Ervebo (Ebola Zaire vaccine) is a live vaccine that is used in the prevention of disease caused Ebola Zaire virus.

Indications of Ervebo (Ebola Zaire vaccine):

• Zaire ebolavirus prevention:

  • It is effective in immunization against disease caused by Zaire ebolavirus in adults.
• Limitations of use:
  • Duration of protection and efficacy of the vaccine, when given in combination with antiviral medication, immune globulin, and/or blood or plasma transfusions, is unknown.
  • Protection against other species of Ebolavirus or Marburgvirus cannot be provided.
  • ERVEBO® is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in patients 18 years of age and older.

Ebola Zaire vaccine dose in adults:

Ervebo Dosage And Administration

For Intramuscular Administration Only.

• Dosage

  • Administer 1 ml dose of ERVEBO.

Ervebo (Ebola Zaire vaccine) dose in children:

The safety and effectiveness of ERVEBO in individuals younger than 18 years of age have not been established.

Pregnancy Risk Summary

• All pregnancies can lead to adverse outcomes, including birth defects or pregnancy loss.
• The background risk of miscarriage and major birth defects in the U.S. population is between 2% and 4%, and 15% to 20% for those with clinically diagnosed pregnancies.
• The data on ERVEBO in pregnancy are not available and have not been well controlled.
• The human data from clinical trials using ERVEBO are not sufficient to confirm the existence or absence of vaccine-associated pregnancy risk.
• The woman's potential exposure to Zaire ebolavirus will determine whether or not she is vaccinated during pregnancy.
• A developmental toxicity study of female rats was done by administering a single dose of ERVEBO to four times.
• This included three times before mating, one during pregnancy and one during lactation.

Ebola Zaire vaccine use During Breast-Feeding

• It is not known if the vaccine virus could be transmitted from mother to fetus/neonate.

Dose in Renal Disease:

No Adjustments required.

Dose in Liver Disease:

No adjustments required.

Common Side Effects of Ervebo (Ebola Zaire vaccine):

• Hematologic & oncologic:

  • Lymphocytopenia
  • Neutropenia

• Local:

  • Pain at the injection site
  • Swelling at the injection site
  • Erythema at the injection site
  • Arthralgia
  • Arthritis

Rare Side Effects of Ebola Zaire vaccine:

• Dermatologic:

  • Skin rash
  • Vesicular eruption

• Neuromuscular & skeletal:

  • Chills
  • Paresthesia

Contraindications to Ervebo (Ebola Zaire vaccine):

• Anaphylaxis (severe allergic reaction) to any vaccine component, including rice protein.
• Patients who have had a history of severe allergic reactions (e.g. Anaphylaxis to any vaccine component, including rice protein, should be avoided

Warning and Precautions

• Acute Allergic Reactions Management

  • Two cases of anaphylaxis were reported in 15,399 people who had been vaccinated with ERVEBO.
  • After vaccination with ERVEBO, it is important to monitor hypersensitivity reactions for signs and symptoms.
  • If there is an anaphylactic reaction to ERVEBO administration, it is important that appropriate medical supervision and treatment are available.

• Limitations in Vaccine Effectiveness

  • Vaccination with ERVEBO is not a universal method of protecting all individuals.
  • To prevent Zaire ebolavirus transmission and infection, vaccinated individuals must continue to follow infection control protocols.

• Immunocompromised Individuals

  • The safety and efficacy of ERVEBO in immunocompromised patients has not been evaluated.
  • In immuno-compromised patients, ERVEBO may not be as effective.
  • The risk of vaccination with ERVEBO (a live virus vaccine) in immuno-compromised patients should be weighed against Zaire ebolavirus disease.

• Transmission

  • RT-PCR has detected Vaccine Virus RNA in the blood, saliva and urine of vaccinated adults.
  • Transmission of vaccine virus can be theoretically possible.

Ebola Zaire vaccine (live): Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

None mentioned.

How to administer Ervebo (Ebola Vaccine)?

For Intramuscular Administration Only.

• Dosage

  • Administer 1 mL dose of ERVEBO.

• Preparation

  • Vial should be thawed at room temperature until no visible ice is present. Vial should not be thawed in a refrigerator.
  • Vial should be inverted several times.
  • The vaccine is a colorless to slightly brownish-yellow liquid with no particulates visible.
  • The drug should be checked for any discoloration or any particulate matter before administration, whenever solution and container permit.
  • The vial should be discarded if there is particulate or any discoloration.
  • The vaccine should be immediately consumed after thawing.
  • If not used immediately, the vaccine may be stored for 4 hours at room temperature (up to 25°C; 77°F) protected from light. DO NOT REFREEZE [see How Supplied/Storage and Handling (16)].
  • One mL dose of vaccine should be withdrawn from the vial using a sterile needle and sterile syringe.

• Administration

  • 1 mL dose of ERVEBO should be injected intramuscularly, preferably in the deltoid area of the nondominant arm.
  • The unused portion should be discarded.

• Dosage forms and strengths:

  • ERVEBO is a suspension for injection supplied as a 1 mL dose in single-dose vials.

Mechanism of Action of Ervebo (Ebola vaccine):

• ERVEBO (Ebola Zaire Vaccine Live) is a sterile suspension that can be intramuscularly injected.
• It is a live, recombinant virus vaccine. It consists of a VSV backbone that has been deleted and replaced with the Zaire envelope glycoprotein (Kikwit 1995).
• The vaccine virus is grown in serum-free Vero cells.
• The virus is taken from the cell culture medium and purified. It is then prepared with a stabilizer solution. Vials are filled and frozen.
• After thawing, ERVEBO is a colorless to slightly yellowish-yellow liquid that has no particulates.
• Each 1 mL dose (72 million plaque-forming unit) of ERVEBO vaccine virus is contained in a stabilizer solution containing 10 mM Tromethamine, Tris (Tris), and 2.5 mg/mL rice derived recombinant serum albumin.
• In 1 ml of dose, residual amounts of host cell DNA (=10ng) or benzonase (15ng) may be present.
• Rice protein can also be found in trace amounts. The product contains no preservatives. The vaccine vial cap is made without natural rubber latex.
• After immunization, you can expect a healthy immune response and protection against the Zaire ebolavirus.
• It is not known what the relative contributions of cell-mediated, humoral and innate immunity are to Zaire ebolavirus protection.

Viremia

• 186 participants in seven clinical studies were vaccinated against ERVEBO.
• The plasma of most individuals was positive for vaccine virus RNA from Day 1 through Day 7, with only one subject having a positive plasma RTPCR test 14 days later.

Shedding

• In seven clinical studies, 299 subjects who had been vaccinated with ERVEBO (or lower dose) were tested for vaccine virus shedding in their saliva or urine.
• Some people had vaccine virus RNA detected using RT-PCR in their urine or saliva at various time points ranging between Day 1 and Day 14 after vaccination.
• In the two studies, which assessed Day 28 shedding, no samples were positive.
• RT-PCR was used to detect RNA from vaccine virus in vesicular fluid samples taken from certain subjects.
• A sample taken 20 days after vaccination was positive for vaccine virus RNA using RT-PCR in one subject.

Ebola Zaire vaccine Brand Names (International):

• Ervebo

Ebola vaccine Brand Names in Pakistan:

No Brands Available in Pakistan.