Rabies Vaccine
Single-dose 1ml and 0,5ml vial, both equivalent to 1 vaccination dose (IM)
Executive Summary
(May 22, 2023)
Rabies is a zoonotic disease positioned as one of the most lethal viral infections; mortality approaches 100%. It is also preventable in nearly 100% of expositions when vaccination (+/- rabies immunoglobulin) has been properly administered.
Adult and pediatric vaccination regimen for post-exposure prophylaxis (PEP)(4, 8, 9)
Immunocompetent without prior rabies immunization:
4 doses IM, days 0-3-7 and 14*Immunocompromised without prior rabies immunization:
5 doses IM, days 0-3-7-14 and 28Prior rabies immunization**:
2 doses IM, days 0 and 3
*Some regions and their local guidelines still recommend a universal 5-dose regimen for PEP as previously was recommended by the US-CDC (3), and currently some manufacturers (10).
**Complete 4 doses of PEP scheme or 3 doses of PrEP (pre-exposure prophylaxis).
About rabies
It is a zoonotic disease caused by RNA viruses in the Family Rhabdoviridae that is typically present in the saliva of clinically ill mammals (dogs contribute 99% of all transmissions to humans), and is transmitted through a bite.
After an incubation period of an average of 1-3 months (days to years) it enters the central nervous system causing an acute, progressively catastrophic encephalomyelitis (3). Up to 2022 there’ve been only 30 reported survivors worldwide (8, 9) and all but one of them received post-exposure prophylaxis before the onset of symptoms.
Vaccination and Immunoglobulin
Vaccination of rabies was pioneered in 1885 (1) and is now is globally recommended for pre-exposure and post-exposure prophylaxis (PrEP and PEP respectively)(4, 7, 8), for it is extremely successful in preventing the disease, being one of the most effective vaccines ever invented (8). It has an achievable cost-effectiveness when appropriately indicated (3, 8).
Rabies vaccines and immunoglobulin are periodically in short supply, it is important to follow current guidelines considering local epidemiology and individual risk in order to achieve public health goals (4, 5, 6).
There are different rabies vaccines depending on the production method, but dosing schemes are the same for all of them. Since 1984, the World Health Organization (WHO) has strongly recommended “discontinuation of production and use of nerve tissue vaccines and their replacement by modern, concentrated, purified cell culture and embryonated egg-based rabies vaccines (CCEEVs). Nerve tissue vaccines can induce severe adverse reactions more frequently and are less immunogenic than CCEEVs” (7).
For optimal immunogenic response it must be administered in the deltoid muscle, not in the gluteal area as it leads to lower antibody titers (2, 7, 8).
Two inactive virus vaccines (non nerve-tissue-based) are currently licensed by the US-FDA: RabAvert® and Imovax® (10). Other vaccines are widely authorized for their use in Eurasia, Latin America and Africa such as Verorab® (11).
Rabies Immunoglobulin (RIG)
Different management strategies have been proposed for RIG.
The US-CDC recommends it to be given routinely in all cases when vaccination is indicated for PEP with the only exception of individuals that have already received PrEP or complete PEP (day 0, with first dose of vaccine)(4).
WHO guidelines and other countries recommend RIG administration in selected cases, such as exposure to confirmed or suspected rabid dogs, bleeding bites to high innervated areas, and exposure to bites of high risk animals like bats (7).
Note: every bite injury must be properly managed based upon local standard wound care, tetanus and rabies protocols.
Adult and Pediatric dose
Rabies Vaccination for Post-Exposure Prophylaxis (PEP)(4, 8, 9)
Immunocompetent without prior rabies immunization:
4 doses IM, days 0-3-7 and 14*Immunocompromised without prior rabies immunization:
5 doses IM, days 0-3-7-14 and 28Prior rabies immunization**:
2 doses IM, days 0 and 3
*Some regions and their local guidelines still recommend a universal 5-dose regimen for PEP as previously was recommended by the US-CDC (MMWR 2008).
**Complete 4 doses of PEP scheme or 3 doses of PrEP (pre-exposure prophylaxis).
For adults and older children, the vaccine should be injected into the deltoid muscle (2, 6, 7). In infants and small children, the anterolateral aspect of the thigh may be preferable, depending on age and body mass.
Renal, hepatic, or other adjustments
No renal or hepatic adjustments needed.
Pregnancy and Lactation
Pregnancy: US-FDA Category C (no studies have been done in animals, and no well-controlled studies have been done in pregnant women. Rabies vaccine should be given to a pregnant woman only if potential benefits outweigh potential risks).
Pregnancy is not considered a contraindication to postexposure prophylaxis (3, 7).
Lactation: Rabies vaccine and rabies immune globulin can be administered safely to pregnant and lactating women (7).
References
Pasteur L: Méthode pour prévenir la rage après morsure. Comptes Rendus 1885.
Academie-SciencesFishbein DB, Sawyer LA, Reid-Sanden FL, Weir EH. Administration of human diploid-cell rabies vaccine in the gluteal area. N Engl J Med. 1988;318(2):124-125. doi:10.1056/NEJM198801143180219.
PubmedManning SE, Rupprecht CE, Fishbein D, et al. Human rabies prevention, United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2008;57(RR-3):1-28
PubmedRupprecht CE, Briggs D, Brown CM, et al. Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the advisory committee on immunization practices [published correction appears in MMWR Recomm Rep. 2010 Apr 30;59(16):493]. MMWR Recomm Rep. 2010;59(RR-2):1-9.
PubmedWorld Health Organization, Food and Agriculture Organization of the United Nations & World Organisation for Animal Health. (2018). Zero by 30: the global strategic plan to end human deaths from dog-mediated rabies by 2030. World Health Organization.
WHOWorld Health Organization, Food and Agriculture Organization of the United Nations & World Organisation for Animal Health. (2019). Zero by 30: the global strategic plan to end human deaths from dog-mediated rabies by 2030: United Against Rabies Collaboration: first annual progress report: global strategic plan to end human deaths from dog-mediated rabies by 2030. World Health Organization.
WHOWorld Health Organization. Rabies vaccines: WHO position paper, April 2018 - Recommendations. Vaccine. 2018;36(37):5500-5503. doi:10.1016/j.vaccine.2018.06.061.
PubmedFooks AR, Jackson AC. Rabies. Fourth Edition. Academic Press; 2020.
ElsevierJackson AC. Rabies and Other Rhabdovirus Infections. In: Loscalzo J, Fauci A, Kasper D, Hauser S, Longo D, Jameson J. Harrison's Principles of Internal Medicine. 21th Edition. McGraw Hill; 2022.
McGraw-HillUS-FDA (United States Food and Drug Administration) Purple Book, Database of Licensed Biological Products. Search: “Rabies Vaccine”, accessed May 2022.
US-FDA Purple BookEMA (European Medicines Agency), List of nationally authorised medicinal products, Active substance: rabies vaccine, Procedure no.: PSUSA/00009277/202103. 28 October 2021, accessed May 2022.
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