Administer a single dose (approximately 0.5 mL) of ABRYSVO intramuscularly.

ABRYSVO is supplied in a kit that includes a vial of Lyophilized Antigen Component (a sterile white powder), a prefilled syringe containing Sterile Water Diluent Component and a vial adapter.

Vial of Lyophilized Antigen Component	Syringe of Sterile Water Diluent Component	Vial Adapter

To form ABRYSVO, reconstitute the Lyophilized Antigen Component with the accompanying Sterile Water Diluent Component as described in the panels below.

	Step 1. Preparation of vial and vial adapter •Remove plastic flip off cap from vial and cleanse the rubber stopper.•Without removing the vial adapter from its packaging, peel off the top cover.
	Step 2. Attachment of vial adapter •Hold the base of the vial on a flat surface.•Keep the vial adapter in the packaging and orient it vertically over the center of the vial so that the adapter spike aligns with the center of the vial’s rubber stopper.•Connect the vial adapter to the vial with a straight downward push. The vial adapter will lock into place.•Do not push vial adapter in at an angle as this may result in leaking during use.•Remove the vial adapter packaging.
	Step 3. Removal of syringe cap •For all syringe assembly steps, hold the syringe only by the Luer lock adapter located at the tip of the syringe. This will prevent the Luer lock adapter from detaching during use.•Remove the syringe cap by slowly turning the cap counter-clockwise while holding the Luer lock adapter.
	Step 4. Connection of syringe to vial adapter •Hold the syringe’s Luer lock adapter and connect it to the vial adapter by turning clockwise.•Stop turning when you feel resistance, overtightening the syringe may result in leaking during use.•Once the syringe is securely attached to the vial adapter, there will be a small space between the top of the vial adapter and the Luer lock adapter of the syringe.
	Step 5. Reconstitution of Lyophilized Antigen Component to form ABRYSVO •Inject the entire contents of the syringe containing the Sterile Water Diluent Component into the vial.•Do not remove the empty syringe.•While holding the plunger rod down, gently swirl the vial in a circular motion until the powder is completely dissolved (less than 1 minute).•Do not shake.
	Step 6. Withdrawal of reconstituted vaccine •Invert the vial completely with the vial adapter and syringe still attached.•Slowly withdraw the entire contents into the syringe to ensure an approximately 0.5 mL dose of ABRYSVO for administration.•Do not pull the plunger rod out.
	Step 7. Disconnection of syringe •Hold the Luer lock adapter of the syringe and disconnect the syringe from the vial adapter by turning counter-clockwise.
	Step 8. Attachment of needle •Attach a sterile needle suitable for intramuscular injection to the syringe containing ABRYSVO.
	Step 9. Visual inspection •ABRYSVO is a clear and colorless solution.•Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if either condition is present.

For intramuscular injection only

After reconstitution, administer ABRYSVO immediately or store at room temperature [15°C to 30°C (59°F to 86°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an anaphylactic reaction occurs following administration of ABRYSVO.

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

Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to ABRYSVO.

Vaccination with ABRYSVO may not protect all vaccine recipients.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

The safety of ABRYSVO was evaluated in Study 1 (NCT05035212) in which 17,215 participants received ABRYSVO and 17,069 received placebo (0.5 mL dose, containing the same buffer ingredients in the same quantities as in a single dose of ABRYSVO [see Description (11)]). Study 1 is an ongoing Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of ABRYSVO in individuals 60 years of age and older. This study is being conducted in the USA, South Africa, Japan, Canada, Finland, the Netherlands, and Argentina. Demographic characteristics among participants who received ABRYSVO and those who received placebo were generally similar with regard to age, sex, race, and ethnicity. Of the participants in the study, 51% were male and 78% were White, 13% were Black or African American, and 37% were Hispanic/Latino. The median age of participants was 67 years (range 59-97 years).

Solicited local and systemic reactions were collected using electronic diaries for 7 days after study vaccination in 7,169 participants (3,630 ABRYSVO participants and 3,539 placebo recipients) from a subset of sites. For all participants, unsolicited adverse events were collected for one month after study vaccination; serious adverse events (SAEs) are collected throughout study participation.

The safety and effectiveness of ABRYSVO in individuals younger than 18 years of age have not been established.

ABRYSVO is approved for use in individuals 60 years of age and older. In Study 1, of the 17,215 recipients who received ABRYSVO 62% (n=10,756) were aged 60-69 years of age, 32% (n=5,488) were 70-79 years of age and 6% (n=970) were ≥80 years of age [see Adverse Reactions (6.1) and Clinical Studies (14.1)].

ABRYSVO induces an immune response against RSV pre F that protects against lower respiratory tract disease caused by RSV.

ABRYSVO has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. A developmental and reproductive toxicity study in female rabbits revealed no evidence of impaired female fertility [see Use in Specific Populations (8.1)].

Study 1 is an ongoing Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of ABRYSVO in the prevention of RSV-associated lower respiratory tract disease in individuals 60 years of age and older. Participants are planned to be followed for up to two RSV seasons, approximately 25 months.

Participants were randomized (1:1) to receive ABRYSVO (n=17,197) or placebo (n=17,186). Randomization was stratified by age, 60-69 years (n=21,499, 63%), 70-79 years (n=10,948, 32%), and ≥80 years (n=1,934, 6%). Healthy adults and adults with stable chronic diseases were included. Among enrolled participants 15% had stable chronic cardiopulmonary conditions such as chronic obstructive pulmonary disease (COPD), asthma, or congestive heart failure (CHF).

Starting 14 days after study vaccination (study Day 15), all participants were actively monitored for onset of acute respiratory illness (ARI) symptoms: new or increased sore throat, nasal congestion, nasal discharge, cough, wheezing, sputum production, or shortness of breath. If the participant experienced 1 or more ARI symptoms, a mid-turbinate nasal swab was collected within 7 days of onset of symptoms and tested by reverse transcriptase polymerase chain reaction (RT-PCR) for RSV.

RSV-associated lower respiratory tract disease (RSV-LRTD) was evaluated in Study 1. A case of RSV-LRTD was defined as an RT-PCR confirmed RSV illness with two or more, or three or more, of the following respiratory symptoms within 7 days of symptom onset and lasting more than 1 day during the same illness: new or increased cough, wheezing, sputum production, shortness of breath, or tachypnea (≥25 breaths/min or 15% increase from resting baseline). A case of RSV-associated severe lower respiratory tract disease was defined as a case meeting the RSV-LRTD criteria plus at least one of the following: hospitalization due to RSV-LRTD, new or increased oxygen supplementation, or mechanical ventilation including Continuous Positive Airway Pressure (CPAP).

Efficacy against Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease

Vaccine efficacy (VE), against RSV-LRTD, defined as the relative risk reduction of first episode of RSV-LRTD in the ABRYSVO group compared to the placebo group in the first RSV season, was assessed.

The study met the pre-specified success criteria for demonstration of efficacy of ABRYSVO for the primary objectives of prevention of RSV-LRTD with ≥2 symptoms and prevention of RSV-LRTD with ≥3 symptoms. The median duration of follow-up for efficacy was 7 months.

Vaccine efficacy information is presented in Table 3.

There were 2 cases of RSV associated severe lower respiratory tract disease in the placebo group and no cases in the ABRYSVO group.

ABRYSVO is supplied in a kit that includes a vial of Lyophilized Antigen Component (NDC 0069-0207-01), a prefilled syringe containing Sterile Water Diluent Component (NDC 0069-0250-01) and a vial adapter. The Lyophilized Antigen Component is reconstituted with the Sterile Water Diluent Component to form a single dose of ABRYSVO.

ABRYSVO is supplied in cartons of 1, 5, and 10 kits.

The vial stopper and the tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

Storage Before Reconstitution

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Discard if the carton has been frozen.