Fake Hepatitis B Vaccines Found on the Market in Uganda

During routine surveillance from the National Drug Authority, falsified hepatitis B vaccines were discovered at 8 health facilities in Uganda, according to an official statement from the Republic of Uganda Ministry of Health.

About 257 million individuals are living with hepatitis B virus infection, according to the World Health Organization (WHO). The areas of highest prevalence include the WHO Western Pacific Region and the WHO African region, where about 6.1% of the adult population is infected. In Uganda, about 4.3% of the adult population is infected, and as a result, the Ministry of Health launched a vaccination program for adults and adolescents in 2015. The Busoga region, as well as the Bukedi and Bugisu subregions of the country, are currently undergoing vaccination exercises.

The health facilities which held the falsified vaccines are Mbarara Community Hospital, Divine mercy, Mayanja Memorial, Family Doctors clinic Ntungamo, Mbarara City clinic, UMC Hospital Bukoto, Malcolm Health care Kisaasi, and Kampala Medical Chambers Buganda Road, located in the following districts: Mbarara, Mbale, Wakiso and Kampala districts.

The falsified 10 mL vaccines are stated to be from Serum Institute of India; however, all were bought from unlicensed dealers with fake addresses on the invoices and receipts.

According to the statement, genuine vaccines vials from Serum Institute of India should have the following characteristics:

• Batch number
• Manufacturing and expiry dates with a shelf life of 3 years
• Two purple bands (top and bottom) on the label
• Only available in Government health facilities and bears the mark “Government of Uganda, Not for Sale.”

In the statement, the Honorable, Sarah Opendi, Minister of Health shared that only a select number of registered brands supply hepatitis B vaccines to Uganda. These are:

• Biological E represented by Gittoes
• Glaxo SmithKline represented by Eris Ltd
• Human Biologicals Institute represented by TATA (U)
• LG Life sciences, Sanofi Pasteur & Pasteur Merieux represented by Laborex
• Serum Institute of India represented by Norvik Enterprises
• Shantha Biotec represented by Laborex

The National Drug Authority has been authorized to “recall the 10 ml vial of hepatitis B vaccine from Serum Institute of India from all private facilities (hospitals, clinics, pharmacies) [and to] test the falsified products to establish the contents of the vaccine,” according to the statement. Furthermore, residents are being encouraged to seek out the vaccine only at accredited private facilities (listed in the statement). Hepatitis B vaccine camps are being strongly discouraged, as is the practice of purchasing any drugs from unlicensed suppliers.