Fake Rabies Vaccine Latest News
- Health authorities in Australia have advised citizens vaccinated for rabies in India to check whether they require replacement doses, following concerns about counterfeit rabies vaccines.
- Similar advisories have been issued by the United Kingdom and the United States.
- This episode highlights critical issues of drug supply chain integrity, regulatory enforcement, and public confidence in vaccines—especially significant for India, which bears a high rabies burden and plays a key role in global vaccine supply.
Rabies: Transmission and Prevention
- Rabies is a viral infection transmitted through the saliva of infected animals.
- Human infection can occur through bites, scratches, or saliva contact with open wounds, commonly involving dogs, cats, monkeys, and bats.
- Symptoms range from fever, headache, and nausea to excessive salivation, hydrophobia (fear of water), hallucinations, and partial paralysis.
- Importantly, rabies is preventable through timely post-exposure vaccination, which is why prompt medical treatment after animal exposure is essential.
India’s Rabies Burden
- According to India’s National Rabies Control Programme, 6,644 clinically suspected human rabies cases and deaths were reported between 2012 and 2022, though this is believed to be an under-estimate.
- The World Health Organisation estimates 18,000–20,000 rabies deaths annually worldwide, with one-third to two-thirds occurring in children under 15 years.
- India alone accounts for nearly 36% of global rabies deaths, highlighting the public health significance of vaccine safety and regulatory oversight.
Background: Concerns Over Abhayrab Vaccine
- Health authorities in Australia, the UK, and the US have issued advisories urging citizens who received rabies vaccinations in India to verify whether they require replacement doses.
- The alerts point to possible circulation of counterfeit rabies vaccines in India since 2023.
- The advisories stem from concerns that fake batches of Abhayrab, a rabies vaccine manufactured by the Human Biologicals Institute (a key division of PSU Indian Immunologicals), may be in circulation.
- The issue has triggered international alarm because rabies is almost 100% fatal once symptoms appear, making vaccine efficacy critical.
Company’s Response and Identification of Counterfeit Batch
- Indian Immunologicals Limited (IIL) stated that in January 2025, it detected one counterfeit batch (#KA24014) with altered packaging.
- The company informed Indian regulators and law enforcement immediately.
- It maintains that no other counterfeit batches have been found.
Nature of the Counterfeit: Packaging Diversion, Not Fake Vaccine
- Investigations revealed that:
- Counterfeit products were detected in Delhi, Mumbai, Agra, Lucknow, Kanpur, and Patna.
- Raids were conducted in Delhi, Mumbai, and Agra.
- Tests conducted at the Central Drug Testing Laboratory, Kasauli, found the seized vaccines to contain the genuine product.
- Experts clarified that the issue involved tampered outer packaging, allegedly used to divert government-supplied vaccines into the open market, rather than fake or substandard vaccine contents.
Why Abhayrab Is Central to the Concern
- Abhayrab is among the most widely used rabies vaccines in India, holding around 40% market share.
- IIL is the largest rabies vaccine producer globally, supplying vaccines for over 25 years.
- Company officials warned that international advisories could fuel vaccine hesitancy, particularly in rural areas where Abhayrab may be the only available option.
Expert Reassurance on Public Health Impact
- Experts in India sought to allay fears:
- In India, patients usually receive five doses of rabies vaccine after an animal bite.
- Even if one dose were ineffective, protection is likely ensured through remaining doses and rabies immunoglobulin.
WHO-Recommended Vaccination Protocol
- As per World Health Organisation guidelines:
- Unimmunised persons: At least three intramuscular doses or Two intradermal doses, plus immunoglobulin on day zero.
- Previously immunised persons: Only two booster doses are required.
Recent Rabies Cases and Vaccine Failure Concerns
- In Kerala, a spike in rabies deaths was reported in 2022, raising public concern as several deceased individuals had reportedly received rabies vaccines.
- This led to suspicions of vaccine failure or ineffective vaccines.
Findings of the Union Health Ministry Committee
- A committee constituted by the Union Health Ministry investigated the cases and ruled out vaccine failure as the primary cause.
- It concluded that deaths occurred due to:
- Improper wound washing after animal bites
- Non-administration of rabies immunoglobulin in Category 3 bites
- Category 3 bites include multiple bites or scratches breaking the skin, or situations where broken skin is licked by an animal, which carry the highest risk of infection.
- The committee highlighted limited availability of rabies immunoglobulin and vaccines as a major systemic challenge, which compromised timely and complete post-exposure prophylaxis.
Fake Rabies Vaccine FAQs
Q1: Why have countries issued alerts on rabies vaccines received in India?
Ans: Australia, the UK, and the US warned travelers due to concerns about counterfeit Abhayrab vaccines circulating in India since 2023, raising doubts about vaccine efficacy.
Q2: What is the issue related to the Abhayrab rabies vaccine?
Ans: Authorities flagged tampered packaging of one Abhayrab batch, allegedly diverting government supply to private markets, though vaccine contents were found genuine.
Q3: Why is rabies a major public health concern in India?
Ans: Rabies is nearly 100% fatal once symptoms appear. India accounts for about 36% of global rabies deaths, with children forming a large proportion.
Q4: Have recent rabies deaths been linked to vaccine failure?
Ans: Investigations into Kerala’s 2022 rabies deaths found causes linked to poor wound washing and lack of immunoglobulin, not vaccine failure.
Q5: Why does this controversy matter for India globally?
Ans: It tests India’s drug regulation credibility, supply-chain oversight, and vaccine confidence, crucial given India’s role as a major global vaccine producer.