COMMONWEALTH of VIRGINIA New River Health District J. Henry Hershey, M.D., M.P.H. Director Headquarters Office Floyd County Health Department P.O. Box 157 Floyd, VA 24019 (540) 745-2141 FAX (540) 745-4929 Montgomery County Health Department 210 S. Pepper St., Suite A Christiansburg, VA 24073 Giles County Health Department 120 North Main St. Pearisburg, VA 24134 (540) 921-2891 FAX (540) 921-1335 Montgomery County Health Department 210 S. Pepper St., Suite A Christiansburg, VA 24073 (540) 381-7100 FAX (540) 381-7104 Pulaski County Health Department 170 4th St, NW Pulaski, VA 24301 (540) 994-5030 FAX (540) 994-5036 Radford City Health Department 212 Third Avenue Radford, VA 24141 (540) 831-5774 FAX (540) 831-6109 MEMORANDUM TO: All Physicians and Group Practices, Nurse Practitioners, Physician Assistants, Hospital Infection Control Nurses, Hospital Laboratory Directors, Head Nurses of Emergency Rooms, Hospital CEOs/Administrators, Student Health Services, Edward Via Virginia College of Osteopathic Medicine FROM: J. Henry Hershey, M.D., M.P.H., Director DATE: May 20, 2008 SUBJECT: Rabies Biological Supply (IMOVAX) Effective May 19, 2008, Sanofi Pasteur maker of IMOVAX Rabies (Rabies Vaccine) will, temporarily, only be available for post-exposure prophylaxis (PEP). Sanofi Pasteur will continue to supply their vaccine to health care providers to treat patients who have had documented rabies exposures. Providers should consult local public health officials, as needed, with any questions regarding PEP. These measures will allow responsible management of currently limited supplies of this vaccine. A letter from the manufacturer explaining this change should have been released to you on Monday. Novartis, the other supplier of rabies vaccine in the United States, currently has limited amounts of rabies vaccine, RabAvert, which is available for postexposure prophylaxis use only. It is expected that additional RabAvert will be available to the market by approximately July 2008. It is hoped that the demand for pre-exposure vaccine supplies will be met at this time. Discussions among federal, state, and local public health personnel are ongoing to review additional strategies to handle pre-exposure vaccination needs (Pre-EP). Pre-EP should be delayed until vaccine is available. It is expected that additional vaccine will be available again approximately in July 2008. Persons at increased risk for rabies exposure should take appropriate precautions to avoid rabies exposure (http://www.cdc.gov/rabies/exposure/). I am attaching general rabies awareness and prevention messages (e.g., avoid wildlife contact, vaccinate pets/livestock, etc.) for your use and to provide to your patients. Additionally, I am including two other documents that might be helpful to you--(1) questions and answers on the current vaccine supply issue and (2) the PEP vaccination section from the Virginia Guidelines for Rabies Prevention and Control. The complete Guidelines can be found at: http://www.vdh.virginia.gov/epidemiology/DEE/Rabies/vgrpc.htm. As always, any questions regarding PEP should be directed to Reba Hite, RN, District Nurse Epidemiologist, Paige Bordwine, District Epidemiologist, or me at 381-7100 ext. 196, ext. 152, or 156 respectively during normal business hours (8:00 a.m. - 4:30 p.m, M-F). After normal business hours, you may direct emergency rabies questions through the New River Health District’s Emergency Event Reporting System at 381-7100 ext.183 by leaving a message containing contact information, subject, and a brief message. Public inquiries may be made to the Centers for Disease Control and Prevention at 1-800-CDC-INFO. Attachments GENERAL RABIES PREVENTION MESSAGES Post-exposure prophylaxis: Post-exposure prophylaxis (PEP) is indicated for persons exposed to a rabid animal. Exposures include animal bites or mucous membrane contamination with infectious tissue or fluids such as saliva. Blood, feces and urine do not contain the virus and are not infectious. (For more information on types of exposures, see the 2008 ACIP Guidelines: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr57e507a1.htm). PEP should begin as soon as possible after an exposure. Administration of rabies PEP is a medical urgency, not a medical emergency. There have been no vaccine failures in the United States (i.e., someone who developed rabies after vaccination) when PEP was given promptly and appropriately after an exposure. Physicians should evaluate each possible exposure to rabies and, as necessary, consult with local public health officials regarding the need for rabies PEP. Post-exposure prophylaxis regimen: In the United States, PEP for previously unvaccinated persons consists of a regimen of one dose of rabies immune globulin and five doses of rabies vaccine over a 28-day period. The immune globulin and first dose of vaccine should be given as soon as possible after exposure. Additional doses of rabies vaccine should be given on days 3, 7, 14, and 28 after the first vaccination. Current vaccines are relatively painless and are given in the arm, like an influenza or tetanus vaccine. Pre-exposure vaccination series: When available again for this purpose, pre-exposure vaccination should be offered to persons in high-risk groups, such as rabies diagnostic workers, veterinarians, and animal handlers that work in rabies enzootic areas,. When available again for this purpose, pre-exposure vaccination also should be considered for other persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies. The pre-exposure series consists of three doses of rabies vaccine administered on days 0, 7 and 21 or 28. Messages for the general public on rabies prevention: All dogs, cats and ferrets should be vaccinated against rabies. Consider vaccinating valuable livestock and horses. Animals that have frequent contact with humans should be vaccinated. Pet owners can reduce the possibility of pets being exposed to rabies by not letting them roam free. Spaying or neutering your pet will prevent unwanted pregnancies and reduce contributions to dog and cat overpopulation. Don’t feed or water your pets outside. Empty bowls can attract wild and stray animals. Keep your garbage securely covered. Open garbage will attract wild or stray animals. Wild animals should not be kept as pets. Enjoy all wild animals from a distance and teach children never to handle unfamiliar animals-even if they appear friendly. If you see a wild animal acting strangely, report it to city or county animal control officials. Bat-proof your home in the fall and winter. Contact your local or state health department for assistance with animal diagnostic testing and medical advice. New River Health District, May 20, 2008 GENERAL RABIES PREVENTION MESSAGES (continued) What to do when your pet bites someone: Contact your local health department or local animal control. A dog, cat or ferret that bites a human, needs to be examined by a licensed veterinarian immediately. The local public health official may require monitoring the pet at home or at a veterinary clinic for 10 days. Report any illness or unusual behavior by your pet to the local health department and to your veterinarian immediately. What to do when your pet gets bitten by another animal: Consult your veterinarian immediately and have your veterinarian examine your pet and assess your pet’s medical and vaccination needs. Contact local animal control if the bite was from a stray or wild animal. Monitor your pet at home or in a veterinary clinic for a specified time period by state law or local ordinance (usually at least 45 days) if an unvaccinated or wild animal bit your pet. What to do if you are bitten by an animal: Wash the wound thoroughly with soap and water for at least 15 minutes. Contact your physician immediately. Report the bite to your local health department and local animal control. If necessary, you will be assessed for rabies post-exposure prophylaxis. Prompt and appropriate action after being bitten and before the disease develops can stop rabies infection and prevent the disease. Useful Websites: CDC Rabies Website: www.cdc.gov/rabies 2008 ACIP Human Rabies Prevention: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr57e507a1.htm or http://www.cdc.gov/mmwr/pdf/rr/rr57e507.pdf NASPHV Compendium of Animal Rabies Control and Prevention: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5702a1.htm or http://www.cdc.gov/mmwr/pdf/rr/rr5702.pdf New River Health District, May 20, 2008 RABIES BIOLOGICAL SUPPLY Questions and Answers Why is there an interruption in supply? Starting in June 2007, Sanofi Pasteur began renovating its IMOVAX Rabies vaccine production facility in France to maintain compliance with the most current requirements from FDA and the French regulatory body. Prior to these renovations, Sanofi Pasteur established an inventory based on historical levels of sales and projected market demand. The facility is scheduled to be approved and operational by mid-tolate 2009. Until the facility is operational, Sanofi Pasteur has a finite amount of IMOVAX Rabies vaccine. After the renovations began, Novartis, the other supplier of rabies vaccine for the United States, was unable to meet projected rabies vaccine supplies. Since early 2008, Novartis has been supplying its rabies vaccine, RabAvert, for post-exposure use only. Consequently, Sanofi Pasteur has been supplying nearly all of the market for rabies vaccine. The increase in demand for IMOVAX is outpacing the company’s historical levels of supply. How long will vaccine for pre-exposure prophylaxis (Pre-EP) not be available? We are unsure how long rabies Pre-EP will not be available. We are hopeful that supplies will begin to improve in approximately July 2008. What do I do for someone that is in the middle of a Pre-EP regimen? Pre-EP should only begin only if adequate supply of vaccine is available. If it has already begun, it would be better to complete the Pre-EP regimen; however, additional stocks may not be released for this purpose. Completion of the regimen will have to be done using already purchased stocks. If this is not possible, the Pre-EP should be discontinued, and the person considered as non-vaccinated. If needed, the Pre-EP course in such persons should be restarted when the adequate vaccine supply for Pre-EP is available. Will vaccine be available for persons that had Pre-EP and now have a low titer? No. No additional stocks of rabies vaccine will be released for Pre-EP usage. Persons at increased risk for rabies exposure should take appropriate precautions to avoid rabies exposure. Individuals who are concerned about their titer should request a rapid fluorescent focus inhibition test (RFFIT) (used by ACIP as an indicator of an adequate adaptive immune response). Does this change affect all risk groups for Pre-EP or just the lower risk group (i.e., infrequent or travelers)? Yes, this change affects all risk groups. Individuals who are traveling should limit travel to high rabies risk areas unless otherwise necessary. Travelers should be aware of anti-rabies vaccination options in that country in case exposure is likely. How does this affect providers that purchase/provide rabies vaccine? Sanofi does not have any vaccine for stockpiles; therefore, the provider will have to call and place an order for each patient that needs PEP. Sanofi will fax the attending physician a form that must be completed and returned before the vaccine can be sent. (The signed form is for tracking purposes.) The vaccine will then be shipped in 24 hours. Rabies vaccine that providers presently have in stock can be used for pre-exposure if desired. However, at the current time, providers that purchase vaccine directly will only be able to purchase it for PPE usage. New River Health District, May 20, 2008 Virginia Department of Health. Virginia Guidelines for Rabies Prevention and Control, August 2006, pages 11-12.