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| LETTER TO THE EDITOR |
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| Year : 2023 | Volume
: 55
| Issue : 2 | Page : 141-142 |
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Inclusion of Rabishield in the WHO guidelines for rabies postexposure prophylaxis
Vamsi Krishna Kaza1, Balamurugan Nathan2
1 Department of Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
2 Department of Emergency Medicine and Trauma, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| Date of Submission | 07-Jan-2023 |
| Date of Decision | 05-May-2023 |
| Date of Acceptance | 08-May-2023 |
| Date of Web Publication | 03-Jun-2023 |
Correspondence Address:
Balamurugan Nathan
No. 8 Pavithra Nivas, Parvathy Street, Priyadarshini Nagar, Puducherry - 605 006
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijp.ijp_18_23
How to cite this article:
Kaza VK, Nathan B. Inclusion of Rabishield in the WHO guidelines for rabies postexposure prophylaxis. Indian J Pharmacol 2023;55:141-2 |
Sir,
Rabishield is the first monoclonal antibody form of passive immunization in humans developed by the Serum Institute of India and has been approved for rabies postexposure prophylaxis (PEP) in India. It is an immunoglobulin G1 monoclonal antibody that binds to the surface protein of the rabies virus and is used for local infiltration and thereby neutralization of the virus.
Here, we review the significant evidence on efficacy, safety, and benefits of approving the Rabishield for passive immunization worldwide in patients at risk of developing rabies after category 3 animal bites. A study done in India pointed out that Rabishield lacked certain adverse effects such as serum sickness and transmissibility of blood pathogens. Although rare, these were reported with the equine and human-derived immunoglobulin versions. Its local side effects such as pain, infection, and swelling were comparable/noninferior to the human and equine immunoglobulins.[1] Skin testing is not required for Rabishield making it more convenient to administer for medical personnel. Another study done in India concluded that Rabishield was a safe and potent human monoclonal antibody and that it was a viable alternative for the passive immunization component of PEP in patients.[2] Due to a lower requirement per kilogram, it is available at a lower cost than human rabies immunoglobulin. It is also devoid of the risk of allergic reactions, which have been reported with the equine rabies immunoglobulin. It was brought to light that the Rabishield, having only one monoclonal antibody, was not effective against a rare variant of the virus found in the Peruvian bat. This problem was addressed by the SAGE group who finally concluded that although it is less effective in the American region, its wide neutralizing ability and the fact that it was the only approved monoclonal antibody are reasons enough to approve its use in specific areas and epidemiological conditions.[3] This would help address the huge supply-demand mismatch of passive immunization, which is prevalent in the world. Only about 2.1% of severely wounded patients receive passive immunization through rabies immunoglobulin in India and fewer than 3% received it in Thailand.[4],[5] In our institute, we have been solely relying on the Rabishield for passive immunization in all category 3 wound patients who could afford it and have been doing so since the beginning of 2018. No cases of rabies were reported in any of these patients. A literature search revealed no documented cases of rabies worldwide in patients who received Rabishield prophylaxis.
With significant evidence on its advantages and proven efficacy, approval of Rabishield worldwide for PEP in patients with category 3 animal bites would greatly reduce the unmet need of passive immunization.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| » References | |  |
| 1. | Shivalingaiah AH, Shankaraiah RH, Hanumanthaiah AN. Safety of new indigenous human Rabies Monoclonal Antibody (RMAb) for post exposure prophylaxis. Indian J Community Health 2018;30:196-201.  |
| 2. | Gogtay NJ, Munshi R, Ashwath Narayana DH, Mahendra BJ, Kshirsagar V, Gunale B, et al. Comparison of a novel human rabies monoclonal antibody to human rabies immunoglobulin for postexposure prophylaxis: A phase 2/3, randomized, single-blind, noninferiority, controlled study. Clin Infect Dis 2018;66:387-95. |
| 3. | Background Paper: Proposed Revision of the Policy on Rabies Vaccines and Rabies Immunoglobulins. Prepared by the SAGE Working Group on Rabies Vaccines and Immunoglobulins and the World Health Organization (WHO) Secretariat; September 22, 2017. Available from: www.who.int/immunization/sage/meetings/2017/october/1_Background_paper_WG_RABIES_final.pdf. [Last accessed on 2018 Nov 23]. |
| 4. | Sudarshan MK, Mahendra BJ, Madhusudana SN, Ashwoath Narayana DH, Rahman A, Rao NS, et al. An epidemiological study of animal bites in India: Results of a WHO sponsored national multi-centric rabies survey. J Commun Dis 2006;38:32-9. |
| 5. | Kamoltham T, Singhsa J, Promsaranee U, Sonthon P, Mathean P, Thinyounyong W. Elimination of human rabies in a canine endemic province in Thailand: Five-year programme. Bull World Health Organ 2003;81:375-81. |
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