Key points
- The Ebola vaccine, ERVEBO®, should only be given to patients who meet certain eligibility requirements.
- The vaccine must be stored properly and should be examined before being administered.
- Healthcare providers should practice aseptic technique and standard precautions when preparing and administering ERVEBO® intramuscularly.
Patient eligibility
ERVEBO is approved by the U.S. Food and Drug Administration for prevention infection with the Ebola virus (species orthoebolavirus zairense) in people 12 months of age and older. ERVEBO is not currently commercially marketed in the United States. It is, however, in the U.S. Strategic National Stockpile and is made available through CDC.
ERVEBO can be given as pre-exposure vaccination for adults aged ≥18 years who fall into one of the three occupational categories:
- Outbreak responders who will be traveling to an area with an active outbreak of Ebola virus (species orthoebolavirus zairense).
- Laboratory scientists and support staff working at biosafety level 4 (BSL-4) or Laboratory Response Network facilities in the United States that handle specimens that contain or might contain replication-competent Ebola virus.
- Healthcare personnel* at federally designated Ebola Treatment Centers or state-designated Special Pathogens Treatment Centers** who are involved in the care and/or transport of patients with lab-confirmed or suspect Ebola disease.
Disclaimer: The mention of any product names or non-United States Government entities on CDC Ebola websites is not meant to serve as an official endorsement of any such product or entity by the CDC, the Department of Health and Human Service, or the United States Government.
Preparing for administration
- Thaw the vaccine vial at room temperature until no visible ice is present, ~10 to 15 minutes.
- Do not thaw the vial in a refrigerator as the vaccine is sensitive to slow thawing.
- Do not thaw the vial in a refrigerator as the vaccine is sensitive to slow thawing.
- Gently invert vial several times.
- The vaccine should be a colorless to slightly brownish-yellow liquid with no particulates visible.
- Do not use if particulate matter or discoloration exist.
- The vaccine should be a colorless to slightly brownish-yellow liquid with no particulates visible.
- Use the vaccine immediately after thawing.
Administration
Required supplies
- ERVEBO (supplied as 1-mL single dose vial containing ≥ 7.2 × 107 pfu)
- Sterile syringe (e.g., 3-mL syringe)
- Sterile needle for intramuscular (IM) administration (e.g., 22-25 gauge, 1- to 1.5-inch length needle)
Administering the vaccine
Using aseptic technique, withdraw a 1 mL dose using a syringe with a sterile injection needle. Administer the vaccine by IM injection in the deltoid area of the recipient's non-dominant arm at a 90º angle into the muscle tissue. Be sure to use a needle long enough to ensure IM deposition of the vaccine.
- Do not inject the vaccine intravascularly.
- No data are available for administration via the subcutaneous or intradermal routes.
After administering the vaccine
Administering healthcare providers should monitor vaccine recipients for signs and symptoms of reactions for 15 minutes following vaccination. Appropriate medical treatment and supervision must be available in case of an anaphylactic event.
After giving the vaccine, the used vial and syringe should be disposed of as biohazardous waste, in accordance with the participating site's policy, as applicable. Used vials and syringes can be disposed of in normal biohazard containers, as the product does not contain Ebola virus.
Vaccine storage
The vaccine will be shipped frozen at -80°C to -60°C (-112°F to -76°F).
When stored/maintained at -80°C to -60°C (-112°F to -76°F), ERVEBO can be used by the indicated expiration date on the vaccine vial.
If -80°C to -60°C (-112°F to -76°F) storage is not possible at the receiving vaccination site, thawed vaccine can be stored at 2°C to 8°C (35.6°F to 46.4°F) for up to 14 days.
If not used immediately, the vaccine may be stored for up to 14 days at 2ºC to 8ºC (35.6ºF to 46.4ºF) or for up to four hours at room temperature (up to 25°C; 77°F) protected from light. Do NOT re-freeze any thawed vaccine.
- *Healthcare personnel (HCP) refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to EVD patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These healthcare personnel include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, physician assistants, technicians, clinical laboratory personnel, autopsy personnel, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).Adapted from Infection Control for Healthcare Providers
- **Healthcare facilities that intend to receive and are able to provide care for a suspected or confirmed patient with Ebola disease for the duration of their illness, as assessed by their state health department. In addition to Ebola disease, these facilities may also be designated by the states to treat other high consequence pathogens.