Vaccine Information: Arexvy

AREXVY- respiratory syncytial visus vaccine recombinant, adjuvanted
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE

AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 Dose and Schedule

Administer a single dose (0.5 mL) of AREXVY as an intramuscular injection.

2.2 Preparation

AREXVY is supplied in 2 vials that must be combined prior to administration. Prepare AREXVY by reconstituting the lyophilized antigen component (a sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid). Use only the supplied adjuvant suspension component for reconstitution. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

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Figure 4
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Figure 1. Cleanse both vial stoppers. Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the adjuvant suspension component (liquid) by slightly tilting the vial. Vial 1 of 2.

Figure 2. Slowly transfer entire contents of syringe into the lyophilized antigen component vial (powder). Vial 2 of 2.

Figure 3. Gently swirl the vial until powder is completely dissolved. Do not shake vigorously.

Figure 4. After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine and administer intramuscularly.

2.3 Administration

For intramuscular injection only.

After reconstitution, administer AREXVY immediately or store protected from light in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

3 DOSAGE FORMS AND STRENGTHS

AREXVY is a suspension for injection supplied as a single-dose vial of lyophilized antigen component to be reconstituted with the accompanying vial of adjuvant suspension component. A single dose after reconstitution is 0.5 mL.

4 CONTRAINDICATIONS

Do not administer AREXVY to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of AREXVY [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Preventing and Managing Allergic Vaccine Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of AREXVY.

5.2 Syncope

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

5.3 Altered Immunocompetence

Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY.

6 ADVERSE REACTIONS

In a clinical trial (NCT04886596), the most commonly reported (≥10%) adverse reactions were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%).

6.1 Clinical Trials Experience

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

The safety of AREXVY was evaluated in 15,845 vaccine recipients.

Study 1 (NCT04886596) is a placebo-controlled, Phase 3 clinical study conducted in Europe, North America, Asia, and the Southern Hemisphere (South Africa, Australia, and New Zealand), involving 24,966 participants, 60 years of age and older, who received AREXVY (n = 12,467) or saline placebo (n = 12,499). Study 2 (NCT04732871) is a non-placebo-controlled, open-label, Phase 3 clinical study conducted in Europe, North America, and Asia, involving 1,653 participants, 60 years of age and older, who received AREXVY. Study 3 (NCT04841577) is a non-placebo-controlled, open-label, Phase 3 clinical study conducted in New Zealand, Panama, and South Africa, involving participants 60 years of age and older who received 1 dose of AREXVY and FLUARIX QUADRIVALENT concomitantly (n = 442) or sequentially (n = 443).

At the time of vaccination in Study 1, the median age of the population was 69.0 years; 13,943 (55.8%) participants were 60 to 69 years of age, 8,978 (36.0%) participants were 70 to 79 years of age, and 2,045 (8.2%) participants were 80 years of age and older. The majority of participants were White (79.4%), followed by Black (8.7%), Asian (7.6%), and other racial/ethnic groups (4.3%); 5.5% were of Hispanic or Latino ethnicity; 51.7% were female. In Study 2, the median age of the population at the time of vaccination was 69.0 years; 820 (49.6%) participants were 60 to 69 years of age, 621 (37.6%) participants were 70 to 79 years of age, and 212 (12.8%) participants were 80 years of age and older. In Study 2, the majority of participants were White (67.8%), followed by Asian (30.0%), Black (2.0%), and other racial/ethnic groups (0.2%); 1.9% were of Hispanic or Latino ethnicity; 54.6% were female. In Study 3, the median age of the population at the time of the vaccination was 67.0 years; 519 (58.6%) participants were 60 to 69 years of age, 288 (32.5%) participants were 70 to 79 years of age, and 78 (8.8%) participants were 80 years of age and older, respectively. In Study 3, the majority of the participants were of mixed race (50.3%), followed by White (30.7%), and Black (16.0%); 34.7% were of Hispanic or Latino ethnicity; 51.5% were female.

Safety Data from Study 1

Solicited Adverse Reactions: In Study 1, a subset of study participants (solicited safety set) was monitored for solicited adverse reactions using standardized paper diary cards during the 4 days (i.e., day of vaccination and the next 3 days) following a dose of AREXVY or placebo; 879 participants received AREXVY and 874 participants received 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 1.

Table 1. Percentage of Participants with Solicited Local Adverse Reactions and Systemic Adverse Reactions within 4 Days of Vaccination in Adults 60 Years of Age and Older (Solicited Safety Set with 4-Day Diary Card)
N = Exposed set for solicited safety set included all participants with at least 1 documented dose.
a Placebo was a saline solution.
b Any grade pain: Defined as any pain neither interfering with nor preventing normal everyday activities (Grade 1), painful when limb is moved and interferes with everyday activities (Grade 2), or significant pain at rest and prevents normal everyday activities (Grade 3).
c Any grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).
d Temperature taken by any route (oral, axillary, or tympanic).

AREXVY

%

Placeboa

%

Local Adverse Reactions

N = 879

N = 874

Pain, Anyb

60.9

9.3

Pain, Grade 3b

1

0

Erythema, >20 mm

7.5

0.8

Erythema, >100 mm

0.2

0

Swelling, >20 mm

5.5

0.6

Swelling, >100 mm

0.2

0

Systemic Adverse Reactions

N = 879

N = 878

Fatigue, Anyc

33.6

16.1

Fatigue, Grade 3c

1.7

0.5

Myalgia, Anyc

28.9

8.2

Myalgia, Grade 3c

1.4

0.3

Headache, Anyc

27.2

12.6

Headache, Grade 3c

1.3

0

Arthralgia, Anyc

18.1

6.4

Arthralgia, Grade 3c

1.3

0.6

Fever, ≥38.0°C/100.4°Fd

2.0

0.3

Fever, >39.0°C/102.2°Fd

0.1

0.1

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 Study 1, 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. There were no other notable patterns or numerical imbalances between groups for specific categories of unsolicited adverse events.

Serious Adverse Events: In Study 1, 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%). Serious events of atrial fibrillation were reported in 13 participants who received AREXVY and 15 participants who received placebo within 6 months after vaccination.

Deaths: From vaccination through the first analysis of the ongoing Study 1, 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 Study 1, 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.

Serious Adverse Events Reported From Other Studies

Study 2: Guillain-Barré syndrome beginning 9 days after AREXVY vaccination was reported in a participant enrolled in a study site in Japan.

Study 3: Acute disseminated encephalomyelitis was reported in 2 participants enrolled in a study site in South Africa; the onset of the symptoms was 7 and 22 days post vaccination, respectively. One event was fatal and the other non-fatal. These participants received AREXVY concomitantly with FLUARIX QUADRIVALENT.

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