IMMUNOGENICITY
most had a
response BY
3 WEEKS

Almost everyone had a seroresponse by Day 22, with 97.8% of people ages 12–64, and 87.3% of those 65 and over showing a response. So even patients traveling within the next month can get vaccinated.2

maintained FOR
6 MONTHS

85.5% of people ages 12–64 and 75.5% of people 65+ maintained a seroresponse at 6 months, so they’re prepared for long-term travel and spontaneous itineraries, or can even get vaccinated ahead of time.1

Approved for
people ages
12 and over1

VIMKUNYA can be given to patients ages 12 years or older,1 making it helpful for traveling families and students.

VIMKUNYA CLINICAL TRIAL RESULTS1-3 *

ages-12-to-65 ages-12-to-65
ages-65-over ages-65-over

At 6 months, 85.5% of people ages 12–64 still had a seroresponse, along with 75.5% of people 65 and over—helping them stay protected for repeat trips or longer trips.§

*A main objective for two Phase 3 trials was to compare the anti-CHIKV SNA response to VIMKUNYA and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (VIMKUNYA minus placebo).1

†Among people ages 12–64, 97.8% (n=2503/2559) achieved a seroresponse at Day 22 with VIMKUNYA, vs 1.2% (n=5/424) with placebo; 96.8% (n=2355/2434) achieved a seroresponse at Day 15, vs 0.8% (n=3/395) with placebo.1

‡Among those ≥65, 87.3% (n=165/189) achieved a seroresponse at Day 22 with VIMKUNYA, vs 1.1% (n=2/183) with placebo; 82.3% (n=149/181) achieved a seroresponse at Day 15, vs 2.8% (n=5/176) with placebo.1

§Among people ages 12–64, 85.5% (n=1967/2301) achieved a seroresponse at Day 183, vs 1.5% (n=6/401) with placebo. Among those ≥65, 75.5% (n=139/184) achieved a seroresponse at Day 183, vs 1.2% (n=2/173) with placebo.1-3

STUDY DESIGN:

VIMKUNYA immunogenicity and tolerability was
assessed in two Phase 3 trials1-5:

EBSI-CV-317-004

Vaccination with CHIKV VLP or placebo

Blood draw for anti-CHIKV NT80 SNA testing

Safety assessment on all study days

EBSI-CV-317-005

Co-primary endpoints EBSI-CV-317-004
(randomized, double-blind, placebo-controlled)

  • Safety and tolerability of VIMKUNYA in healthy adult and adolescent participants 12–64 years old
  • Antichikungunya serum neutralizing antibody (SNA) response to VIMKUNYA and placebo at Day 22, as measured by:
    • GMT
    • Clinically relevant difference in seroresponse rate
  • Lot consistency of antichikungunya SNA GMT at Day 22 (18–45 years of age)

Pre-specified key secondary endpoints
Seroresponse rates at Days 8, 15, and 183 vs placebo

Baseline characteristics
The mean age was 39 (same as placebo); with 1358 men (vs 233 placebo), and 1436 women (vs 231 placebo)

Co-primary endpoints EBSI-CV-317-005
(randomized, double-blind, placebo-controlled)

  • Safety and tolerability of VIMKUNYA in adults ages 65+
  • Antichikungunya SNA response to VIMKUNYA and placebo at Day 22, as measured by
    • GMT
    • Clinically relevant difference in seroresponse rate

Pre-specified key secondary endpoints
Seroresponse rates at Days 15 and 183 vs placebo

Baseline characteristics
The mean age was 71 (same as placebo); with 81 men (vs 90 placebo), and 125 women (vs 117 placebo)

EBSI-CV-317-005

Co-primary endpoints EBSI-CV-317-005
(randomized, double-blind, placebo-controlled)

  • Safety and tolerability of VIMKUNYA in adults ages 65+
  • Antichikungunya SNA response to VIMKUNYA and placebo at Day 22, as measured by
    • GMT
    • Clinically relevant difference in seroresponse rate

Pre-specified key secondary endpoints
Seroresponse rates at Days 15 and 183 vs placebo

Baseline characteristics
The mean age was 71 (same as placebo); with 81 men (vs 90 placebo), and 125 women (vs 117 placebo)

Among adult and adolescent patients, 96.8% demonstrated a seroresponse at Day 15 and 97.8% at Day 22.1,2

96.8% (n=2355/2434) vs 0.8% (n=3/395) with placebo at Day 15; 97.8% (n=2503/2559) vs 1.2% (n=5/424) with placebo at Day 22

At Day 22, VIMKUNYA demonstrated a GMT of 1597.01

n=2559; vs 7.9 with placebo (n=424)

The majority (85.5%) of patients maintained a seroresponse at Day 183 (6 months)2

n=1967/2301 vs 1.5% (n=6/401) with placebo

Antichikungunya SNA response rate2,||

SNA

Antichikungunya SNA GMT1,2,4,||

GMT
||Seroresponse rate (considered the presumptive seroprotection rate) was defined as the percentage of subjects who achieved an antichikungunya SNA NT80 titer ≥100.3

Among patients 65+, 82.3% demonstrated a seroresponse at
Day 15
increasing to 87.3% at Day 221,3

82.3% (n=149/181) vs 2.8% (n=5/176) with placebo at Day 15; 87.3% (n=165/189) vs 1.1% (n=2/183) with placebo at Day 22

At Day 22, VIMKUNYA demonstrated a GMT of 721.01

n=189; vs 8.08 with placebo (n=183)

75.5% of patients maintained a seroresponse at Day 183 (6 months)3

n=139/184 vs 1.2% (n=2/173) with placebo

Antichikungunya SNA response rate3,||

adult-sna adult-sna

Antichikungunya SNA GMT1,3,5,||

older-gmt older-gmt
||Seroresponse rate (considered the presumptive seroprotection rate) was defined as the percentage of subjects who achieved an antichikungunya SNA NT80 titer ≥100.3

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Indications and Usage

VIMKUNYA is a vaccine indicated for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older. The indication is approved under accelerated approval based on anti-chikungunya virus neutralizing antibody levels. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

Important Safety Information

Contraindications

Do not administer VIMKUNYA to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

Warnings and Precautions


Adverse Reactions

In clinical studies, the most common solicited adverse reactions (>10%) in individuals 12 through 64 years of age were pain at the injection site (23.7%), fatigue (19.9%), headache (18%), and myalgia (17.6%). The most commonly reported solicited adverse reactions (>5%) in individuals 65 years of age and older were injection site pain (5.4%), myalgia (6.3%), and fatigue (6.3%).

Use in Specific Populations

There are no clinical studies of VIMKUNYA in pregnant individuals.

To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic Inc. at
1-833-365-9596 or drug.safety@bavarian-nordic.com or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see full Prescribing Information here.

References

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Indications and Usage

VIMKUNYA is a vaccine indicated for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older. The indication is approved under accelerated approval based on anti-chikungunya virus neutralizing antibody levels. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

Important Safety Information

Contraindications

Do not administer VIMKUNYA to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

Warnings and Precautions

  • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions.
  • Immunocompromised individuals, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VIMKUNYA.
  • Syncope (fainting) may occur in association with administration of injectable vaccines including VIMKUNYA. Procedures should be in place to avoid injury from fainting.

Adverse Reactions

In clinical studies, the most common solicited adverse reactions (>10%) in individuals 12 through 64 years of age were pain at the injection site (23.7%), fatigue (19.9%), headache (18%), and myalgia (17.6%). The most commonly reported solicited adverse reactions (>5%) in individuals 65 years of age and older were injection site pain (5.4%), myalgia (6.3%), and fatigue (6.3%).

Use in Specific Populations

There are no clinical studies of VIMKUNYA in pregnant individuals.

To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic Inc. at
1-833-365-9596 or drug.safety@bavarian-nordic.com or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see full Prescribing Information here.

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