Chikungunya Vaccine (Recombinant) (Monograph)

Brand name: Vimkunya
Drug class: Vaccines

Introduction

Chikungunya vaccine (recombinant) is a recombinant vaccine containing purified virus-like particles (VLPs) consisting of chikungunya virus (CHIKV) capsid protein (C) and envelope proteins E1 and E2, derived from CHIKV Senegal strain 37997.

Uses for Chikungunya Vaccine (Recombinant)

Chikungunya vaccine (recombinant) has the following uses:

Chikungunya vaccine (recombinant) is 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 and description of clinical benefit in a confirmatory trial.

Chikungunya Vaccine (Recombinant) Dosage and Administration

General

Chikungunya vaccine (recombinant) is available in the following dosage form(s) and strength(s):

Injectable suspension supplied in single-dose prefilled syringes. A single dose is 0.8 mL.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

For intramuscular use.

Administer chikungunya vaccine (recombinant) as a single 0.8 mL dose. See Full Prescribing Information for additional details on administration.

Cautions for Chikungunya Vaccine (Recombinant)

Contraindications

Do not administer chikungunya vaccine (recombinant) to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of chikungunya vaccine (recombinant).

Warnings/Precautions

Management of Allergic Reactions

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of chikungunya vaccine (recombinant).

Altered Immunocompetence

Immunocompromised individuals, including individuals receiving immunosuppressive therapy, may have a diminished immune response to chikungunya vaccine (recombinant).

Syncope

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

Specific Populations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to chikungunya vaccine (recombinant) during pregnancy. Women who receive chikungunya vaccine (recombinant) during pregnancy are encouraged to contact, or have their healthcare provider contact, 1-888-230-2491 to enroll in or obtain information about the registry.

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There are no clinical studies of chikungunya vaccine (recombinant) in pregnant women. Data on chikungunya vaccine (recombinant) administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

A developmental toxicity study was performed in female rabbits, administered the equivalent of a single human dose of chikungunya vaccine (recombinant) on 5 occasions, twice prior to mating, twice during gestation and once during lactation. In this study, postnatal survival of the kits was reduced; there were no adverse effects on other postnatal development parameters. There were no adverse effects on female fertility; and there was no evidence of harm to the fetus due to the vaccine. A developmental toxicity study was performed in female rats administered the equivalent of a single human dose of chikungunya vaccine (recombinant) on 5 occasions, twice prior to mating, twice during gestation and once during lactation. In this study there were no adverse effects on postnatal survival and on other postnatal development parameters. There were no adverse effects on female fertility.

Vertical transmission of wild-type CHIKV to neonates from pregnant women with viremia at delivery is common and can cause severe, potentially fatal CHIKV disease in neonates, with neurologic (e.g., encephalopathy, intracranial hemorrhage) and myocardial manifestations.

Lactation

Human data are not available to assess the impact of chikungunya vaccine (recombinant) on milk production, its presence in breast milk, or its effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for chikungunya vaccine (recombinant) and any potential adverse effects on the breastfed child from chikungunya vaccine (recombinant) or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine.

Pediatric Use

The safety and effectiveness of chikungunya vaccine (recombinant) in individuals 12 through 17 years of age are based on data from this age group and data from adults.

The safety and effectiveness of chikungunya vaccine (recombinant) in individuals younger than 12 years of age have not been established.

Geriatric Use

In one of the principal efficacy studies, the 206 individuals who received chikungunya vaccine (recombinant) were 65 years of age and older; among these, 47 individuals (22.8%) were 75 years of age and older. The incidence of solicited adverse reactions in individuals 65 years of age and older was generally lower than that observed in individuals less than 65 years of age. The seroresponse rate in individuals 65 years of age and older was lower than that observed in individuals less than 65 years of age.

Common Adverse Effects

• The most commonly reported solicited adverse reactions (>10%) in individuals 12 through 64 years of age were injection site pain (23.7%), fatigue (19.9%), headache (18.0%), 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%).

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

The exact mechanism of protection has not been determined. Chikungunya vaccine (recombinant) elicits CHIKV-specific immune responses.

Advice to Patients

• Advise vaccine recipients about the potential benefits and risks associated with vaccination with chikungunya vaccine (recombinant).

• Advise vaccine recipients that vaccination with chikungunya vaccine (recombinant) 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 drug.safety@bavarian-nordic.com), or through the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (or online at [Web].

• Encourage women exposed to chikungunya vaccine (recombinant) 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.

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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