IPSIndian Journal of Pharmacology
Home  IPS  Feedback Subscribe Top cited articles Login 
Users Online : 11569 
Small font sizeDefault font sizeIncrease font size
Navigate Here
  Search
 
  
Resource Links
   Similar in PUBMED
   Article in PDF (224 KB)
   Citation Manager
   Access Statistics
   Reader Comments
   Email Alert *
   Add to My List *
* Registration required (free)

 
In This Article
   References

 Article Access Statistics
    Viewed780    
    Printed44    
    Emailed0    
    PDF Downloaded40    
    Comments [Add]    

Recommend this journal

 


 
 Table of Contents    
LETTER TO THE EDITOR
Year : 2023  |  Volume : 55  |  Issue : 2  |  Page : 141-142
 

Inclusion of Rabishield in the WHO guidelines for rabies postexposure prophylaxis


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 Submission07-Jan-2023
Date of Decision05-May-2023
Date of Acceptance08-May-2023
Date of Web Publication03-Jun-2023

Correspondence Address:
Balamurugan Nathan
No. 8 Pavithra Nivas, Parvathy Street, Priyadarshini Nagar, Puducherry - 605 006
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijp.ijp_18_23

Rights and Permissions



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

How to cite this URL:
Kaza VK, Nathan B. Inclusion of Rabishield in the WHO guidelines for rabies postexposure prophylaxis. Indian J Pharmacol [serial online] 2023 [cited 2023 Sep 22];55:141-2. Available from: https://www.ijp-online.com/text.asp?2023/55/2/141/378027




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 Top

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.  Back to cited text no. 1
    
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.  Back to cited text no. 2
    
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].  Back to cited text no. 3
    
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.  Back to cited text no. 4
    
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.  Back to cited text no. 5
    




 

Top
Print this article  Email this article
 

    

Site Map | Home | Contact Us | Feedback | Copyright and Disclaimer | Privacy Notice
Online since 20th July '04
Published by Wolters Kluwer - Medknow