Consumer medicine information

Spikevax Bivalent Original/Omicron COVID-19 Vaccine

Elasomeran; Imelasomeran

BRAND INFORMATION

Brand name

Spikevax Bivalent Original/Omicron

Active ingredient

Elasomeran; Imelasomeran

Schedule

SUMMARY CMI

SPIKEVAX BIVALENT ORIGINAL/OMICRON COVID-19 VACCINE

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about being given this vaccine, speak to your healthcare provider.

▼ 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 SPIKEVAX BIVALENT ORIGINAL/OMICRON?

SPIKEVAX BIVALENT ORIGINAL/OMICRON contains the active ingredients elasomeran and imelasomeran. It is a vaccine used as a booster dose to prevent COVID-19 disease caused by SARS-CoV-2 in individuals aged 18 years and older.

For more information, see Section 1. Why am I being given SPIKEVAX BIVALENT ORIGINAL/OMICRON? in the full CMI.

2. What should I know before I am given SPIKEVAX BIVALENT ORIGINAL/OMICRON?

You should not be given SPIKEVAX BIVALENT ORIGINAL/OMICRON if you have ever had an allergic reaction to SPIKEVAX (original) or SPIKEVAX BIVALENT ORIGINAL/OMICRON or any of the ingredients listed at the end of the CMI.

Check with your doctor, pharmacist, or nurse before vaccination if you: have previously had a severe allergic reaction after any other vaccine injection or after you were given SPIKEVAX (original) in the past; have a very weak or poorly functioning immune system; have ever fainted following any needle injection; have a bleeding disorder; have a high fever or severe infection; have any serious illness; have anxiety related to injections.

Talk to your doctor if you have a weakened immune system, have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

SPIKEVAX BIVALENT ORIGINAL/OMICRON should not be given to children and adolescents under the age of 18 years.

For more information, see Section 2. What should I know before I am given SPIKEVAX BIVALENT ORIGINAL/OMICRON? 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 SPIKEVAX BIVALENT ORIGINAL/OMICRON?

Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm. SPIKEVAX BIVALENT ORIGINAL/OMICRON may be given as a booster dose at least 3 months following a primary series and / or previous booster dose with SPIKEVAX (original) or another authorized / approved COVID-19 vaccine. A doctor, pharmacist or nurse will observe you for at least 15 minutes after being given SPIKEVAX BIVALENT ORIGINAL/OMICRON.

More instructions can be found in Section 4. How will I be given SPIKEVAX BIVALENT ORIGINAL/OMICRON? in the full CMI.

5. What should I know about being given SPIKEVAX BIVALENT ORIGINAL/OMICRON?

Things you should know	As with any vaccine, SPIKEVAX BIVALENT ORIGINAL/OMICRON may not fully protect all those who receive it and it is not known how long you will be protected.
Driving or using machines	Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.

For more information, see Section 5. What should I know after being given SPIKEVAX BIVALENT ORIGINAL/OMICRON? in the full CMI.

6. Are there any side effects?

Common side effects include swelling in the underarm, headache, nausea, vomiting, muscle aches, joint aches, and stiffness, pain or swelling at the injection site, feeling very tired, chills, fever, rash, redness, or hives at the injection site.

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

SPIKEVAX BIVALENT ORIGINAL/OMICRON COVID-19 VACCINE

Active ingredients: Elasomeran and imelasomeran

This vaccine has provisional approval in Australia as a booster dose to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals 18 years and older. This approval has been granted on the basis of immunogenicity and short term safety data. Evidence of longer term benefits 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 SPIKEVAX BIVALENT ORIGINAL/OMICRON. You should also speak to your doctor, pharmacist, or nurse if you would like further information or if you have any concerns or questions about using this medicine.

Where to find information in this leaflet:

1. Why am I being given SPIKEVAX BIVALENT ORIGINAL/OMICRON?
2. What should I know before I am given SPIKEVAX BIVALENT ORIGINAL/OMICRON?
3. What if I am taking other medicines?
4. How will I be given SPIKEVAX BIVALENT ORIGINAL/OMICRON?
5. What should I know about being given SPIKEVAX BIVALENT ORIGINAL/OMICRON?
6. Are there any side effects?
7. Product details

1. Why am I being given SPIKEVAX BIVALENT ORIGINAL/OMICRON?

SPIKEVAX BIVALENT ORIGINAL/OMICRON contains the active ingredients elasomeran and imelasomeran. SPIKEVAX BIVALENT ORIGINAL/OMICRON is a vaccine which stimulates the body's natural defenses (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19 disease. It uses a substance called messenger ribonucleic acid (mRNA) to carry instructions to cells in the body that are used to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19 disease.

SPIKEVAX BIVALENT ORIGINAL/OMICRON is used as a booster dose to prevent COVID-19 disease caused by SARS-CoV-2. It is given to individuals aged 18 years and older.

2. What should I know before I am given SPIKEVAX BIVALENT ORIGINAL/OMICRON?

Warnings

You should not be given SPIKEVAX BIVALENT ORIGINAL/OMICRON if:

you are allergic to elasomeran or imelasomeran, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can be given this vaccine.

Check with your doctor, pharmacist, or nurse before vaccination if you:

Have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after you were given SPIKEVAX (original) or SPIKEVAX BIVALENT ORIGINAL/OMICRON in the past.
Have a very weak or poorly functioning immune system.
Have ever fainted following any needle injection.
Have a bleeding disorder.
Have a high fever or severe infection; however, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
Have any serious illness.
Have anxiety related to injections. Anxiety and stress related reactions can occur, however, they will be temporary.
Take any medicines for any other condition.

There is an increased risk for myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with SPIKEVAX (original) or SPIKEVAX BIVALENT ORIGINAL/OMICRON. These conditions can develop within just a few days after vaccination, and have primarily occurred within two weeks. They are seen more often after the second vaccination, and more often occurred in younger men; however, they are also seen in a number of women. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, a noticeably rapid, strong, or irregular heartbeat and chest pain. Additionally, non-specific signs such as feeling very tired, nausea and vomiting, stomach pain, dizziness or fainting, fluid retention and cough have been reported in some recipients with myocarditis or pericarditis. Seek immediate medical attention should these occur.

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?

Capillary leak syndrome (CLS) flare-ups

A few cases of capillary leak syndrome flare-ups (causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint, low blood pressure) have been reported following vaccination with SPIKEVAX (original). If you have previously had episodes of CLS, talk to a doctor before you are given SPIKEVAX BIVALENT ORIGINAL/OMICRON.

If you have a weakened immune system (immunocompromised)

The efficacy of SPIKEVAX BIVALENT ORIGINAL/OMICRON may be lower in people who have weaker immune systems. In these cases, you should continue to maintain physical precautions such as mask wearing and social distancing to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.

Pregnancy and breastfeeding

SPIKEVAX BIVALENT ORIGINAL/OMICRON can be used during pregnancy. A large amount of information from pregnant women vaccinated with SPIKEVAX (original) during the second and third trimester has 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.

Check with your doctor, pharmacist, or nurse if you are pregnant or intend to become pregnant.

SPIKEVAX BIVALENT ORIGINAL/OMICRON can be given during breastfeeding. A large amount of information from breastfeeding women vaccinated with SPIKEVAX (original) has not shown negative effects in breastfed babies.

Talk to your doctor, pharmacist, or nurse if you are breastfeeding or intend to breastfeed.

Use in Children

SPIKEVAX BIVALENT ORIGINAL/OMICRON is not recommended for children and adolescents aged under 18 years.

3. What if I am taking other medicines?

Tell your doctor, pharmacist, or nurse if you are taking 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, pharmacist, or nurse if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SPIKEVAX BIVALENT ORIGINAL/OMICRON.

4. How will I be given SPIKEVAX BIVALENT ORIGINAL/OMICRON?

How much is given

SPIKEVAX BIVALENT ORIGINAL/OMICRON will be given to you as an injection.
Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm.
After the injection of the vaccine, your doctor, pharmacist, or nurse will watch over you for at least 15 minutes to monitor for signs of an allergic reaction.

If you use too much

As SPIKEVAX BIVALENT ORIGINAL/OMICRON is given under the close supervision of a doctor, pharmacist, or nurse it is unlikely that you will be given too much.
If you are concerned that you have been given too much SPIKEVAX BIVALENT ORIGINAL/OMICRON, tell your doctor, pharmacist, or nurse immediately.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know about being given SPIKEVAX BIVALENT ORIGINAL/OMICRON?

Things you should know

As with any vaccine, SPIKEVAX BIVALENT ORIGINAL/OMICRON may not completely protect all those who receive it and it is not known how long you will be protected.

Driving or using machines

Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.

Looking after your vaccine

Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly.

6. Are there any side effects?

All vaccines 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, pharmacist, or nurse if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
Swelling in the underarm Headache Nausea Vomiting Muscle ache, joint aches, and stiffness Heavy menstrual (period) bleeding Pain or swelling at the injection site Feeling very tired Chills Fever Rash Rash, redness, or hives at the injection site (some of which may occur sometime after the injection)	Speak to your doctor, pharmacist, or nurse if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Feeling faint or light-headed Changes in your heartbeat Shortness of breath Wheezing Swelling of your lips, face, or throat Hives or rash Nausea or vomiting Stomach pain Decreased sense of touch or sensation Tingling, pricking or pins and needles feeling	Call your doctor, pharmacist, or nurse straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor, pharmacist, or nurse 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 SPIKEVAX BIVALENT ORIGINAL/OMICRON contains

Active ingredients	Elasomeran and imelasomeran
Other ingredients (Inactive ingredients)	Heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate Cholesterol Distearoylphosphatidylcholine 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 Trometamol Trometamol hydrochloride Acetic acid Sodium acetate trihydrate Sucrose Water for injections

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

What SPIKEVAX BIVALENT ORIGINAL/OMICRON looks like

SPIKEVAX BIVALENT ORIGINAL/OMICRON is a white to off white suspension supplied in a glass vial with a rubber stopper and a plastic flip-off cap with aluminum seal or in a pre-filled syringe:

0.1 mg/ml vial (AUST R 389513)

0.1 mg/ml pre-filled syringe (AUST R 396452)

Not all presentations may be marketed.

Sponsor

Moderna Australia Pty Ltd
Level 6, 60 Martin Place
Sydney,
NSW, 2000
www.modernacovid19global.com/au
Phone: 1800 344 018
Email address: [email protected]

This leaflet was prepared in February 2023.

Published by MIMS April 2023

BRAND INFORMATION

Brand name

Spikevax Bivalent Original/Omicron

Active ingredient

Elasomeran; Imelasomeran

Schedule

1 Name of Medicine

Elasomeran/imelasomeran.

2 Qualitative and Quantitative Composition

See Table 1.
Elasomeran 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.
Imelasomeran contains mRNA, 5'-capped, encoding a full-length, codon-optimised pre-fusion stabilised conformation variant (K983P and V984P) of the SARSCoV-2 spike (S) glycoprotein (Omicron variant, B.1.1.529).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.
White to off white suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Spikevax Bivalent Original/Omicron (elasomeran/imelasomeran) COVID-19 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 immunogenicity and short-term safety data. Continued approval depends on the evidence of longer term benefits and safety from ongoing clinical trials and post-market assessment.

4.2 Dose and Method of Administration

Dose.

See Table 2 for dosing.

Paediatric population.

The safety and efficacy of Spikevax Bivalent Original/Omicron in children and adolescents less than 18 years of age have not yet been established. No data are available.

Elderly population.

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

Method of administration.

The vaccine should be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm.
Do not administer this vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see Section 4.4 Special Warnings and Precautions for Use.
The vaccine should be prepared and administered by a trained healthcare professional using aseptic techniques to ensure sterility of the suspension.
The vaccine comes ready to use once thawed. Thawed vials and pre-filled syringes can be handled in room light conditions.
Do not shake or dilute.
Multidose vials. Spikevax Bivalent Original/Omicron vials are multidose.
Swirl the vial gently after thawing and before each withdrawal.
Inspect the vials visually for foreign particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.
For practical reasons, if the contents of the vial are to be used within a short period of time, drawing up the content in multiple syringes at once may be considered.
Five (5) doses (of 0.5 mL volume each) can be withdrawn from each 2.5 mL vial.
Ten (10) doses (of 0.5 mL volume each) can be withdrawn from each 5 mL vial.

Thaw each vial before use.

2 hours and 30 minutes in refrigerator: 2°C to 8°C (within the 30 days shelf life at 2°C to 8°C). Let vial sit at room temperature for 15 minutes before administering.
1 hour at room temperature: 15°C to 25°C.

Instructions once thawed.

Unpunctured vial.

Maximum times. 30 days: Refrigerator 2°C to 8°C.
24 hours: Cool storage up to room temperature 8°C to 25°C.

After first dose has been withdrawn.

Maximum time. 19 hours: Refrigerator or room temperature.
Vial should be held between 2°C to 25°C. Record the date and time of discard on the vial label.
Discard punctured vial after 19 hours.
Withdraw each dose of vaccine from the vial using a new sterile needle and syringe for each injection to prevent transmission of infectious agents from one person to another.
The dose in the syringe should be used immediately.
Contains no antimicrobial preservative.
Once the vial has been punctured to withdraw the initial dose, the vaccine should be used immediately and be discarded after 19 hours.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Never refreeze thawed vaccine.

Administration.

Swirl vial gently after thawing and before each withdrawal.
The vaccine comes ready to use once thawed. Do not shake or dilute.
Prior to injection, inspect each dose to:
Confirm liquid is white to off-white in colour in both vial and syringe.
Verify syringe volume.
The vaccine may contain white or translucent product-related particulates.
If dosage is incorrect, or discolouration and other particulate matter is present, do not administer the vaccine.
Pre-filled syringe. One (1) dose of 0.5 mL can be administered from each pre-filled syringe.
Thaw each pre-filled syringe before use following the instructions below.

Thaw in refrigerator.

Thaw between 2°C to 8°C for 2 hours. Let each syringe stand at room temperature (15°C to 25°C) for 15 minutes before administering.

Thaw at room temperature.

Alternatively, thaw between 15°C to 25°C for 1 hour.
For instructions on disposal of the vaccine, see Section 6.6 Special Precautions for Disposal.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 List of Excipients or in individuals with known severe allergic reactions (e.g. anaphylaxis) to a previous dose of Spikevax (original) or Spikevax Bivalent Original/Omicron.

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 clearly recorded.

Hypersensitivity and anaphylaxis.

Anaphylaxis has been reported in individuals who have received Spikevax (original). Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine.
Close observation is recommended following vaccination as follows:

30 minutes.

People with a history of an immediate allergic reaction of any severity to another vaccine or injectable therapy.
People with a history of anaphylaxis due to any cause.

15 minutes.

All other persons.
Subsequent doses of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Spikevax (original) or Spikevax Bivalent Original/Omicron, see Section 4.3 Contraindications.

Myocarditis and pericarditis.

There is an increased risk for myocarditis and pericarditis following vaccination with Spikevax (original) or Spikevax Bivalent Original/Omicron.
These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second dose, and more often, but not exclusively, in adolescent and young adult males. There have also 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. Available short-term follow-up data suggest that the symptoms resolve in most individuals, however, severe outcomes, including death, have been rarely reported and information on long-term sequelae is lacking.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis including atypical presentations.
Vaccine recipients 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. Additionally, non-specific symptoms such as fatigue, nausea and vomiting, abdominal pain, dizziness or syncope, oedema and cough have been reported in some recipients with myocarditis or pericarditis. 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.

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.

Capillary leak syndrome flare-ups.

A few cases of capillary leak syndrome (CLS) flare-ups have been reported in the first days after vaccination with Spikevax (original). Healthcare professionals should be aware of signs and symptoms of CLS to promptly recognise and treat the condition. In individuals with a medical history of CLS, planning of vaccination should be made in collaboration with appropriate medical experts.

Immunocompromised individuals.

The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Spikevax Bivalent Original/Omicron may be lower in immunocompromised individuals.

Duration of protection.

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

Limitations of vaccine effectiveness.

Individuals may not be fully protected until 14 days after their second dose. As with all vaccines, vaccination with Spikevax Bivalent Original/Omicron may not protect all vaccine recipients.

Excipients with known effect.

Sodium.

This vaccine contains less than 1 mmol sodium (23 mg) per 0.5 mL dose, that is to say, essentially 'sodium-free'.

Use in the elderly.

Use of Spikevax Bivalent Original/Omicron and Spikevax (original) in the elderly is described in Section 5.1 Pharmacodynamic Properties.

Paediatric use.

The safety and efficacy of Spikevax Bivalent Original/Omicron in children and adolescents less than 18 years of age have not yet been established. No data are available.

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 Spikevax (original) or Spikevax Bivalent Original/Omicron with other vaccines has not been studied.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity in females.
In a combined fertility and developmental toxicity study, 100 micrograms of mRNA (elasomeran) and other ingredients included in a single human dose of Spikevax (original) was administered to female rats by the intramuscular route on four occasions: 28 and 14 days prior to mating, and on gestation days 1 and 13. SARS-CoV-2 antibody responses were present in dams from prior to mating to the end of the study on lactation day 21 as well as in fetuses and offspring. There were no vaccine-related adverse effects on female fertility, pregnancy, embryofetal or offspring development or post-natal development. No data are available on Spikevax (original) or Spikevax Bivalent Original/Omicron vaccine placental transfer or excretion in milk. The effect on male fertility has not been determined.
(Category B1)
A large amount of observational data from pregnant women vaccinated with Spikevax (original) during the second and third trimester has not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see Effects on fertility). Spikevax Bivalent Original/Omicron can be used during pregnancy.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Spikevax Bivalent Original/Omicron is negligible. Observational data from women who were breastfeeding after vaccination have not shown a risk for adverse effects in breastfed newborns/infants. Spikevax Bivalent Original/Omicron can be used during breastfeeding.

4.7 Effects on Ability to Drive and Use Machines

Spikevax Bivalent Original/Omicron 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 the safety profile.

Spikevax Bivalent Original/Omicron booster dose. The safety, reactogenicity, and immunogenicity of a bivalent booster dose of Spikevax Bivalent Original/Omicron are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years of age and older (mRNA-1273-P205). In this study, 437 participants received the Spikevax Bivalent Original/Omicron 50 microgram booster dose, and 377 participants received the Spikevax (original) 50 microgram booster dose.
The Spikevax Bivalent Original/Omicron booster had a reactogenicity profile similar to that of the Spikevax original booster given as a second booster dose. The frequency of adverse reactions after immunisation with Spikevax Bivalent Original/Omicron was also similar or lower relative to that of a first booster dose of Spikevax original (50 micrograms) and relative to the second dose of the Spikevax (original) primary series (100 micrograms). The safety profile of Spikevax Bivalent Original/Omicron (median follow-up period of 113 days) was favourable and similar to the safety profile of Spikevax (original) (median follow-up period of 127 days).
Spikevax (original).

Participants 18 years of age and older.

The safety of Spikevax (original) was evaluated in an ongoing Phase 3 randomised, placebo-controlled, observer-blind clinical study conducted in the United States involving 30,351 participants 18 years of age and older who received at least one dose of Spikevax (original) (n = 15,185) or placebo (n = 15,166) (Study P301, NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range 18-95); 22,831 (75.2%) of participants were 18 to 64 years of age and 7,520 (24.8%) of participants were 65 years of age and older.
Solicited adverse reactions were reported more frequently among vaccine participants than placebo. The most frequently reported adverse reactions were pain at the injection site (92%), fatigue (70%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23%), axillary swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness (10%). Adverse reactions 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.
Delayed injection site reactions that began > 7 days after vaccination were reported in 1.2% of vaccine recipients and 0.4% of placebo recipients. Delayed injection site reactions included pain, erythema, and swelling, and are likely related to vaccination.
Overall, there was a higher incidence of some adverse reactions in younger age groups: the incidence of axillary swelling/tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, and fever was higher in adults aged 18 to < 65 years than in those aged 65 years and above. Grade 3 solicited local adverse reactions were more frequently reported after Dose 2 than after Dose 1. Systemic adverse reactions were reported more frequently by vaccine participants after Dose 2 than after Dose 1. Grade 3 systemic adverse reactions (fatigue, myalgia, arthralgia, and headache) were reported more frequently after Dose 2 than after Dose 1.

Tabulated list of adverse reactions from clinical studies and post-authorisation experience in individuals 18 years of age and older.

The safety profile presented below is based on data generated in a placebo-controlled clinical study in 30,351 adults ≥ 18 years of age and post-marketing experience.
Adverse reactions reported are listed according to the following frequency convention:
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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness (see Table 3).

The reactogenicity and safety profile in 343 subjects receiving Spikevax (original), that were seropositive for SARS-CoV-2 at baseline, was comparable to that in subjects seronegative for SARS-CoV-2 at baseline.

Participants 18 years of age and older (Spikevax (original) booster dose).

The safety, reactogenicity, and immunogenicity of a booster dose of Spikevax (original) are evaluated in an ongoing Phase 2, randomised, observer-blind, placebo-controlled, dose-confirmation study in participants 18 years of age and older (NCT04405076). In this study, 198 participants received two doses (0.5 mL, 100 micrograms 1 month apart) of the Spikevax (original) vaccine primary series. In an open-label phase of this study, 167 of those participants received a single booster dose (0.25 mL, 50 micrograms) at least 6 months after receiving the second dose of the primary series. The solicited adverse reaction profile for the booster dose (0.25 mL, 50 micrograms) was similar to that after the second dose in the primary series.

Description of selected adverse reactions.

Myocarditis.

Spikevax Bivalent Original/Omicron.

The risk of myocarditis after a booster dose (50 microgram) of Spikevax Bivalent Original/Omicron has not yet been fully characterised, however myocarditis and pericarditis have been reported following booster doses of Spikevax.

Spikevax (original).

The increased risk of myocarditis after vaccination with Spikevax (original) is highest in younger males (see Section 4.4). There have also been reports in females.
Two large European pharmacoepidemiological studies have estimated the excess risk in younger males following the second dose of Spikevax (original). One study showed that in a period of 7 days after the second dose, there were about 1.316 (95% CI 1.299 - 1.333) extra cases of myocarditis in 12 to 29 year-old males per 10,000 compared to unexposed persons. In another study, in a period of 28 days after the second dose, there were 1.88 (95% CI 0.956 - 2.804) extra cases of myocarditis in 16 to 24 year-old males per 10,000 compared to unexposed persons.
Myocarditis and pericarditis have been reported following booster doses of Spikevax.

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

No case of overdose has been reported.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX03

Mechanism of action.

Elasomeran and imelasomeran contain mRNA encapsulated in lipid nanoparticles.
The mRNA encodes for the full-length SARS-CoV-2 spike protein modified with 2 proline substitutions within the heptad repeat 1 domain (S-2P) to stabilise the spike protein into a prefusion conformation. After intramuscular injection, cells at the injection site and the draining lymph nodes take up the lipid nanoparticle, effectively delivering the mRNA sequence into cells for translation into viral spike protein. The delivered mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is expressed transiently mainly by dendritic cells and subcapsular sinus macrophages. The expressed, membrane-bound spike protein of SARS-CoV-2 is then recognised by immune cells as a foreign antigen. This elicits both T-cell and B-cell responses to generate neutralising antibodies, which may contribute to protection against COVID-19.

Clinical trials.

Spikevax Bivalent Original/Omicron.

Immunogenicity in participants 18 years of age and older - after Spikevax Bivalent Original/Omicron booster dose (0.5 mL, 50 micrograms).

The safety, reactogenicity, and immunogenicity of a bivalent booster dose of Spikevax Bivalent Original/Omicron are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years of age and older (mRNA-1273-P205). In this study, 437 participants received the Spikevax Bivalent Original/Omicron 50 microgram booster dose, and 377 participants received the Spikevax (original) 50 microgram booster dose.
Study P205 Part G evaluated the safety, reactogenicity and immunogenicity of the Spikevax Bivalent Original/Omicron vaccine when administered as a second booster dose to adults who previously received 2 doses of Spikevax (original) (100 micrograms) as a primary series and a booster dose of Spikevax (original) (50 micrograms) at least 3 months prior to enrollment. In P205 Part F, study participants received Spikevax (original) (50 micrograms) as a second booster dose and the Part F group serves as a within-study, non-contemporaneous comparator group to the Spikevax Bivalent Original/Omicron group.
In this study, the primary immunogenicity analysis was based on the primary immunogenicity set which includes participants with no evidence of SARS-CoV-2 infection at baseline (pre-booster) (see Table 4).

Three-month antibody persistence of Spikevax Bivalent Original/Omicron booster vaccine against COVID-19.

Participants in Study P205 Part G were sequentially enrolled to receive 50 micrograms of Spikevax (original) (n = 376) or Spikevax Bivalent Original/Omicron (n = 437) as second booster doses. In participants with no pre-booster incidence of SARS-CoV-2, Spikevax Bivalent Original/Omicron elicited Omicron-BA.1-neutralising antibody titres (observed GMT) that were significantly higher (964.4 [834.4, 1114.7]) than those of Spikevax (original) (624.2 [533.1, 730.9]) and similar between boosters against ancestral SARS-CoV-2 at three months.
Spikevax (original).

Clinical efficacy of Spikevax (original) in adults.

Study P301 was a randomised, placebo-controlled, observer-blind Phase 3 clinical study (NCT04470427) that excluded individuals who were immunocompromised or who had received immunosuppressants within 6 months, as well as participants who were pregnant, or with a known history of SARS-CoV-2 infection. Participants with stable HIV disease were not excluded. Influenza vaccines could be administered 14 days before or 14 days after any dose of Spikevax (original).
Participants were also required to observe a minimum interval of 3 months after receipt of blood/plasma products or immunoglobulins prior to the study in order to receive either placebo or Spikevax (original).
A total of 30,351 subjects were followed for a median of 92 days (range: 1-122) for the development of COVID-19 disease.
COVID-19 was defined as symptomatic COVID-19 requiring positive RT-PCR result and at least 2 systemic symptoms or 1 respiratory symptom. Cases starting 14 days after the second dose.
The primary efficacy analysis population (referred to as the Per Protocol Set or PPS), included 28,207 subjects who received either Spikevax (original) (n = 14,134) or placebo (n = 14,073) and had a negative baseline SARS-CoV-2 status. The PPS study population included 47.4% female, 52.6% male, 79.5% White, 9.7% African American, 4.6% Asian, and 6.2% other. 19.7% of participants identified as Hispanic or Latino. The median age of subjects was 53 years (range 18-94). A dosing window of -7 to +14 days for administration of the second dose (scheduled at Day 29) was allowed for inclusion in the PPS. 98% of vaccine recipients received the second dose 25 days to 35 days after Dose 1 (corresponding to -3 to +7 days around the interval of 28 days).
COVID-19 cases were confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and by a Clinical Adjudication Committee. Vaccine efficacy overall and by key age groups are presented in Table 5.

Among all subjects in the PPS, no cases of severe COVID-19 were reported in the vaccine group compared with 30 of 185 (16%) cases reported in the placebo group. Of the 30 participants with severe disease, 9 were hospitalised, 2 of which were admitted to an intensive care unit. The majority of the remaining severe cases fulfilled only the oxygen saturation (SpO2) criterion for severe disease (≤ 93% on room air).
The vaccine efficacy of Spikevax (original) to prevent COVID-19, regardless of prior SARS-CoV-2 infection (determined by baseline serology and nasopharyngeal swab sample testing) from 14 days after Dose 2 was 93.6% (95% confidence interval 88.5, 96.4%).
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.

Immunogenicity in participants 18 years of age and older - after Spikevax (original) booster dose (0.25 mL, 50 micrograms).

The safety, reactogenicity, and immunogenicity of a booster dose of Spikevax (original) are evaluated in an ongoing Phase 2, randomised, observer-blind, placebo-controlled, dose-confirmation study in participants 18 years of age and older (NCT04405076). In this study, 198 participants received two doses (0.5 mL, 100 micrograms 1 month apart) of the Spikevax (original) vaccine as primary series. In an open-label phase, 149 of those participants (Per-Protocol Set) received a single booster dose (0.25 mL, 50 micrograms) at least 6 months after receiving the second dose in the primary series. A single booster dose (0.25 mL, 50 micrograms) was shown to result in a geometric mean fold rise (GMFR) of 12.99 (95% CI: 11.04, 15.29) in neutralising antibodies from pre-booster compared to 28 days after the booster dose. The GMFR in neutralising antibodies was 1.53 (95% CI: 1.32, 1.77) when compared 28 days post-dose 2 (primary series) to 28 days after the booster dose.

Immunogenicity of a booster dose of Spikevax (original) following primary vaccination with another authorised or approved COVID-19 vaccine in adults 18 years of age and older.

Effectiveness of a Spikevax (original) (0.25 mL) booster dose in individuals who completed primary vaccination with another authorised or approved COVID-19 Vaccine (heterologous booster dose) is inferred from immunogenicity data supporting effectiveness of a Spikevax (original) (0.25 mL) booster dose administered following completion of a Spikevax (original) primary series and from immunogenicity data from an independent Phase 1/2 open-label clinical trial (NCT04889209) conducted in the United States that evaluated a heterologous booster dose (0.5 mL) of Spikevax (original). In this study, adults who had completed primary vaccination with a Spikevax (original) 2-dose series (N = 151), a COVID-19 Vaccine Janssen single dose (N = 156), or a Comirnaty 2-dose series (N = 151) at least 12 weeks prior to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of three vaccines: Spikevax (original), COVID-19 Vaccine Janssen, or Comirnaty. Neutralizing antibody titers, as measured by a pseudovirus neutralization assay using a lentivirus expressing the SARS-CoV-2 Spike protein with D614G mutation, were assessed on Day 1 prior to administration of the booster dose and on Day 15 after the booster dose. A booster response to Spikevax (original) (0.5 mL) was demonstrated regardless of primary vaccination.
Elderly population. Spikevax Bivalent Original/Omicron was assessed in 437 individuals 18 years of age and older (P205 Part G, safety analysis set), including 38 subjects 75 years of age and older. A total of 174 of the 437 participants (39.8%) were ≥ 65 years of age.
Spikevax (original) was assessed in individuals 6 months of age and older, including 3,768 subjects 65 years of age and older. The efficacy of Spikevax (original) was consistent between elderly (≥ 65 years) and adolescents and younger adult subjects (12-64 years).

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity and reproductive and developmental toxicity. The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established.

Genotoxicity.

The novel lipid components SM-102 and PEG-2000-DMG of Spikevax (original) and Spikevax Bivalent Original/Omicron were negative in the bacterial reverse mutation Ames test and in vitro micronucleus test in human peripheral blood lymphocytes. A luciferase mRNA in SM102-containing lipid nanoparticles was negative in a rat bone marrow micronucleus assay (IV dose of SM-102 28.5 mg/kg, PEG-2000-DMG 2.8 mg/kg), whilst a surrogate ZIKA mRNA-based vaccine formulated in SM-102-containing lipid nanoparticles induced micronuclei in male rats, but not in females (IV dose of SM-102 60 mg/kg, PEG-2000-DMG 6 mg/kg). The weight of evidence suggests the genotoxicity potential of the novel lipid components SM-102 and PEG-2000-DMG is very low.
The other components of Spikevax (original) or Spikevax Bivalent Original/Omicron (other lipids and mRNA) are not expected to be genotoxic.

Carcinogenicity.

Carcinogenicity studies were not performed. The components of the vaccine (lipids and mRNA) are not expected to have carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate, cholesterol, distearoylphosphatidylcholine, 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000, trometamol, trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products or diluted.

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 multidose vial and pre-filled syringe.

The unopened vial and pre-filled syringes may be stored refrigerated at 2°C to 8°C, protected from light, for a maximum of 30 days. Once thawed the vaccine should not be re-frozen.
The unopened vial and pre-filled syringe may be stored at 8°C to 25°C up to 24 hours after removal from refrigerated conditions.
The pre-filled syringe is for single use in one patient only. Discard any residue.

Punctured multidose vial.

Chemical and physical in-use stability has been demonstrated for 19 hours at 2°C to 25°C after initial puncture (within the allowed use period of 30 days at 2°C to 8°C and 24 hours at 8°C to 25°C).
Contains no antimicrobial preservative. From a microbiological point of view, the product should be used immediately. Do not refreeze.

6.4 Special Precautions for Storage

Store frozen between -50°C to -15°C.
Store in the original carton to protect from light. Do not store below -50°C.
For storage conditions after thawing and first opening, see Section 6.3 Shelf Life.

Transportation of thawed vials in liquid state at 2°C to 8°C.

If transport at -50°C to -15°C is not feasible, available data support transportation of one or more thawed vials in liquid state for up to 12 hours at 2°C to 8°C (within the 30 days shelf life at 2°C to 8°C). Once thawed and transported in liquid state at 2°C to 8°C, vials should not be refrozen and should be stored at 2°C to 8°C until use.

Transportation of thawed pre-filled syringes in liquid state at 2°C to 8°C.

Pre-filled syringes can be transported at 2°C to 8°C when shipped using shipping containers that have been qualified to maintain 2° to 8°C. Once thawed and transported in liquid state at 2° to 8°C, pre-filled syringes should not be refrozen and should be stored at 2° to 8°C until use.

6.5 Nature and Contents of Container

2.5 mL multidose vial (0.1 mg/mL).

2.5 mL suspension in a vial (type 1 or type 1 equivalent glass) with a stopper (chlorobutyl rubber) and a blue flip-off plastic cap with seal (aluminium seal).
Each vial contains 2.5 mL.
Pack size: 10 multidose vials.

5 mL multidose vial (0.1 mg/mL).

5 mL suspension in a vial (type 1 or type 1 equivalent glass) with a stopper (chlorobutyl rubber) and a blue flip-off plastic cap with seal (aluminium seal).
Each vial contains 5 mL.
Pack size: 10 multidose vials.

Pre-filled syringe (0.1 mg/mL).

0.5 mL suspension in a pre-filled syringe (polymeric) with plunger stopper (coated bromobutyl rubber) and a tip cap (bromobutyl rubber, without needle).
The pre-filled syringe is packaged in 5 clear blisters containing 2 pre-filled syringes in each blister.
Each pre-filled syringe contains 0.5 mL.
Pack size: 10 pre-filled syringes.

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.

2457298-05-2 (elasomeran).
2763208-92-8 (imelasomeran).

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

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Spikevax Bivalent Original/Omicron COVID-19 Vaccine

Elasomeran; Imelasomeran

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