Consumer medicine information

Comirnaty Original/Omicron BA.1 COVID-19 Vaccine

Tozinameran; Riltozinameran

BRAND INFORMATION

Brand name

Comirnaty Original/Omicron BA.1

Active ingredient

Tozinameran; Riltozinameran

Schedule

SUMMARY CMI

COMIRNATY^® Original/Omicron BA.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 Original/Omicron BA.1?

COMIRNATY Original/Omicron BA.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, 18 years of age and older. COMIRNATY Original/Omicron BA.1 contains the active ingredients tozinameran and riltozinameran. For more information, see Section 1. Why am I being given COMIRNATY Original/Omicron BA.1? in the full CMI.

2. What should I know before I am given COMIRNATY Original/Omicron BA.1?

You should not be given COMIRNATY Original/Omicron BA.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 COMIRNATY 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. As with any vaccine, COMIRNATY Original/Omicron BA.1 may not fully protect all those who receive it, and it is not known how long you will be protected. 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. This vaccine should not be given to adolescents or children under 18 years. For more information, see Section 2. What should I know before I am given COMIRNATY Original/Omicron BA.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 Original/Omicron BA.1?

COMIRNATY Original/Omicron BA.1 will be given as an injection into the muscle of your upper arm by a doctor, nurse or pharmacist. You will be given one dose at least 5 months after the primary course. A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given the vaccine. COMIRNATY Original/Omicron BA.1 is only given as booster doses. For primary vaccination, ask your doctor or pharmacist. For more information, see Section 4. How will I be given COMIRNATY Original/Omicron BA.1? in the full CMI.

5. What should I know while being given COMIRNATY Original/Omicron BA.1?

Things you should know	An initial dose of COMIRNATY Original/Omicron BA.1 may be given as a booster at least 5 months after the primary vaccination for people 18 years of age and older. COMIRNATY Original/Omicron BA.1 may also be given as a booster dose in individuals 18 years of age and older who have received a primary vaccination comprised of another COVID-19 vaccine.
Driving or using machines	Be careful before you drive or use any machines or tools until you know how the vaccine affects you. Some of the side effects of the vaccine may temporarily affect your ability to drive or use machines.

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

6. Are there any side effects?

Very common side effects of COMIRNATY Original/Omicron BA.1 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^® Original/Omicron BA.1 COVID-19 VACCINE

Active ingredients: tozinameran and riltozinameran

This vaccine has provisional approval in Australia to prevent COVID-19 disease caused by SARS-CoV-2 virus in adults, 18 years of age and older. This approval has been granted on the basis of short term safety and efficacy data. Evidence of longer term efficacy and safety from ongoing clinical trials and vaccination in the community continues to be gathered and assessed.

Consumer Medicine Information (CMI)

This leaflet provides important information about using COMIRNATY Original/Omicron BA.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 Original/Omicron BA.1.

Where to find information in this leaflet:

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

1. Why am I being given COMIRNATY Original/Omicron BA.1?

COMIRNATY Original/Omicron BA.1 contains the active ingredients tozinameran and riltozinameran. COMIRNATY Original/Omicron BA.1 is an mRNA (messenger ribonucleic acid) vaccine.

COMIRNATY Original/Omicron BA.1 is a vaccine given to prevent COVID-19 disease caused by SARS-CoV-2 virus in adults, 18 years of age and older.

COMIRNATY Original/Omicron BA.1 is only given as booster doses. For primary vaccination, ask your doctor or pharmacist.

COMIRNATY Original/Omicron BA.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 Original/Omicron BA.1?

Warnings

COMIRNATY Original/Omicron BA.1 should not be given:

if you are allergic to tozinameran, riltozinameran 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 COMIRNATY 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 occurred in younger men. 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.

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 Original/Omicron BA.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 Original/Omicron BA.1 should not be given to adolescents or children under 18 years.

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 Original/Omicron BA.1.

4. How will I be given COMIRNATY Original/Omicron BA.1?

COMIRNATY Original/Omicron BA.1 will be given as an injection into the muscle of your upper arm by a doctor, nurse or pharmacist.
An initial dose of COMIRNATY Original/Omicron BA.1 may be given as a booster at least 5 months after the primary vaccination for people 18 years of age and older.
A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given COMIRNATY Original/Omicron BA.1.
COMIRNATY Original/Omicron BA.1 is only given as booster doses. For primary vaccination, ask your doctor or pharmacist.

5. What should I know while being given COMIRNATY Original/Omicron BA.1?

Things you should know

An initial dose of COMIRNATY Original/Omicron BA.1 may be given as a booster at least 5 months after the primary vaccination for people 18 years of age and older.
COMIRNATY Original/Omicron BA.1 may also be given as a booster dose in individuals 18 years of age and older who have received a primary vaccination comprised of another COVID-19 vaccine

Driving or using machines

Be careful before you drive or use any machines or tools until you know how COMIRNATY Original/Omicron BA.1 affects you.

Some of the side effects of COMIRNATY Original/Omicron BA.1 may temporarily affect your ability to drive 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 effects	What to do
pain/swelling at injection site tiredness headache muscle pain chills joint pain fever	Speak to your doctor if you have any of these very common side effects and they worry you.

Common side effects

Common side effects	What 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 effects	What to do
enlarged lymph nodes feeling unwell arm pain insomnia decreased appetite 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 effects	What 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 headache (including migraine)	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 Original/Omicron BA.1 contains

Active ingredients (main ingredients)	Tozinameran Riltozinameran
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 Original/Omicron BA.1 looks like

COMIRNATY Original/Omicron BA.1 is a white to off-white suspension.

COMIRNATY Original/Omicron BA.1 is provided in packs of 10 and 195 in multidose clear glass vials with grey flip-off caps. Each dose is 0.3 mL and each vial contains 6 doses of vaccine (2.25 mL fill).

AUST R 394890.

Not all presentations may be available.

Who distributes COMIRNATY Original/Omicron BA.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 April 2024.

Published by MIMS May 2024

BRAND INFORMATION

Brand name

Comirnaty Original/Omicron BA.1

Active ingredient

Tozinameran; Riltozinameran

Schedule

1 Name of Medicine

Tozinameran and Riltozinameran.

2 Qualitative and Quantitative Composition

Tozinameran 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) (Original).
Riltozinameran 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 SARS-CoV-2 (Omicron BA.1).
This is a multidose vial with a grey cap. Do not dilute prior to use.
One vial (2.25 mL) contains 6 doses of 0.3 mL.
One dose (0.3 mL) contains 15 micrograms of tozinameran and 15 micrograms of riltozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles). For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.
The vaccine is a white to off-white frozen suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Comirnaty Original/Omicron BA.1 Vaccine has provisional approval for the indication below:
As a booster dose for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 18 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
The decision has been made on the basis of short term immunogenicity and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

4.2 Dose and Method of Administration

Dosage.

Booster dose in individuals 18 years of age and older.

A booster dose of Comirnaty Original/Omicron BA.1 may be administered intramuscularly at least 5 months after the completion of a COVID-19 vaccine primary series in individuals 18 years of age and older.
Comirnaty Original/Omicron BA.1 may also be given as a booster dose in individuals 18 years of age and older who have received a primary course comprised of another COVID-19 vaccine.
The decision when and for whom to implement a booster dose should be made based on available vaccine safety and immunogenicity data (see Section 4.4 Special Warnings and Precautions for Use; Section 5.1 Pharmacodynamic Properties), in accordance with official recommendations.

Primary vaccination course.

Comirnaty Original/Omicron BA.1 is indicated only for booster doses.
For details on the primary vaccination course for ages 12 and above, please refer to the Product Information for Comirnaty (tozinameran) 30 micrograms/dose for injection.

Elderly population.

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

Method of administration.

Comirnaty Original/Omicron BA.1 should be administered intramuscularly. The preferred site of administration is the deltoid muscle of the upper arm.
Do not inject Comirnaty Original/Omicron BA.1 intravascularly, subcutaneously or intradermally.
Comirnaty Original/Omicron BA.1 should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering Comirnaty Original/Omicron BA.1, see Section 4.4 Special Warnings and Precautions for Use.
Vials of Comirnaty Original/Omicron BA.1 have a grey cap, contain six doses of 0.3 mL of vaccine and do not require dilution. In order to extract six doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:
Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Do not pool excess vaccine from multiple vials.
For instructions on the handling, thawing and dose preparation of the vaccine before administration see Handling instructions.

Handling instructions.

Comirnaty Original/Omicron BA.1 for individuals 18 years of age and older should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared suspension.
Comirnaty Original/Omicron BA.1 (for age 18 years and above, do not dilute).

Dose verification.

Verify that the vial has a grey plastic cap and a grey border around the label and the product name is Comirnaty Original/Omicron BA.1 15/15 micrograms per dose suspension for injection.
If the vial has a grey plastic cap and a grey border and the product name is Comirnaty 30 micrograms/dose suspension for injection, please refer to the Product Information for this formulation.
If the plastic cap and border around the label have another colour, such as purple or orange, please refer to Product Information for these Comirnaty vaccines.

Handling prior to use.

If the multidose vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of 2°C to 8°C to thaw; a 10 vial pack may take 6 hours to thaw. Ensure vials are completely thawed prior to use.
Update the expiry date on the carton.
Unopened vials can be stored for up to 10 weeks at 2°C to 8°C.
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30°C for immediate use.
Gently mix by inverting vial 10 times prior to use. Do not shake.
Prior to mixing, the thawed suspension may contain white to off-white opaque amorphous particles.
After mixing, the vaccine should present as a white to off-white suspension with no particulates visible. Do not use the vaccine if particulates or discoloration are present.

Preparation of individual 0.3 mL doses.

Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw 0.3 mL of Comirnaty Original/Omicron BA.1.
Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
Each dose must contain 0.3 mL of vaccine.
Discard syringe and needle after administration to a single patient.
Use a new, sterile needle and syringe to draw up each new dose.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Discard any unused vaccine 12 hours after first puncture. Record the appropriate date/time on the vial.

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 the vaccine.
The individual should be kept under close observation for at least 15 minutes following vaccination. Comirnaty Original/Omicron BA.1 should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty.

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. 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.
The risk of myocarditis after a booster dose of Comirnaty or Comirnaty Original/Omicron BA.1 has not yet been characterised.
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, the vaccine 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 Original/Omicron BA.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 Original/Omicron BA.1 may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of the vaccine.

Use in the elderly.

Clinical studies of Comirnaty Original/Omicron BA.1 include participants 55 years of age and older and their data contributes to the overall assessment of safety and immunogenicity. See Section 5.1 Pharmacodynamic Properties, Clinical trials, Relative vaccine immunogenicity in participants greater than 55 years of age - after bivalent Omicron BA.1 (second booster dose). No dosage adjustment is required in elderly individuals ≥ 65 years of age.
The data for use in the frail elderly 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.

Paediatric use.

The safety and efficacy of Comirnaty Original/Omicron BA.1 in individuals aged less than 18 years of age have not yet been established.
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 Original/Omicron BA.1 with other vaccines has not been studied.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no animal reproductive toxicity studies with Comirnaty Original/Omicron BA.1.
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 Original/Omicron BA.1 during pregnancy.
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 Original/Omicron BA.1 in pregnancy should only 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 Original/Omicron BA.1 during breast-feeding.
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 Original/Omicron BA.1 has no, or negligible, influence on the ability to drive and use machines. However, some of the effects mentioned under Section 4.8 Adverse Effects (Undesirable Effects) may temporarily affect the ability to drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

Summary of safety profile.

Comirnaty Original/Omicron BA.1 (tozinameran/riltozinameran).

Participants 55 years of age and older - after bivalent Omicron BA.1 booster dose.

In a subset from Study C4591031 (Phase 3), 305 adults greater than 55 years of age who had completed 3 doses of Comirnaty, received a booster (fourth dose) of Comirnaty Original/Omicron BA.1 (15/15 micrograms) 4.7 to 11.5 months after receiving Dose 3. Participants who received a booster (fourth dose) of Comirnaty Original/Omicron BA.1 had a median follow-up time of at least 1.7 months.
The overall safety profile for the Comirnaty Original/Omicron BA.1 booster (fourth dose) was similar to that seen after the Comirnaty booster (third dose). The most frequent adverse reactions in participants greater than 55 years of age were injection site pain (> 50%), fatigue (> 40%), headache (> 30%), myalgia (> 20%), chills and arthralgia (> 10%). No new adverse reactions were identified for Comirnaty Original/Omicron BA.1.

Participants 18 to ≤ 55 years of age - after monovalent Omicron BA.1 booster dose.

The safety of a Comirnaty Original/Omicron BA.1 booster dose in individuals from 18 to ≤ 55 years of age is extrapolated from safety data from a subset of 315 adults 18 to ≤ 55 years of age who received a booster (fourth dose) of Omicron BA.1 30 micrograms (monovalent) after completing 3 doses of Comirnaty. The most frequent adverse reactions in these participants 18 to ≤ 55 years of age were injection site pain (> 70%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills (> 30%) and arthralgia (> 20%).
Comirnaty (tozinameran). The safety of Comirnaty was evaluated in participants 5 years of age and older in 3 clinical studies that included 24,675 participants (comprised of 22,026 participants 16 years of age and older, 1,131 adolescents 12 to 15 years of age and 1,518 children 5 to < 12 years of age) that have received at least one dose of Comirnaty.
Additionally, 306 existing Phase 3 participants 18 to 55 years of age received a booster dose of Comirnaty 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.

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 30 micrograms 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 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 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 and 7,407 placebo) participants 16 to 55 years of age and a total of 10,540 (5,327 Comirnaty 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, 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.

Participants 18 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 original Comirnaty 2-dose course, received a booster dose of Comirnaty approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2.
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%).

Tabulated list of adverse reactions from clinical studies.

Adverse reactions observed during clinical studies are listed in Table 1 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).

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 Table 2.

Post-marketing experience.

Although the events listed in Table 3 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.

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 micrograms 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: J07BX03.

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. The vaccine elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute to protection against COVID-19.

Clinical trials.

Immunogenicity.

Comirnaty Original/Omicron BA.1 (tozinameran/riltozinameran).

Relative vaccine immunogenicity in participants greater than 55 years of age - after bivalent Omicron BA.1 (second booster dose).

In an interim analysis of a subset from Study C4591031 (Substudy E), 610 adults greater than 55 years of age who had completed a series of 3 doses of Comirnaty received 1 of the following as a booster dose (fourth dose): Comirnaty (30 micrograms) or Comirnaty Original/Omicron BA.1 (15/15 micrograms). GMRs and seroresponse rates were evaluated at 1 month after Comirnaty Original/Omicron BA.1 (15/15 micrograms) booster vaccination up to a data cut-off date of 16 May 2022, which represents a median of 1.7 months post-booster follow-up. The Comirnaty Original/Omicron BA.1 (15/15 micrograms) booster dose was administered 4.7 to 11.5 months (median 6.3 months) after the third dose.
The primary objective of the analysis was to assess superiority with respect to level of neutralising titre and noninferiority with respect to seroresponse rate of the anti-Omicron immune response induced by a dose of Comirnaty Original/Omicron BA.1 (15/15 micrograms) relative to the response elicited by a dose of Comirnaty (30 micrograms) given as a fourth dose in Comirnaty-experienced participants greater than 55 years of age.
Superiority of Comirnaty Original/Omicron BA.1 (15/15 micrograms) to Comirnaty (30 micrograms) were met, as the lower bound of the 2-sided 95% CI for GMR was > 1. See Table 4.

The difference in proportions of participants who achieved seroresponse between the Comirnaty Original/Omicron BA.1 (15/15 micrograms) group and Comirnaty (30 micrograms) group was 14.6 (2-sided 95% CI: 4.0, 24.9). Noninferiority was met, as the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse was > -5% (Table 5).

Comirnaty (tozinameran). 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 preexisting 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 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. 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.
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 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 group and 68 in the placebo group) and 1616 participants 75 years of age and older (804 in the Comirnaty 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 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 efficacy information is presented in Table 6.

In the second primary analysis, efficacy of Comirnaty 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 7.

Efficacy against severe COVID-19 in participants 12 years of age and 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 (Table 8) 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 and placebo groups.

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

Effectiveness of a booster dose of Comirnaty 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 9.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity/carcinogenicity.

Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine (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.

24 months when stored at -90°C to -60°C.
Comirnaty Original/Omicron BA.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 24-month 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.

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 are the responsibility of the user.

6.4 Special Precautions for Storage

Comirnaty Original/Omicron BA.1 can be stored in a refrigerator at 2°C to 8°C for a single period of up to 10 weeks, not exceeding the original expiry date (EXP). Alternatively, the vaccine may be stored in a freezer at -90°C to -60°C. The expiry date for storage at -90°C to -60°C is printed on the vial and outer carton after "EXP".
The vaccine 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. Upon moving the product to 2°C to 8°C storage, the updated expiry 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 has been updated to reflect the refrigerated EXP date and that the original expiry date has been crossed out.
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.
Once thawed, the vaccine cannot be re-frozen.
Thawed vials can be handled in room light conditions.
For storage conditions after thawing and dilution of the medicinal product, see Section 6.3 Shelf Life.
For additional advice on storing Comirnaty Original/Omicron BA.1, contact Pfizer Australia on 1800 675 229.

6.5 Nature and Contents of Container

Comirnaty Original/Omicron BA.1: 2 mL clear multidose vial (Type I glass) with a stopper (synthetic bromobutyl rubber) and a grey flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see Section 4.2 Dose and Method of Administration.
Pack size: 10 vials, 195 vials.

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.

2417899-77-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

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Comirnaty Original/Omicron BA.1 COVID-19 Vaccine

Tozinameran; Riltozinameran

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