Western NSW Immunisation Update - COVID-19 and Influenza vaccines 20 April 2021 A/Professor Nicholas Wood Associate Director, NCIRS
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Western NSW Immunisation Update COVID-19 and Influenza vaccines 20 April 2021 A/Professor Nicholas Wood Associate Director, NCIRS
Topics
• COVID-19 vaccine information
• Co-administration of vaccines
• 2021 Influenza vaccination
Page 2
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COVID-19 in Australia
Total cases: 27,244 (20269 in
Reported daily
Victoria)
cases
Total deaths: 897 (809 in Victoria)
July Aug Sept
Covid19data.com.au
Vaccines @ pandemic speed
Current vaccine candidates for Australia:
• Pfizer/BioNTech vaccine (mRNA)
• Oxford AstraZeneca (Viral vector)
• Novavax (Protein subunit)
https://www.ncirs.org.au/covid-19/covid-19-vaccine-development-landscape
Page 5
Experience gained world-wide already…….
>329 million doses
https://ourworldindata.org/covid-vaccinations
Which vaccines where and when for Australia?
Pfizer/BioNTech
mRNA vaccine
- 800 C storage
Aus: 10m doses
2 doses: 21 days
apart
Started: 22 Feb 2021
Novavax Hubs in major metro
Protein sub-unit ACF outreach
With adjuvant
2-80 C
Aus:51m doses AstraZeneca/Oxford
2 dose schedule Viral vector vaccine
2-80 C
Not yet registered TGA Registration
Aus:53.8m doses
2 doses:12 weeks
apart
Started: 7 March:
hubs
https://www.nps.org.au/australian-prescriber/articles/covid-19-vaccines-are-we-there-yet 22 March: GPs,
clinics,
? pharmacy
Vaccines registered or with phase III data efficacy data….
Vaccine Type Efficacy / Effectiveness Registration and Program rollout Protection against virus
2021 variants
Oxford/AstraZeneca adenovirus 62% -70% TGA Approved Low SA variant
(CSL local production) vector (chimp) ~80% with dose spacing 7 March Australia Good UK variant
95% v. hospitalisation
(Scotland)
Comirnaty mRNA 95% TGA Approved; Pending
BioNTech/Pfizer 85% v. hospitalisation 22 Feb Australia (immune response ↓)
(Scotland)
NVX-CoV2373 Protein 89% (press release) TGA Rolling submission Moderate to SA variant
Novavax adjuvanted
Ad26.CoV2.S adeno26 vector 72% (press release) End Feb FDA approval Moderate to SA variant
Janssen (J&J) (single dose 85% v. severe disease TGA Rolling submission
only)
mRNA-1273Moderna mRNA 94% Not applied to Australia Pending
USA, EU, other approvals androllout
CoronaVac Inactivated ~85% (press release) China, some use in other countries ?
Sinovac 50-78% Brazil
COVID-19 vaccines Inactivated China, some use in other countries ?
Wuhan and Beijing Institute
Gam-COVID-Vac Adeno 5/26 92% Russia, some use in other countries ?
(Sputnik 5) Gamaleya vector
BBV152/Covaxin Inactivated India, phase 3 data awaited ?
Bharat Biotech India
Page 8
COVID-19 vaccines registered in Australia
Pfizer/BioNTech COMIRNATY vaccine
• mRNA vaccine
• Priority group Phase 1a
• 30-50 hospital/RACF hubs throughout Australia
AstraZeneca COVID-19 vaccine
• A single recombinant, non-replicating viral vector vaccine
Comirnaty and AstraZeneca COVID-19 vaccines do not
contain any gelatine
https://www.health.gov.au/news/tga-provisionally-approves-pfizerbiontech-covid-19-vaccine-for-use-in-australia
National roll-out strategy https://www.health.gov.au/resources/publications/australias-covid-19-vaccine-national-roll-out-strategy
The COVID-19 vaccine program
• Aim: reduce serious illness and death, and disease transmission
• Key determinants of vaccine program strategy:
• Vaccine supply (initially limited to priority populations)
• Vaccine characteristics (including presentation)
• Local epidemiology (low community transmission setting)
Vaccination is strongly encouraged but not mandatory
Page 11COVID-19 vaccine recommendations
• Recommended for everyone of eligible age (≥16 years for Comirnaty; ≥50 years for
COVID-19 Vaccine AstraZeneca*)
• Priority population groups
• Border/quarantine workers
• Aged care and disability care residents and staff
• Healthcare workers at increased risk of exposure to persons infected with SARS-CoV-
2
• Elderly adults (progressive vaccine delivery to decreasing age cohorts)
• People with medical risk factors for severe COVID-19
• Aboriginal and Torres Strait Islander adults
• Critical and high risk workers
* ATAGI recommends that the COVID-19 vaccine by Pfizer (Comirnaty) is
preferred over COVID-19 Vaccine AstraZeneca in adults aged under 50
years (8 April 2021)
https://www.health.gov.au/news/atagi-statement-on-astrazeneca-vaccine-in-response-to-new-
vaccine-safety-concerns
Page 12Vaccine, doses and administration
Comirnaty (generic name BNT162b2) COVID-19 Vaccine AstraZeneca
Sponsor Pfizer Australia Pty Ltd AstraZeneca Pty Ltd
Approval age for use ≥16 years ≥18 years
Recommended for ≥50 years
Presentation Multi-dose vial without preservative, each vial Multi-dose vial without preservative, each vial
containing 6 doses in 0.45 mL. containing 10 doses in 5 mL.
Volume/Strength 0.3 mL (30 μg) per dose 0.5 mL per dose
Schedule 2 doses, at least 21 days apart 2 doses, 12 weeks apart (min 4 weeks apart)
Administration route Intramuscular injection into deltoid muscle Intramuscular injection into deltoid muscle
Ingredients • ((4-hydroxybutyl)azanediyl)bis(hexane- • Histidine
(List of excipients) 6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) • Histidine hydrochloride monohydrate\
• 2-[(polyethylene glycol)-2000]-N,N- • Sodium chloride
ditetradecylacetamide (ALC-0159) • Magnesium chloride hexahydrate
• Distearoylphosphatidylcholine (DSPC) • Disodium edetate (EDTA)
• Cholesterol • Sucrose
• Potassium chloride • Ethanol absolute
• Monobasic potassium phosphate • Polysorbate 80
• Sodium chloride • Water for injection
• Dibasic sodium phosphate dihydrate
• Sucrose
• Water for injections
Australian Technical Advisory Group on Immunisation (ATAGI): Clinical guidance on use of COVID-19 vaccine in Australia in 2021 (v2.0) Page 13NCIRS Ribbon > Header&Footer > Edit footer >Apply to All Page 14
Page 15
Precautions for COVID-19 vaccine
Precaution Recommendation
Acute illness (e.g. fever ≥ 38.5°C) Defer vaccination until well.
Bleeding disorder or receiving anticoagulation • Subcutaneous administration not
recommended.
• Refer to AIH for guidance on optimal
timing of vaccination
People with immediate (within 4 hours) and generalised symptoms of a • Consultation with an allergist
possible allergic reaction (e.g. urticaria/hives) to a previous dose of a • Vaccination in a facility with medical staff
COVID-19 vaccine and post-vaccination observation for at
least 30 minutes
People with a generalised allergic reaction (without anaphylaxis) to any
component of the COVID-19 vaccine to be administered (e.g. PEG in
Comirnaty or polysorbate 80 in COVID-19 Vaccine AstraZeneca)
People with a prior history of anaphylaxis to previous vaccines and/or
multiple drugs (injectable and/or oral) where ingredients such as PEG or
polysorbate 80 may conceivably be the cause
People with a known systemic mast cell activation disorder with raised
mast cell tryptase that requires treatment. If people in these categories
are vaccinated, they may require vaccination in a facility with medical www.allergy.org.au
staff in attendance, and to be observed for 30 minutes following
administration of a COVID-19 vaccine dose. See also ASCIA guidelines
for more information.
Page 16People who are immunocompromised
• COVID-19 vaccine is recommended and considered safe for people who are
immunocompromised because of their risk of severe illness with COVID-19
• No theoretical safety concerns for Comirnaty or COVID-19 Vaccine AstraZeneca
• Possible reduced efficacy – should continue other protective measures against
COVID-19
• Very limited safety data, no efficacy data – mostly excluded from both clinical
trials
• Before vaccination provide counselling about the safety and efficacy of COVID-
19 vaccine, and lack of data in immunocompromised recipients.
Page 17Women who are pregnant, breastfeeding or
planning pregnancy
• COVID-19 vaccine during pregnancy is not routinely recommended, but is not
contraindicated
• No clinical trial data on safety in pregnancy or effect on pregnancy outcomes
• Some pregnant women may choose to be vaccinated after considering
individual risks and benefits of vaccination, including:
• High-risk priority group
• High-risk of exposure
• Underlying medical conditions that put patients at high risk of serious complications
from COVID-19
• Considered safe for breastfeeding women and their babies
• A clinical trial with Comirnaty has commenced in pregnant women
www.health.gov.au
Page 18Frail elderly
• Vaccination is recommended for this group
• Frail elderly individuals are at increased risk of severe illness and death from
COVID-19
• Discuss benefits and risks including possible adverse events following
immunisation
• Particularly in people receiving end-of-life care
• No evidence of increased incidence of serious adverse events following
Comirnaty or COVID-19 Vaccine AstraZeneca in frail elderly individuals
Page 19Influenza and COVID-19 vaccines
ATAGI advice on influenza and COVID-19 vaccines:
• Co-administration not recommended
• Recommended 14 day interval between influenza vaccine and COVID-19
vaccines
• No requirement regarding the order of receiving a dose of influenza vaccine and
either the first or second dose of a COVID-19 vaccine
• allows flexibility to allow for any supply or operational constraints
• If an influenza vaccine has been inadvertently co-administered or given within a
shorter interval than 14 days with a COVID-19 vaccine, revaccination with either
vaccine is not necessary
https://www.health.gov.au/resources/publications/atagi-advice-on-influenza-and-covid-19-vaccinesCo-administration Other vaccines • Co-administration of a COVID-19 vaccine on the same day as another vaccine is not recommended. • Minimum 14 day interval between COVID-19 vaccines and any other vaccine (live or non-live) • If a COVID-19 vaccine has inadvertently been administered on the same day or within 14 days before or after other vaccines, no vaccine doses need to be repeated. Antipyretics/analgesics • Prophylactic use of paracetamol or ibuprofen is not recommended • Antipyretics and analgesics can be taken after vaccination for management of vaccine-related side effects https://www.health.gov.au/resources/publications/atagi-advice-on-influenza-and-covid-19-vaccines
Post-marketing COVID-19 vaccine safety data
Experience gained world-wide already…….
>329 million doses
https://ourworldindata.org/covid-vaccinationsActive, enhanced, national Vaccine Safety Surveillance
AusVaxSafety Active surveillance Participant-provided adverse event details via SMS
COVID-19 vaccine safety survey
Page 26AusVaxSafety safety data (11 April 2021) • Day 3 survey responses • Both Comirnaty and AstraZeneca • Data complements the TGA enhanced safety surveillance activities • Tasmania and Victoria will commence participation shortly https://www.ausvaxsafety.org.au/safety-data/ covid-19-vaccines
COMIRNATY Dose 1
n=84,439 responses to Day 3 survey (11 April 2021)
37% reported one/more adverse event
0.6% reported medical attendance
www.ausvaxsafety.org.au Page 28COMIRNATY Dose 2 (n= 44,888 responses to Day 3 survey (11 April 2021) www.ausvaxsafety.org.au Page 29
AstraZeneca Dose 1
n=47,660 responses to Day 3 survey (11 April 2021)
64% reported any adverse event
1.6% reported medical attendance
www.ausvaxsafety.org.au Page 30Real-world vaccination UK:
Self-reported systemic adverse events after vaccines
Pfizer vaccine
Dose 1 Dose 2 Astra Zeneca vaccine
Dose 1
Menni et al. (2021) preprint: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3795344
Page 31GACVS statement on flu like illness
GACVS COVID-19 Vaccine Safety subcommittee meeting to review reports on influenza-like illness in individuals
Page 32
vaccinated with COVID-19 vaccines (who.int)Isolation or testing following adverse events • COVID-19 testing may not be required fever, headache, fatigue or other systemic symptoms within and lasting for
Venous-thrombotic embolism (VTE) after
vaccination?
Link between blood clots and Astra Zeneca
vaccine under investigation = rare link
VTE occur naturally – approx. 17000 cases
annually in Australia (0.83 per 1000)
1. Tran et al MJA 2019
Thromboembolic events being monitored in
vaccinated people – 3 cases in Australia (to date)
https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine
MHRA: www.gov.uk/government/news/mhra-response-to-irish-authorities-action-to-temporarily-suspend-the-
astrazeneca-covid-19-vaccine
EMA: www.ema.europa.eu/en/en/news/emas-safety-committee-continues-investigation-covid-19-vaccine-
astrazeneca-thromboembolic-eventsPage 35
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Thrombosis and thrombocytopenia
Page 37Thrombosis and thrombocytopenia
Page 38AZ vaccine and clots
Page 39Talk to local haematologist – samples and
data collection form
Page 40Risk and benefit NCIRS Ribbon > Header&Footer > Edit footer >Apply to All Page 41
Take home messages AstraZeneca
• Preference Pfizer for under 50 year olds
• ? availability
• Under 50 yr olds can weigh individual risk-benefit
• AZ = not contraindicated
• Rare but severe event
• ?1 per 200 000 doses
• Onset 4-20 days post vaccine
• Only reported after dose 1
Page 42Other questions?
• What about those aged 50-60 years old?
• If no contraindication – current advice is proceed
• What if I have had “clots” in the past?
• If acquired – eg DVT after leg surgery – then current recommendation is safe
to proceed
• If congenital thrombotic disorder
• Advice is being generated by ATAGI – due for release in next week
• What if I have already had dose 1 of AZ?
• If no reactions continue with dose 2
• Should I get a different vaccine for dose 2?
• At the moment = No
• Mixed vaccine schedule studies underway in the UK
Page 43AZ vaccine and “clots”
Microsoft Word - COVID-19-astrazeneca-vaccine-information (2).docx (health.gov.au)
Page 44Allergic reactions
after COVID-19
vaccines
Page 45ASCIA – advice COVID-19 Vaccination FAQ - Australasian Society of Clinical Immunology and Allergy (ASCIA)
Anaphylaxis after COVID-19 vaccine
• Contraindications
• Anaphylaxis to a previous dose of the same vaccine
• Anaphylaxis to a component of the vaccine, including
• polyethylene glycol (PEG) for Comirnaty
• polysorbate 80 for COVID-19 Vaccine AstraZeneca
• Estimated anaphylaxis reporting rates following COVID-19 vaccines based on
VAERS reports and reported doses administered (period 13/12/2020- 14/01/2021)
Reported vaccine doses Reported anaphylaxis Doses administered
administered
Pfizer-BioNTech 50 5.0 per million doses
9,943,247 administered
Moderna 21 2.8 per million doses
7,581,429 administered
Astra Zeneca Estimated at approx. 1 per million dose
Specialist immunisation services available in each state and territory
https://www.ncirs.org.au/health-professionals/specialist-immunisation-services
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-01/06-COVID-Shimabukuro.pdfCase study
• 45 year old nurse
• 10 minutes after Pfizer dose 1
• Complains of “throat tightness”
• Some lip tingling
• Hand “’buzzing”
• What to do next?
Page 48Allergic reactions- clinical story important
• Essential role for GP and nurse immuniser to collect enough and right
clinical data
• To inform whether true anaphylaxis
• Safety of 2nd dose
• Clinical observations at the time = critical
• Dermatologic
• Urticaria, angioedema, pruritus
• Cardiovascular
• Hypotension, tachycardia
• Respiratory
• Wheeze, stridor, upper airway swelling, respiratory distress
Page 49Page 50
Page 51
Anaphylaxis is likely when --- NCIRS Ribbon > Header&Footer > Edit footer >Apply to All Page 52
Allergic reaction versus anxiety or stress
Page 53Pfizer COMIRNATY vaccine cold chain and
storage updated – 8th April
https://www.tga.gov.au/media-release/wider-storage-and-transportation-conditions-pfizer-covid-19-vaccine-now-approved
Page 54Take home messages
• Informed consent
• Explain side effects
• www.ausvaxsafety.org.au
• Pfizer preferred for under 50 year olds
• Past history of CVST or HIT = contraindication for AZ
• Novavax – ?3rd to 4th quarter of 2021
• Rolling TGA determination
• Phase 3 trial results not yet published
• Availability ?
• Await new ATAGI advice – within next 2 weeks
Page 55Useful links
• www.health.gov.au
• www.ncirs.org.au
• www.ausvaxsafety.org.au
• www.tga.gov.au
• www.mbsonline.gov.au
https://www.ncirs.org.au/health-
professionals/ncirs-newsletters
NCIRS upcoming webinar - 17/3/2021: COVID-19
vaccine safety in focus
Page 56Frequently asked questions
How long will immunity from the COVID-19 vaccine last?
• As clinical trials are ongoing, and people have only started to be vaccinated in some other
countries since around December 2020, we do not yet know how long immunity from the
COVID-19 vaccine will last.
• We will gather more information about the duration of protection over the coming months.
Do I need the vaccine if I have already had COVID-19 in the past?
• Yes. It is important that the COVID-19 vaccine is available to the entire population, even
people with a past history of COVID-19.
• The vaccine clinical trials included some previously infected people and these people
responded to the vaccine well. They had a good immune response and had similar mild
and expected side effects to people who weren’t previously infected.
• If you have previously been diagnosed with COVID-19, you should talk to your healthcare
provider about the best time to have a COVID-19 vaccination. You may be advised to wait
until around 6 months after you have recovered from COVID-19 to have your vaccine.
https://www.ncirs.org.au/covid-19/covid-19-vaccines-frequently-asked-questions
Page 57Mandatory reporting to AIR
Legislation has been passed and all immunisation encounters must be
recorded on AIR
• All COVID – 19 vaccines – February 2021
• All Influenza vaccines - 1 March 2021
• All NIP vaccines – 1 July 2021
This is all for all providers including general practice, pharmacy, hospitals, RACFs and
corporate providers (eg. workplace flu)
Page 58Current and future data needs
Current:
• Growing body of data on vaccine safety; clear safety profile from phase 3 studies
• mRNA vaccines and viral vector vaccines more reactogenic > protein/adjuvanted >
inactivated vaccines
• No concerning serious adverse events seen to date
• No evidence of vaccine enhanced disease
• Still many unknowns – safety surveillance critical
Future:
• Pregnant women
• Children
• Past COVID-19
• Current COVID-19
• Immunocompromised
• Medical conditions
• Co-administration with other vaccines
Page 59Resources
Decision guides coming soon
for Immunocompromised and
palliative care
Page 60Useful links
• www.health.gov.au
• www.ncirs.org.au
• www.ausvaxsafety.org.au
• www.tga.gov.au
• www.mbsonline.gov.au
https://www.ncirs.org.au/health-
professionals/ncirs-newsletters
NCIRS upcoming webinar – 30 April 2021: COVID-19
vaccine uptake and acceptance
Page 61Influenza 2021 NCIRS Ribbon > Header&Footer > Edit footer >Apply to All Page 62
Influenza notifications, by month and year since 2009
2017
2019
2009
2020What do we think vaccine coverage is like?
Influenza vaccine uptake in Indigenous Australians by age group,
2019 versus 2020
100
2019 2020
Cumulative proportion vaccinated (%)
90
80 75.1 76.2
70
60 56.4
52.0
50
39.9 40.1
40
32.5 32.1
30.0 28.9
30
20
10
0
6mo-How good is the vaccine at protecting against
influenza?
FluCAN 2019 data
FLUCAN data 2020
2020: Of the 14 cases reported at all
sites where vaccination status was
known, 2 (13%) were vaccinated.
Based on a crude analysis, this
suggests a high vaccine
effectiveness (85%, 95% CI: 32%,
97%)Conclusions • Almost no influenza season in 2020 after March • Vaccine coverage • Stable in children and adults • Discordance in estimates in elderly
2021 Influenza vaccine
https://www.health.gov.au/news/influenza-flu-vaccination-in-2021
Page 68Key points for administration - 2021 influenza vaccines
• Annual influenza vaccination is recommended for all people ≥6 months of age.
• All vaccines available in 2021 are quadrivalent influenza vaccines (QIVs)
• For adults aged ≥65 years the adjuvanted QIV, Fluad® Quad, is preferentially
recommended over standard QIVs
• The dose of influenza vaccines for all ages is 0.5mL – no half doses for children
• Co-administration of influenza vaccine on the same day as a COVID-19 vaccine
is not recommended.
• Administration of an influenza vaccine and a COVID-19 vaccine should be a minimum
of 14 days apart.
• Flucelvax Quad® is a cell-based influenza vaccine, newly registered for use in
adults and children from 9 years of age. (Not NIP funded, private purchase)
• Mandatory reporting of influenza vaccines to the AIR
https://www.health.gov.au/resources/publications/atagi-advice-on-seasonal-influenza-vaccines-in-2021
Page 69Recommendations and NIP eligibility
All people ≥6 months of age are strongly recommended to receive annual influenza vaccine.
NIP funded groups:
• All people aged 6 months to less than 5 years
• All Aboriginal and Torres Strait Islander people aged 6 months and over
• Pregnant women (during any stage of pregnancy)
• All people aged 65 years and over
• People aged 6 months and over with medical conditions which increase the risk
of influenza disease complications
Page 702021 Influenza vaccines
A new cell-based influenza vaccine (Flucelvax Quad®) is available but not funded
under the National Immunisation Program (NIP).
https://www.health.gov.au/resources/publications/atagi-advice-on-seasonal-influenza-vaccines-in-2021
NCIRS Ribbon > Header&Footer > Edit footer >Apply to All Page 71Eligibility for free vaccines
6 months to < 5 years
Vaxigrip Tetra and Fluarix Tetra
• Funded for this age group
• Give two doses one month apart for children aged 6 months toWhen is the best time to receive the influenza
vaccination?
• Annual vaccination should occur before the onset of each influenza
season
• Optimal protection against influenza occurs within the first 3 to 4 months
following vaccination
• Vaccination should continue to be offered as long as influenza viruses
are circulating and a valid vaccine
• When available: ideally April to May…… but don’t stop offering
vaccine, especially for
• Pregnant women to protect mother and baby
• Children when they turn 6 months of age
Page 73When is a second dose of influenza recommended? • A single annual dose of influenza vaccine is recommended • 2 doses at least 4 weeks apart are only recommended for: • children aged 6 months to
Timing of influenza and COVID-19 doses
When scheduling influenza and COVID-19 vaccinations, the following
principles should be considered:
• People in earlier phases for COVID-19 vaccination should ensure they receive the
COVID-19 vaccine as soon as it is available to them, and then receive their
influenza vaccine.
• People in later phases for COVID-19 vaccination should receive their influenza
vaccine as soon as it is available, and then receive their COVID-19 vaccine when
it becomes available to them.
https://www.health.gov.au/sites/default/files/documents/2021/03/covid-19-vaccine-general-questions-for-vaccine-providers_1.pdf
Page 75Frequently asked questions
Can a person with an egg allergy receive the flu vaccines?
Yes. Egg allergy is not a contraindication. People with egg allergy, including
anaphylaxis, can be safely vaccinated with influenza vaccines.
Can a person with a latex allergy receive the flu vaccines?
Yes. Influenza vaccines used in Australia are latex-free and safe for use by people
with a latex allergy or sensitivity.
www.ncirs.org.au
Page 76Influenza resources
Page 77Sharing Knowledge About Immunisation (SKAI)
SKAI provides:
• a suite of resources and information
for parents and carers of babies and
young children
• vaccination communication support
tools for healthcare workers,
designed to support conversations
about childhood vaccination.
1. Parent website: www.talkingaboutimmunisation.org.au
2. eLearning module for providers: https://learn.nps.org.au
3. Provider website:
http://providers.talkingaboutimmunisation.org.au
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