Minister Opendi bans fake Hepatitis B vaccines countrywide

Minister Sarah Opendi and Rasha Kelej, Chief Social Officer Merck Healthcare during the Merck Uganda Diabetes Day.

Hon. Sarah Opendi, the state minister of Health and General Duties has suspended private Hepatitis B health camps citing falsified Hepatitis B vaccine on the market.

National Drug Authority (NDA) during its routine post-marketing surveillance encountered falsified Hepatitis B vaccines from eight health facilities in Mbarara, Mbale, Wakiso and Kampala districts.

These facilities 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.

Hepatitis B Vaccine is administered to healthy people to immunize them against Hepatitis B disease.

The 10 ml multi-dose vial is supplied to the public (Government) sector and is identified by a white label with two purple bands at the top and bottom part of the label, respectively.

The vial supplied to Public Health Facilities also bears the words, “Government of Uganda, Not for sale”.

According to Opendi, the genuine 10ml vial of Hepatitis B vaccine imported from Serum Institute of India has the following features: batch number, manufacturing and expiry dates with a shelf life of 3 years and 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.”

The available information, however, shows that all eight facilities named above, found with the suspected falsified Hepatitis B vaccines bought them from unlicensed dealers with fake addresses on the invoices and receipts.

For instance, Kumate Diagnostics Ltd -Kampala, Forever Green Enterprises Old – Kampala Some suspects have been arrested and are currently under police custody to assist with investigations while others have recorded statements at the respective police stations.

Ministry of Health is carrying out the following measures to curb the supply of falsified Hepatitis B vaccines.

Minister Opendi has instructed NDA to recall the 10ml vial of Hepatitis B vaccine from Serum Institute of India from all private facilities (hospitals, clinics, pharmacies).

NDA will also test the falsified products to establish the contents of the vaccine while the general public is encouraged to receive Hepatitis B vaccination from only the accredited private facilities and Government Health Facilities as investigations into the matter take course.

The private health facilities that have been cleared to provide the Hep B Vaccine are: Nsambya Hospital, Kibuli Hospital, Mengo Hospital, Rubaga Hospital, International Hospital Kampala (IHK), Norvik Hospital, Case Hospital and Nakasero Hospital.

“We shall advise the public on other facilities that have been cleared for Hepatitis B vaccination in two weeks,” she said.

The ministry of Health has also suspended vaccination camps for Hepatitis B by private providers until cleared by the Ministry of Health.

“DHOs and RDCs are instructed to ensure that this directive is complied with. Immunization of children as part of the routine Pentavalent vaccine will continue.”

The Ministry of Health appealed to the general public to: be vigilant and provide any information about suspicious Hepatitis B Vaccine, report any camps for Hepatitis B Vaccine being organized in your community and refrain from purchasing drugs from unlicensed suppliers.

According to the Uganda Population-based HIV Impact Assessment Survey (UPHIA), the prevalence of Hepatitis B infection among adults in Uganda stands at 4.3% (5.6% among men and 3.1% among women).

Hepatitis B prevalence was highest in Northern region with 4.6% in mid North, 4.4% in North East and 3.8% in West Nile.

Hepatitis B infection was lower in the rest of the country with a range of 0.8% in South West region to 2.7% in East Central region.

The Ministry of Health started the vaccination of adolescents and adults against Hepatitis B virus disease in 2015.



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