Rabies Biologics

Rabies biologics currently available in the U.S.

The tables below summarize the human rabies vaccines and immunoglobulins currently available in the United States.

Single-dose vials of rabies vaccine should be reconstituted with accompanying sterile diluent to a final volume of 1mL before administration. Rabies vaccine should be administered intramuscularly in the deltoid area for adults, in the deltoid or the anterolateral aspect, or in the thigh for children. Vaccines should not be administered in the buttocks or gluteal area.

¹ Note HyperRab^® immunoglobulin product has a different concentration compared to all other rabies immunoglobulins (including the very similarly named HyperRab™S/D)—requiring lower volumes to administer the recommended dose of 20 IU/kg; care should be taken to ensure the correct dose of immunoglobulin is administered to ensure adequate immune response.

Post-exposure prophylaxis with human rabies immunoglobulins (HRIG) is indicated for ONLY those people who 1) did not receive appropriate pre-exposure prophylaxis and 2) have not previously received post-exposure prophylaxis for rabies following ACIP recommendations.

The recommended dose of HRIG is 20 IU/kg body weight for all age groups, including children. If the wound is small and on a distal extremity (e.g., a finger, or toe), use clinical judgment to decide how much HRIG to inject to avoid complications (e.g., ischemia) due to localized swelling of the finger or fingers. Deliver any remaining dose intramuscularly at a site distant from where the vaccine was given.

If wounds are extensive, do not exceed the dose-appropriate volume of HRIG. If the indicated volume is inadequate to inject all wounds, you can dilute the HRIG with normal saline to ensure sufficient volume to inject all wounds. The one exception is the newer more concentrated version of HRIG (HyperRAb 300 IU/ml), which requires using dextrose 5% in water (D5W) as the diluent. HRIG dilution is particularly important in children whose body weight might be small in relation to the size and number of wounds.

Common errors when administering rabies biologicals

The vaccine was administered in the gluteal area

• All US-licensed rabies vaccines must be administered intramuscularly.
• Intramuscular administration is unreliable when given in the gluteal area. Vaccines administered here must be repeated.
• Gluteal administration should be avoided to reduce the risk of sciatic nerve damage.

Vaccine and HRIG administered in the same location

• HRIG can neutralize vaccines if they are given at the same site. These products must be administered in separate anatomical locations.
• If they are administered in the same anatomical location, contact a public health professional to determine the best course of action.
• Vaccine will need to be re-administered in a new location.
• HRIG may also need to be re-administered, however, do not administer more than 40 IU/kg in total to the patient.

HRIG was administered, but not into the wound

• HRIG works by binding the rabies virus that is present in the wound. The most important location of administration is the wound.
• While the recommended dose is 20 IU/kg, exceeding 40 IU/kg may negatively impact the patient’s response to the vaccination.
• Ensure that the wound is adequately infiltrated while avoiding exceeding 40 IU/kg.

HRIG was not administered

• HRIG is a critical component of post-exposure prophylaxis to prevent patients from developing rabies.
• HRIG provides passive immunity that provides protection to the patient while they mount an immune response to the vaccine.
• HRIG is no longer necessary after the third dose of vaccine is administered, as patients reliably produce an antibody response that exceeds the benefits of HRIG.

The recommended schedule was not followed

• Deviations of several days are not a concern.
• Longer deviations may have unpredictable consequences for the patient. A tool to determine if the deviation requires consultation with a public health professional can be found in the supporting information of this publication.
• If a deviation has occurred, the recommended spacing between doses should be maintained for subsequent doses.

Adverse reactions to rabies biologics

Rabies post-exposure prophylaxis should not be interrupted due to mild reactions to the treatment. Mild reactions should be managed with anti-inflammatory drugs like ibuprofen or acetaminophen. For patients with a history of strong allergic or inflammatory reactions to vaccines administer antihistamines and have epinephrine ready to counteract anaphylactic reactions. Patients should be closely monitored post-vaccination. Serious reactions to rabies vaccines are rare and require careful consideration before discontinuing vaccination. Seek advice from local or state health departments for managing serious reactions.

Report all significant adverse events following rabies biologics to VAERS, even if the cause is unknown, to enhance vaccine safety monitoring. VAERS reporting forms and information are available electronically or by calling 800-822-7967.

Allergies

For individuals with a history of serious allergic reactions to vaccines, administer antihistamines and have epinephrine ready to counteract anaphylactic reactions, should they occur. These patients should be closely monitored post-vaccination. People with a history of serious allergic reactions to components of rabies vaccine should be revaccinated with caution.

Ideally, the same vaccine should be used throughout the series (either HDCV or PCEC). However, if severe allergic reactions occur, switching to an alternate vaccine may be necessary to complete the series.

Patient assistance programs

Patient assistance programs that provide medication to uninsured or underinsured patients may be available for qualified patients through rabies vaccine and rabies immunoglobulin manufactures. For more information on these programs including eligibility requirements, please contact the manufacturers directly.

Rabies vaccine

Sanofi Pasteur–Imovax^®
Phone: 1-800-822-2463
www.sanofipasteur.us

Bavarian Nordic–Rabavert^®
Phone: 1-844-422-8274
https://bnvaccines.com

Human rabies immunoglobulin

Grifols–HyperRab^®
Phone: 1-833-504-9983
www.hypermunes.com/en/hcp

Kedrion–KEDRAB^®
Phone: 1-866-234-3732
https://mykedrab.medmonk.com

Where to request rabies virus serology using the Rapid Fluorescent Focus Inhibition Test (RFFIT)

Currently, the RFFIT may be available in a state through a state health department or University. The state or local health department may assist with obtaining serological testing if available. In addition, three commercial laboratories perform the RFFIT for rabies virus antibody testing.

Atlanta Health Associates*
309 Pirckle Ferry Road, Suite D300
Cumming, GA 30040
Phone: 770-205-9091 or 800-717-5612
Fax: 770-204-9021
www.atlantahealth.net

Kansas State University*
1800 Denison Avenue
Manhattan, KS 66506-5600
Phone: 785-532-4483
www.ksvdl.org/rabies-laboratory

Testing at KSU may also be requested through Quest Labs as Rabies Vaccine Response End Point Titer (order # 5789).

University of Missouri One Health–Rabies Laboratory*
Veterinary Medical Diagnostic Laboratory
University of Missouri
901 E. Campus Loop
Columbia, MO 65211
Phone: 573-882-3646 or 800-862-8635
Fax: 573-882-7120
Email: muvmdlrabies@missouri.edu
vmdl.missouri.edu/one-health-rabies

*Use of trade names, commercial sources, or private organizations is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services and/or CDC.