chikungunya vaccine, live (Rx)

>10%

Headache (31.6%)

Fatigue (28.5%)

Grade 1 neutropenia, 1,500-2,000 cell/mm³ (27.6%)

Grade 1 leukopenia, 2,500-3,500 cell/mm³ (27.3%)

Myalgia/muscle pain (23.9%)

Grade 1 lymphopenia, 750-1,000 cell/mm³ (19.1%)

Arthralgia/joint pain (17.2%)

Fever (13.5%)

Grade 2 neutropenia, 1,000-1,499 cell/mm³ (11.3%)

Nausea (11.2%)

Injection site tenderness (10.6%)

1-10%

Injection site pain (6.2%)

Grade 2 leukopenia, 1,500-2,499 cell/mm³ (4.4%)

Grade 2 lymphopenia, 500-749 cell/mm³ (4.1%)

Grade 3 neutropenia, 500-999 cell/mm³ (3%)

Rash (2.3%)

Vomiting (1.9%)

Injection site erythema/redness, ≥2.5 cm (1.5%)

Injection site induration, ≥2.5 cm (1.4%)

Fever, severe (1.4%)

<1%

Injection site swelling, ≥2.5 cm (0.7%)

Grade 3 leukopenia, 1,000-1,499 cell/mm³ (0.3%)

Grade 3 lymphopenia, 250-499 cell/mm³ (0.3%)

Grade 4 neutropenia, <500 cell/mm³ (0.3%)

Myalgia/muscle pain, severe (0.3%)

Arthralgia/joint pain, severe (0.3%)

Fatigue, severe (0.2%)

Headache, severe (0.1%)

Injection site pain, severe (0.03%)

Contraindications

Individuals who are immunodeficient or immunosuppressed due to disease or medical therapy (eg, from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy, or patients with HIV infection who are severely immunocompromised)

History of severe allergic reactions (Anaphylaxis) to any component of vaccine

Cautions

Administer in setting that provides appropriate medical treatment used to manage immediate allergic reactions

Vaccination may cause severe or prolonged chikungunya-like adverse reactions

Syncope (fainting) may occur; procedures should be in place to avoid injury from fainting

Vaccination may not protect all individuals

Potential for vertical transmission of vaccine virus and fetal/neonatal adverse reactions

• Vertical transmission of wild-type CHIKV infection to neonates from pregnant individuals with viremia at delivery is common and can cause severe, potentially fatal CHIKV disease in neonates
• Vertical transmission of wild-type CHIKV and fetal death attributable to CHIKV in the context of antepartum infection is infrequent
• Vaccine viremia occurs in first week following administration, with resolution of viremia by 14 days after vaccination [
• Unknown if vaccine virus can be transmitted from pregnant females fetus or neonate and cause fetal or neonatal adverse reactions
• Decisions to administer during pregnancy should take into consideration individual risk of exposure to wild-type CHIKV, gestational age, and risks to fetus or neonate from vertical transmission of wild-type CHIKV
• Closely monitor neonates for 7 days after birth for potential disease due to vaccine virus if they are born within 14 days of their mother receiving vaccine

Pregnancy

There are no adequate and well-controlled studies in pregnant females, and human data available from clinical trials are insufficient to establish presence or absence of vaccine-associated risk during pregnancy

Pregnancy registry

• Pregnant patients who received vaccine or their clinicians should contact OXON Epidemiology at 1-855-417-6214 to enroll in or obtain information about the registry

Animal studies

• Rats were administered a single human dose of chikungunya vaccine live on 2 occasions, once before mating and once during gestation
• Study revealed no evidence of harm to fetus and no adverse effects on postnatal development

Clinical considerations

• Disease-associated maternal and/or embryo/fetal risk

  • Vertical transmission of wild-type CHIKV to neonates from pregnant individuals with viremia at delivery is common and can cause severe, potentially fatal CHIKV disease in neonates, with neurologic (eg, encephalopathy, intracranial hemorrhage) and myocardial manifestations
  • Vertical transmission of wild-type CHIKV and fetal death attributable to CHIKV in the context of antepartum infection has been reported to occur infrequently

• Fetal/neonatal adverse reactions

  • Vaccine viremia occurred in first week following administration, with resolution of viremia by 14 days after vaccination
  • Unknown if vaccine virus can be transmitted from a pregnant individual to fetus or neonate and cause fetal or neonatal adverse reactions
  • Decisions to administer during pregnancy should take into consideration individual’s risk of exposure to wild-type CHIKV, gestational age, and risks to fetus or neonate from vertical transmission of wild-type CHIKV
  • Closely monitor neonates for 7 days after birth

Lactation

Human data are not available to assess the vaccine’s effects on milk production, presence in breast milk, or effects on breastfed children

Clinical considerations

• Vaccine viremia occurs after vaccination
• In a clinical trial, vaccine virus was not detectable at 14 days after vaccination

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Conveys active immunity by stimulating production of endogenously produced antibodies

IM Preparation

Reconstitute lyophilized antigen component only with accompanying sterile water diluent component

Lyophilized antigen is a white to slightly yellowish powder; once reconstituted, it should appear as a clear, colorless to slightly yellowish liquid solution

Inspect visually for particulate matter and discoloration; do not administer if particulate matter or discoloration observed

Reconstitute lyophilized powder

• Cleanse vial stopper of lyophilized antigen component
• Slowly transfer entire contents of prefilled syringe of sterile water diluent into vial
• Do not remove syringe from vial
• Do NOT shake or invert vial; gently swirl vial to dissolve lyophilized powder
• After swirling, wait for at least 1 minute for complete reconstitution of vaccine

Prepare dose

• After reconstitution, slightly tilt vial and withdraw entire contents into syringe
• Do not invert vial

IM Administration

After reconstitution, immediately administer by IM injection

Does not contain a preservative

Storage

Unopened vial of lyophilized vaccine and syringe of sterile water diluent

• Refrigerate at 2-8ºC (35-46ºF)
• Store in original carton to protect from light
• Do not freeze