Parliament’s Health Committee has ordered private health facilities to stop Hepatitis B Vaccination pending laboratory tests on counterfeit Hepatitis B vaccines circulating on the market.
The decision was made Wednesday afternoon during a meeting between the committee and officials from the National Drug Authority (NDA). The MPs also noted that the public cannot continue being exposed to counterfeit vaccines whose side-effects are not yet established.
Their demand followed a submission from NDA’s Board Chairman Medard Bitekyerezo that they could not tell the side effects of the counterfeit Hepatitis B pending laboratory tests. Bitekyerezo told MPs that they could not suspend the vaccination countrywide since there are genuine vaccines on the market and the suspension would expose more people to the disease.
MP’s Gaffa Mbwatekamwa and Beatrice Rwakimari among others demanded that vaccinations be halted until the government is certain that people’s lives are not at risk.
The Health Committee Chairperson Dr Micheal Bukenya ruled that all private facilities should stop the Hepatitis B vaccination until they receive a written approval from the Ministry of Health. The committee also resolved that vaccination can continue in the government facilities so that people are not exposed to the Hepatitis B disease.
Yesterday, NDA reported the impounding of counterfeit Hepatitis B vaccines from 8 private health facilities and two immunization camps.
The vaccines were impounded from Family Doctors’ Clinic- Ntungamo, UMC Hospital-Bukoto, Malcolm Health Care-Kisaasi and Kampala Medical Chambers. The others were Mbarara Community Hospital, Devine Mercy, Mbarara City Clinic and Mayanja Memorial Hospital.
Other counterfeit vaccines were impounded from immunization camps at Mbale Central Market and Mbarara University camp which was organized by Sanyu Medical Centre, Katabi-Entebbe.
The counterfeit drugs are a replica of the Hepatitis B Vaccine brand manufactured by Serum Institute of India. The brand is available in two registered pack sizes including the 1ml bottles and 10ml multi-dose vials. The 10ml multi-dose vials are supplied specifically to the public sector and bear the words, “Government of Uganda, Not for Sale” while the 1ml bottles are supplied to the private facilities. The product registered importer is Norvik Enterprises Ltd.
The genuine 10ml vial vaccine from Serum Institute of India has a batch number, manufacturing, and expiry dates with a shelf-life of 3 years, two purple bands on the label and only available in government health facilities with a ‘Not for sale’ mark.
NDA says that the counterfeit 10ml vial vaccines currently being possessed by private health facilities have no manufacturing date while those with one indicated have their expiry dates exceeding 4 years.
The fake 1ml vaccines also have no batch numbers and if they have the expiry date, they do not have the manufacturing date. They have a shelf life of two years and below and words on the bottle can be easily rubbed off.
According to the ministry of Health, it is estimated that 3.5 million (10%) people out of the total population of 35 million are infected with the Hepatitis B virus in Uganda. 1 million of those infected are chronically ill and require treatment.
The Hepatitis B disease is transmitted through blood and infected body fluids. This can occur through; direct blood to blood contact, unprotected sex, contaminated skin piercing instruments e.g. needles, and from an infected woman to her newborn baby during the delivery.