by far outweighs the risks of the COVID-19 vaccines.
► As with all medicines, side effects can occur following a COVID-19 vaccine. However, these are mild and transient (24-
48 hours), and serious side effects (allergic reactions) are exceedingly rare.
► It is important to get 2 doses of the vaccine, even after experiencing mild side effects after the first dose.
► Prepare the public
► “misattributed side effects” will occur as elderly population is vaccinated first.
► Robust surveillance systems and processes are in place to monitor, detect and investigate potentially rare and serious
side effects and enable effective public health response.
8You can also read
