Ebola Zaire Vaccine

Ebola Zaire Vaccine is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.

• Ebola Zaire Vaccine is available under the following different brand names: Ervebo

Common side effects of Ebola Zaire Vaccine include:

• injection-site reactions (pain, swelling, and redness)
• headache
• fever
• muscle pain
• fatigue
• nausea
• joint pain and stiffness
• rash
• abnormal sweating

Serious side effects of Ebola Zaire Vaccine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• cough
• difficulty swallowing
• dizziness
• fast heart rate
• rash
• itching
• tightness in the chest
• unusual tiredness
• weakness

Rare side effects of Ebola Zaire Vaccine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, suspension

• 1 mL (single-dose vial)

Immunization against Ebola Zaire virus

Adult and pediatric dosage

• 1 mL IM once
• ACIP recommendations
  • Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommends preexposure vaccination for the following people who:
  • Are responding to an outbreak of Ebola virus disease; or
  • Work as healthcare personnel at federally designated Ebola Treatment Centers (ETCs) in the U.S.; or
  • Work as laboratorians or other staff at biosafety-level 4 facilities in the U.S.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ebola Zaire Vaccine has severe interactions with no other drugs
• Ebola Zaire Vaccine has serious interactions with the following drugs:
  • abrocitinib
  • anifrolumab
  • atoltivimab/maftivimab/odesivimab
  • axicabtagene ciloleucel
  • ciltacabtagene autoleucel
  • cyclosporine
  • elivaldogene autotemcel
  • idecabtagene vicleucel
  • ofatumumab SC
  • ozanimod
  • ponesimod
  • ritlecitinib
  • satralizumab
  • teplizumab
  • tisagenlecleucel
  • voclosporin
• Ebola Zaire Vaccine has moderate interactions with the following drugs:
  • betibeglogene autotemcel
  • leniolisib
  • ublituximab
• Ebola Zaire Vaccine has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to any component of the Vaccine, including rice protein

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ebola Zaire Vaccine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ebola Zaire Vaccine?”

Cautions

• There were 2 reports of anaphylaxis; monitor for signs and symptoms of hypersensitivity reactions following vaccination; appropriate medical treatment and supervision must be available in case of an anaphylactic event following administration
• Vaccination may not protect all individuals; vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission
• Safety and effectiveness have not been assessed in immunocompromised individuals; weigh the risk of vaccination in immunocompromised individuals against the risk of disease due to Zaire ebolavirus
• Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults; transmission of vaccine virus is a theoretical possibility
• Drug interaction overview
  • Interference with laboratory tests
  • Following vaccination, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens
  • GP-based testing may have limited diagnostic value during the period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the Vaccine

Pregnancy and Lactation

• There are no adequate and well-controlled studies in pregnant women, and human data available from clinical trials are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy
• Consider the woman’s risk of exposure to Zaire ebolavirus before vaccination
• Clinical considerations
  • Fetal and neonatal outcomes are universally poor among pregnant women infected with Zaire ebolavirus
  • Majority of such pregnancies end in miscarriage or stillbirth
  • In pregnancies where live birth does occur, neonates generally do not survive
  • The potential for transmission of the Vaccine virus from the mother to the fetus/neonate is unknown
• Lactation
  • Human data are not available to assess the effects on milk production, its presence in breast milk, or its effects on the breastfed child
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition
  • For preventive Vaccines, the underlying condition is susceptibility to disease prevented by the Vaccine