Drug Authority Cautions Public of Counterfeit Hepatitis B Vaccine on Market

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National Drug Authority (NDA) has warned the public that there are counterfeit Hepatitis B vaccines that have been found in circulation in different parts of Uganda.

The drug Authority has revealed that over the last three weeks, they seized counterfeit vaccines from atleast 8 private health facilities including clinics and hospitals. These included Mbarara Community Hospital, Devine Mercy, Mayanja Memorial Hospital, Mbarara City Clinic, all in Mbarara, Family Doctors’ Clinic in Ntungamo, UMC Hospital in Bukoto, Malcolm Health Care in Kisasi and Kampala Medical Chambers.

While addressing a news conference at the NDA headquarters in Kampala on Tuesday, Hellen Ndagije the NDA Director for Products Safety said that the seizure followed a tip off in Mbarara district.

She revealed that the exercise to rid these facilities of the fake vaccines led to impounding of more of such vaccines from immunization camps in Mbale and Mbarara.

The brand that is reported to have been manipulated is one manufactured by Serum Institute in India. The authentic Serum manufactured vaccine is available in two registered pack sizes (1 mil litre ampoule and 10 mil litre multi-dose vials).

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However, as opposed to the genuine vaccine, the counterfeit one does not bear the manufacturing date and expiry date, its shelf life is 4 years (an excess of one year) and the words on the vial can easily run off. The receipts provided by the different sellers also lacked physical addresses, which has led the Authority to believe they are mere hawkwers.

The genuine vaccine is packed in a 10ml vial with two purple colored bands on the top and bottom of the label, and a 1ml ampoule with green colored bands on the lable.

“The Authority is conducting investigations to establish the source of the product. The available information shows that all facilities found with the counterfeit had bought them from unlicensed dealers with fake addresses on the invoices,” Ndagije said.

Several journalists asked about the likely effects or side effects caused by the counterfeit vaccine especially on those to whom is has already been administered. But NDA said that establishing this will require to first examine the contents of the counterfeit vaccine and subsequently what its impact could be.

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Ndagije explained that since the product is a vaccine, whose purpose is to safeguard individuals from a particular disease (Hepatitis B), the most certain effect of the fake vaccine would be the failure by one to acquire immunity.

Regarding the timeline for the ongoing investigation, Amos Atumanya, the Regulatory Officer from the NDA Directorate of Inspectorate and Enforcement said; “Establishing what is in the [counterfeit] product requires lab analysis. It takes time. We shall in the due course advise the public on what to do next”.

However, NDA has urged members of the public to continue to go for vaccination in public health facilities saying that the genuine vaccine are still available and that “the disease can’t wait”.

It has also called on all private health facilities in possession of the 10 mil litre multi-dose vaccine vials manufactured by Serum Institute of India to immediately halt using them and take them to the nearest NDA offices.

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Meanwhile two persons who were found vending the counterfeit vaccines have so far been arrested while others recorded Police statements.

Hepatitis B vaccine is a drug given to healthy people to immunize them against Hepatitis B disease. Hepatitis B is an infectious disease caused by the hepatitis B virus (HBV) that affects the liver. It can cause both acute and chronic infections.

Many people have no symptoms during the initial infection but some develop a rapid onset of sickness with vomiting, yellowish skin, tiredness, dark urine and abdominal pain.




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Drug Authority Cautions Public of Counterfeit Hepatitis B Vaccine on Market was first posted on March 13, 2018 at 2:21 pm.
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