Open Vial Policy for Anti-Rabies Vaccine
No, anti-rabies vaccine vials do NOT follow the open vial policy and must be reconstituted and used immediately just before administration.
Vaccine Preparation Requirements
The licensed rabies vaccines in the United States are supplied as lyophilized (freeze-dried) preparations that require specific reconstitution protocols:
- Human Diploid Cell Vaccine (HDCV) is supplied as a single-dose vial containing lyophilized vaccine that must be reconstituted with the accompanying diluent to a final volume of 1.0 mL just before administration 1
- Intradermal HDCV formulation comes as a single-dose syringe containing lyophilized vaccine that is reconstituted in the syringe to 0.1 mL just before administration 1
- The emphasis on "just before administration" in the guidelines indicates these are single-use products that should not be stored after reconstitution 1
Critical Distinction: Rabies Immunoglobulin (HRIG)
It's important to clarify that Rabies Immunoglobulin (HRIG) is NOT a vaccine - it is a passive immunization product:
- HRIG is supplied as a liquid preparation in 2-mL (300 IU) and 10-mL (1,500 IU) vials 1
- HRIG provides immediate passive antibody coverage and is administered only once at the beginning of postexposure prophylaxis 2
- The full dose should be infiltrated around wounds with any remaining volume given intramuscularly at a site distant from vaccine administration 2
Why Open Vial Policy Does Not Apply
The single-dose, reconstitute-immediately design of rabies vaccines makes the open vial policy irrelevant for these products:
- Each vial is designed for single-patient use 1
- The lyophilized vaccine requires reconstitution immediately prior to injection, leaving no opportunity for multi-dose use 1
- There is no guidance in ACIP recommendations suggesting that opened rabies vaccine vials can be retained for later use 1
Practical Implications
- Calculate exact doses needed before opening vials to minimize waste
- Do not attempt to save reconstituted vaccine for subsequent patients
- For HRIG, calculate the 20 IU/kg dose carefully and use appropriately sized vials (2-mL for pediatric, 10-mL for adult use) to reduce waste 2
- Any unused portion of reconstituted vaccine should be discarded according to facility protocols 1
Common Pitfall to Avoid
Do not confuse the multi-dose vial policies that apply to some other vaccines (like certain influenza vaccines) with rabies biologics - rabies vaccines are explicitly designed as single-dose products requiring immediate reconstitution and use 1.