Public Alert No. 0003/2019 – Alert on Falsified Rabies Vaccines Circulating in the Philippines

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by the World Health Organization (WHO) that two (2) versions of falsified Verorab® vaccines are in circulation in the Philippines.

Verorab® vaccine is used for the prevention of rabies in children and adults. It can be used to protect those who are at risk of exposure to rabies (pre-exposure vaccination) or to prevent the development of rabies after exposure has occurred, usually following the bite of an animal suspected of having rabies (post exposure prophylaxis).

Genuine Verorab® Rabies Vaccine (Inactivated) manufactured by Sanofi Pasteur SA, 2, Avenue Pont Pasteur 69007 Lyon, France is registered by NAFDAC. The registered genuine Verorab® Rabies Vaccine is imported and distributed by Sanofi Aventis Nigeria Limited.

Rabies is a vaccine-preventable viral disease that is almost always fatal following the onset of clinical symptoms. Rabies is present in all continents, with over 95% of human deaths occurring in Asia and Africa.

The details of the two versions of falsified Verorab® vaccines identified in the Philippines are as follows:

 VERORAB, Powder and Solvent for Suspension for Injection.  Version 1

Product Name Verorab, Rabies Vaccine for Human use, prepared on Cell Cultures (inactivated)
Stated Manufacturer Sanofi Pasteur
Presentation  Secondary Packaging (Pack/Carton) Primary Packaging (Powder in Vial and Solvent in Prefilled Syringe
Batch Number NIE35 Unknown
Expiry Date 04-2019 Unknown
Date of Manufacture 23 MAY 16 Unknown

VERORAB, Powder and Solvent for Suspension for Injection. Version 2

Product Name Verorab, Rabies Vaccine for Human use, Prepared on Cell Cultures (Inactivated)
Stated Manufacturer SANOFI PASTEUR
Presentation Secondary Packaging (Pack/Carton) and Primary Packaging (Powder in Vial) Primary Packaging (Solvent in Ampoule)
Batch Number H1833 H7720
Expiry Date 10-2020 10-2020 or 10-2021
Date of Manufacture 30 NOV 17 09 OCT 17

The stated manufacturer, Sanofi Pasteur, has confirmed that they did not manufacture the falsified vaccines.

NAFDAC implores all importers, wholesalers and retailers not to illegally import, distribute and sell the falsified Verorab Rabies Vaccine.

Surveillance has been strengthened by NAFDAC at all ports of entry to prevent importation of falsified Verorab Rabies Vaccines from the Philippines. The Agency has also heightened surveillance to prevent distribution and sale of falsified Verorab Rabies Vaccine.

Anybody in possession of the falsified vaccines should submit them to the nearest NAFDAC office.

Health care providers and other members of the public are advised to obtain genuine NAFDAC registered Verorab Rabies Vaccines imported and distributed by Sanofi Aventis Nigeria Limited from authentic and reliable sources.

Consumers are advised to report Adverse events related to the use of vaccines to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng.

NAFDAC…..…. Safeguarding the health of the nation!!!