Consumer medicine information

Arexvy

Respiratory syncytial virus pre-fusion F protein vaccine, recombinant adjuvanted

BRAND INFORMATION

Brand name

Arexvy

Active ingredient

Respiratory syncytial virus pre-fusion F protein vaccine, recombinant adjuvanted

Schedule

SUMMARY CMI

AREXVY

Consumer Medicine Information (CMI) summary

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

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

1. Why am I being given AREXVY?

AREXVY is a vaccine that helps to protect adults over the age of 60 against Respiratory Syncytial Virus (RSV) infection. RSV is a highly contagious respiratory virus that causes infections of the lungs and breathing passages. Infection can occur at any age. It usually causes mild, cold-like symptoms in adults. RSV can also cause more serious respiratory illnesses in infants and older adults.

For more information, see Section 1. Why am I being given AREXVY? in the full CMI.

2. What should I know before I am given AREXVY?

You should not be given AREXVY if you have ever had an allergic reaction to any of the ingredients listed at the end of the CMI.

Talk to your doctor or nurse if you are currently unwell, have any other medical conditions or take any other medicines. AREXVY is not intended to be used in pregnant or breastfeeding women but talk to your doctor if you are meant to receive this vaccine when you are pregnant, intending to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I am given AREXVY? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AREXVY and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is AREXVY given?

Your doctor or nurse will give you AREXVY as a single injection into a muscle (usually in the upper arm).

More instructions can be found in Section 4. How is AREXVY given? in the full CMI.

5. What should I know when being given AREXVY?

Things you should do	Remind the person who is giving you your vaccination if you are taking other medicines. Keep a record of your immunisation history.
Driving or using machines	Be careful before you drive or use any machines or tools until you know how AREXVY affects you.
Looking after your vaccine	AREXVY will normally be stored at the doctor's surgery or in the pharmacy. If you need to store AREXVY, it is important to keep it in the pack to protect it from light. Store AREXVY in the refrigerator between 2°C and 8°C. Do not freeze.

For more information, see Section 5. What should I know when being given AREXVY? in the full CMI.

6. Are there any side effects?

Side effects which have been reported following administration of AREXVY include itching, pain, redness or swelling at the injection site, fever, chills, tiredness, headache, muscle pain, joint pain, a runny nose, generally feeling unwell, nausea, stomach pain and swelling of the lymph nodes.

Allergic reactions have also occurred following administration of AREXVY. Allergy is rare and severe reactions will usually occur within the first few hours of vaccination. If this occurs go to the Emergency Department of the nearest hospital immediately.

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 medicine 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

AREXVY

Active ingredient(s): Recombinant Respiratory Syncytial Virus pre-fusion F protein (RSVPreF3)

Consumer Medicine Information (CMI)

This leaflet provides important information about using AREXVY. You should also speak to your doctor or nurse if you would like further information or if you have any concerns or questions about using AREXVY.

Where to find information in this leaflet:

1. Why am I being given AREXVY?
2. What should I know before I am given AREXVY?
3. What if I am taking other medicines?
4. How is AREXVY given?
5. What should I know when being given AREXVY?
6. Are there any side effects?
7. Product details

1. Why am I being given AREXVY?

AREXVY is a vaccine that contains the active ingredient Recombinant Respiratory Syncytial Virus pre-fusion F protein (RSVPreF3). It is mixed with an adjuvant suspension to form the vaccine that you will receive.

The adjuvant is used to improve the body's response to the vaccine.

AREXVY helps to protect adults over the age of 60 against RSV infection.

Respiratory Syncytial Virus (RSV) is a highly contagious respiratory virus that causes infections of the lungs and breathing passages. It usually causes mild, cold-like symptoms in adults and infection can occur at any age.

RSV can also cause more serious respiratory illnesses in infants and older adults. It can lead to serious illness such as pneumonia and RSV infection may also worsen some existing conditions such as long-term respiratory conditions or heart disease.

The vaccine works by helping your body make antibodies and special white blood cells to reduce your chances of experiencing a serious illness due to RSV infection.

AREXVY does not contain the RSV virus and it cannot cause lung infection.

As with all vaccines, AREXVY may not fully protect all people who are vaccinated.

2. What should I know before I am given AREXVY?

Warnings

Do not use AREXVY if:

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

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

Check with your doctor if you:

have any other medical conditions.
have lowered immunity.
have a bleeding problem or bruise easily.
take any medicines for any other condition.
currently have a severe infection with a high temperature.

Your doctor or nurse may decide to delay vaccination with AREXVY until the illness has passed. A minor infection such as a cold is not usually a reason to delay vaccination but talk to your doctor about this before being vaccinated.

If you are unwell and cannot receive AREXVY, talk to your doctor or nurse about when you can receive it.

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?

Pregnancy and breastfeeding

AREXVY is not recommended during pregnancy or breastfeeding. Talk to your doctor if you are pregnant or intend to become pregnant or are breastfeeding.

Fainting

Fainting can occur following, or even before, any needle injection. Tell the person giving you your injection if you have ever fainted with a previous injection.

Multiple vaccinations

If AREXVY is given at the same time as another vaccine, a different injection site will be used for each injection.

3. What if I am taking other medicines?

Tell your doctor 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.

Some medicines may interfere with AREXVY and affect how it works.

Check with your doctor or nurse if you are not sure about what medicines, vitamins or supplements you are taking and if these affect AREXVY.

4. How is AREXVY given?

How much is given

Your doctor will give you AREXVY as an injection.
The dosage is 0.5 mL.

How it is given

AREXVY is generally injected into a muscle (usually in the upper arm).

If you are given too much AREXVY

If you think that you have been given too much AREXVY, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

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

5. What should I know when being given AREXVY?

Things you should do

If applicable, remind the person who is giving you your vaccination that you are taking other medicines.

Keep a record of this vaccination for your medical history.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how AREXVY affects you.

However, you should not drive or use machines if you are feeling unwell.

Looking after your vaccine

AREXVY will usually be stored at the doctor's clinic or at the pharmacy.
If you need to store AREXVY it is important to keep it in the pack to protect it from light.
Store AREXVY in the refrigerator between 2°C and 8°C.
DO NOT FREEZE AREXVY.

Follow the instructions in the carton on how to take care of your vaccine properly.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this vaccine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this vaccine after the expiry date.

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.

Less serious side effects

Less serious side effects	What to do
itching or pain at the injection site redness and swelling at the injection site fever chills tiredness headache muscle pain joint pain runny nose generally feeling unwell nausea, stomach pain swelling of the lymph nodes	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

allergic reaction

Signs of an allergic reaction include:
swelling of the limbs, face, eyes, inside of the nose, mouth or throat
shortness of breath, breathing or swallowing difficulties
hives, itching (especially of the hands or feet), reddening of the skin (especially around the ears) or severe skin reactions
unusual tiredness or weakness that is sudden and severe
Allergy to AREXVY is rare. Severe reactions will usually occur within the first few hours of vaccination. If this occurs go to the Emergency Department of the nearest hospital immediately.

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.

Tell your doctor 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.

Always make sure you speak to your doctor or nurse before you decide to stop taking any of your medicines.

7. Product details

This vaccine is only available with a doctor's prescription.

What AREXVY looks like

Each dose of AREXVY is made up of 2 vials:

Vial containing the RSV powder which is white.
Vial containing the AS01E adjuvant suspension which is an opalescent, colourless to pale brownish liquid. The adjuvant is used to improve the body's response to the vaccine.

The contents of both vials are mixed prior to vaccination.

AREXVY is available as either a single dose (2 vials) or a 10 dose (20 vials) multipack (AUST R 400657).

Not all presentations and pack sizes may be marketed.

What AREXVY contains

Active ingredient (main ingredient)	RSV vial: Respiratory syncytial virus (RSV) glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) Adjuvant vial: plant extract Quillaja saponaria saponin (QS-21) 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota
Other ingredients (inactive ingredients)	RSV vial: Trehalose dihydrate Polysorbate 80 Monobasic potassium phosphate Dibasic potassium phosphate Adjuvant vial: Dioleoylphosphatidylcholine Cholesterol Sodium chloride Dibasic sodium phosphate Monobasic potassium phosphate Water for injections

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

Who distributes AREXVY

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067

Trade marks are owned by or licensed to the GSK group of companies.

This leaflet was prepared in July 2023.

Version 1.0

Published by MIMS March 2024

BRAND INFORMATION

Brand name

Arexvy

Active ingredient

Respiratory syncytial virus pre-fusion F protein vaccine, recombinant adjuvanted

Schedule

1 Name of Medicine

Recombinant Respiratory Syncytial Virus pre-fusion F protein (RSVPreF3) (AS01_E adjuvanted vaccine).

2 Qualitative and Quantitative Composition

After reconstitution, 1 dose (0.5 mL) contains 120 micrograms of RSVPreF3¹ antigen adjuvanted with AS01_E².
¹ Respiratory syncytial virus (RSV) glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
² The GlaxoSmithKline proprietary AS01_E Adjuvant System is composed of the plant extract Quillaja saponaria saponin (QS-21) (25 micrograms) and 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota (25 micrograms).

List of excipients with known effect.

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder and suspension for suspension for injection.
The powder is white.
The suspension is an opalescent, colourless to pale brownish liquid.

4 Clinical Particulars

4.1 Therapeutic Indications

Arexvy is indicated for active immunisation of individuals 60 years and older for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV).
The use of this vaccine should be in accordance with official recommendations.

4.2 Dose and Method of Administration

Dosage.

Arexvy is administered as a single dose of 0.5 mL.
The need for revaccination has not been established.

Method of administration.

Arexvy is for intramuscular injection only, preferably in the deltoid muscle.
For instructions on reconstitution of the medicinal product before administration, see Use and handling.

Use and handling.

The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not reconstitute the vaccine.

How to prepare Arexvy.

Arexvy must be reconstituted prior to administration.
1. Withdraw the entire contents of the vial containing the suspension into a syringe.
2. Add the entire contents of the syringe into the vial containing the powder.
3. Gently swirl until the powder is completely dissolved.
The reconstituted vaccine is an opalescent, colourless to pale brownish liquid.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine.
After reconstitution, the vaccine should be used promptly; if not possible, the vaccine should be stored in the refrigerator (2°C - 8°C) or at room temperature up to 25°C. If not used within 4 hours it should be discarded.

Before administration.

1. Withdraw 0.5 mL of the reconstituted vaccine into the syringe.
2. Change the needle so that you are using a new needle.
Administer the vaccine intramuscularly.
Arexvy is for single use in one patient only. Discard any residue.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

4.3 Contraindications

Hypersensitivity to the active substances or to any component of the vaccine (see Section 2 Qualitative and Quantitative Composition; Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

Prior to immunisation.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
As with other vaccines, vaccination with Arexvy should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.

Precautions for use.

Do not administer the vaccine intravascularly or intradermally. No data are available on subcutaneous administration of Arexvy.
As with other vaccines administered intramuscularly, Arexvy should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these individuals.

Systemic immunosuppressive medications and immunodeficiency.

Safety and immunogenicity data on Arexvy are not available for immunocompromised individuals. Patients receiving immunosuppresive treatment or patients with immunodeficiency may have a reduced immune response to Arexvy.

Use in the elderly.

There are no special precautions for use in the elderly.

Paediatric use.

The safety and efficacy of Arexvy have not been established in children and adolescents.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Use with other vaccines.

Arexvy can be given concomitantly with inactivated unadjuvanted seasonal influenza vaccine (Flu Quadrivalent containing a combined total of 60 micrograms Hemagglutinin (HA) per dose). There was no evidence of interference in the immune response to the antigens contained in the co-administered vaccines (see Section 5.1 Pharmacodynamic Properties, Clinical trials). For adverse effects, please see Section 4.8 Adverse Effects (Undesirable Effects), Safety data from RSV OA=ADJ-007.
Data are currently not available for concomitant administration with other vaccines.
If Arexvy is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data on the effects of Arexvy on human fertility. Effects on male or female fertility have not been evaluated in animal studies.
(Category B2)
There are no data from the use of Arexvy in pregnant women. Arexvy is not recommended during pregnancy.
After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo.
In a reproductive and developmental toxicity study, female rats were administered AS01_B adjuvant alone by intramuscular injection 28 and 14 days prior to mating, on gestation days 3, 8, 11, and 15, and on lactation Day 7. The total dose was similar to the dose of AS01_E in Arexvy. No adverse effects on preweaning development up to post-natal day 25 were observed. There was no vaccine related fetal malformations or variations.
In another reproductive and developmental toxicity study, female rabbits were administered the AS01_B adjuvant by intramuscular injection 28 and 14 days prior to mating, on gestation days 3, 11, 16, and 24, and on lactation Day 7. The total dose was 2 times the dose of AS01_E in Arexvy. AS01_B produced no adverse effects on embryofetal or pre- and post-natal survival, growth or development of the offspring up to day 35 of age.
There are no data on the excretion of Arexvy in human or animal milk. Arexvy is not recommended in breastfeeding/lactating women.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects of Arexvy on the ability to drive and use machines have been performed. However, some of the effects mentioned under Section 4.8 Adverse Effects (Undesirable Effects) (e.g. fatigue) may temporarily affect the ability to drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data.

The safety profile presented below is based on a placebo-controlled Phase III clinical study RSV OA=ADJ-006 (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥ 60 years of age in which 12,467 adults received one dose of Arexvy and 12,499 received placebo.
Adverse drug reactions (ADRs) are listed (see Table 1) by MedDRA system organ class and by frequency.
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.

Safety data from RSV OA=ADJ-006.

Solicited adverse reactions.

A subset of study participants (solicited safety set) was monitored for solicited adverse reactions using standardised paper diary cards during the 4 days (i.e. day of vaccination and the next 3 days) following a dose of Arexvy or placebo. The other study participants did not prospectively record solicited reactions on a diary card but may have reported them as unsolicited adverse reactions.
The reported frequencies of specific solicited local (administration site) and systemic adverse reactions (per participant) are presented in Table 2.

In the solicited safety set, the local administration site adverse reactions reported with Arexvy had a median duration of 2 days, and the systemic adverse reactions reported with Arexvy had a median duration ranging between 1 and 2 days.

Unsolicited adverse events.

In all participants from RSV OA=ADJ-006, unsolicited adverse events were monitored using paper diary cards during the 30-day period following vaccination (day of vaccination and the next 29 days).
Among participants in the solicited safety set, (Arexvy, n = 879 or placebo, n = 878), unsolicited adverse events occurring within 30 days after vaccination were reported in 14.9% and 14.6% of participants who received Arexvy and placebo, respectively.
In the exposed set, 24,966 participants 60 years of age and older, received at least 1 dose of Arexvy (n = 12,467) or placebo (n = 12,499). Unsolicited adverse events occurring within 30 days of vaccination were reported in 33.0% and 17.8% of participants, respectively. The higher frequency of reported unsolicited adverse events among participants who received Arexvy, compared to participants who received placebo, was primarily attributed to events that are consistent with adverse reactions solicited among participants in the reactogenicity subset.
Within 30 days after vaccination, atrial fibrillation was reported in 10 participants who received Arexvy and 4 participants who received placebo (of which 7 events in Arexvy arm and 1 event in placebo arm were serious); the onset of symptoms ranged from 1 to 30 days post vaccination. The currently available information on the atrial fibrillation is insufficient to determine a causal relationship to the vaccine.

Serious adverse events.

In RSV OA=ADJ-006, participants were monitored for all serious adverse events (SAEs) that occurred during the 6-month period following administration of Arexvy (n = 12,467) or placebo (n = 12,499).
SAEs with onset within 6 months following vaccination were reported at similar rates in participants who received Arexvy (4.2%) or placebo (4.0%).

Deaths.

From vaccination through the first analysis of the ongoing RSV OA=ADJ-006, adverse events leading to death were reported for 49 participants (0.4%) who received Arexvy (n = 12,467) and 58 participants (0.5%) who received placebo (n = 12,499). Based on available information, there is no evidence of causal relationship to Arexvy. Causes of death among participants were consistent with those generally reported in adult and elderly populations.

Potential immune-mediated diseases.

In RSV OA=ADJ-006, participants were monitored for all potential immune-mediated diseases (pIMDs) that occurred during the 6-month period following administration of Arexvy (n = 12,467) or placebo (n = 12,499).
New onset pIMDs or exacerbation of existing pIMDs within 6 months following vaccination were reported for 0.3% of participants who received Arexvy and 0.3% of participants who received placebo. There were no notable imbalances between study groups in individual pIMDs reported.
Safety data from RSV OA=ADJ-007. In the open-label Phase III RSV OA=ADJ-007 clinical study, participants 60 years of age and older received 1 dose of Arexvy and inactivated unadjuvanted seasonal influenza vaccine (Flu Quadrivalent containing a combined total of 60 micrograms Hemagglutinin (HA) per dose) either concomitantly at Day 1 (N = 442), or 1 dose of Flu Quadrivalent at Day 1 followed by a dose of Arexvy 1 month later (N = 443).
The reported frequencies of specific solicited local (administration site) and systemic adverse reactions are presented in Table 3.

Serious adverse events reported from other studies.

Study RSV OA=ADJ-004 (NCT04732871).

One case of Guillain-Barré syndrome beginning 9 days after Arexvy vaccination was reported in a participant enrolled in a study site in Japan.

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

Insufficient data are available.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The RSVPreF3 antigen in Arexvy is derived from the laboratory-adapted RSV-A A2 strain, stabilised in the pre-fusion conformation of the naturally occurring F protein for which both RSV-A and B subtypes share high amino acid sequence homology. The risk of developing RSV-associated LRTD increases with age and with presence of underlying comorbidities. Arexvy induces the functional humoral immune responses against the RSV-A and RSV-B subtypes and the antigen-specific cellular immune responses which contribute to protect against RSV-associated LRTD (see Immunogenicity of Arexvy).
In a Phase I/II clinical trial, formulation adjuvanted with AS01_E showed the ability to induce RSVPreF3-specific CD4+ T cells in adults 60 to 80 years of age to levels similar to those observed in young adults, despite lower baseline levels in the older adults.
Non-clinical data show that AS01_E induces a local and transient activation of the innate immune system. The adjuvant effect of AS01_E is the result of interactions between MPL and QS-21 formulated in liposomes. This facilitates the recruitment and activation of antigen presenting cells carrying vaccine-derived antigens in the draining lymph node, which in turn leads to the generation of RSVPreF3-specific CD4+ T cells and induction of RSV-A and RSV-B neutralising antibody responses. In addition, RSVPreF3 formulated with AS01_E can elicit specific binding antibodies directed to site O/, a highly neutralising sensitive epitope, exposed only on the pre-fusion conformation of the F protein.

Clinical trials.

Efficacy of Arexvy. Efficacy of Arexvy against RSV-associated LRTD in adults 60 years and older was evaluated in RSV OA=ADJ-006, an ongoing, Phase III, randomised, placebo-controlled, observer-blind clinical study conducted in 17 countries from Northern and Southern Hemispheres. Participants are planned to be followed for up to 36 months.
The study excluded participants who were immunocompromised. Participants with pre-existing, chronic, stable disease such as diabetes, hypertension, or cardiac disease were allowed to participate in the study if considered by the investigator as medically stable at the time of vaccination.
The primary population for efficacy analysis (referred to as the modified Exposed Set, included adults 60 years of age and older receiving 1 dose of Arexvy or placebo and who did not report an RSV-confirmed acute respiratory illness (ARI) prior to Day 15 after vaccination) included 24,960 participants randomised equally to receive 1 dose of Arexvy (N = 12,466) or placebo (N = 12,494). At the time of the primary efficacy analysis, participants had been followed for the development of RSV-associated LRTD for up to 10 months (median of 6.7 months).
At baseline, 39.3% of participants had at least one comorbidity of interest; 19.7% of participants had an underlying cardiorespiratory condition (COPD, asthma, any chronic respiratory/pulmonary disease, or chronic heart failure) and 25.8% of participants had endocrinometabolic conditions (diabetes, advanced liver or renal disease).
Using the Gait speed test, 38.3% of participants were ranked as pre-frail (0.4-0.99m/s walking speed) and 1.5% as frail (< 0.4 m/s walking speed or who were not able to perform the test).

Efficacy against RSV-associated LRTD.

The primary objective was to demonstrate the efficacy of Arexvy in the prevention of a first episode of confirmed RSV-A and/or B associated LRTD during the first season. Confirmed RSV cases were determined by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) on nasopharyngeal swab. LRTD was defined based on the following criteria: the participant must have experienced at least 2 lower respiratory symptoms/signs including at least 1 lower respiratory sign for at least 24 hours, or experienced at least 3 lower respiratory symptoms for at least 24 hours. Lower respiratory 'symptoms' included: new or increased sputum, new or increased cough, new or increased dyspneoa (shortness of breath). Lower respiratory 'signs' included: new or increased wheezing, crackles/rhonchi, respiratory rate ≥ 20 respirations/min, low or decreased oxygen saturation (O₂ saturation < 95% or ≤ 90% if baseline is < 95%) or need for oxygen supplementation.
Compared with placebo, Arexvy significantly reduced the risk of developing RSV-associated LRTD by 82.6% (96.95% CI: [57.9, 94.1]) in participants 60 years of age and older, which met the pre-specified success criterion for the primary study objective (see Table 4). High vaccine efficacy against RSV-LRTD is observed through the median follow-up period of 6.7 months.
The vaccine efficacy against RSV A-associated LRTD cases and RSV B-associated LRTD cases was 84.6% (95% CI [32.1, 98.3]) and 80.9% (95% CI [49.4, 94.3]), respectively.

Compared with placebo, Arexvy significantly reduced the risk of developing RSV-associated LRTD by 84.4% (95% CI: [46.9, 97.0]) in participants 70 years of age and older. The vaccine efficacy in the subgroup of participants 80 years of age and older (1016 participants in Arexvy vs 1028 participants in placebo) cannot be concluded due to the low number of total cases accrued (2 cases among participants who received Arexvy and 3 cases among participants who received placebo).
Compared with placebo, Arexvy significantly reduced the risk of developing RSV-associated LRTD in pre-frail participants by 92.9% (95% CI [53.4, 99.8]). The vaccine efficacy in the frail subgroup (189 participants in Arexvy vs 177 participants in placebo) cannot be concluded due to the low number of total cases accrued (2 cases).

Efficacy against severe RSV-associated LRTD and RSV-associated ARI.

In study RSV-OA=ADJ-006, severe RSV-associated LRTD was defined as RT-PCR confirmed RSV-associated LRTD with at least 2 lower respiratory signs, or as an RT-PCR confirmed RSV-associated LRTD episode assessed as 'severe' by the investigator. One case of severe RSV-associated LRTD in the Arexvy group and 17 cases in the placebo group were reported, amongst which 2 cases required supportive therapy. Compared with placebo, Arexvy significantly reduced the risk of developing severe RSV-associated LRTD by 94.1% (95% CI [62.4, 99.9]) in participants 60 years of age and older.
Acute respiratory illness (ARI) was defined by the presence of at least 2 respiratory symptoms/signs for at least 24 hours, or at least 1 respiratory symptom/sign + 1 systemic symptom/sign (fever or feverishness, fatigue, body aches, headache, decreased appetite) for at least 24 hours. Arexvy significantly reduced the risk of developing confirmed RSV-associated ARI in adults ≥ 60 years of age by 71.7% (95% CI [56.2, 82.3]). See Table 5.

Immunogenicity of Arexvy. An immunological correlate of protection has not been established; therefore, the level of immune response that provides protection against RSV-associated LRTD is unknown.
The immune responses to Arexvy were evaluated in a Phase III immunogenicity and safety study RSV OA=ADJ-004 in adults 60 years and older. Functional humoral immune responses post-vaccination compared to pre-vaccination were evaluated with results from 940 participants for RSV-A and 941 participants for RSV-B for month 1 vs. pre-vaccination, and 928 participants for RSV-A and 929 participants for RSV-B at month 6 vs. pre-vaccination. The cell-mediated immune responses were evaluated with results from 471 participants at pre-vaccination, 410 at month 1 and 440 at month 6.
Arexvy elicited RSV-specific humoral and cellular immune responses. The geometric mean increase of the RSV-A and RSV-B neutralising titers compared to pre-vaccination were 10.5-fold (95% CI [9.9, 11.2]) and 7.8-fold (95% CI [7.4, 8.3]) at 1-month post-vaccination, respectively, and 4.4-fold (95% CI [4.2, 4.6]) and 3.5-fold (95% CI [3.4, 3.7]) at 6-months post-vaccination, respectively. The median frequency (percentile [25th, 75th]) of the RSVPreF3-specific CD4+ T-cells (per million of CD4+ T cells) was 1339.0 (829.0, 2136.0) 1-month post-vaccination and 666.0 (428.0, 1049.5) 6-months post-vaccination as compared to 191.0 (71.0, 365.0) pre-vaccination.

Immunogenicity following concomitant vaccination.

In an open-label Phase III clinical study, participants 60 years of age and older received 1 dose of Arexvy and inactivated unadjuvanted seasonal influenza vaccine (Flu Quadrivalent containing a combined total of 60 micrograms Hemagglutinin (HA) per dose) at month 0 (N = 442), or 1 dose of Flu Quadrivalent at month 0 followed by a dose of Arexvy at month 1 (N = 443).
There was no evidence for interference in the immune response to any of the antigens contained in both co-administered vaccines. The criteria for non-inferiority of the immune responses in the control versus co-administration group were met as the 2-sided 95% confidence interval upper limits on the group geometric mean titer ratios were below 1.50 for the RSV-A neutralising antibodies and haemagglutinin inhibition antibodies against the strains Flu A/Hong Kong/H3N2, Flu A/Victoria/H1N1, Flu B/Phuket/Yamagata, and Flu B/Washington/Victoria.
Currently no clinical data is available on coadministration of Arexvy with other vaccines.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Arexvy was not tested for genotoxicity.

Carcinogenicity.

Arexvy was not tested for carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Powder (RSVPreF3 antigen).

Trehalose dihydrate, polysorbate 80, monobasic potassium phosphate, dibasic potassium phosphate.

Suspension (AS01E adjuvant system).

Dioleoylphosphatidylcholine, cholesterol, sodium chloride, dibasic sodium phosphate, monobasic potassium phosphate, water for injections.

6.2 Incompatibilities

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

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.
For shelf-life after reconstitution of the medicinal product, see Section 4.2 Dose and Method of Administration, Use and handling.

6.4 Special Precautions for Storage

Store in a refrigerator (2°C - 8°C).
Do not freeze. Discard if the vial has been frozen.
Store in the original package in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see Section 4.2 Dose and Method of Administration, Use and handling.

6.5 Nature and Contents of Container

Arexvy is presented as:
Powder for 1 dose in a vial (type I glass) with stopper (butyl rubber).
Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber).
Arexvy is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension.
Not all strengths, dose forms, pack sizes, container types may be distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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Arexvy

Respiratory syncytial virus pre-fusion F protein vaccine, recombinant adjuvanted

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