Consumer medicine information

Comirnaty JN.1 Covid-19 Vaccine

Bretovameran

BRAND INFORMATION

Brand name

Comirnaty JN.1

Active ingredient

Bretovameran

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Comirnaty JN.1 Covid-19 Vaccine.

SUMMARY CMI

COMIRNATY® JN.1 COVID-19 vaccine

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about receiving this vaccine, speak to your doctor or pharmacist.

▼ This vaccine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I being given COMIRNATY JN.1?

COMIRNATY JN.1 is a vaccine given to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults, infants and children from 6 months of age and older. COMIRNATY JN.1 contains the active ingredient bretovameran. For more information, see Section 1. Why am I being given COMIRNATY JN.1? in the full CMI.

2. What should I know before I am given COMIRNATY JN.1?

You should not be given COMIRNATY JN.1 if you have had an allergic reaction to any of the ingredients in the vaccine. See list at the end of the CMI. Check with your doctor if you have had: a severe allergic reaction or breathing problems after any other vaccine or after being given any other COMIRNATY COVID-19 vaccine in the past; fainted following any needle injection; a severe illness or infection with high fever; a weakened immune system or are on a medicine that affects your immune system; a bleeding disorder, bruise easily or are on a blood thinning medicine. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. COMIRNATY JN.1 should not be given to infants under 6 months of age. For more information, see Section 2. What should I know before I am given COMIRNATY JN.1? in the full CMI.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription. Tell your doctor or pharmacist if you have recently received any other vaccine. For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given COMIRNATY JN.1?

COMIRNATY JN.1 will be given as an injection into the muscle of your upper arm or thigh by a doctor, nurse or pharmacist. For children and adults 5 years of age and older, you will be given one dose followed by a second dose at least 21 days later as the primary vaccination. For infants and children 6 months to less than 5 years of age, a third dose will be given at least 8 weeks after the second dose as a part of the primary vaccination. A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given the vaccine. You may receive additional dose(s) at least 3 months after the previous dose. For more information, see Section 4. How will I be given COMIRNATY JN.1? in the full CMI.

5. What should I know while being given COMIRNATY JN.1?

Things you should know
  • If you receive one dose of COMIRNATY JN.1, you should continue to receive the same vaccine to complete the primary vaccination schedule.
  • Additional dose(s) of COMIRNATY JN.1 may be given at least 3 months after the previous dose for people 5 years of age and older.
  • You may not be protected against COVID-19 disease until at least seven days after the last dose of your primary vaccination schedule. It is very important you complete your primary vaccination.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how COMIRNATY JN.1 affects you. Some of the side effects of COMIRNATY JN.1 may temporarily affect your ability to drive or use machines.

For more information, see Section 5. What should I know while being given COMIRNATY JN.1? in the full CMI.

6. Are there any side effects?

Very common side effects of COMIRNATY include pain/swelling at injection site, tiredness, headache, muscle pain, chills, joint pain and fever. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

▼ This vaccine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.



FULL CMI

COMIRNATY® JN.1 COVID-19 vaccine

Active ingredient: bretovameran

Consumer Medicine Information (CMI)

This leaflet provides important information about using COMIRNATY JN.1. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about receiving COMIRNATY JN.1.

Where to find information in this leaflet:

1. Why am I being given COMIRNATY JN.1?
2. What should I know before I am given COMIRNATY JN.1?
3. What if I am taking other medicines?
4. How will I be given COMIRNATY JN.1?
5. What should I know while being given COMIRNATY JN.1?
6. Are there any side effects?
7. Product details

1. Why am I being given COMIRNATY JN.1?

COMIRNATY JN.1 contains the active ingredient bretovameran.

COMIRNATY JN.1 is an mRNA (messenger ribonucleic acid) vaccine.

COMIRNATY JN.1 is a vaccine given to prevent COVID-19 disease caused by SARS-CoV-2 virus in adults, infants and children from 6 months of age and older.

COMIRNATY JN.1 works by triggering your immune system to produce antibodies and blood cells that work against the virus, to protect against COVID-19 disease.

2. What should I know before I am given COMIRNATY JN.1?

Warnings

COMIRNATY JN.1 should not be given:

  • if you are allergic to bretovameran or any of the ingredients listed at the end of this leaflet.

Check with your doctor if you have:

  • had a severe allergic reaction or breathing problems after any other vaccine or after being given any other COMIRNATY COVID-19 vaccine in the past.
  • fainted following any needle injection.
  • a severe illness or infection with high fever. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
  • a weakened immune system, such as due to HIV infection or are on a medicine that affects your immune system.
  • a bleeding disorder, bruise easily or are on a blood thinning medicine.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have been reported after vaccination with COMIRNATY. The cases have mostly occurred within two weeks following vaccination, more often after the second vaccination, and more often, but not always, in younger men. There have been cases in women. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur. Sometimes the symptoms of myocarditis and pericarditis may not be specific and could include tiredness, dizziness, nausea and vomiting, abdominal pain, swelling, and cough.

You may develop a temporary, stress-related response associated with the process of receiving your injection. This may include dizziness, fainting, sweating, increased heart rate and/or anxiety. If you start to feel faint at any time during the process of receiving your injection, let your doctor, nurse or pharmacist know and take actions to avoid falling and injuring yourself, such as sitting or lying down.

As with any vaccine, COMIRNATY JN.1 may not fully protect all those who receive it and it is not known how long you will be protected.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.

Children and adolescents

COMIRNATY JN.1 should not be given to infants under 6 months of age.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor or pharmacist if you have recently received any other vaccine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect, or are affected by, COMIRNATY JN.1.

4. How will I be given COMIRNATY JN.1?

  • COMIRNATY JN.1 will be given as an injection into the muscle of your upper arm or thigh by a doctor, nurse or pharmacist.
  • For primary vaccination, you will be given two doses. One dose followed by a second dose at least 21 days later. If you miss the second dose, ask your doctor for advice.
  • If you are immunocompromised, you may receive a third dose of the vaccine at least 28 days after the second dose as part of the primary vaccination.
  • For infants and children 6 months to less than 5 years of age, a third dose will be given at least 8 weeks after the second dose to complete the primary vaccination.
  • A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given the vaccine.
  • Additional dose(s) of COMIRNATY JN.1 may be given at least 3 months after the primary vaccination for people 5 years of age and older.

5. What should I know while being given COMIRNATY JN.1?

Things you should know

  • If you receive one dose of COMIRNATY JN.1, you should continue to receive the same vaccine to complete the primary vaccination schedule.
  • If you are immunocompromised, you may receive a third dose of COMIRNATY JN.1 at least 28 days after the second dose as part of the primary vaccination.
  • Additional dose(s) of COMIRNATY JN.1 may be given at least 3 months after the previous dose for people 5 years of age and older.
  • You may not be protected against COVID-19 disease until at least seven days after primary vaccination.
  • You may not be protected if you only receive one dose, so it is very important that you complete your primary vaccination.

Driving or using machines

Be careful before you drive, cycle or use any machines or tools until you know how COMIRNATY JN.1 affects you.

Some of the side effects of COMIRNATY JN.1 may temporarily affect your ability to drive, cycle or use machines.

Storage of the vaccine

A doctor, nurse or pharmacist will prepare the injection for you before you are given it.

Getting rid of any unwanted vaccine

A doctor, nurse or pharmacist will dispose of any unused vaccine.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Very common side effects

Very common side effectsWhat to do
  • pain/swelling/tenderness at injection site
  • tiredness
  • headache
  • muscle pain
  • chills
  • joint pain
  • fever
  • irritability (in 6 months to less than 2 years of age)
Speak to your doctor if you have any of these very common side effects and they worry you.

Common side effects

Common side effectsWhat to do
  • redness at injection site
  • nausea
Speak to your doctor if you have any of these common side effects and they worry you.

Uncommon side effects

Uncommon side effectsWhat to do
  • enlarged lymph nodes
  • feeling unwell
  • arm pain
  • insomnia
  • decreased appetite (very common in 6 months to less than 2 years of age)
  • excessive sweating
  • night sweats
  • physical weakness and/or lack of energy
Speak to your doctor if you have any of these side effects and they worry you.

Rare side effects

Rare side effectsWhat to do
  • temporary one-sided facial drooping
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice this side effect.

Other side effects (frequency unknown)

Other side effects (frequency unknown)What to do
  • severe allergic reaction
  • allergic reactions such as rash, itching, hives or swelling of the face
  • inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in chest pain, breathlessness and/or palpitations
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
  • diarrhoea
  • vomiting
  • pain in arm
  • extensive swelling of vaccinated arm
  • swelling of face (people who have had facial dermal fillers)
  • unusual sensation (e.g. tingling or pricking, “pins-and-needles”)
  • numbness
  • skin lesions (bull's-eye-shaped)
  • dizziness
  • genital ulcers
  • heavy menstrual (period) bleeding
  • breast swelling, redness and/or pain
Speak to your doctor if you have any of these side effects and they worry you.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this vaccine.

7. Product details

What COMIRNATY JN.1 contains

Active ingredient
(main ingredient)
  • bretovameran
Other ingredients
(inactive ingredients)
  • ((4-hydroxybutyl)azanediyl) bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
  • 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
  • Distearoylphosphatidylcholine (DSPC)
  • Cholesterol
  • Sucrose
  • Trometamol
  • Trometamol hydrochloride
  • Water for injections

Do not receive this vaccine if you are allergic to any of these ingredients.

What COMIRNATY JN.1 looks like

COMIRNATY JN.1 (Grey, Orange and Maroon cap) is a white to off-white frozen suspension.

COMIRNATY JN.1 (Blue and Yellow cap) is a clear to slightly opalescent solution. COMIRNATY JN.1 – Single dose Glass Prefilled Syringes and Single dose Plastic Prefilled Syringes is a white to off-white suspension.

Yellow cap vial (For Age 6 months to less than 5 Years):

COMIRNATY JN.1 (Yellow cap) is provided in packs of 10 and 195 in clear glass vials with yellow flip-off caps. After dilution, each dose is 0.3 mL and each vial contains 3 doses of vaccine (0.48 mL fill). AUST R 457690

Maroon cap vial (For Age 6 months to less than 5 Years):

COMIRNATY JN.1 (Maroon cap) is provided in packs of 10 and 195 in clear glass vials with maroon flip-off caps. After dilution, each dose is 0.2 mL and each vial contains 10 doses of vaccine (0.4 mL fill). AUST R 457688

Blue cap vial (For Age 5 to less than 12 Years):

COMIRNATY JN.1 (Light or Dark Blue cap) is provided in packs of 10 in clear glass vials with blue flip-off caps. No dilution required. Each dose is 0.3 mL.

Each single dose vial (Light Blue) contains 1 dose of vaccine (0.48 mL fill). AUST R 457686

Each multidose vial (Dark Blue) contains 6 doses of vaccine (2.25 mL fill). AUST R 457685

Orange cap vial (For Age 5 to less than 12 Years):

COMIRNATY JN.1 (Orange cap) is provided in packs of 10 and 195 in clear glass vials with orange flip-off caps. After dilution, each dose is 0.2 mL and each vial contains 10 doses of vaccine (1.3 mL fill). AUST R 457680

Grey cap vial (For Ages 12 Years and older):

COMIRNATY JN.1 (Light or Dark Grey cap) is provided in packs of 10 in clear glass vials with grey flip-off caps. No dilution required. Each dose is 0.3 mL.

Each single dose vial (Light Grey) contains 1 dose of vaccine (0.48 mL fill). AUST R 457679

Each multidose vial (Dark Grey) contains 6 doses of vaccine (2.25 mL fill). AUST R 457677

Single dose Glass Prefilled Syringes (For Ages 12 Years and older):

COMIRNATY JN.1 – Single dose Glass Prefilled Syringes is provided in packs of 10 in clear glass syringes with a rigid cap. No dilution is required. Each dose is 0.3 mL.

Each single dose glass syringe contains 1 dose of vaccine (0.418 mL fill). AUST R 459385

Single dose Plastic Prefilled Syringes (For Ages 12 Years and older):

COMIRNATY JN.1 – Single dose Plastic Prefilled Syringes is provided in packs of 10 in transparent plastic syringes with a rigid cap. No dilution is required. Each dose is 0.3 mL.

Each single dose plastic syringe contains 1 dose of vaccine (0.432 mL fill). AUST R 459366

Not all presentations may be available.

Who distributes COMIRNATY JN.1

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedinfo.com.au

COMIRNATY® is a registered trademark of BioNTech SE. Used under license.

This leaflet was prepared in October 2024.

© Copyright

Published by MIMS December 2024

BRAND INFORMATION

Brand name

Comirnaty JN.1

Active ingredient

Bretovameran

Schedule

S4

 

1 Name of Medicine

Bretovameran.

2 Qualitative and Quantitative Composition

Bretovameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (JN.1). See Table 1.
Each dose contains COVID-19 mRNA Vaccine embedded in lipid nanoparticles. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

See Table 2.
Comirnaty JN.1 (Grey, Orange and Maroon cap) is a white to off-white frozen suspension.
Comirnaty JN.1 (Blue and yellow cap) is a clear to slightly opalescent solution.
Comirnaty JN.1 - Single dose Glass Prefilled Syringes (AUST R 459385) and Single dose Plastic Prefilled Syringes (AUST R 459366), 30 microgram, for 12 years and older is a white to off-white suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 6 months of age and older.
The use of this vaccine should be in accordance with official recommendations.

4.2 Dose and Method of Administration

Dosage.

See Table 3.
Primary series, when clinically indicated, can be given to the individuals such as those who are vaccine-naïve and immunocompromised.
The decision when and for whom to administer Comirnaty JN.1 should be made based on available vaccine safety and effectiveness data (see Section 4.4 Special Warnings and Precautions for Use; Section 5.1 Pharmacodynamic Properties), in accordance with official recommendations.

Severely immunocompromised aged 12 years and older.

In accordance with official recommendations, a third dose may be given, as part of the primary series, at least 28 days after the second dose to individuals who are severely immunocompromised (see Section 4.4 Special Warnings and Precautions for Use).

Elderly population.

No dosage adjustment is required in elderly individuals ≥ 65 years of age.

Paediatric population.

Children who will turn from 4 years to 5 years of age or from 11 years to 12 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the individual's age at the start of the vaccination series.

Interchangeability.

There are limited data on the interchangeability of Comirnaty with other COVID-19 vaccines to complete the primary vaccination course or any subsequent doses. Individuals who have received 1 dose of Comirnaty COVID-19 vaccineshould continue to receive Comirnaty JN.1 to complete the primary vaccination course and for any additional doses.

Method of administration.

In individuals 5 years of age and older, administer the vaccine intramuscularly in the deltoid muscle.
In individuals 1 to < 5 years of age and older, administer the vaccine intramuscularly in the anterolateral aspect of the thigh or the deltoid muscle.
In individuals from 6 to < 12 months of age, administer the vaccine intramuscularly in the anterolateral aspect of the thigh.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
Comirnaty JN.1 should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering Comirnaty JN.1, see Section 4.4 Special Warnings and Precautions for Use.
Handling instructions for vaccines in vials.

Handing prior to use.

Frozen vials must be completely thawed prior to use. Frozen vials should be transferred to 2°C to 8°C to thaw. Thaw times for 10-vial packs are noted in Table 4.
Upon moving frozen vaccine to 2°C to 8°C storage, update the expiry date on the carton. The updated expiry date should reflect 10 weeks from the date of transfer to refrigerated conditions (2°C to 8°C) and not exceeding the original printed expiry date (EXP).
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30°C for immediate use.
If the vaccine is received at 2°C to 8°C it should continue to be stored at 2°C to 8°C. Check that the carton has been previously updated to reflect the 10-week refrigerated expiry date.
Unopened vials can be stored for up to 12 hours at temperatures up to 30°C. Total storage time between 8°C to 30°C, inclusive of storage before and after puncture, should not exceed 24 hours.
Comirnaty JN.1 - suspension for injection.

Preparation for administration.

Comirnaty JN.1 Suspension for Injection should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared suspension.
Vials of Comirnaty JN.1 Suspension for Injection have either a grey or a blue cap, contain either 1 or 6 doses of 0.3 mL of vaccine and do not require dilution.
Light Grey or Light Blue cap: single dose vial.
Dark Grey or Dark Blue cap: 6 dose multidose vial.

Vial verification.

Prior to administration, check the name and strength of the vaccine on the vial label and the colour of the vial cap and vial label border to ensure it is the intended presentation. Check whether the vial is a single dose vial or a multidose vial and check if the vial requires dilution.
Check appearance of vaccine prior to mixing and administration.
Grey cap vials: Prior to mixing, the vaccine is a white to off-white dispersion and may contain white to off-white opaque amorphous particles.
Blue cap vials: Prior to mixing, the vaccine is a clear to slightly opalescent dispersion and may contain white to off-white opaque amorphous particles.
Gently invert the vial 10 times. Do not shake.
Do not use the vaccine if particulates or discoloration are present after mixing.

Preparation of individual doses.

Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw a 0.3 mL single dose.
For Dark Grey or Dark Blue cap multidose vials (6 doses per vial):
After first puncture, record appropriate date and time on the vial and store at 2°C to 30°C for up to 12 hours. Do not re-freeze.
Each dose must contain 0.3 mL of vaccine. Low dead volume syringes and/or needles should be used in order to extract all doses from a single vial. The low dead volume syringe and needle combination should have a dead volume of no more than 35 microliters.
If the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and any excess volume.
Comirnaty JN.1 - concentrated suspension for injection. Vials of Comirnaty JN.1 Concentrated Suspension for Injection have an Orange or a Maroon or a Yellow cap and requires dilution.

Preparation for administration.

Comirnaty JN.1 Concentrated Suspension for Injection should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared diluted suspension.
Vials of Comirnaty JN.1 concentrated suspension for Injection contain:
Orange or Maroon cap: 10 doses of 0.2 mL of vaccine after dilution.
Yellow cap: 3 doses of 0.3 mL of vaccine after dilution.

Vial verification.

Prior to administration, check the name and strength of the vaccine on the vial label and the colour of the vial cap and vial label border to ensure it is the intended presentation. Check whether the vial is a single dose vial or a multidose vial and check if the vial requires dilution.

Prior to dilution.

After the thawed vial has reached room temperature, gently invert it 10 times prior to dilution. Do not shake.
Check appearance of vaccine.
Orange or Maroon cap vials: Prior to dilution, the vaccine is a white to off-white dispersion and may contain white to off-white opaque amorphous particles.
Yellow cap vials: Prior to dilution, the vaccine is a clear to slightly opalescent solution.

Dilution instructions.

Thawed vaccine must be diluted in its original vial with sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques. Volume of sodium chloride 9 mg/mL (0.9%) required are noted below:
Orange cap vials: 1.3 mL of sodium chloride 9 mg/mL.
Maroon cap vials: 2.2 mL of sodium chloride 9 mg/mL.
Yellow cap vials: 1.1 mL of sodium chloride 9 mg/mL.
Equalize vial pressure before removing the needle from the vial stopper by withdrawing air into the empty diluent syringe. Volume of air required are noted below:
Orange cap vials: 1.3 mL of air.
Maroon cap vials: 2.2 mL of air.
Yellow cap vials: 1.1 mL of air.
Gently invert the diluted dispersion 10 times. Do not shake.
Check appearance of vaccine after dilution.
Orange or Maroon cap vials: The diluted vaccine should present as a white to off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discoloration are present.
Yellow cap vials: After mixing, the vaccine should present as a clear to slightly opalescent dispersion with no particulates visible. Do not use the vaccine if particulates or discoloration are present.
After dilution, mark vial with appropriate date/time, store at 2°C to 30°C and use within 12 hours. Do not re-freeze.

Preparation of individual doses.

Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw a single dose.
Orange or Maroon cap multidose vials (10 doses per vial):
Each dose must contain 0.2 mL of vaccine.
Low dead volume syringes and/or needles should be used in order to extract all doses from a single vial. The low dead volume syringe and needle combination should have a dead volume of no more than 35 microliters.
Yellow cap multidose vials (3 doses per vial):
Each dose must contain 0.3 mL of vaccine.
Standard syringes can be used.
If the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and any excess volume.
Handling instructions for vaccines in prefilled syringes.

Comirnaty JN.1 - single dose glass prefilled syringes, 30 microgram 12 years and older (do not dilute).


If glass prefilled syringe has been frozen, discard.
Do not shake.
Remove tip cap by slowly turning the cap counterclockwise while holding the luer lock and attach a sterile needle.
Product is for single use in one patient only. Discard any residue.

Comirnaty JN.1 - single dose plastic prefilled syringes, 30 microgram, 12 years and older (do not dilute).

If syringes are frozen, thaw syringe in the carton in the refrigerator [2°C to 8°C] or at room temperature [up to 30°C]. Do not remove syringe from carton to thaw.
Do not shake.
Remove tip cap and attach a sterile needle.
Product is for single use in one patient only. Discard any residue.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 List of Excipients.

4.4 Special Warnings and Precautions for Use

Traceability.

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be recorded in the Australian Immunisation Register.

General recommendations.

Hypersensitivity and anaphylaxis.

Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of Comirnaty JN.1.
The individual should be kept under close observation for at least 15 minutes following vaccination. A second dose of Comirnaty JN.1 should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty COVID-19 vaccines.

Myocarditis and pericarditis.

Very rare cases of myocarditis and pericarditis have been observed following vaccination with Comirnaty. Cases have occurred following first and second vaccinations and following booster doses. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often, but not exclusively in younger males. There have been reports in females. Based on accumulating data, the reporting rates of myocarditis and pericarditis after primary series in children ages 5 through < 12 years are lower than in ages 12 through 17 years. Rates of myocarditis and pericarditis in booster doses do not appear to be higher than after the second dose in the primary series. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Cases of myocarditis and pericarditis following vaccination have rarely been associated with severe outcomes including death.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis, including atypical presentations. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Non-specific symptoms of myocarditis and pericarditis also include fatigue, nausea and vomiting, abdominal pain, dizziness or syncope, oedema and cough. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.
For further details, please refer to the relevant clinical guidelines developed by the Australian Technical Advisory Group on Immunisation.

Anxiety-related reactions.

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
Some individuals may have stress-related responses associated with the process of vaccination itself. Stress-related responses are temporary and resolve on their own. They may include dizziness, fainting, palpitations, increases in heart rate, alterations in blood pressure, feeling short of breath, tingling sensations, sweating and/or anxiety. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation and precautions should be in place to avoid injury from fainting.

Syncope.

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

Concurrent illness.

Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders.

As with other intramuscular injections, Comirnaty JN.1 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

Immunocompromised individuals.

The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty JN.1 may be lower in immunosuppressed individuals.

Duration of protection.

The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials and observational studies.

Limitations of vaccine effectiveness.

As with any vaccine, vaccination with Comirnaty JN.1 may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their primary course of Comirnaty JN.1.

Use in the elderly.

Clinical studies of Comirnaty (tozinameran) include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy. See Section 5.1 Pharmacodynamic Properties, Clinical trials, Efficacy against COVID-19. No dosage adjustment is required in elderly individuals ≥ 65 years of age.
The data for use in the frail elderly (> 85 years) is limited. The potential benefits of vaccination versus the potential risk and clinical impact of even relatively mild systemic adverse events in the frail elderly should be carefully assessed on a case-by-case basis.
The safety of a booster dose of Comirnaty in individuals 65 years of age and older is based on safety data in 12 booster dose recipients 65 to 85 years of age in Study C4591001, 306 booster dose recipients 18 to 55 years of age in Study C4591001, and 1,175 booster dose recipients 65 years of age and older in Study C4591031. The effectiveness of a booster dose of Comirnaty in individuals 65 years of age and older is based on effectiveness data in 306 booster dose recipients 18 to 55 years of age in Study C4591001, and an efficacy analysis from participants 16 years of age and older in 9,945 participants in Study C4591031.

Paediatric use.

The safety and efficacy of Comirnaty in infants aged less than 6 months of age have not yet been established.
Limited safety and effectiveness data is available for booster dose in adolescents 12 to 15 years of age and no immunogenicity data is available for booster dose in this age group. The safety and effectiveness of a booster dose of Comirnaty in individuals 12 to 17 years of age is based on safety and effectiveness data in adults at least 18 to 55 years of age.
Real world evidence from the Ministry of Health of Israel and surveillance by CDC in USA on the administration of third doses of Comirnaty given after the primary course revealed no new safety concerns in adolescents 12 to 17 years of age.
Very rare cases of myocarditis and pericarditis have been observed following vaccination with Comirnaty in adolescents (see Section 4.4 Special Warnings and Precautions for Use, Myocarditis and pericarditis).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.
Concomitant administration of Comirnaty JN.1 with other vaccines has not been studied.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In a combined fertility and developmental toxicity study, female rats were intramuscularly administered Comirnaty prior to mating and during gestation (4 full human doses of 30 microgram each, spanning between pre-mating day 21 and gestation day 20). SARS CoV-2 neutralising antibodies were present in maternal animals from prior to mating to the end of the study on postnatal day 21 as well as in fetuses and offspring. There were no vaccine related effects on female fertility and pregnancy rate.
(Category B1)
No data are available yet regarding the use of Comirnaty JN.1 during pregnancy. However, a large amount of information from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.
There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition or post-natal development (see Section 4.6 Fertility, Pregnancy and Lactation, Effects on fertility). Administration of Comirnaty JN.1 in pregnancy can be considered when the potential benefits outweigh any potential risks for the mother and fetus.
 No data are available yet regarding the use of Comirnaty JN.1 during breast-feeding. Comirnaty JN.1 can be used while breast-feeding, when the potential benefits outweigh any potential risks for the mother and baby.
It is unknown whether tozinameran is excreted in human milk. A combined fertility and developmental toxicity study in rats did not show harmful effects on offspring development before weaning (see Section 4.6 Fertility, Pregnancy and Lactation, Effects on fertility).

4.7 Effects on Ability to Drive and Use Machines

Comirnaty has no, or negligible, influence on the ability to drive, cycle and use machines. However, some of the effects mentioned under Section 4.8 Adverse Effects (Undesirable Effects), may temporarily affect the ability to drive, cycle or use machines.

4.8 Adverse Effects (Undesirable Effects)

Summary of safety profile.

The safety of Comirnaty JN.1 is inferred from safety data of the prior Comirnaty (tozinameran) vaccines.
The safety of Comirnaty (tozinameran) was evaluated in participants aged 6 months and older in clinical studies (comprised of 22,026 participants 16 years of age and older and 1,131 adolescents 12 to 15 years of age from Study C4591001, and 1,518 children 5 to < 12 years of age, 1,835 participants 2 to < 5 years of age and 1,178 participants 6 months to < 2 years of age from Study C4591007) that have received at least one dose of Comirnaty (tozinameran).
Additionally, 306 existing Phase 3 participants 18 to 55 years of age received a booster dose of Comirnaty (tozinameran) approximately 6 months after the second dose in the non-placebo-controlled booster dose portion of Study C4591001. The overall safety profile for the booster dose was similar to that seen after 2 doses.
In Study C4591031, a placebo-controlled booster study, 5,081 participants 16 years of age and older were recruited from Study C4591001 to receive a booster dose of Comirnaty (tozinameran) at least 6 months after the second dose. The overall safety profile for the booster dose was similar to that seen after 2 doses.
In a subset of C4591007 Phase 2/3 participants, 401 participants 5 to < 12 years of age received a booster dose of Comirnaty (tozinameran) after completing the primary series. 399 of 401 participants in the safety population received the booster dose at 7 - < 9 months after Dose 2 (n = 51 [12.7%] at 7 - < 8 months and n = 348 [86.8%] at 8 - < 9 months). The overall safety profile for the booster dose was similar to that seen after the primary series.

Participants 16 years of age and older - after 2 doses.

In Study C4591001, a total of 22,026 participants 16 years of age or older received at least 1 dose of Comirnaty (tozinameran) 30 microgram and a total of 22,021 participants 16 years of age or older received placebo [including 138 and 145 adolescents 16 and 17 years of age in the Comirnaty (tozinameran) and placebo groups, respectively]. A total of 20,519 participants 16 years of age or older received 2 doses of Comirnaty.
At the time of the analysis of Study C4591001 with a data cut-off of 13 March 2021 for the placebo-controlled blinded follow-up period up to the participants' unblinding dates, a total of 25,651 (58.2%) participants [13,031 Comirnaty (tozinameran) and 12,620 placebo] 16 years of age and older were followed up for ≥ 4 months after the second dose. This included a total of 15,111 [7,704 Comirnaty (tozinameran) and 7,407 placebo] participants 16 to 55 years of age and a total of 10,540 [5,327 Comirnaty (tozinameran) and 5,213 placebo] participants 56 years and older.
The most frequent adverse reactions in participants 16 years of age and older that received 2 doses were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 40%), chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
The safety profile in 545 subjects receiving Comirnaty (tozinameran), that were seropositive for SARS CoV-2 at baseline, was similar to that seen in the general population.
Study C4591001 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. The safety profile of the participants receiving Comirnaty (n=100) in the individuals with stable HIV infection was similar to that seen in the general population.

Adolescents 12 to 15 years of age - after 2 doses.

In an analysis of long term safety follow-up in Study C4591001, 2,260 adolescents [1,131 Comirnaty (tozinameran) 30 microgram; 1,129 placebo] were 12 to 15 years of age. Of these, 1,559 adolescents [786 Comirnaty (tozinameran) and 773 placebo] have been followed for ≥ 4 months after the second dose of Comirnaty (tozinameran). The safety evaluation in Study C4591001 is ongoing.
The most frequent adverse reactions in adolescents 12 to 15 years of age that received 2 doses were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).

Children 5 to < 12 years of age - after 2 doses.

In an analysis of Study C4591007 Phase 2/3, 2,268 children [1,518 Comirnaty (tozinameran) 10 microgram; 750 placebo] were 5 to < 12 years of age. Of these, 2,158 (95.1%) [1,444 Comirnaty (tozinameran) 10 microgram and 714 placebo] children have been followed for at least 2 months after the second dose. The safety evaluation in Study C4591007 is ongoing.
The most frequent adverse reactions in children 5 to < 12 years of age that received 2 doses included injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (> 20%), myalgia and chills (> 10%).

Children 2 to < 5 years of age - after 3 doses.

In an analysis of Study C4591007 (Phase 2/3), 2,750 children [1,835 Comirnaty (tozinameran) 3 microgram and 915 placebo] were 2 to < 5 years age. Based on data in the blinded placebo-controlled follow-up period up to the cutoff date of 29 April 2022, 886 children 2 to < 5 years of age who received a 3-dose primary course [606 Comirnaty (tozinameran) 3 microgram and 280 placebo] have been followed a median of 1.4 months after the third dose.
The most frequent adverse reactions in children 2 to < 5 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%).

Infants 6 months to < 2 years of age - after 3 doses.

In an analysis of Study C4591007 (Phase 2/3), 1,776 infants [1,178 Comirnaty (tozinameran) 3 microgram and 598 placebo] were 6 months to < 2 years of age. Based on data in the blinded placebo-controlled follow-up period up to the cutoff date of 29 April 2022, 570 infants 6 months to < 2 years of age who received a 3-dose primary course [386 Comirnaty 3 microgram and 184 placebo] have been followed for a median of 1.3 months after the third dose.
The most frequent adverse reactions in infants 6 months to < 2 years of age that received any primary course dose included irritability (> 60%), decrease appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%).

Participants 12 years of age and older - after booster dose.

A subset from Study C4591001 Phase 2/3 participants of 306 adults 18 to 55 years of age who completed the Comirnaty (tozinameran) 2-dose course, received a booster dose of Comirnaty (tozinameran) approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2. Of these, 301 participants have been followed for ≥ 4 months after the booster dose of Comirnaty (tozinameran).
The most frequent adverse reactions in participants 18 to 55 years of age were injection site pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%).
In Study C4591031, a placebo-controlled booster study, participants 16 years of age and older recruited from Study C4591001 received a booster dose of Comirnaty (tozinameran) (5,081 participants), or placebo (5,044 participants) at least 6 months after the second dose of Comirnaty (tozinameran). Overall, participants who received a booster dose, had a median follow-up time of 2.8 months (range 0.3 to 7.5 months) after the booster dose in the blinded placebo-controlled follow-up period to the cut-off date (8 February 2022). Of these, 1281 participants (895 Comirnaty and 386 placebo) have been followed for ≥ 4 months after the booster dose of Comirnaty (tozinameran).

Participants 18 years of age and older - after subsequent booster doses.

A subset of 325 adults 18 to ≤ 55 years of age who had completed 3 doses of Comirnaty received a booster (fourth dose) of Comirnaty (tozinameran 30 microgram) 90 to 180 days after receiving Dose 3. Participants who received a booster (fourth dose) of Comirnaty (tozinameran 30 microgram) had a median follow-up time of 1.4 months. The most frequent adverse reactions in these participants were injection site pain (> 70%), fatigue (> 60%), headache (> 40%), myalgia and chills (> 20%) and arthralgia (> 10%).
In a subset from Study C4591031 (Phase 3), 305 adults greater than 55 years of age who had completed 3 doses of Comirnaty (tozinameran), received a booster (fourth dose) of Comirnaty (tozinameran 30 microgram) 5.3 to 13.1 months after receiving Dose 3. Participants who received a booster (fourth dose) of Comirnaty (tozinameran 30 microgram) had a median follow-up time of at least 1.7 months up to a data cutoff date of 16 May 2022. The most frequent adverse reactions in participants greater than 55 years of age were injection site pain (60%), fatigue (> 40%), headache (> 20%), myalgia and chills (> 10%).

Children 5 to < 12 years of age - after booster dose.

In a subset from C4591007, a total of 401 children 5 to < 12 years of age received a booster dose of Comirnaty (tozinameran) 10 microgram after completing the primary series. 399 of 401 participants in the safety population received the booster dose at 7 - < 9 months after Dose 2 (n = 51 [12.7%] at 7 - < 8 months and n = 348 [86.8%] at 8 - < 9 months). The analysis of the C4591007 Phase 2/3 subset is based on data up to the cut-off date of 22 March 2022 (median follow-up time of 1.3 months).
The most frequent adverse reactions in participants 5 to < 12 years of age were injection site pain (> 70%), fatigue (> 40%), headache (> 30%), myalgia, chills, injection site redness, and swelling (> 10%). A higher frequency of lymphadenopathy was observed in C4591007 in participants receiving a booster dose compared to participants receiving 2 doses (2.5% vs. 0.9%).

Tabulated list of adverse reactions from clinical studies.

Adverse reactions observed during clinical studies are listed below according to the following frequency categories:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data). See Table 5.
The safety profile in 545 subjects receiving Comirnaty, that were seropositive for SARS-CoV-2 at baseline, was similar to that seen in the general population. See Tables 6, 7, 8, 9, and 10.

Post-marketing experience.

Although the events listed in Table 9 were not observed in the clinical trials, they are considered adverse drug reactions for Comirnaty as they were reported in the post-marketing experience. As these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known. See Table 11.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 microgram of Comirnaty. The Comirnaty recipients did not report an increase in reactogenicity or adverse reactions.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: vaccines, other viral vaccines, ATC code: J07BN01.

Mechanism of action.

The nucleoside-modified messenger RNA in the vaccine is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 spike (S) antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. Comirnaty elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute to protection against COVID-19.

Clinical trials.

The efficacy of Comirnaty JN.1 is inferred from efficacy data of the prior Comirnaty (tozinameran) vaccines.

Efficacy.

Study C4591001 is a multicentre, multinational, Phase 1/2/3 randomised, placebo-controlled, observer-blind dose-finding, vaccine candidate selection and efficacy study in participants 12 years of age and older. Randomisation was stratified by age: 12 to 15 years of age, 16 to 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥ 56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV).

Efficacy in participants 16 years of age and older - after 2 doses.

In the Phase 2/3 portion of Study C4591001, based on data accrued through 14 November 2020, approximately 44,000 participants were randomised equally and were to receive 2 doses of Comirnaty (tozinameran) or placebo. The efficacy analyses included participants that received their second vaccination within 19 to 42 days after their first vaccination. The majority (93.1%) of vaccine recipients received the second dose 19 days to 23 days after Dose 1. Participants are planned to be followed for up to 24 months after Dose 2, for assessments of safety and efficacy against COVID-19. In the clinical study, participants were required to observe a minimum interval of 14 days before and after administration of an influenza vaccine in order to receive either placebo or Comirnaty (tozinameran). In the clinical study, participants were required to observe a minimum interval of 60 days before or after receipt of blood/plasma products or immunoglobulins through to conclusion of the study in order to receive either placebo or Comirnaty (tozinameran).
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older [18,242 in the Comirnaty (tozinameran) group and 18,379 in the placebo group] who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. In addition, 134 participants were between the ages of 16 to 17 years of age [66 in the Comirnaty (tozinameran) group and 68 in the placebo group] and 1616 participants 75 years of age and older [804 in the Comirnaty (tozinameran) group and 812 in the placebo group].
At the time of the primary efficacy analysis, participants had been followed for symptomatic COVID-19 for in total 2,214 person-years for the Comirnaty (tozinameran) group and in total 2,222 person-years for the placebo group.
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. asthma, body mass index (BMI) ≥ 30 kg/m2, chronic pulmonary disease, diabetes mellitus, hypertension).
Comirnaty (tozinameran) efficacy information is presented in Table 12.
In the second primary analysis, efficacy of Comirnaty (tozinameran) in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 94.6% (95% credible interval of 89.9% to 97.3%) in participants 16 years of age and older with or without evidence of prior infection with SARS-CoV-2.
Additionally, subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across genders, ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.
Updated efficacy analyses were performed with additional confirmed COVID-19 cases accrued during blinded placebo-controlled follow-up through 13 March 2021, representing up to 6 months of follow up after Dose 2 for participants in the efficacy population.
The updated vaccine efficacy information is presented in Table 13.

Efficacy against severe COVID-19 in participants 12 years of age or older - after 2 doses.

As of 13 March 2021, vaccine efficacy against severe COVID-19 is presented only for participants with or without prior SARS-CoV-2 infection (see Table 14) as the COVID-19 case counts in participants without prior SARS-CoV-2 infection were the same as those in participants with or without prior SARS-CoV-2 infection in both the Comirnaty (tozinameran) and placebo groups.

Efficacy and immunogenicity in adolescents 12 to 15 years of age - after 2 doses.

An analysis of Study C4591001 has been performed in adolescents 12 to 15 years of age up to a data cut-off date of 13 March 2021.
In an analysis of Study C4591001 in adolescents 12 to 15 years of age without evidence of prior infection, there were no cases in 1005 participants who received the vaccine and 16 cases out of 978 who received placebo. The point estimate for efficacy is 100% (95% confidence interval 75.3, 100.0). In participants with or without evidence of prior infection there were 0 cases in the 1119 who received vaccine and 18 cases in 1110 participants who received placebo. This also indicates the point estimate for efficacy is 100% (95% confidence interval 78.1, 100.0). No cases of severe disease occurred in adolescents.
In Study C4591001, an analysis of SARS-CoV-2 neutralising titres in a randomly selected subset of participants was performed to demonstrate non-inferior immune responses (within 1.5-fold) comparing adolescents 12 to 15 years of age to participants 16 to 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection. The immune response to Comirnaty (tozinameran) in adolescents 12 to 15 years of age (n = 190) was non-inferior to the immune response in participants 16 to 25 years of age (n = 170), based on results for SARS CoV-2 neutralising titres at 1 month after Dose 2. The geometric mean titres (GMT) ratio of the adolescents 12 to 15 years of age group to the participants 16 to 25 years of age group was 1.76, with a 2 sided 95% CI of 1.47 to 2.10, meeting the 1.5-fold non inferiority criterion (the lower bound of the 2 sided 95% CI for the geometric mean ratio [GMR] > 0.67).
An updated efficacy analysis of Study C4591001 has been performed in approximately 2,260 adolescents 12 to 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cut off date of 2 September 2021, representing up to 6 months of follow-up after Dose 2 for participants in the efficacy population. The dominant SARS-CoV-2 variant at the time of the efficacy study was B.1.1.7 (Alpha).
The updated vaccine efficacy information in adolescents 12 to 15 years of age is presented in Table 15.

Efficacy in children 5 to < 12 years of age - after 2 doses.

A descriptive interim efficacy analysis of Study C4591007 has been performed in 1,968 children 5 to 11 years of age without evidence of infection prior to 7 days after Dose 2. This analysis evaluated confirmed symptomatic COVID-19 cases accrued up to a data cut off date of 8 October 2021.
The descriptive vaccine efficacy results in children 5 to 11 years of age without evidence of prior SARS CoV 2 infection are presented in Table 16. None of the cases accrued met criteria for severe COVID-19 or multisystem inflammatory syndrome in children (MIS-C). No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.

Immunogenicity in children 5 to < 12 years of age - after 2 doses.

Study C4591007 is a Phase 1/2/3 study comprised of an open-label vaccine dose finding portion (Phase 1) and a multicentre, multinational, randomised, saline placebo-controlled, observer-blind efficacy portion (Phase 2/3) that has enrolled participants 5 to < 12 years of age.
In C4591007, an analysis of SARS-CoV-2 50% neutralising titres (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated effectiveness by immunobridging of immune responses comparing children 5 to < 12 years of age in the Phase 2/3 part of Study C4591007 to participants 16 to 25 years of age in the Phase 2/3 part of Study C4591001 who had no serological or virological evidence of past SARS CoV-2 infection up to 1 month after Dose 2, meeting the prespecified immunobridging criteria for both the geometric mean ratio (GMR) and the seroresponse difference with seroresponse defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from baseline (before Dose 1).
The ratio of the SARS-CoV-2 NT50 in children 5 to < 12 years of age to that of young adults 16 to 25 years of age was 1.04 (2-sided 95% CI: 0.93, 1.18), as presented in Table 17.
Among participants without prior evidence of SARS-CoV-2 infection up to 1 month after Dose 2, 99.2% of children 5 to < 12 years of age and 99.2% of participants 16 to 25 years of age had a seroresponse from before vaccination to 1 month after Dose 2. The difference in proportions of participants who had seroresponse between the 2 age groups (children - young adult) was 0.0% (2 sided 95% CI: -2.0%, 2.2%) as presented in Table 18.

Efficacy and immunogenicity in infants and children 6 months to < 5 years of age - 3-dose primary course.

A preliminary descriptive efficacy analysis was performed across the combined population of participants 6 months to < 5 years of age based on cases confirmed among 992 participants in the Comirnaty (tozinameran) group and 464 participants in the placebo group who received all 3 doses of study intervention during the blinded follow-up period. The observed vaccine efficacy from at least 7 days after Dose 3 to the cutoff date (29 April 2022) was 80.3% (2 sided 95% CI: 13.9, 96.7) based on 3 cases in the Comirnaty (tozinameran) group and 7 cases in the placebo group, adjusted for surveillance time (noting 2:1 randomisation ratio). Vaccine efficacy analyses were associated with wide confidence intervals. In addition, the preliminary nature of the data (prespecified number of cases not yet reached in Study C4591007) may preclude any definitive vaccine efficacy conclusions.
Children 2 to < 5 years of age - after 3 doses. A descriptive efficacy analysis of Study C4591007 has been performed in participants 2 to < 5 years of age. This analysis evaluated confirmed symptomatic COVID-19 cases accrued up to a data cutoff date of 29 April 2022.
Dosing intervals: In the evaluable efficacy population, there was a wide dosing interval range between Comirnaty (tozinameran) Dose 2 and Dose 3 for participants 2 to < 5 years of age was 6.0 to 34.1 weeks with a median interval of 11.0 weeks.
The descriptive vaccine efficacy results after Dose 3 in participants 2 to < 5 years of age are presented in Table 19.
Additional evaluation of vaccine efficacy for cases confirmed at least 7 days after Dose 2 and before Dose 3 was performed. In the evaluable efficacy population in participants without prior evidence of SARS-CoV-2 infection before or during the vaccination regimen the observed vaccine efficacy from at least 7 days after Dose 2 and before Dose 3 was 35.9% (2 sided 95% CI: 11.0, 53.7). The vaccine efficacy in participants with or without prior evidence of SARS-CoV-2 infection before or during the vaccination regimen was similar.
Analysis of COVID-19 cases that excluded those involving coinfection with other respiratory pathogens did not meaningfully impact the estimated vaccine efficacy in this population.
Severe COVID-19 criteria (as described in the protocol, based on FDA definition and modified for children) were fulfilled for 7 cases [6 Comirnaty (tozinameran) and 1 placebo] among participants 2 to < 5 years of age, of which 5 of the 6 cases in the Comirnaty group fulfilled a single criterion of increased heart rate or respiratory rate and 1 case in the placebo group fulfilled a single criterion of decreased peripheral oxygen saturation (88% on room air). None of the cases accrued met criteria for multisystem inflammatory syndrome in children (MIS-C).
Immunogenicity analyses have been performed in the immunobridging subset of 143 C4591007 participants 2 to < 5 years of age without evidence of infection up to 1 month after Dose 3 based on a data cutoff date of 29 April 2022.
SARS-CoV-2 50% neutralising antibody titres (NT50) were compared between an immunogenicity subset of Phase 2/3 participants 2 to < 5 years of age from C4591007 at 1 month after the 3-dose primary course and a randomly selected subset from C4591001 Phase 2/3 participants 16 to 25 years of age at 1 month after the 2 dose primary course, using a microneutralisation assay against the reference strain (USA_WA1/2020). The primary immunobridging analyses compared the geometric mean titres (using a geometric mean ratio [GMR]) and the seroresponse (defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from before Dose 1) rates in the evaluable immunogenicity population of participants without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 3 in participants 2 to < 5 years of age and up to 1 month after Dose 2 in participants 16 to 25 years of age. The prespecified immunobridging criteria were met for both the GMR and the seroresponse difference (Table 20 and Table 21, respectively).

Omicron and Delta variants.

Using a non-validated fluorescence focus reduction neutralisation test assay against the Omicron variant of SARS-CoV-2 (BA.1), the NT50 GMT at 1 month after Dose 3 among a subset of 34 study participants without evidence of prior SARS-CoV-2 infection (82.5 [2-sided 95% CI: 55.4, 122.9]) was increased compared to the NT50 GMT before Dose 3 (14.0 [2-sided 95% CI: 10.6, 18.5]).
By comparison, in the same subset of 34 study participants without evidence of prior SARS-CoV-2 infection, there were notable higher NT50 GMTs at 1 month after Dose 3 against the Delta variant and wildtype SARS-CoV-2 (471.4 [2-sided 95% CI: 341.2, 651.1] and 471.4 [2-sided 95% CI: 344.6, 644.8], respectively). The NT50 GMTs before Dose 3 against the Delta variant and wildtype SARS-CoV-2 were 68 [2-sided 95% CI: 49.5, 93.3] and 70.1 [2-sided 95% CI: 51.1, 96], respectively.
An additional descriptive immunogenicity analysis was performed for participants 2 to < 5 years of age who received a 3-dose course of Comirnaty (tozinameran) in Phase 2/3 C4591007, compared with a subset of participants 18 to 50 years of age in Phase 3 Study C4591017 who had received a 2-dose primary course followed by a booster dose of Comirnaty 30 microgram. The comparator group (participants 18 to 50 years of age) in this analysis had a similar interval between Comirnaty (tozinameran) Dose 2 and Dose 3 (median 13.0 weeks) as the participants 2 to < 5 years of age (median 10.6 weeks). Among 34 participants 2 to < 5 years of age without evidence of prior SARS CoV-2 infection who received 3 doses of Comirnaty 3 microgram, neutralising GMTs were 114.3 at 1-month post-Dose 3. Among 27 participants 18 to 50 years of age without evidence of prior SARS CoV 2 infection who received 3 doses of Comirnaty 30 microgram, Omicron neutralising GMTs were 164.2 at 1-month post Dose 3.
Infants 6 months to < 2 years of age - after 3 doses. A descriptive efficacy analysis of C4591007 has been performed in participants 6 months to < 2 years of age. This analysis evaluated confirmed symptomatic COVID-19 cases accrued up to a data cutoff date of 29 April 2022.
Dosing intervals: In the evaluable efficacy population, there was a wide dosing interval range between Comirnaty (tozinameran) Dose 2 and Dose 3 for participants 6 months to < 2 years of age was 8.0 to 31.9 weeks with a median interval of 16.0 weeks.
The descriptive vaccine efficacy results after dose 3 in participants 6 months to < 2 years of age are presented in Table 22.
Additional evaluation of vaccine efficacy for cases confirmed at least 7 days after Dose 2 and before Dose 3 was performed. In the evaluable efficacy population in participants without prior evidence of SARS-CoV-2 infection before or during the vaccination regimen the observed vaccine efficacy from at least 7 days after Dose 2 and before Dose 3 was 16.1% (2 sided 95% CI: -24.9, 43.1). The vaccine efficacy in participants with or without prior evidence of SARS-CoV-2 infection before or during the vaccination regimen was similar.
Analysis of COVID-19 cases that excluded those involving coinfection with other respiratory pathogens did not meaningfully impact the estimated vaccine efficacy in this population.
One participant in the placebo group, had confirmed COVID-19 which met a single severe case criterion described in the protocol (increased heart rate [172 bpm]). None of the cases accrued met criteria for multisystem inflammatory syndrome in children (MIS-C).
Immunogenicity analyses have been performed in the immunobridging subset of 82 C4591007 participants 6 months to < 2 years of age without evidence of infection up to 1 month after Dose 3 based on a data cutoff date of 29 April 2022.
SARS-CoV-2 50% neutralising antibody titres (NT50) 1 month after the vaccination course were compared between an immunogenicity subset of Phase 2/3 participants 6 months to < 2 years of age from C4591007 and a randomly selected subset from C4591001 Phase 2/3 participants 16 to 25 years of age, using a microneutralisation assay against the reference strain (USA_WA1/2020). The primary immunobridging analyses compared the geometric mean titres (using a GMR) and the seroresponse (defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from before Dose 1) rates in the evaluable immunogenicity population of participants without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 3 in participants 6 months to < 2 years of age and up to 1 month after Dose 2 in participants 16 to 25 years of age. The prespecified immunobridging criteria were met for both the GMR and the seroresponse difference (Table 23 and Table 24, respectively).

Omicron and Delta variants.

Using a non-validated fluorescence focus reduction neutralisation test assay against the Omicron variant of SARS-CoV-2 (BA.1), the NT50 GMT at 1 month after Dose 3 among a subset of 32 study participants without evidence of prior SARS-CoV-2 infection (127.5 [2-sided 95% CI: 90.2, 180.1]) was increased compared to the NT50 GMT before Dose 3 (16.3 [2-sided 95% CI: 12.8, 20.8]).
By comparison, in the same subset of 32 study participants without evidence of prior SARS-CoV-2 infection, there were notable higher NT50 GMTs at 1 month after Dose 3 against the Delta variant and wildtype SARS-CoV-2 (606.3 [2-sided 95% CI: 455.5, 806.9] and 640.0 [2-sided 95% CI: 502.6, 815.0], respectively). The NT50 GMTs before Dose 3 against the Delta variant and wildtype SARS-CoV-2 were 94.1 [2-sided 95% CI: 67.9, 130.5] and 103.7 [2-sided 95% CI: 78.4, 137.3], respectively.
An additional descriptive immunogenicity analysis was performed for participants 6 months to < 2 years of age who received a 3-dose course of Comirnaty (tozinameran) in Phase 2/3 C4591007, compared with a subset of participants 18 to 50 years of age in Phase 3 Study C4591017 who had received a 2-dose primary course followed by a booster dose of Comirnaty 30 microgram. The comparator group (participants 18 to 50 years of age) in this analysis had a similar interval between Comirnaty (tozinameran) Dose 2 and Dose 3 (median 13.0 weeks) as the participants 6 months to < 2 years of age (median 12.9 weeks). Among 32 participants 6 months to < 2 years of age without evidence of prior SARS CoV 2 infection who received 3 doses of Comirnaty 3 microgram, Omicron neutralising GMTs were 128.8 at 1-month post-Dose 3. Among 27 participants 18 to 50 years of age without evidence of prior SARS-CoV-2 infection who received 3 doses of Comirnaty (tozinameran) 30 microgram, Omicron neutralising GMTs were 164.2 at 1-month post Dose 3.

Immunogenicity in participants 18 years of age and older - after booster dose.

Effectiveness of a booster dose of Comirnaty (tozinameran) was based on an assessment of 50% neutralising titres (NT50) against SARS-CoV-2 (USA_WA1/2020). In Study C4591001, analyses of NT50 1 month after the booster dose compared to 1 month after the primary series in individuals 18 to 55 years of age who had no serological or virological evidence of past SARS CoV-2 infection up to 1 month after the booster vaccination demonstrated noninferiority for both GMR and difference in seroresponse rates. Seroresponse for a participant was defined as achieving a ≥ 4-fold rise in NT50 from baseline (before Dose 1), These analyses are summarised in Table 25.

Relative vaccine efficacy in participants 16 years of age and older - after booster dose.

An interim efficacy analysis of Study C4591031, a placebo-controlled booster study, was performed in approximately 10,000 participants 16 years of age and older who were recruited from Study C4591001, evaluated confirmed COVID-19 cases accrued from at least 7 days after booster vaccination up to a data cut-off date of 8 February 2022 (a period when Delta and then Omicron was the predominant variant), which represents a median of 2.8 months (range 0.3 to 7.5 months) post-booster follow-up. Vaccine efficacy of the Comirnaty (tozinameran) booster dose after the primary series relative to the placebo booster group who only received the primary series dose was assessed. The relative vaccine efficacy information for participants 16 years of age and older is presented in Table 26.

Immunogenicity in children 5 to < 12 years of age - after booster dose.

In a subset from C4591007, a total of 123 children 5 to < 12 years of age received a booster dose of Comirnaty (tozinameran) 10 microgram after completing the primary series. All participants in the 3-Dose immunogenicity subset, received the booster dose 7 - < 9 months after Dose 2, (n = 37 [30.1%] at 7 - < 8 months and n = 86 [69.9%] at 8 - < 9 months).
Effectiveness of a booster dose of Comirnaty (tozinameran) was based on an assessment of NT50 against the reference strain of SARS CoV 2 (USA_WA1/2020). Analyses of NT50 1 month after the booster dose compared to before the booster dose demonstrated an increase in GMTs in individuals 5 to < 12 years of age who had no serological or virological evidence of past SARS CoV-2 infection up to 1 month after the booster dose. This analysis is summarised in Table 27.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity/ carcinogenicity.

Neither genotoxicity nor carcinogenicity studies were performed. The components of Comirnaty JN.1 (lipids and mRNA) are not expected to have genotoxic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315); 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159); distearoylphosphatidylcholine (DSPC); cholesterol; trometamol; trometamol hydrochloride; sucrose; water for injections.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in Section 4.2 Dose and Method of Administration.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Unopened vial.

Comirnaty JN.1 may be received frozen at -90°C to -60°C or at -25°C to -15°C. Frozen vaccine can be stored either at -90°C to -60°C or 2°C to 8°C upon receipt.
Once removed from frozen storage, the unopened vial may be stored refrigerated at 2°C to 8°C for a single period of up to 10 weeks within the shelf life.
Upon moving the product to 2°C to 8°C storage, the updated expiry date must be written on the outer carton and the vaccine should be used or discarded by the updated expiry date. The original expiry date should be crossed out.
If the vaccine is received at 2°C to 8°C it should be stored at 2°C to 8°C. Check that the expiry date on the outer carton has been updated to reflect the refrigerated expiry date and that the original expiry date has been crossed out.
When stored frozen at -90°C to -60°C, the vaccine can be thawed at either 2°C to 8°C or at temperatures up to 30°C.
Vaccine may be stored at temperatures between 8°C to 30°C for up to 24 hours, including any time within these temperatures following first puncture.
Thawed vials can be handled in room light conditions.
Once thawed, the vaccine should not be re-frozen.

Comirnaty JN.1 - suspension for injection (grey or blue cap).

Opened vial.

Chemical and physical in-use stability has been demonstrated for 12 hours at 2°C to 30°C. From a microbiological point of view, unless the method of opening precludes the risks of microbial contamination, the product should be used immediately after the first puncture. If not used immediately, in-use storage times and conditions cannot be longer than 12 hours at 2°C to 30°C.

Comirnaty JN.1 - concentrated suspension for injection (orange or maroon or yellow cap).

Diluted medicinal product.

Chemical and physical in-use stability has been demonstrated for 12 hours at 2°C to 30°C, after dilution with sodium chloride 9 mg/mL (0.9%) solution for injection. From a microbiological point of view, unless the method of opening precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions cannot be longer than 12 hours at 2°C to 30°C.

Comirnaty JN.1 - single dose glass prefilled syringes, 30 microgram, intended for refrigerated storage.

Comirnaty glass prefilled syringes may be stored at 2°C to 8°C until the expiration date printed on the carton and syringe labels. Do not freeze.
The total time out of refrigeration (at temperatures between 8°C and 30°C) must not exceed 12 hours.

Comirnaty JN.1 - single dose plastic prefilled syringes, 30 microgram.

Comirnaty plastic prefilled syringes may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Once received, frozen plastic prefilled syringes may be immediately transferred to the refrigerator at 2°C to 8°C, thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. Cartons of 10 single dose plastic prefilled syringes may take up to 2 hours to thaw at this temperature. Once thawed, they should not be refrozen.
Alternatively, frozen plastic prefilled syringes may be stored in an ultra-low temperature freezer at-90°C to -60°C. Do not store prefilled syringes at -25°C to -15°C.
Cartons of Comirnaty plastic prefilled syringes may be received at 2°C to 8°C, and they should be stored at 2°C to 8°C. Check that the carton has been previously updated to reflect the 10-week refrigerated expiry date.
The total time out of refrigeration (at temperatures between 8°C and 30°C) must not exceed 12 hours.

6.4 Special Precautions for Storage

Thawing and storage of vials.

Store in the original package in order to protect from light.
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
When stored frozen at -90°C to -60°C, the vaccine can be thawed at either 2°C to 8°C or at room temperature (up to 30°C). For detailed instructions see Section 4.2 Dose and Method of Administration Handling instructions (Handling prior to use) for appropriate dosage form.
Once thawed, the vaccine cannot be re-frozen.
Thawed vials can be handled in room light conditions.

Storage of glass prefilled syringes.

After removing the tip cap and attaching an appropriate needle, the glass prefilled syringe should be used immediately. If it cannot be used immediately, it must be used within 4 hours.

Thawing and storage of plastic prefilled syringes.

Frozen Comirnaty plastic prefilled syringes should be thawed in the carton, preferably at 2°C to 8°C for 2 hours. A full carton of plastic prefilled syringes may also be thawed at room temperature (up to 30°C) for 60 minutes. Plastic prefilled syringes thawed in the carton by either method may be stored in the refrigerator for 10 weeks. If individual frozen plastic prefilled syringes are thawed at room temperature outside of the carton, they can be kept at room temperature and must be used within 4 hours of thawing.
After removing the tip cap and attaching an appropriate needle, the plastic prefilled syringe should be used immediately. If it cannot be used immediately, it must be used within 4 hours.
For storage conditions after thawing and dilution of the medicinal product, see Section 6.3 Shelf Life.
For additional advice on storing Comirnaty JN.1, contact Pfizer Australia on 1800 675 229.

6.5 Nature and Contents of Container

Comirnaty JN.1 - suspension for injection (grey or blue cap).

2 mL clear vial (Type I glass) with a stopper (synthetic bromobutyl rubber) and a Grey or Blue flip-off plastic cap with aluminium seal. Each vial contains either 1 or 6 doses, see Section 4.2 Dose and Method of Administration.
Light Grey or Light Blue cap: single dose vial.
Dark Grey or Dark Blue cap: 6 dose multidose vial.

Comirnaty JN.1 - concentrated suspension for injection (orange or maroon or yellow cap).

2 mL clear multidose vial (Type I glass) with a stopper (synthetic bromobutyl rubber) and an Orange or a Maroon or a Yellow flip-off plastic cap with aluminium seal. Each vial contains 10 or 3 doses after dilution, see Section 4.2 Dose and Method of Administration.
Orange or Maroon cap: 10 dose multidose vial after dilution.
Yellow cap: 3 dose multidose vial after dilution.
Pack size: 10 vials, 195 vials.

Comirnaty JN.1 prefilled glass syringe.

1 mL clear glass syringe (Type I glass) with polypropylene rigid cap with a 1 mL plunger stopper (bromobutyl elastomer). Each prefilled glass syringe contains 1 dose.
Pack size: 10 Prefilled glass syringes.

Comirnaty JN.1 prefilled plastic syringe.

1 mL transparent plastic (cyclic-olefin-copolymer plastic) syringe with polycarbonate rigid cap with a 1 mL plunger stopper (bromobutyl elastomer). Each prefilled plastic syringe contains 1 dose.
Pack size: 10 Prefilled plastic syringes.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

CAS number.

3026600-00-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes