IMAC_C19_Clinical_Toolkit_FEBRUARY_0

FEBRUARY 2022

COVID-19 Immunisation Clinical Toolkit This Toolkit provides key clinical information required pre- and post-vaccination. It is designed to help frontline clinical staff provide ‘on the day’ efficient and safe COVID-19 immunisation.

Please provide feedback on this toolkit here (tinyurl.com/pznjd9dw).

Important reminders • To provide sufficient pre- and post-vaccination advice in line with guidance (pages 6-9).

• Label every syringe with vaccine details.

• Prepare different vaccines in separate designated preparation areas.

• Check emergency equipment is age appropriate eg, Paediatric bag valve mask resuscitator (page 10).

• Rotate vaccine stock, regularly check expiry dates, and remove expired vaccine from cold chain.

• Review instructions (page 9) to ensure that you are correctly identifying the injection site to avoid potential vaccine administration harm.

• Myocarditis symptoms have been updated under Key points here (tinyurl.com/56rd5txe). The fact sheet will be updated shortly.

• Additional table setting out paediatric vaccine consent and any prescribing requirements (page 6).

• Vaccine supplies table now includes needle for smaller arms (page 5).

• Updated IMAC factsheet COVID-19 and COVID-19 vaccination in pregnancy (tinyurl.com/2brmhmaj).

Who can administer Paediatric Pfizer?

Omicron and booster doses

Full and Provisional Authorised Vaccinators AND vaccinating Pharmacists can give Paediatric Pfizer/ BioNTech provided they have completed the online Paediatric COVID-19 Vaccinator Education Course (tinyurl. com/927r8wu9) and gained the certificate of competence.

Pfizer/BioNTech 12+ boosters are now given from 3 months after completion of primary course (page 7).

A Covid-19 Vaccinator Working Under Supervision is NOT able to administer Paediatric Pfizer/BioNTech.

• All vaccines must be entered under the vaccinator’s CIR login. Do not share your login.

Recent changes & new information • Paediatric Pfizer/BioNTech vaccination is now available.

See links to key resources (page 2).

• Version 15 update of Immunisation Handbook 2020 (tinyurl.com/4h32aedf), published 20 January.

• Updated 12+ & Paediatric pre-vaccination screening and guidance V10 (tinyurl.com/bdexaf9r).

• Pfizer/BioNTech vs AstraZeneca vaccine comparison table including cold chain requirements (page 3).

• Update webinar: Consent, screening and post-vaccine advice (tinyurl.com/53884fum).

IMAC 02/2022

• COVID-19 Vaccine consent form general (tinyurl.com/k298kyy9).

• Update to current 0800IMMUNE FAQs (page 12).

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

Contents 1. RESOURCES AND DEVELOPMENT OPPORTUNITIES.....................................................2 2. COMPARING VACCINES.........................................3 3. COLD CHAIN...........................................................3 4. VACCINE PREPARATION........................................ 4 5. PRE-VACCINATION................................................ 6 6. VACCINE ADMINISTRATION.................................. 8 7. ADVERSE EVENTS................................................10 8. VACCINE ERRORS, SERIOUS ADVERSE EVENTS & EARLY SECOND DOSES.........................11 9. USEFUL INFORMATION/ CONTACTS/Q&As................................................. 12 CALL 0800 IMMUNE (466 863) FOR CLINICAL ADVICE

1

SECTION 1 | RESOURCES AND DEVELOPMENT OPPORTUNITIES Paediatric Pfizer/BioNTech resources

Other newer and updated resources

An IMAC Vaccinating 5 to 11 year olds webinar is available here (tinyurl.com/2p8hfc8t).

IMAC written resources can be accessed here (tinyurl.com/5xjp47nz).

IMAC written resources:

Non-IMAC resources:

• Vaccinating 5 to 11 year old Fact Sheet (tinyurl.com/yc4df832)

• I mmunisation Handbook version 15 (tinyurl.com/7sjhm5d5)

• IMAC CC Comparison - mRNA-CV (10 mcg) and mRNACV (30 mcg) version 3 (tinyurl.com/3dk8ebu7)

• Ministry of Health version 31 of Vaccine Operating Guidelines (tinyurl.com/2p95j4c3)

• IMAC Adult and Paediatric pre-vaccination screening and guidance version 10 (tinyurl.com/bdexaf9r) • IMAC Paediatric Pfizer/BioNTech mRNA-CV 10ug Vaccine Preparation version 1 (tinyurl.com/mmn37rz8) • Paediatric mRNA-CV (10mcg) Vaccine Dilution Records forms – individual & multiple vials (tinyurl.com/5xjp47nz) • A4 Childrens activity sheet (tinyurl.com/2n7n9228) Ministry of Health resource:

IMAC 02/2022

COVID-19 vaccination and children (tinyurl.com/2p9xuank)

For IMAC COVID-19 related video resources go to covid.immune.org.nz/faq-resources/video-resources.

COVID-19 education Access to the Provisional Vaccinator Foundation Course (PVFC) reopened on 1st February 2022. Course codes are provided by DHBs & PHOs not by IMAC. Courses are accessed at immune.org.nz/health‑professionals/education including:

Key AstraZeneca resources

• Paediatric COVID-19 Vaccinator Education Course (tinyurl.com/927r8wu9)

• General information and resource links can be found here (tinyurl.com/3a5tb9ps).

• AstraZeneca COVID-19 Vaccine Course (tinyurl.com/bdf4reav)

• Healthcare professionals who are COVID-19 vaccinators will need to complete the online AstraZeneca COVID-19 Vaccine Course prior to administering AstraZeneca vaccines. Access is via lms.immune.org.nz/user.

Webinars are accessed here (tinyurl.com/2p8dxs6p) including most recently:

• An IMAC AstraZeneca general information webinar is available here (tinyurl.com/yckr2yeu).

• Vaccinating 5-11 years

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

• Ask the experts Q&A

• Update Consent Screening and Post-Vaccine Advice

CALL 0800 IMMUNE (466 863) FOR CLINICAL ADVICE

2

IMAC 02/2022

Purple

mRNA

2 doses at least 21 days apart

3rd primary dose available 8 weeks after 2nd dose

Single dose administered 3 months after primary course if ≥18 years

≥12 years Pfizer is the preferred COVID-19 vaccine for use in NZ, reflecting its excellent safety and efficacy profile

• Prescribers • Authorised/provisional vaccinators (after COVID-19 Vaccinator Education course completed) • COVID-19 Vaccinators Working Under Supervision

Safe to administer during any stage of pregnancy or conception

Yes

• Written or verbal consent for 1st, 2nd or booster doses • Written consent required for 3rd primary dose

3rd primary dose for immunocompromised

Clear to off-white, particle free

Must dilute with 1.8mL sodium chloride 0.9% prior to use

6 doses per vial (5 or 7 doses per vial acceptable dependent on needle selection)

0.3 mL

1mL syringe with 25-38mm, 21-25G standard or LDS needle

Maximum 12 hours transport time of undiluted vaccine from freezer storage

Undiluted 31 days with expiry printed on box label

Stable for 2 hours prior to adding diluent, or 6 hours from adding diluent

Must use by 6 hours from time diluent added (+2°C to +30°C)

Technology

Primary Schedule

Severe immunocompromised

Booster

Eligibility

Who can administer

Pregnancy

Breastfeeding

Written consent

Prescription required

Appearance

Dilution

Doses per vial

Injection volume

Syringe/needle

Travel time restrictions

Refrigerator (+2°C to +8°C)

Room temperature (+2°C to +30°C)

Use by (ie, administer to patient)

12+ years Comirnaty

Pfizer/BioNTech (30mcg)

Vial cap colour

VERSION 1

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022 Must use by 6 hours from time diluent added (+2°C to +30°C)

• Stable for 2 hours prior to adding diluent, 12 hours from adding diluent • Doses kept in syringes may be stored for up to 6 hours cumulatively

Undiluted 10 weeks with USE BY on box label

No transport time consideration

Sol-M 1ml syringe + 25G 16mm needle (comes attached) or 25G 25mm non-LDS needle

0.2 mL

10-12 doses per vial (dependent on needle selection)

Must dilute with 1.3mL sodium chloride 0.9% prior to use

Clear to off-white, particle free

No

Written or verbal consent by legal guardian for 1st and 2nd doses

N/A

N/A

• Prescribers • Authorised/provisional vaccinators (after Paediatric COVID-19 Vaccinator Education course completed)

5-11 years

N/A

N/A

2 doses 8 weeks apart

mRNA

Orange

5-11 years Comirnaty Paediatric

Pfizer/BioNTech (10mcg)

CALL 0800 IMMUNE (466 863) FOR CLINICAL ADVICE

10/02/2022

• Must be used within 5 hours (+2°C to +30°C) of draw up or 48 hours from first opening vial, whichever occurs first • Vial must be returned to fridge when not in use

Doses kept in syringes may be stored for up to 5 hours cumulatively (if within 48 hours from vial opening)

• 6 months with expiry printed on vial label • Vaccine stable for 48 hours from first opening of vial if kept at +2°C to +8°C

No transport time consideration

• 1mL FluPlus syringes with permanently attached 23G 25mm needle • If longer needle required, use 1mL syringe plus 38mm 21-25G needle

0.5 mL

10 doses per vial (11 doses possible if using LDS needles)

No dilution required

Clear to slightly opaque, colourless to slightly brown, particle free

For mixed schedule of COVID-19 vaccines and for booster dose

Required for all AstraZeneca vaccination events

Yes

• Insufficient data so not routinely recommended in pregnancy • If Pfizer vaccine is C/I, the AstraZeneca vaccine can be given

• Prescribers • Authorised/provisional vaccinators (after AstraZeneca COVID-19 Vaccine course completed)

≥18 years

Single dose administered 4 months after primary course if ≥18 years

No 3rd primary dose indicated

2 doses 4 to 12 weeks apart

Non-replicating viral vector

Dark orange/red

Vaxzevria

AstraZeneca

SECTION 2 | COMPARING VACCINES

Also in A3 poster (tinyurl.com/yckker9m) format.

3

SECTION 3 | COLD CHAIN Important reminder

Expiring stock

Vaccine must be kept within cold chain temperature requirements in its diluted or undiluted states.

During warm weather it is important to monitor room temperature frequently. In non-air-conditioned areas where vaccine is stored or used, we recommend checking room temperature hourly. If room temperature exceeds 28°C, vaccine should be stored in pre-cooled vaccine chilly bins. See Ambient air temp monitoring record COVID-19 (tinyurl.com/2c3zu6md).

Please highlight expiry dates on the vaccine boxes when stock arrives. To prevent errors, we also advise writing this date on the side of the box and inside the lid of the box, as a reminder to use the box expiry date not the vial one.

Advice for managing cold chain breaches – specific to COVID-19 vaccines At delivery: Check the logger that accompanies the Credo-Cube to confirm whether a temperature excursion has occurred in transit. Each shipment contains detailed instructions on managing these loggers.

North Island deliveries will have a logger with a flashing light. Check that this is flashing green. DO NOT press any buttons on the logger. If the light is flashing red, quarantine the Credo-Cube in your vaccine fridge and contact: covid-19.logistics@ health.govt.nz or call 0800 335 778.

South Island deliveries will have a logger that will show a √ symbol if the cold chain is intact. If there is a X symbol, quarantine the Credo-Cube in your vaccine fridge and contact: covid-19.logistics@ health.govt.nz or call 0800 335 778.

IMAC 02/2022

Initial actions when cold chain breaches arise within a clinical setting

1

Clearly label the vaccines ‘NOT FOR USE’.

Inform clinic staff.

2

If the refrigerator is NOT within the +2° to +8° range, look for obvious reversible causes (e.g. door open, power interruption, ice buildup).

Download your datalogger, inform your Clinical Lead and contact your local IMAC COVID-19 Facilitator or Regional Advisor.

3

The next step may include packing labelled vaccines into a chilly bin, with a temperature monitoring device and transportation to your backup refrigeration provider (details are in your cold chain policy). DO NOT discard any vaccine without written advice from IMAC.

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

Cold chain breaches and excursions To document cold chain breaches and excursions, use the IMAC COVID-19 Cold Chain Reporting Form (tinyurl.com/4wkhe4mt).

Movement of vaccines There is a limit to the amount of time that Pfizer/BioNTech 12+ vials can be transported. This is specified by the manufacturer to ensure viability of the vaccine, in addition to maintaining cold chain. The total allowable transit time of an undiluted vial at +2°C to +8°C is 12 hours. This includes the original delivery from the warehouse, plus any further travel time. Diluted vials can be transported for a maximum of 6 hours in line with their expiry time post-dilution. This does not apply to Pfizer/BioNTech Paediatric and AstraZeneca which has no travel time limits.

Moving stock that is near expiry: • All movements must comply with the National Standards for Vaccine Storage and Transportation.

• Sites which have received their vaccine stock from a DHB Pharmacy can contact that pharmacy which may be able to arrange to move whole packs. Please ensure tight stock management to minimise waste, and if a stock transfer is necessary, please plan ahead to give the pharmacy plenty of warning.

• Non-DHB sites who have received stock from either DHL or HCL are unable to move stock from these sites, so extra care is needed when ordering stock to reduce wastage.

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4

SECTION 4 | VACCINE PREPARATION Reducing risk of vaccination errors Some recent COVID-19 vaccination errors include vaccine given to wrong age group, shorter than recommended dosing intervals, dosage errors and vaccine administration errors.

Paediatric Pfizer/BioNTech • Vaccinators must check the age of the recipient on the day they present at vaccination event regardless of whether that age will soon change, for example 1 week prior to 12th birthday.

• If the child starts with a paediatric dose they continue with that same schedule.

• Paediatric Pfizer/BioNTech vaccine can be given concomitantly with childhood schedule vaccines.

Key vaccine preparation documents • Pfizer/BioNTech 12+ (30mcg) full guidance V2 (tinyurl.com/2p8fuyry)

The following actions are recommended at all COVID-19 immunisation venues: • Take your time, have regular breaks • Separate vaccine preparation areas, prevent interruptions, ensure second checker, keep dilution records • Label every syringe, draw up doses together to check correct number of doses per vial • Keep syringes in different colour trays/containers • Check, check & check again!

• Slow down, ensure paediatric appointments are long enough to complete all the essential checks • Review systems to ensure practise meets clinical guidelines Other systems to reduce risk of errors: • Where possible, one vaccinator gives only one type of vaccine.

• Pfizer/BioNTech Paediatric (10mcg) full guidance (tinyurl.com/mmn37rz8)

• Consumers could move from child to adult vaccination areas.

• AstraZeneca: full guidance (tinyurl.com/2p83kubz) & quick reference guide (tinyurl.com/yckab3ku)

• Vaccinator wears a different colour T-shirt eg, paeds wear orange, adult wears purple.

Supplies Logistics supply syringes and needles. Currently supplies are: Vaccine

Item

Number

To be used for

Pfizer/BioNTech only

Nipro 25G 25mm Standard Needle Orange

1170095

Diluting the vaccine

BD 3ml LL Syringe

1165009

Drawing up diluent

Vernacare 25G 25mm LDS Needle Orange

1165446

Drawing up and administering the vaccine

Sol-M 1ml syringe + 25G 16mm needle*

182025S

Administering into smaller arms (Paediatric)

10ml Saline

1165013

Diluting the vaccine (use for one vaccine vial only)

Larger arms: Both Pfizer/ BioNTech & AstraZeneca

Unifix 1ml Luer Slip Syringe

1169565

For administering the vaccine

Vernacare 23G 38mm LDS Needle

1169128

For administering into larger arms

AstraZeneca only

Flu+ syringes with fixed needles

1165003

Drawing up and administering the vaccine

Use the Orange standard needles for diluting the Pfizer/BioNTech vaccine, NOT the 21G larger needles, or you may end up with rubber debris in the vial and the vaccine being wasted.

IMAC 02/2022

* Do not use paediatric LDS syringes with LDS needles. If you need a 25mm needle use the non-LDS drawing up needle.

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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5

SECTION 5 | PRE-VACCINATION (1) IMPORTANT REMINDER

Vaccine schedules

In order to gain informed consent from a consumer, the vaccinator must confirm person/caregiver has received adequate information about the vaccine, including the benefits, the common side effects and the rare but serious adverse events, including anaphylaxis and myocarditis for mRNA-CV vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS) for AstraZeneca.

Offer them an opportunity for questions.

Pfizer/BioNTech 12+ • Standard schedule is 2 doses at least 21 days apart, booster 3 months after primary course • Severely immunocompromised schedule is 2 doses at least 21 days apart, 3rd dose 8 weeks after 2nd dose, booster 3 months after 3rd dose (3+1) Pfizer/BioNTech Paediatric

Also see post COVID-19 vaccination advice in Section 6 Vaccine Administration (page 9).

• Standard schedule is 2 doses recommended 8 weeks apart (minimum of 21 days)

Key pre-vaccination screening and guidance documents

• Severely immunocompromised schedule is same as standard – currently no 3rd dose

• Pfizer/BioNTech

12+ & Paediatric pre-vaccination screening & guidance Version 10 (tinyurl.com/bdexaf9r)

AstraZeneca

• No booster dose currently

• 2 doses 4-12 weeks apart, booster is currently 4 months from 2nd dose (2+1). Ministry is due to review this and offer guidance.

• AstraZeneca

Version 2 (tinyurl.com/3wwwrbn5)

• Severely immunocompromised schedule is 2 doses recommended 4-12 weeks apart, 3rd dose 8 weeks after 2nd dose, booster 4 months after primary course Note: 3rd primary dose and booster doses are currently only licensed for 18+ years.

When is written consent or a prescription required?

Please also refer to Ministry of Health Operating Guidelines (tinyurl.com/4b3krr3s) and Booster Vaccination Policy Statement (tinyurl.com/yc6rn5er).

Pfizer BioN/Tech 12+ 30mcg

Pfizer BioN/Tech PAEDIATRIC 10mcg

Record of consent

Prescription required?

Record of consent

Prescription required?

Primary Course: Dose 1

Verbal or written

No

Verbal or written

No

Primary Course: Dose 2

Verbal or written

No

Verbal or written

No

Primary Course: Dose 3*

Written only

Yes

NA

NA

Verbal or written

No

NA

NA

Booster

IMAC 02/2022

AstraZeneca Record of consent

Prescription required?

Primary Course: Dose 1

Written only

No

Primary Course: Dose 2 after Dose 1 was AstraZeneca

Written only

No

Primary Course: Dose 2 after Dose 1 was NOT AstraZeneca

Written only

Yes

Primary Course: Dose 3*

Written only

Yes

Booster

Written only

Yes

* This 3rd dose is off-label eg, severely immune-compromised, extension AstraZeneca & Pfizer/BioNTech consent form (tinyurl.com/k298kyy9). Note: If a consent form is required for an AstraZeneca vaccination, the top section on page 2 must be completed, by a medical practitioner ie, a practitioner with prescribing rights.

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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6

SECTION 5 | P RE-VACCINATION (2) Consent for 5 to 11 year olds Further information on informed consent, including information around those who lack capacity, see Section 2.1.2 Immunisation Handbook, 2020 (tinyurl.com/zd6tbax6).

Your own DHB or organisation may have its own policies and procedures around who can consent on behalf of a 5-11 year old to be vaccinated with mRNA-CV 10mcg. It is important you are familiar with these.

Pfizer booster doses now 3 month spacing Announcement on 2 February: Booster doses are now recommended with a minimum spacing of 3 months.

Within in a couple of months, the Omicron variant has spread rapidly in many countries. Its spike protein enables it to better infect upper airways, but it appears to be less able to infect lung cells than Delta. It is associated with less severe disease than previous variants. Some people can still develop severe disease and require hospital care. Vaccinated individuals can still become infected and transmit this virus because this Omicron variant is highly infectious. Antibody levels wane with time since vaccination, and this is most marked in those, such as older adults, who may not have had an optimal initial response to the vaccine.

Booster doses increase the antibody to a highly protective level in the short-term. In this way, they will help to reduce the risk of infection, development of symptoms and onwards transmission, thereby slowing the spread of the virus. Cellular immunity of vaccinated people continues to reduce the risk for severe disease, even when antibody is less able to prevent infection.

• Approved from 18 years - given a minimum 3 months from 2nd dose. The vaccine used is mRNA-CV (30 mcg), the same vaccine as for their previous doses.

• Not currently recommended for anyone under 18.

• Individuals, aged 18+, can choose to have an AstraZeneca booster instead of Pfizer/BioNTech vaccine (4 month gap).

• In pregnancy: mRNA-CV vaccine is safe and recommended at all stage of pregnancy. Pregnant women/people who already had two doses of vaccine prior to pregnancy are recommended to receive a booster dose of mRNA-CV.

Third primary dose for severely immunocompromised See IMAC’s Additional COVID vaccine for severely immunocompromised people (tinyurl.com/nwkfvuae).

The Ministry of Health’s Third Primary Dose of the Pfizer/ BioNTech Vaccine Policy Statement and Clinical Guidance can be found here (tinyurl.com/53wh4zf8).

Previous adverse events If you have concerns as to whether someone is safe to receive their second vaccine, please contact IMAC (0800 466 863) to discuss the AEFI. For further information and guidance on managing and reporting AEFIs, see: Clinical review of early onset AEFIs (tinyurl.com/5ctt7yan) and/or Clinical review of late onset AEFIs (tinyurl.com/5yt6t298).

Pfizer/BioNTech myocarditis conversations • Information for health professionals: IMAC factsheet Myocarditis and the mRNA COVID-19 vaccine in New Zealand (tinyurl.com/yy2myypj) • Information for general public: Ministry of Health Myocarditis webpage (tinyurl.com/mrts2u6y)

AstraZeneca conversations Information for health professionals: IMAC factsheet COVID-19 Vaccine AstraZeneca (tinyurl.com/2p9fup2b).

Pregnancy/breastfeeding/ fertility conversations • Information for health professionals: See IMAC factsheet COVID-19 and COVID-19 vaccination in pregnancy (tinyurl.com/2brmhmaj).

• Information for general public: Ministry of Health webpage Pregnancy and breastfeeding (tinyurl. com/2wwxm8rw). This includes a video COVID-19 vaccine and pregnancy featuring Dr Nikki Turner.

Also see IMAC consumer Vaccination, pregnancy & breastfeeding resource (tinyurl.com/yckk3axh)

Other resources See page 14 for links to resources for Māori, Pacific Peoples and disabled people.

• Particularly recommended for individuals most at high risk of exposure to SARS-CoV-2 or with significant medical issues that increase their risk for severe COVID-19.

IMAC 02/2022

See here (tinyurl.com/3bc5m3rv) for consumer information about booster doses.

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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7

SECTION 6 | VACCINE ADMINISTRATION (1) Reminder: The 7 rights of COVID-19 vaccine administration below is a vital tool in avoiding many vaccine errors.

Key pre-vaccination screening and guidance documents

It is based on this article The Immunization Action Coalition - Technically Speaking (tinyurl.com/5n8phnm9).

Guidance supporting the administration of mRNA-CV vaccine (tinyurl.com/4m2fy46j).

For a printable business card/lanyard version click here (tinyurl.com/4pt2p4bz).

Locating correct injection site

7 RIGHTS of COVID-19 vaccine administration 1 RIGHT Person 2 RIGHT Vaccine & diluent

• Find acromion process (the highest point on the shoulder) and the deltoid tuberosity (the lower deltoid attachment point).

4 RIGHT Dosage Route, needle length 5 &RIGHT technique

Needle size and guide

6 RIGHT Injection site 7 RIGHT Documentation immune.org.nz 09/03/2022

ALWAYS CHECK: • • • • Card back

• The vaccinee should be seated with their arm removed from their clothing and relaxed at their side.

• The injection site is central to these two landmarks in the bulkiest part of the muscle, usually in line with the axilla.

3 RIGHT Time Card front

Errors are still being reported. Please check that you are identifying the correct location to avoid administering the vaccine with the potential to cause injury.

Name and age on CIR Are they aged <12 or <18?

Informed consent Check correct: - vaccine for age - time since last dose - volume in syringe - needle length - injection site • Documentation completed & post-vaccination advice provided

• A 16mm needle should be sufficient to effect deep IM deposition in the deltoid in most children.

• If a longer needle is required, then the vaccine must be drawn up using the 25mm or the 38mm needle, so the needle hub contains vaccine. If needles are swapped after draw up, dose is lessened due to vaccine left in needle.

• Note: Do not use paediatric LDS syringes with LDS needles. If you need 25mm needle use the non-LDS drawing up needle.

DO NOT

give lollipops to children due to the risk of choking!

immune.org.nz

IMAC 02/2022

09/03/2022

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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8

SECTION 6 | VACCINE ADMINISTRATION (2) Requests to Aspirate Occasionally consumers are requesting that the vaccinators aspirate the needle (pull back slightly to check for any minor blood vessels) prior to administration of the Pfizer COVID-19 vaccine. While this is currently not best practice and may be more uncomfortable for the patient, there is no danger associated with accommodating the consumers’ requests.

Post COVID-19 vaccination advice It is important that every consumer is given clear post vaccination advice verbally and in writing.

This advice is needed for each dose of vaccine and for all ages and MUST include the following information: • Discussion of potential minor side effects as well as the rare but serious ones. The advice should include expected side effect and how to manage them with the use of paracetamol or other analgesia for pain, or discomfort, and if unwell rest, drinking fluids and avoid vigorous activities, such as going to the gym.

• Awareness that anaphylaxis, although very unlikely, could occur within a few hours of vaccination and should they have any breathing difficulties, they should dial 111.

• Cardiac problems are extremely rare but can be serious, so ensure they understand the importance of seeking medical advice early for any out of character symptoms such as: chest pain, chest heaviness, discomfort or tightness, shortness breath or breathing difficulty, feeling lightheaded, faint or dizzy, heart palpitations, racing or fluttering heart, skipped beats.

These symptoms should not be ignored. It is important that they seek advice from a doctor or Healthline. For those who are insulin dependent diabetics, discuss the need to closely monitor blood sugars for next few days, as high or low sugars can. occasionally be a side effect of the vaccine.

IMAC 02/2022

• For those who have had AstraZeneca, the usual advice post COVID-19 vaccine applies, plus guidance on the need to seek immediate medical attention if they develop symptoms such as a severe or persistent headaches, blurred vision, confusion, seizures, shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal pain or unusual skin bruising and/ or petechia a few days after vaccination.

• Supply information on how and when to make a second appointment. See After your child’s Pfizer vaccination (tinyurl.com/2p9xjwrt) and for 12+ years see After your Pfizer vaccination (tinyurl.com/5n6thks7). For Astra Zeneca guidance, see Things you need to know about the AstraZenenca vaccine (tinyurl.com/3nvhyn79).

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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9

SECTION 7 | ADVERSE EVENTS Those who have had a previous anaphylaxis allergic reaction to ANYTHING should wait 30 minutes post-vaccination.

Assess carefully. Distinguishing between Anaphylaxis and Acute Stress Response can sometimes be difficult.

See Comparison chart (tinyurl.com/ysvaxtrc). For more detailed information see Immunisation Stress-related Response (tinyurl.com/4nkhjt67).

Emergency equipment See Immunisation Handbook Table 2.12 in section 2.3.3.

Anaphylaxis and emergency management (tinyurl.com/4ktzm687).

• Adrenaline: 1:1000 (at least 3 ampoules) and dose chart • Syringes: 1.0 mL (tuberculin NOT insulin) • Needles: a range of needle lengths and gauges, for deep IM injection • Access to a phone • Age appropriate bag valve masks

Anaphylaxis AGE

DOSE

<2 years

100 mcg (0.1ml)

2-4 years

200 mcg (0.2mL)

5-11 years

300 mcg (0.3mL)

12 years and over

500 mcg (0.5mL)

Expect to see some response to the adrenaline within 1-2 minutes.

If necessary, adrenaline can be repeated at 5-15 minute intervals, while waiting for assistance.

Ensure Adrenaline is labeled with dose per age, and that you have the anaphylaxis for all ages chart displayed: Anaphylaxis management, all ages (tinyurl.com/ mrphx5wb).

ANY provisional or fully authorised vaccinators can administer adrenaline without prescription or standing order. Please keep detailed records of observations and doses given.

Important Note: Adrenaline vials must be stored below 25°C. Room temperature where adrenaline is stored should be monitored during warm summer months to ensure it does not exceed this temperature.

The updated Anaphylaxis Checklist for Vaccinator Version 2, 9 Feb 2022 (tinyurl.com/yeyms32v) should be completed after the event and scanned to CARM.

Reporting Adverse Events Following Immunisation While in clinic: Report via CIR, this saves to their profile AND forwards to CARM. After leaving clinic: Report straight to CARM, either online nzphvc.otago.ac.nz/reporting or paper form (pdf) (tinyurl.com/ykmtuhjv). This includes any side effects reported when attending for next vaccine.

IMAC 02/2022

These do not report back to the CIR.

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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SECTION 8 | VACCINE ERRORS, SERIOUS ADVERSE EVENTS & EARLY SECOND DOSES Guidance in this section comes from Sections 31.6 & 31.7, and Appendix I of Version 29 of Ministry of Health’s Operating Guidelines for DHBs and Providers: COVID-19 Vaccine Immunisation Programme (tinyurl.com/4b3krr3s).

In the event of a vaccine administration error: 1. Ensure consumer is safe and if still on site ask them to wait in observation area 2. Inform your site lead 3. Contact IMAC on 0800 IMMUNE (466 863) for clinical guidance 4. Inform the consumer/s involved. This should ideally occur at the time, following discussion with site lead and IMAC. i. Apologise, ensure they know how to seek help and are aware of symptoms to be alert for. Give advice on spacing of second dose, arrange follow up call/s with whanau (confirm contact details) ii. Document ‘care plan’ in CIR under notes 5. Record the error in CIR under adverse events error to provide for reporting on vaccine administration errors. See Additional or replacement doses in response to an error (tinyurl.com/25aws645).

6. Complete in house review to determine how the error occurred to provide for strategies to be implemented to prevent a recurrence.

7. Report to the Ministry, refer to Appendix I: CVIP Serious Adverse Event Process (tinyurl.com/4b3krr3s) of MoH Operating Guidelines for DHBs and Providers: COVID-19 Vaccine Immunisation Programme.

8. Ensure vaccine entry in CIR is correct, if necessary correct following CIR guidance.

9. Complete follow up call

IMAC 02/2022

10. Document ‘care plan’ in CIR under notes

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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SECTION 9 | USEFUL INFORMATION/CONTACTS/Q&As (1)

IMAC 02/2022

0800 IMMUNE frequently asked questions Question

Answer

Can we administer a booster dose earlier than 3 months?

No, Pfizer/BioNTech 12+ boosters are now given from minimum spacing of 3 months after completion of primary course 2nd dose.

Can we shorten the spacing of the Pfizer/BioNTech Paediatric dose schedule from 8 weeks to 21 days?

The recommended spacing is 8 weeks for 2nd dose for 5-11 year olds of mRNA-CV (10mcg) for an optimal immune response. This can be reduced to 21 days in situations where an earlier interval is important for quicker protection, eg, significant medical issues such as immunosuppression, or if delaying vaccine might cause access issues.

Should vaccine doses be adjusted based on consumer’s size?

No, all vaccines doses are calculated based on age.

Paediatric Pfizer/BioNTech vaccine 5-11 year old criteria is by chronological age of the child’s immune system not by the child’s weight or size.

What 2nd dose should be given to a child who turns 12 after dose 1?

If the child starts with a paediatric dose they continue with that same schedule.

Can Paediatric Pfizer/BioNTech vaccine be given with other vaccines?

Paediatric Pfizer/BioNTech vaccine can be given concomitantly with childhood schedule vaccines.

What documents are needed if someone wants to swap from Pfizer to AstraZeneca vaccines?

The patient will need to have a prescription and a consent form signed by a practitioner with prescribing rights. If the practitioner has signed the prescription but not the consent form, then the clinical lead of the vaccination centre can sign the medical practitioner part of the consent form.

Can I give booster doses in pregnancy ?

mRNA-CV vaccine (30mcg) is recommended at all stages of pregnancy. Booster doses for those aged 18 and older can be given from 4 months after the second dose of the primary course. Booster doses are particularly recommended for individuals most at high risk of exposure to SARS-CoV-2 or with significant medical issues that increase their risk for severe COVID-19.

Prescriber wants to do an e-script for a patient’s AstraZeneca dose, what would I find that under?

3 different variations: • ChAdOx-1 virus 50 billion viral particles/0.5mL • COVID-19 Vaccine AstraZeneca (ChAdOx1-S virus 50 billion viral particles/0.5ml) • AD26 COV2.s virus 50 billion viral particles/0.5mL

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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SECTION 9 | USEFUL INFORMATION/CONTACTS/Q&As (2)

IMAC 02/2022

Help with cold chain What Do You Need?

Resource & Guidance

To report a cold chain breach

1. Inform your local cold chain or clinical lead for immediate actions 2. Complete the COVID-19 Cold Chain Reporting Form (tinyurl.com/3jrkmxh8) and send to your local COVID-19 RIA

To contact my local IMAC COVID-19 Regional Advisor (RIA) for specific mRNA-CV vaccine storage advice.

View your local IMAC COVID-19 Education Team staff: covid.immune.org.nz/about/meet-team (tinyurl.com/th5hfcae)

To orientate a new staff member to the cold chain process in our clinic

See Staff cold chain orientation guide (tinyurl.com/yams35n7)

Our clinic needs Cold Chain Accreditation/ Compliance OR ours has expired

1. Complete

the CCA Self-assessment form found here: health.govt.nz/coldchain 2. Contact your local Immunisation Coordinator to arrange a date for review (tinyurl. com/6jtdhsc9)

In-depth information on cold chain processes and National Standards

See National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (2nd Ed.) (tinyurl.com/dnkja69s) See 2021 Addendum to Standards (Pfizer Covid-19 vaccine specific) (tinyurl.com/568p6hs)

Cold chain requirements for vaccinating community pharmacies

All requirements (including appropriate equipment, monitoring, recording, and policies and procedures) are outlined in the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (2nd Edition) (tinyurl.com/dnkja69s) See immune.org.nz/cold-chain for more information

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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SECTION 9 | U SEFUL INFORMATION/CONTACTS/Q&As (3) Help with consumables/resources/supply issues What Do You Need?

Who do you contact, and when?

Help with a vaccine or consumables supply issue

0800 223 987 8am-8pm 7 days Covid-19.logistics@health.govt.nz 8am-5pm weekdays

Help with a privacy concern or reporting a privacy breach

COVIDPrivacy@health.govt.nz 9am-5pm weekdays

Our Interwaste vial disposal bin to be collected

0800 102 131 8am-5pm weekdays

COVID-19 information in a specific language or easy-toread format

MOH webpage COVID-19: Vaccine resources (tinyurl.com/7tbmwwdr) For resources for whānau, hapū, iwi, and Māori communities see karawhiua.nz (tinyurl.com/3x74fav5) For Pacific Peoples resources see here (tinyurl.com/3xnfj28v)

IMAC 02/2022

To support disabled people: • See Toolkit for organisations working with disabled people (tinyurl.com/5y2bpfxj) • Consumers can call to speak with a support specialist, call 0800 28 29 26, 8am – 8pm Mon to Fri More printed COVID-19 patient resources

Contact your local Communications Manager or visit the MOH webpage COVID-19: Vaccine resources (tinyurl.com/7tbmwwdr)

Clinical advice regarding the vaccine or immunisation process

0800 466 863 (0800 IMMUNE) 8am-8pm 7 days

To contact my local IMAC COVID-19 representative

IMAC COVID-19 webpage Meet the team (tinyurl.com/snnvbbsj) 9am-5pm weekdays

To access the latest clinical info regarding COVID-19, vaccines, operating guidelines, vaccine admin and vaccine storage

See MOH website (tinyurl.com/mh74fr52) to find useful resources, guidance and the latest information on the COVID-19 vaccine for the health sector, DHBs, health providers and vaccinators.

See IMAC COVID-19 written resources (tinyurl.com/3n9n29j6) for vaccine administration information, COVID-19 vaccine datasheets, access to the Immunisation Handbook and cold chain information.

Check the Āwhina App on your phone (tinyurl.com/yrbmcasy). It is strongly recommended to download the Āwhina App.

Help with an IMAC training or education query

0800 882 873 9am-4.30pm weekdays imacetadmin@auckland.ac.nz

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

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SECTION 9 | U SEFUL INFORMATION/CONTACTS/Q&As (4) Help with COVID-19 Immunisation Register What Do You Need?

Who do you contact, and when are they available?

Help accessing CIR, resetting my password, or after-hours help with CIR

0800 223 987 8am-6pm 7 days help@c-19imms.min.health.nz

Help entering vaccine doses into CIR

See Quick Step Guides to recording on CIR of: • Booster doses (tinyurl.com/2b55z3vh) • Additional or replacement doses in response to an error (tinyurl.com/25aws645) • Paediatric Pfizer doses (tinyurl.com/5n94vttv) • Overseas Vaccinations (tinyurl.com/2f8zfa99)

CIR training

IMAC Learning lms.immune.org.nz has a combined ‘CIR and BookMyVaccine’ training course.

It is embedded in the COVID-19 Vaccinator Education Course for Vaccinators, or as a stand-alone course for reception/admin staff. Visit anytime

Live virtual training for CIR

The Ministry runs daily Q&A sessions at 9:30am. Click here to join the meeting (tinyurl.com/b3hyaydc).

For primary health (GP practices and pharmacies) the Ministry live training sessions can be booked via the live training dashboard (tinyurl.com/p3ppa38x)

The latest training notes for CIR

Book My Vaccine Detailed Release Notes-21-8 (tinyurl.com/s6m9zj3t) Access by logging into CIR. Notes can be downloaded.

Help with Book My Vaccine What Do You Need?

Who do you contact, and when?

Info on how clients book, move or cancel their vaccine appointment

Encourage them to visit bookmyvaccine.nz or call the COVID Vaccination Health line on 0800 28 29 26 Visit anytime, or call 8am-8pm, 7 days/week

Book My Vaccine quick guide notes

See Book My Vaccine Quick Step Guides (tinyurl.com/xx7fsa6y) Access by logging into CIR. Video can be downloaded.

To attend virtual Book My Vaccine training

The Ministry runs Q&A sessions. Click here to join the meeting (tinyurl.com/b3hyaydc). Daily at 9:30am

To teach clients how to use the booking system

See Bookings Demo Video (tinyurl.com/4dm69sf7) Access by logging into CIR. Video can be downloaded.

Consumer information

IMAC 02/2022

See Ministry of Health webpage What to expect when you get your vaccination (tinyurl.com/ycku2nb6) for information about: • • • • • • •

What will happen at your appointment Giving consent for children aged 5 to 11 Giving consent if you are aged 12 to 15 If you are unwell on the day of your appointment Which vaccine you will be given Effectiveness of vaccination against variants Common side effects

COVID-19 IMMUNISATION CLINICAL TOOLKIT | FEBRUARY 2022

• Getting your second dose • Protecting yourself and others from COVID-19 • What will happen at your appointment

My Vaccine Pass See Ministry of Health information on how to get a My Vaccine Pass (tinyurl.com/yckntbxa).

Vaccine exemption Ministry of Health COVID-19 vaccine exemption information, including clinical criteria and a process flowchart, can be found here (tinyurl.com/2dvaw565).

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