Counterfeit batches of rabies vaccine (Abhayrab®) reported in India

What is the issue?

The Australian Technical Advisory Group on Immunisation (ATAGI) has been alerted to the circulation of counterfeit batches of the rabies vaccine Abhayrab^® in India since 1 November 2023. This vaccine is not available in Australia but people who have received this vaccine while in India may be impacted.

People who have received the counterfeit vaccine may not be fully protected against rabies and are recommended to receive replacement doses with a rabies vaccine registered in Australia.

Rabies is a rare but highly fatal disease that affects the central nervous system. It is caused by the rabies virus, and it spreads to people from infected animals. It does not occur in Australia but is found in many parts of the world, including India. Symptoms of rabies can occur within days or up to several years after exposure. Immediate wound care and post-exposure prophylaxis with rabies vaccine +/- rabies immunoglobulin prevent against disease following exposure to infected animals.

Who is at risk?

People may be impacted if they:

• received rabies vaccine in India from 1 November 2023 onwards, AND
• were administered one or more doses of Abhayrab^®, OR the administered vaccine brand is unknown.

People who have completed their full rabies vaccine course in a country other than India, including Australia, or have documented evidence of receiving a different rabies vaccine brand are not affected by this issue.

Recommendations

For the public

Actions for people affected by this issue:

• Anyone who has received one or more doses of Abhayrab^®, or an unknown rabies vaccine brand, in India from 1 November 2023 onwards are advised to see their GP or healthcare provider. You may be recommended to receive replacement vaccine doses.

General advice for people visiting countries where rabies occurs:

• Speak to your GP, travel health clinic or immunisation provider about recommended vaccines for travel.
• Avoid contact with wild and domestic animals when visiting countries where rabies occurs. If bitten, scratched or exposed to the saliva of an animal, seek immediate medical care.
• Keep detailed records of any vaccines received while overseas, including the dates received, product names and batch numbers. Take a photo of the packaging and label if possible.
• Upon returning to Australia, discuss if any additional vaccine doses are needed with your GP.

For health professionals

• For people who have received one or more doses of Abhayrab^®, or an unknown rabies vaccine brand, in India from 1 November 2023 onwards:
  • replace any dose(s) of Abhayrab®, or unknown rabies vaccine brand, with dose(s) of a valid rabies vaccine registered in Australia such as Rabipur® or Verorab®.
  • see the ATAGI statement for further advice.
• It is difficult to confirm whether a person has received genuine or counterfeit vaccine. As a precaution, people who have received any dose of Abhayrab® in India from 1 November 2023 onwards should be considered to have potentially received the counterfeit vaccine and offered replacement doses.
• People who have completed their full rabies vaccine course in a country other than India or have documented evidence of receiving a different valid rabies vaccine brand do not require replacement doses.
• People travelling to high-risk areas should be counselled on rabies prevention and where appropriate, offered rabies vaccine as pre-exposure prophylaxis prior to travel. Advise overseas travellers to keep detailed records of vaccines administered outside of Australia, including date, product name, and batch number, and where possible, to take a photo of the vaccine packaging and label.
• Contact your Local Public Health Unit on 1300 651 160 for additional guidance.