Rabies is a zoonotic viral disease which infects domestic and wild animals. It is transmitted to other animals and humans through close contact with saliva from infected animals (i.e. bites, scratches, licks on broken skin and mucous membranes). Once symptoms of the disease develop, rabies is fatal to both animals and humans. Rabies differs from many other infections in that the development of clinical disease can be prevented through timely immunization even after exposure to the infecting agent.

Two types of vaccines to protect against rabies in humans exist – nerve tissue and cell culture vaccines. WHO recommends replacement of nerve tissue vaccines with the more efficacious, safer vaccines developed through cell culture as soon as possible. Cell culture vaccines which are more affordable and require less vaccine have been developed in recent years.

Rabies vaccine is given to people at high risk of rabies to protect them if they are exposed. People at high risk of exposure to rabies should be offered pre-exposure rabies vaccination, including: Veterinarians, animal handlers, and veterinary students.

 

Rabies vaccine can prevent rabies.

Rabies is mainly a disease of animals. Humans get rabies when they are bitten or scratched by infected animals.

  • Human rabies is rare in the United States. Wild animals like bats, raccoons, skunks, and foxes are the most common source of human rabies infection in the United States.

 

  • Rabies is more common in other parts of the world where dogs still carry rabies. Most rabies deaths in people around the world are caused by bites from unvaccinated dogs.

Rabies infects the central nervous system. After infection with rabies, at first there might not be any symptoms. Weeks or even months after a bite, rabies can cause general weakness or discomfort, fever, or headache. As the disease progresses, the person may experience delirium, abnormal behavior, hallucinations, hydrophobia (fear of water), and insomnia.

If a person does not receive appropriate medical care after an exposure, human rabies is almost always fatal. Rabies can be prevented by vaccinating pets, staying away from wildlife, and seeking medical care after potential exposures and before symptoms start.

 

How to Spot Fake Rabies Vaccine

Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health. Rabies is a vaccine-preventable viral disease that is almost always fatal following the onset of clinical symptoms. Rabies is present worldwide, with over 95% of human deaths occurring in the Asia and Africa regions. Genuine Verorab, Speeda and Rabipur vaccines are used for pre-exposure vaccination or post-exposure prophylaxis. Genuine Equirab anti-rabies serum provides passive immunization against rabies.

WHO recently received confirmation that falsified batches of Verorab, Speeda, Rabipur and Equirab were available at patient level in the Philippines. Investigations are ongoing, and laboratory analyses are being facilitated for available samples to determine their contents and better assess the risk to public health. At this stage, no adverse reactions attributed to the below mentioned falsified products have been reported to WHO. 

1. VERORAB, Rabies Vaccine for Human Use, Prepared on Cell Cultures (Inactivated)

Falsified versions of 4 different combinations of batch numbers have so far been discovered. Product details are listed in Table 1 below and are also contained in the Philippines Food and Drug Administration Advisory No. 2019-190. Please refer to Annex 1 for available photographs.

Sanofi Pasteur, the genuine manufacturer and marketing authorization holder of Verorab, Rabies Vaccine for Human Use, Prepared on Cell Cultures (Inactivated) in the Philippines, stated:

  • They did not manufacture the above listed products.

 

  • The above listed products display labelling and packaging inconsistencies.

 

  • The variable data do not correspond to the genuine manufacturing records.

 

  • H1833, H1742, and N1J75V are falsified batch numbers.

 

  • Batch number N1E353M is not a valid batch number for the Philippines market.

 

2. SPEEDA, Purified Rabies Vaccines (Vero Cell)

Falsified versions of 4 different combinations of batch numbers have so far been discovered. Product details are listed in Table 2 below and are also contained in the Philippines Food and Drug Administration Advisory No. 2019-153 Please refer to Annex 2 for available photographs.

Liaoning Cheng Da Biotechnology Co., Ltd., the genuine manufacturer of Speeda, Purified Rabies Vaccines (Vero Cell), stated:

  • They did not manufacture the above listed products.

 

  • The above listed products display labelling and packaging inconsistencies.

 

3. RABIPUR, PCEC rabies vaccine for human use

Falsified versions of 2 different combinations of batch numbers have so far been discovered. Product details are listed in Table 3 below and are also contained in the Philippines Food and Drug Administration Advisory No. 2019-170. Please refer to Annex 3 for available photographs.

GlaxoSmithKline (GSK), the genuine marketing authorization holder of Rabipur, and Chiron Behring Vaccines Pvt. Ltd, the genuine manufacturer of Rabipur, stated:

  • They did not manufacture the above listed products.

 

  • The above listed products display labelling and packaging inconsistencies.

 

  • Since July 2017, Chiron Behring Vaccines Pvt. Ltd has not exported this product nor has GSK imported this product into the Philippines.

 

4. EQUIRAB, Anti-Rabies Serum (Equine)

Falsified versions of 3 different combinations of batch numbers have so far been discovered. Product details are listed in Table 4 below and are also contained in the Philippines Food and Drug Administration Advisory No. 2019-152. Please refer to Annex 4 for available photographs.

Bharat Serums and Vaccines Limited, the genuine manufacturer of Equirab, stated:

  • They did not manufacture the above listed products.

 

  • The above listed products display labelling and packaging inconsistencies

WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of vaccines.

If you are in possession of the above products, please do not use. If you have used these falsified products, or if you suffer an adverse event having used these products, please seek immediate advice from a qualified healthcare professional, and ensure they report the incident to your local Ministry of Health/National Medicines Regulatory Authorities/National Pharmacovigilance Centre.

All medical products must be obtained from authentic and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.

National health authorities are asked to immediately notify WHO if these falsified medical products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these medical products please contact rapidalert@who.int

WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products
For further information, please visit: http://www.who.int/medicines/regulation/ssffc/en/


Annex 1: Available Photographs of Falsified Verorab, subject of WHO Medical Product Alert N°8/2019

Please note that the photographs below are in the same order as Table 1.

Photographs of falsified Verorab, batch number N1E353M
Photographs of falsified Verorab, batch number H 1742
Photographs of falsified Verorab, batch number H1833

Note: Verorab with batch number H1833 (manufacturing date 30 NOV 17 and expiry date 10 – 2021) is available in two different packaging presentations.

Fake Rabies Vaccine
Photographs of falsified Verorab, batch number N1J75V

Note: No available photographs of powder in vial and solvent in ampoule.

Fake Rabies Vaccine

Annex 2: Available Photographs of Falsified Speeda, subject of WHO Medical Product Alert N°8/2019

Please note that the photographs below are in the same order as Table 2.

Photographs of falsified Speeda, batch number 201803067
Photographs of falsified Speeda, batch number 201708295
Fake Rabies Vaccine
Photographs of falsified Speeda, batch number 201710356

No photos available.

Photographs of falsified Speeda, batch number 201803069

No photos available.

Annex 3: Available Photographs of Falsified Rabipur, subject of WHO Medical Product Alert N°8/2019

Please note that the photographs below are in the same order as Table 3.

Photographs of Falsified Rabipur, batch number 3503
Fake Rabies Vaccine
Photographs of Falsified Rabipur, batch number 3479
Fake Rabies Vaccine

Annex 4: Available Photographs of Falsified Equirab, subject of WHO Medical Product Alert N°8/2019

Please note that the photographs below are in the same order as Table 4.

Photographs of falsified Equirab, batch number A02717008
Fake Rabies Vaccine
Photographs of falsified Equirab, batch number A02718008
Fake Rabies Vaccine
Photographs of falsified Equirab, batch number A02718012

 

See the Impact of FAKE Rabies Vaccine in this Video

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