Counterfeit Rabies Vaccine Alert in India

Health Warning on Counterfeit Anti-Rabies Vaccine in India

Overview

• Counterfeit Vaccine: The CDC and the Australian Technical Advisory Group on Immunisation issued a health warning about the counterfeit human anti-rabies vaccine, Abhayrab, circulating in India since November 1, 2023.
• Impact on Travelers: Travelers from India reported rabies cases after receiving the counterfeit vaccine and were advised to consider their vaccination invalid and seek a new vaccination course.

Reporting and Response

• Manufacturer Response: Indian Immunologicals Limited (IIL) indicated that counterfeit doses of Abhayrab were identified by early January 2025. They worked with regulators and law enforcement and confirmed that counterfeit batches were no longer available on the market.
• Regulatory Oversight: Each batch of Abhayrab is tested and released by the National Control Laboratory, a WHO-Geneva pre-qualified laboratory.

Vaccination Protocols

• Consult Healthcare Providers: If individuals suspect they received a counterfeit vaccine, they are advised to consult a healthcare provider to ascertain the need for replacement doses.
• Re-vaccination Guidance: In cases of uncertainty regarding vaccination:
  • Revaccination is safe and allowed since the rabies vaccine is inactivated (no live virus).
  • Revaccination is recommended if prior vaccinations are:
    • From unknown or suspected sources.
    • Improperly stored or documented.
    • Following new exposure.

Rabies Statistics and Context

• Burden of Rabies in India:
  • India accounts for 36% of global rabies deaths, amounting to 18,000-20,000 deaths annually.
  • About 30-60% of reported rabies cases occur in children under 15 years.
• Preventability: Rabies deaths are preventable through timely medical care.

National Initiatives

• National Rabies Control Programme: Launched to eliminate dog-mediated rabies by 2030.
• Joint National Action Plan: Focuses on a One Health approach, including:
  • Mass dog vaccinations.
  • Improved access to post-exposure prophylaxis (PEP).
  • Health worker training and community awareness on bite prevention.

World Health Organization (WHO) Involvement

• WHO supports efforts to end human deaths from rabies through comprehensive strategies involving vaccination, surveillance, and community engagement.

This situation highlights the critical importance of vaccine authenticity and public health safeguards in infectious disease management, particularly in countries like India where rabies remains a significant health challenge.