Description for Vimkunya
VIMKUNYA, Chikungunya Vaccine, Recombinant, is a sterile injectable suspension for intramuscular use. VIMKUNYA contains purified virus-like particles (VLPs) consisting of CHIKV capsid protein (C) and envelope proteins E1 and E2, derived from CHIKV Senegal strain 37997. The VLPs are produced by transfecting an expression plasmid that encodes for the CHIKV structural polyprotein C-E3-E2-6K-E1 in HEK293 (a continuous line of human embryonic kidney cells) in media containing amino acids, vitamins, and minerals. The VLPs containing C, E1 and E2, are harvested from the media and then purified by a series of chemical and physical methods. After sterile filtration, the purified VLPs are mixed with formulation buffer and adsorbed on aluminum hydroxide [Al(OH)3] as adjuvant.
Each 0.8-mL dose contains approximately 40 mcg of CHIKV VLPs. Each dose also contains 867 mcg Al(OH)3 (approximately 300 mcg aluminum), 59.7 mg sucrose, 5.9 mg sodium citrate dihydrate, 0.9 mg potassium phosphate dibasic, 0.4 mg potassium phosphate monobasic, and water for injection. Each dose may contain residual amounts of HEK293 cell protein (less than 400 ng/dose), HEK293 cell DNA (less than 10 ng/dose), poloxamer 188 (less than 2850 mcg/dose), polyethyleneimine (less than 4 mcg/dose), valproic acid (less than 12.8 mcg/dose), Benzonase (less than 1.6 ng/dose), and plasmid DNA (less than 3.6 ng/dose), from the manufacturing process.
VIMKUNYA does not contain a preservative or antibiotics.
The syringe stoppers and caps are not made with natural rubber latex.
ADVERSE REACTIONS
In participants 12 through 64 years of age who received VIMKUNYA, the most common solicited local adverse reaction (>10%) was injection site pain (23.7%). The most common solicited systemic adverse reactions (>10%) were fatigue (19.9%), headache (18.0%), and myalgia (17.6%).
In participants 65 years of age and older who received VIMKUNYA, the most common solicited local adverse reaction (>5%) was injection site pain (5.4%). The most common solicited systemic adverse reactions (>5%) were myalgia (6.3%) and fatigue (6.3%).
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 to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
The safety of VIMKUNYA was evaluated in two clinical trials [Study 1 (NCT05072080) and Study 2 (NCT05349617)], both conducted in the United States, in which a total of 3,667 participants 12 years of age and older received a single dose of VIMKUNYA or placebo [formulation buffer containing 218 mM sucrose, 10 mM potassium phosphate, 25 mM sodium citrate, pH 7.0 (see Description (11)].
Study 1 was a multicenter, randomized, placebo-controlled, double-blinded trial. Individuals aged 12 through 64 years were randomized in a 6:1 ratio, stratified by age stratum (12-17, 18-45, and 46-64 years of age), to receive a single dose of VIMKUNYA (n=2,794) or placebo (n=464).
Among the overall 3,258 participants randomized in Study 1, the median age was 38 years [with 254 (8%) participants 12 through 17 years of age, 1906 (58%) participants 18 through 45 years of age, and 1098 (34%) participants 46 through 64 years of age]; 51.2% were female; 73.2% were White, 19.1% Black or African American, 2.9% Asian, 1.0% American Indian or Alaska Native, 0.3% Native Hawaiian or Pacific Islander, 2.6% multiple racial groups; and 17.7% were of Hispanic or Latino ethnicity.
Study 2 was a multicenter, randomized, placebo-controlled, double-blinded trial. Individuals aged 65 years and older were randomized in a 1:1 ratio, stratified by age stratum (65-74 and ≥75 years of age), to receive a single dose of VIMKUNYA (n=206) or placebo (n=207).
Among the overall 413 participants enrolled in Study 2, the median age was 70 years, and 58.6% were female; 83.3% were White, 11.9% Black or African American, 1.2% Asian, 0.5% American Indian or Alaska Native, 2.2% multiple racial groups; and 44.3% were of Hispanic or Latino ethnicity.
In Studies 1 and 2, solicited adverse reactions were collected via electronic diary from the vaccination day through 7 days post-vaccination (an 8-day period). Unsolicited adverse events were monitored for 28 days post-vaccination. Serious adverse events were monitored through 6 months post-vaccination. New onset or worsening arthralgia that was medically attended was monitored through 6 months post-vaccination.
Solicited Adverse Reactions
The percentage of participants in Study 1 reporting solicited local (injection site) and systemic adverse reactions is shown in Table 1. In Study 1, the median day of onset was Day 1 for local reactions (Day 1 was the day of vaccination) and Day 2 for systemic reactions following administration of VIMKUNYA. Local and systemic adverse reactions resolved with a median duration of 1 day.
Table 1. Percentages of Participants with Solicited Local and Systemic Adverse Reactions
Through 7 Days After Vaccination (Study 1a, 12 through 64 years of age)
| Adverse Reaction |
VIMKUNYA N=2790 |
Placebo |
| Solicited Local (Injection Site) Adverse Reactionsb | ||
| Pain (any)c,f | 23.7 | 10.7 |
| Pain (severe) | 0.1 | 0 |
| Redness/Erythema (≥25 mm)f | 0.5 | 0 |
| Redness/Erythema (>100 mm) | <0.1 | 0 |
| Swelling (≥25 mm)f | 0.4 | 0 |
| Solicited Systemic Adverse Reactionsb | ||
| Fatigue (any)d,f | 19.9 | 17.0 |
| Fatigue (severe) | 0.7 | 0.2 |
| Headache (any)c,h | 18.0 | 16.6 |
| Headache (severe) | 0.3 | 0.4 |
| Myalgia/Muscle Pain (any)d,f | 17.6 | 9.6 |
| Myalgia/Muscle Pain (severe) | 0.4 | 0.4 |
| Chills (any)d,f | 8.6 | 3.3 |
| Chills (severe) | 0.1 | 0 |
| Arthralgia/Joint Pain (any)d,f | 7.7 | 7.2 |
| Arthralgia/Joint Pain (severe) | 0.3 | 0.2 |
| Nausea (any)e,f | 7.5 | 6.6 |
| Nausea (severe) | 0.4 | 0 |
| Fever (≥38.0°C or ≥100.4°F)g | 0.9 | 0.2 |
| Fever (≥39.0°C or ≥102.1°F) | 0.2 | 0 |
|
Note: Solicited adverse reactions were collected from the vaccination day through 7 days post-vaccination (an 8-day period). Percentages are based on the number of participants in the Study 1 safety population with at least one diary observation for a given symptom for a given day. aNCT05072080 bSeverity=mild, moderate, severe intensity. Absence of rows for severe reactions indicates that no reactions of this severity were reported in either group. cDefined as mild (no interference with activity), moderate (repeated use of non-narcotic pain reliever >24 hours or interference with activity), severe (any use of narcotic pain reliever or prevents daily activity). dDefined as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity). eDefined as mild (no interference with activity or 1 – 2 episodes/24 hours), moderate (some interference with activity or >2 episodes/24 hours), severe (prevents daily activity, requires outpatient intravenous hydration). fThe denominator for injection site pain, redness, swelling, arthralgia, chills, fatigue, myalgia, and nausea is 2,764 for VIMKUNYA and 458 for placebo. gThe denominator for fever is 2,760 for VIMKUNYA and 457 for placebo. hThe denominator for headache is 2,765 for VIMKUNYA and 458 for placebo. |
||
In Study 1, solicited adverse reactions were reported by 94 (44.1%) participants 12 through 17 years of age, 676 (41.8%) participants 18 through 45 years of age, and 289 (31.0%) participants 46 through 64 years of age in the VIMKUNYA group.
The percentage of participants in Study 2 reporting solicited local and systemic adverse reactions is shown in Table 2. In Study 2, the median day of onset was Day 2 for both local and systemic reactions (Day 1 was the day of vaccination) following administration of VIMKUNYA. Local adverse reactions resolved with a median duration of 1 day and systemic adverse reactions resolved with a median duration of 2 days.
Table 2. Percentages of Participants with Solicited Local and Systemic Adverse Reactions
Through 7 Days After Vaccination (Study 2a, 65 years of age and greater)
| Adverse Reaction | VIMKUNYA N=205 % |
Placebo N=200 % |
| Solicited Local (Injection Site) Adverse Reactionsb | ||
| Pain (any)c | 5.4 | 1.5 |
| Redness/Erythema (≥25 mm) | 0 | 0.5 |
| Swelling (≥25 mm) | 0 | 0 |
| Solicited Systemic Adverse Reactionsb | ||
| Myalgia/Muscle Pain (any)d | 6.3 | 6.5 |
| Fatigue (any)d | 6.3 | 6.0 |
| Fatigue (severe) | 0.5 | 0 |
| Headache (any)c | 4.4 | 7.5 |
| Headache (severe) | 0.5 | 0 |
| Arthralgia/Joint Pain (any)d | 2.9 | 4.0 |
| Chills (any)d | 2.9 | 3.0 |
| Nausea (any)e | 2.9 | 1.5 |
| Fever (≥38.0°C or ≥100.4°F) | 0 | 1.0 |
|
Note: Solicited adverse reactions were collected from the vaccination day through 7 days post-vaccination (an 8-day period). N=Number of participants in the Study 2 safety population with at least one diary observation for a given symptom for a given day. aNCT05349617 bSeverity=mild, moderate, severe intensity. Absence of rows for severe reactions indicates that no reactions of this severity were reported in either group. cDefined as mild (no interference with activity), moderate (repeated use of non-narcotic pain reliever > 24 hours or interference with activity), severe (any use of narcotic pain reliever or prevents daily activity). dDefined as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity). eDefined as mild (no interference with activity or 1 – 2 episodes/24 hours), moderate (some interference with activity or >2 episodes/24 hours), severe (prevents daily activity, requires outpatient intravenous hydration). |
||
Unsolicited Adverse Events
In Study 1, unsolicited adverse events that occurred within 28 days following vaccination were reported in 15.5% of 2,790 participants who received VIMKUNYA and 12.7% of 464 participants who received placebo. There was one report of severe dehydration considered related to VIMKUNYA.
In Study 2, unsolicited adverse events that occurred within 28 days following vaccination were reported in 12.6% of 206 participants who received VIMKUNYA and 15.5% of 207 participants who received placebo. There were no severe unsolicited adverse events considered related to VIMKUNYA.
Medically Attended New Onset or Worsening Arthralgia
In Study 1, 3 (0.1%) participants in the VIMKUNYA group (n=2,790) and 1 (0.2%) participant in the placebo group (n=464) reported new onset or worsening arthralgia that was medically attended and considered possibly or probably related to VIMKUNYA (beginning 2, 14 and 84 days post-vaccination, respectively) or possibly related to placebo (beginning 1 day postvaccination); none of these reactions were reported as serious or severe (defined as those that prevented daily activity and/or required medical intervention).
In Study 2, there were no participants in the VIMKUNYA or placebo groups with new onset or worsening arthralgia that was medically attended and considered at least possibly related to the study intervention.
Drug Interactions for Vimkunya
No information provided
Warnings for Vimkunya
Included as part of the PRECAUTIONS section.
Precautions for Vimkunya
Management of Allergic Reactions
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of VIMKUNYA.
Altered Immunocompetence
Immunocompromised individuals, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VIMKUNYA.
Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines including VIMKUNYA. Procedures should be in place to avoid injury from fainting.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
VIMKUNYA has not been evaluated for the potential to cause carcinogenicity, mutagenic potential, or for impairment of male fertility in animals.
Animal Toxicology and/or Pharmacology
A passive transfer study was performed in non-human primates (NHPs) using human antiCHIKV immune sera collected from two Phase 2 studies (NCT03483961 and NCT03992872), from participants who received a single dose of a vaccine formulation containing the same CHIKV VLP used in VIMKUNYA. Sera obtained on Day 22 after vaccination were pooled to generate a serum pool with a NT80 titer of 2470, as determined by a CHIKV luciferase neutralization assay. In the passive transfer study, 20 CHIKV-naïve cynomolgus macaques (M. fascicularis) were administered human anti-CHIKV immune sera at four dose levels (2.4, 1.2, 0.6 and 0.3 mL/kg) and 6 CHIKV-naïve cynomolgus macaques were administered non-immune control sera by intravenous injection. One day after the transfers, serum samples were obtained from the macaques to determine pre-challenge anti-CHIKV neutralizing antibody titers by the CHIKV luciferase neutralization assay. On the same day following sera collection, animals were challenged via the subcutaneous route with 100,000 Plaque Forming Units of wild-type CHIKV strain La Réunion 2006-OPY1, corresponding to 1000 times the 50% animal infectious dose. Animal monitoring included assessment of wild-type CHIKV-induced viremia by plaque assay and RT-qPCR through 10 days after challenge. For those NHPs that received anti-CHIKV sera, no infectious virus was detected in the blood, and the amounts of CHIKV RNA in the blood were reduced in a dose-dependent manner compared with NHPs who received non-immune human sera. Data from the NHP study were analyzed by logistic regression and a NT80 titer of ≥100 was determined to be reasonably likely to predict clinical benefit in the Phase 3 studies.
Patient Information for Vimkunya
Inform the vaccine recipient:
- about the potential benefits and risks associated with vaccination with VIMKUNYA.
- that vaccination with VIMKUNYA may not protect all vaccine recipients and that personal precautions should be taken to reduce exposure to mosquito bites (e.g., adequate clothing, use of repellents, mosquito nets).
Instruct the vaccine recipient to report any adverse reactions to their health care provider, the vaccine manufacturer at 1-833-365-9596 (or online at [email protected]), or through the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (or online at www.vaers.hhs.gov).
Encourage women exposed to VIMKUNYA around the time of conception or during pregnancy to enroll in the pregnancy registry by calling 1-888-230-2491 or by visiting bnpregnancyregistry.com [See Use in Specific Populations (8.1)].
From 
Parenting Resources
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.