Vaccine Type Volume (Dose) Earliest Age-Initial Inoculation Route of Inoculation Labeled Duration of Immunity; IMRAB 1: Merial, Ltd. Dog & cat: Killed (adjuvanted) 1.0 mL: 3 months: IM or SQ: 1 year: IMRAB 1 (TF) Merial, Ltd. Dog & cat: Killed (adjuvanted) 1.0 mL: 3 months: IM or SQ: 1 year: IMRAB 3: Merial, Ltd. Dog, cat & ferret: Killed. Jan 08, 2020 Rabies vaccine can prevent rabies if given to a person after they have had an exposure. Anyone who has been bitten by an animal suspected to have rabies, or who otherwise may have been exposed to rabies, should clean the wound and see a health care provider immediately regardless of vaccination status. Vaccine Information. DEFENSOR vaccines contain inactivated rabies virus from an established cell line. Contains a highly immunogenic fixed strain of rabies virus that originated from Louis Pasteur’s original 1882 isolate and has been extensively tested for freedom from contaminating agents.
Rabies Vaccine (Killed Virus) shall be prepared from virus-bearing cell cultures or nerve tissues obtained from animals that have developed rabies infection following injection with rabies virus. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.200 and the requirements prescribed in this section.
(1) Each lot of Master Seed Virus propagated in tissue or cells of avian origin shall also be tested for extraneous pathogens by procedures prescribed in § 113.37.
(2) Each lot of Master Seed Virus propagated in primary cell cultures of mouse or hamster origin or brain tissues of mouse origin shall be tested for lymphocytic choriomeningitis (LCM) virus by the procedure prescribed in § 113.42. If LCM virus is detected, the Master Seed Virus is unsatisfactory.
(b) The immunogenicity of vaccine prepared with virus at the highest passage from the Master Seed shall be established in each species for which the vaccine is recommended. Tests shall be conducted in accordance with a protocol filed with Animal and Plant Health Inspection Service before initiation of the tests. The vaccine shall be prepared using methods prescribed in the Outline of Production. If Rabies Vaccine is to be in combination with other fractions, the product to be tested shall include all fractions to be tested.
(1) The preinactivation virus titer must be established as soon as possible after harvest by at least five separate virus titrations. A mean relative potency value of the vaccine to be used in the host animalpotency test must be established by at least five replicate potency tests conducted in accordance with the standard NIH test for potency in chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), edited by F.X. Meslin, M.M. Kaplan, and H. Koprowski, World Health Organization, Geneva, Switzerland (ISBN 92 4 154479 1). The provisions of chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), are the minimum standards for achieving compliance with this section and are incorporated by reference. These provisions state that the challenge virus standard to be used as the challenge in the NIH test and the reference vaccine for the test are available from the national control authority. In the United States, that authority is the Animal and Plant Health Inspection Service's Center for Veterinary Biologics Laboratory, located at 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 337-6100; fax (515) 337-6120. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the World Health Organization Publications Center USA, 49 Sheridan Avenue, Albany, NY 12210. Copies may be inspected at the Animal and Plant Health Inspection Service, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) The dose of vaccine to be used in the immunogenicity test shall be no more than the amount which, on the basis of The NIH Test For Potency, has been diluted to the proposed minimum acceptable potency value. 1
(3) Test animals shall be uniform and have no neutralizing antibodies to rabies as determined by serum-neutralization (SN) tests.
(i) Twenty-five or more animals shall be used as vaccinates. Each shall be administered a dose of vaccine at the proposed minimum potency level and by the method specified in the Outline of Production.
(ii) Ten or more additional animals shall be held as controls.
(iii) On or about 30, 90, 180, 270, and 365 days postvaccination, all test animals shall be bled and individual serum samples tested for neutralizing antibodies to rabies virus.
(iv) All surviving test animals shall be challenged intramuscularly with virulent rabies virus furnished or approved by Animal and Plant Health Inspection Service 1 year after vaccinations, except as provided in (b)(4) of this section. The challenged animals shall be observed each day for 90 days as prescribed in § 113.5(b). The brain of each test animal that dies following challenges shall be examined for rabies by the fluorescent antibody test or other method acceptable to Animal and Plant Health Inspection Service.
(v) Requirements for acceptance in challenge tests shall be death due to rabies in at least 80 percent of the controls while at least 22 of 25 or 26 of 30 or a statistically equivalent number of the vaccinates remain well for a period of 90 days.
(4) An alternative to challenging all surviving test animals in accordance with paragraph (b)(3)(iv) of this section may be used when the test animals are of species other than carnivores. Vaccinates shall be challenged at 1 year postvaccination. These shall include five vaccinates with the lowest SN titers at the 270th-day bleeding, five vaccinates with the lowest SN titers at the 365th-day bleeding, and all vaccinates with SN titers below 1:10 by the mouse SN test or below 1:16 by the rapid-fluorescent-focus-inhibition test at any bleeding. At least five SN-negative controls of each species shall be challenged at the same time as the vaccinates. All SN titers shall be titrated to an endpoint. All of the challenged vaccinates must remain well for a period of 90 days, and at least 80 percent of the controls must die of rabies for a satisfactory test without further challenge. If one or more of the vaccinates die from rabies, all the remaining vaccines, regardless of titer, along with the five controls shall be challenged. The cumulative results from the two challenges shall be evaluated for acceptance as specified in paragraph (b)(3)(v) of this section.
(5) An Outline of Production change shall be made before authority for use a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(c) If more than 1 year duration of immunity is to be claimed, a duration of immunity test for the additional time shall be conducted and interpreted as prescribed in paragraph (b) of this section for the 1 year test. The test animals shall be monitored serologically at least every 180 days. The time of challenge may be adjusted accordingly.
(d) Test requirements for release: Each serial and each subserial shall meet the general requirements prescribed in § 113.200 and special requirements in this paragraph.
(1)Purity test. Primary cell cultures of hamster origin or brain tissues of mouse origin used in vaccine production shall be tested for LCM virus as prescribed in § 113.42. Hamster origin cells shall be disrupted and undiluted cell fluids from each lot shall be tested. Where mouse brains are used in production, at least five mice which have not been injected with rabies virus shall be sacrificed and a 10 percent suspension of brain material shall be prepared and tested.
(2)Safety tests. Bulk samples from each serial shall be tested for virus inactivation and safety as follows:
(i) At the end of the inactivation period, each of 20 12 to 16 gram mice shall be injected intracerebrally with 0.03 ml and two rabbits shall be injected into each cerebral hemisphere with 0.25 ml and observed each day for 21 days. The brains of animals dying between the fourth and 21st day post-injection shall be checked for rabies virus. Material from each brain recovered shall be injected into each of five mice and the mice observed each day for 14 days. The fluorescent antibody test or serum neutralization test shall be used to confirm the presence or absence or live rabies virus. If live rabies virus is confirmed, the serial is unsatisfactory unless reprocessed in accordance with § 114.18.
(ii) A test for safety in three young seronegative animals of the most susceptible species for which the vaccine is recommended shall be conducted. Each shall in injected intramuscularly with one recommended dose of vaccine. If unfavorable reactions attributable to the product occur during a 28 day observation period, the serial is unsatisfactory.
(3)Potency test. Bulk or final container samples of completed product from each serial must be tested for potency by tests conducted in accordance with the standard NIH test for potency in Chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), which is incorporated by reference at paragraph (b)(1) of this section. The relative potency of each serial must be at least equal to that used in an approved host animal immunogenicity test.
[39 FR 44715, Dec. 27, 1974, as amended at 42 FR 6794, Feb. 4, 1977; 43 FR 49528, Oct. 24, 1978; 50 FR 20090, May 14, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990; 56 FR 66784, 66786, Dec. 26, 1991; 61 FR 31823, June 21, 1996; 64 FR 45420, Aug. 20, 1999; 69 FR 18803, Apr. 9, 2004; 75 FR 20773, Apr. 21, 2010]
Every year, thousands of people around the world die from rabies. Rabies is a rare disease in the United States, but it’s almost always deadly. The good news is that this disease is preventable with the rabies vaccine.
The rabies vaccine is given to people who are at higher risk of coming in contact with rabies — like veterinarians. It’s also given to people after an animal bite if the animal could have rabies.
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If you’re bitten by an animal that could have rabies, contact your doctor right away. Learn more about seeking medical attention for rabies.
Though it’s rare in the United States, people who get rabies almost always die. In the United States people are most likely to get rabies from wild animals. Rabies is more common in other countries.
If you’ve been bitten by an animal that could have rabies, or are at risk of coming in contact with rabies, it’s very important to get the vaccine.
Rabies is caused by a virus that can be passed to humans through the bite of a rabid animal (an animal who has it). People in the United States are most likely to get rabies from wild animals, especially bats. Animals like raccoons, skunks, and foxes may also spread rabies. It’s also possible to get rabies from pets, like dogs and cats, that haven’t been vaccinated. In countries where rabies is still common, people often get it through the bite of a rabid dog.
Rabies doesn’t generally spread from person to person — though very rarely, it could spread from one person to another during an organ transplant.
Early symptoms of rabies include:
- Weakness
- Fever
- Headache
As the disease gets worse, rabies can cause:
- Trouble sleeping
- Feeling confused
- Anxiety and agitation (feeling nervous, worried, or upset)
- Seizures (sudden, unusal movements or behavior)
- Hallucinations (seeing things that aren’t there)
- Hydrophobia (fear of water)
Once a person shows symptoms of rabies, they almost always die. Learn more about rabies.
People at risk of rabies
The rabies vaccine is recommended for people at high risk of coming in contact with rabies. For example, you may need the rabies vaccine if you:
- Work as a veterinarian or animal handler
- Are a veterinary student
- Study or explore caves
- Study the rabies virus
- Are traveling to other countries where rabies is common
The vaccine is given in 3 doses. The second dose is given 7 days after the first dose, followed by a third dose 21 or 28 days after the first.
Vaccination after an animal bite
If you’re bitten by an animal that could have rabies, you can get the rabies vaccine to keep you from developing the disease. A doctor can help decide if you need the vaccine.
If you haven’t been vaccinated for rabies before, you’ll need 4 doses of the vaccine. You’ll get the first dose right away, followed by additional doses:
- 3 days after the first dose
- 1 week after the first dose
- 2 weeks after the first dose
You’ll also get a shot called Rabies Immune Globulin with the first dose to help your body fight the virus faster.
If you’ve already had the rabies vaccine, you’ll need 2 doses after an animal bite — you’ll get the first dose right away, followed by a second dose 3 days after the first. You won’t need the Rabies Immune Globulin shot.
If you think you or someone in your family needs the rabies vaccine, talk with a doctor.
Some people should not get the rabies vaccine — or may need to wait to get it. Be sure to tell your doctor before getting vaccinated if you:
- Have had an allergic reaction to the rabies vaccine in the past
- Have other severe allergies
- Have HIV/AIDS
- Have cancer
- Are taking medicines that can affect your immune system
- Are pregnant or breastfeeding
If you’ve already come in contact with rabies — like if you’ve been bitten by an animal that could have rabies — you’ll need to get the vaccine even if you have any of these conditions.
Side effects are usually mild and go away in a few days. They may include:
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- Pain, swelling, or redness where the shot was given
- Headache
- Upset stomach
- Stomach pain
- Muscles aches
- Dizziness
Less common side effects of the rabies vaccine include:
- Hives (itchy spots on the skin)
- Joint pain
- Fever
What Is A Valid Rabies Vaccination Certificate? | Bringing An ...
Serious side effects from the rabies vaccine are very rare.
Like any medicine, there's a very small chance that the rabies vaccine could cause a serious reaction. Keep in mind that getting the rabies vaccine is much safer than getting rabies. Learn more about vaccine side effects.
Vaccine Information Statements (VISs) have detailed information about recommended vaccines.
Rabies Vaccine Number Look Up
- Read the VIS for the rabies vaccine.
- Find the VIS for the rabies vaccine in other languages.