Investigation Procedures Following a Report of Potential Lack of Efficacy Report 

for a Rabies Vaccine 

ICWI0006.06 Page 1 of 3 

Author: Douglas C. Murtle 

Issue Date: 04Aug17 

Source Document and Date of Issue or Edition: ICSOP0016, Investigation and Processing of Alleged 

Violations of the Virus-Serum-Toxin Act ; CVBSOP0101, Tests Requested to Assist Investigations –

Processes and Responsibilities

Due to human health concerns, any notification of a potential lack of efficacy of a USDA 

licensed rabies vaccine is classified as an urgent report and will be investigated by the 

Center for Veterinary Biologics-Inspection and Compliance (CVB-IC). 

1. When a potential lack of efficacy notification is received, the person receiving the 

report should complete an Adverse Event Report form. If there is possible human 

exposure, the person taking the call should get as much information concerning the 

exposure as possible. 

2. The CVB-IC Compliance Section Leader, Investigation Manager, or other member 

(or acting member) of the Inspection and Compliance Management Team (ICMT) 

should be informed within 2 hours of the report. 

3. An investigation will be opened following procedures described in ICSOP0016, 

Investigation and Processing of Alleged Violations of the Virus-Serum-Toxin Act.

4. The CVB-IC Compliance Section Leader, Investigation Manager, or their designated 

Acting, will notify by email the following people: 

Operational Director, CVB 

Director, Inspection and Compliance 

Director, Policy, Evaluation, and Licensing (PEL) 

Section Leader, Virology 

Supervisory Microbiologist, Virology 

Section Leader, Compliance 

Investigation Manager 

CDC Contacts: Currently (Human Exposure cases only) 

Dr. Tom Gomez - (Veterinary Services liaison stationed at 

 CDC)

 Dr. Emily Pieracci: 

 Jesse Blanton: 

 Ryan Wallace: 

5. The notification should detail: 

Veterinary Biologics Investigation (VBI) number 

Product involved: True Name, Code, Serial No. 

Manufacturing establishment 

Alleged violation: 9 CFR 113.209 – Potential lack of efficacy with human exposure 

Species and number of animals involved 

Human exposure (How many? any treatment [if known]) 

Details at this time 
Investigation Procedures Following a Report of Potential Lack of Efficacy Report 

for a Rabies Vaccine

ICWI0006.06 Page 2 of 3

Author: Douglas C. Murtle

Issue Date: 04Aug17

Source Document and Date of Issue or Edition: ICSOP0016, Investigation and Processing of Alleged 

Violations of the Virus-Serum-Toxin Act ; CVBSOP0101, Tests Requested to Assist Investigations –

Processes and Responsibilities

Serial status and expiration date

Biologics Specialist assigned to VBI

Plan of action

6. Assigned Biologics Specialist duties:

A. If report came from the public, contact the official liaison of the manufacturer and 

inform them of the situation. The firm should be contacted the same day as the 

report.

B. The following must be requested when in contact with the manufacturer:

a) Request verbally and in writing from the manufacturing firm a summary 

of all adverse events;

b) Request potency test bench records for the serial involved – include mouse 

acquisition records;

c) Request all production records associated with the serial;

d) Request all production records associated with common bulks used in the 

serial;

e) Request all adverse events with bulk lots associated with this adverse 

event.

C. Request from the Biologics Epidemiologist copies of any adverse events reports 

that CVB has received for the serial in question and file these in the VBI folder.

D. The Specialist assigned must run a serial stat from LSRTIS to determine if the 

serial is still within dating. If the serial is still within dating, a potency test may be 

requested after consultation with an IC Program Section Leader and the Section 

Leader, Virology. In an effort to save resources, testing should not commence 

until there is a laboratory confirmation of rabies. Preferably this confirmation 

should come from the CDC. If it is decided that the serial should be tested for 

potency, follow the procedures described in CVBSOP0101, Tests Requested to 

Assist Investigations – Processes and Responsibilities. If the serial has expired, no 

testing will be conducted.

E. Prior to testing being initiated by CVB, the Biologics Specialist will notify the 

manufacturer in writing to inform them that the serial will be tested and will be 

put at risk. To expedite this, verbal communication to the official liaison of the 

firm is acceptable if followed by a letter.

F. Place a copy of the released APHIS Form 2008 (and any CVB-PEL laboratory 

test reports) in the VBI folder.
Investigation Procedures Following a Report of Potential Lack of Efficacy Report 

for a Rabies Vaccine

ICWI0006.06 Page 3 of 3

Author: Douglas C. Murtle

Issue Date: 04Aug17

Source Document and Date of Issue or Edition: ICSOP0016, Investigation and Processing of Alleged 

Violations of the Virus-Serum-Toxin Act ; CVBSOP0101, Tests Requested to Assist Investigations –

Processes and Responsibilities

7. Closure

A. If testing was conducted:

1. And the serial was tested satisfactory, the results are provided to the firm and 

the VBI is closed following ICSOP0016, Investigation and Processing of Alleged 

Violations of the Virus-Serum-Toxin Act;

2. And the serial was tested unsatisfactory, immediately contact an ICMT 

member for further guidance.

B. For investigations in which no testing was conducted, consult with the 

Investigation Manager and/or Compliance Section Leader on appropriate steps.