Medical Device Warning no. 8/2019 (English version)

Counterfeit rabies vaccines and rabies serum are circulating in the Philippines

This medical product alert applies to 3 different counterfeit rabies vaccines (Verorab, Speeda and Rabipur) and 1 counterfeit rabies serum (Equirab) circulating in the Philippines. It is associated with WHO medical device alert no. 1/2019 issued on January 30, 2019 in connection with counterfeit rabies vaccines against Sparrows circulating the Philippines. Rabies is a vaccine-preventable viral disease that is almost always fatal after an onset of clinical symptoms. Rabies is present worldwide, with more than 95% of deaths occurring in Asia and Africa. Original Verorab, Speeda and Rabipur vaccines are used for pre-exposure vaccination or post-exposure prophylaxis. True Equirab rabies serum provides passive rabies immunization.

WHO has recently received confirmation that counterfeit Veroraba, Speeda, Rabipur and Equirab groups are available at the patient level in the Philippines. Research is ongoing and laboratory analyzes are making samples available to determine their content and to better assess public health risk. At this stage, no adverse reactions attributed to the counterfeit products listed below have been reported to WHO. There is a shortage of rabies vaccines in the Philippines.

1. VERORAB, a rabies vaccine for human use, prepared on cell culture (inactive)

Counterfeit versions of 4 different combinations of numbers have been discovered so far. The product details are listed in Table 1 below and are also contained in Food and Drug Administration of the Philippines no. 2019-190, Please see Annex 1 for available photos.

Sanofi Pasteur, a true manufacturer and marketing authorization holder of Verorab, a human-made rabies vaccine prepared for cell culture (inactive) in the Philippines, stated:

• They did not produce the above products.
• The above products show a mismatch in labeling and packaging.
• Variable data does not match the original production data.
• H1833, H1742 and N1J75V are forged batch numbers.
• Serial number N1E353M is not a valid serial number for the Philippine market.

2. SPEEDA, purified rabies vaccines (Vero cell)

Counterfeit versions of 4 different combinations of numbers have been discovered so far. The product details are listed in Table 2 below and are also contained in Food and Drug Administration of the Philippines no. 2019-153 Please see Annex 2 for available photos.

Liaoning Cheng Da Biotechnology Co., Ltd., a true manufacturer of Speed, purified rabies vaccines (Vero Cell), stated:

• They did not produce the above products.
• The above products show a mismatch in labeling and packaging.

3. RABIPUR, a PCEC rabies vaccine for human use

Counterfeit versions of 2 different combinations of numbers have been discovered so far. The product details are listed in Table 3 below and are also contained in Food and Drug Administration of the Philippines no. 2019-170. Please see Annex 3 for available photos.

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

• They did not produce the above products.
• The above products show a mismatch in labeling and packaging.
• As of July 2017, Chiron Behring Vaccines Pvt. Ltd did not export this product, nor did GSK introduce this product to the Philippines.

4. EQUIRAB, rabies serum (equidae)

Counterfeit versions of 3 different combinations of numbers have been discovered so far. The product details are listed in Table 4 below and are also contained in Food and Drug Administration of the Philippines no. 2019-152, Please see Annex 4 for available photos.

Bharat Serums and Vaccines Limited, a true Equirab manufacturer, said:

• They did not produce the above products.
• The above products show a mismatch in labeling and packaging

WHO requires greater vigilance in the supply chains of countries likely to be affected by these counterfeit products. Increased alertness should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and all other vaccine providers.

If you own the above products, do not use them. If you have used these counterfeit products or have suffered an adverse event using these products, seek the advice of a qualified healthcare professional immediately and check that they report the incident to your local Ministry of Health / National Medicines Regulatory Authority / National Pharmacovigilance Center.

All medical products must be obtained from credible and reliable sources. Their authenticity and condition should be carefully checked. If in doubt, seek the advice of a healthcare professional.

National health authorities ask you to notify WHO immediately if false medical devices are detected in their country. If you have any information on the production, distribution or supply of these medical products, please contact [email protected]

WHO Global Surveillance and Surveillance System
for substandard and counterfeit medical products

For more information, visit: http://www.who.int/medicines/regulation/ssffc/en/

Annex 1: Available photographs of counterfeit sparrows, subject to WHO medical device alert No. 8/2019

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

Photos of counterfeit Verorabe, N1E353M series

Photographs of Counterfeit Verorabe, H 1742 Series

Photographs of counterfeit Verorabe, serial number H1833

Note: Verorab with serial number H1833 (production date 30 November 17 and expiration date 10 – 2021) is available in two different packaging presentations.

Photos of counterfeit Verorabe, N1J75V series

Note: No photos of the powder in the bottle and the solvent in the ampoule are available.

Attachment 2: Available photographs of counterfeit Speed, subject to WHO medical alert no. 8/2019

Please note that the photos are lower in the same order as in Table 2.

Photos of Counterfeit Speed, Serial Number 201803067

Photos of Counterfeit Speed, Serial Number 201708295

Photos of Counterfeit Speed, Series Number 201710356

No photos available.

Photos of Counterfeit Speed, Serial Number 201803069

No photos available.

Annex 3: Available photographs of counterfeit rabipur, subject to WHO medical device alert No. 8/2019

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

Photos of forged Rabipur, 3503 series

Photographs of counterfeit Rabipur, series no. 3479

Annex 4: Available photographs of counterfeit equiliber, subject to WHO medical device alert No. 8/2019

Please note that the photos are lower in the same order as in Table 4.

Photos of counterfeit Equirab, Series A02717008

Photos of counterfeit Equirab, Series A02718008

Photos of forged Equirab, series A02718012