Fake Rabies Vaccine Used in India? Australia Makes Shocking Claim, Pharma Company Denies Allegations

Australia has issued a health advisory stating that counterfeit rabies vaccines have been circulating in India since November 2023. Issued by the Australian Technical Advisory Group on Immunisation, or ATAGI,

the recommendation says those who have been vaccinated with the Abhayrab vaccine may not be protected against the viral disease, which is 100 per cent fatal if it spreads. However, the Indian Immunologicals Limited - manufacturers of the Abhayrab vaccine, have now issued a clarification regarding the recent ATAGI refuting the “over-cautious and misplaced reference”, stressing it does not reflect the current situation. According to the World Health Organization, rabies is an extremely deadly, yet preventable, viral disease that attacks the central nervous system, causing fatal inflammation of the brain in mammals, including humans, and spreads through the bite or scratch of an infected animal like bats, dogs, or raccoons via their saliva. Once symptoms appear, like fever, confusion, hallucinations, and paralysis, it is almost always fatal, highlighting the importance of immediate post-exposure treatment after potential exposure, often involving vaccination and immunoglobulin. Children between the ages of 5 and 14 years are the usual victims.

What did the advisory say?

In the alert, ATAGI said that the “counterfeit (fake) batches of the rabies vaccine Abhayrab have been circulating in India since 2023.” The fake vaccine differs from that of the registered vaccine in formulation, packaging, labelling, and manufacturing. The advisory also states that people who received the fake vaccine might not be fully protected against rabies. Hence, they are “advised to get replacement doses to ensure they are adequately protected.” According to news reports, Abhayrab is not used in Australia, and so, the advisory is like a caution for those who travel to India and receive the vaccine from November 1, 2023, onwards. The alert has also suggested that a rabies vaccine registered in Australia should be administered if it is difficult to confirm whether a genuine or fake product was used.

How have the Indian makers responded?

IIL has identified a packaging anomaly in a single specific batch - KA 24014 - and says it notified Indian regulators and law enforcement agencies, while lodging a formal complaint and working closely with authorities to ensure swift action. While IIL maintains it was an isolated incident since the counterfeit batch is no longer available for sale, the company maintains that since Abhayrab has been manufactured by IIL since 2000, more than 210 million doses have been supplied across India and 40 other countries. IIL also holds a 40 per cent market share in India.

Why is the rabies vaccine important?

Rabies vaccine reduces the risk of the virus and does not treat it. It is still possible to get rabies after receiving the vaccine, but the symptoms can be less severe or not last as long. Doctors say it works by helping your immune system learn how to fight off a future infection. According to doctors, the virus attacks your central nervous system and causes encephalopathy, paralysis, and even death. However, it is important that the post-exposure prophylaxis, along with wound cleansing, rabies immunoglobulin, and a series of vaccine doses, is administered before the symptoms appear. High-risk groups include veterinarians, travelers, and lab workers.

Are there any side effects of the vaccine?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions, which include skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Feeling faint or lightheaded
• Dizziness
• High fever
• General discomfort
• Headache or joint and muscle pain
• Pain, redness, or irritation at the injection site
• Swollen lymph nodes in the neck, groin, chest, or underarm area