Hepatitis B vaccines were genuine - UK lab tests

KAMPALA.

Preliminary laboratory test results have shown that contents of the  hepatitis B vaccines found on the Ugandan market in March were genuine but with changed labels.

According to a report issued by National Drug Authority, the vaccine earlier suspected to be counterfeit were found to be genuine but with falsified labelling. 

In collaboration with World Health Organization, the NDA report indicates that samples of both the suspected fake vaccine were subjected to confirmatory tests at the United Kingdom’s Medicines and Health products Regulatory Agency (MHRA).

“The findings from our laboratory and the UK-MHRA laboratories, so far indicate that the falsified vaccine is highly likely to be Hepatitis B vaccine from the Serum Institute of India (SII) delivered to government Health facilities but diverted along the supply chain and sold to private medical facilities,” the NDA statement reads in part. 

The report indicates that samples of the 10 milliliter vials purportedly manufactured by SII together with the genuine Hepatitis B vaccine samples were subjected to both qualitative tests at the National Drug Quality Control Laboratory in Kampala before being flown abroad.       

But the results of the UK-based laboratories contained in the April 25 report indicate that there was no active pharmaceutical ingredient (API) in both samples.

“There are no residual chemicals, contaminants, bacterial or fungi that could cause any adverse effects after administrations,” the report adds.

It further indicates that there were visible differences in labelling between the genuine Hepatitis B vaccines and falsified samples, which is consistent with the NDQCL laboratory report.

Despite the laboratory findings, the NDA Executive secretary Ms Donna Kusemererwa said the vaccine is not genuine once a label has been tempered with.

“Even if we confirm that serum institute made the content, they cannot take responsibility for a product that is tampered with,” Ms Kusemererwa said.

“Whatever the confirmatory test results reveal will not make the product genuine. And therefore will not change anything other than assuring the people who got the vaccine that they were not poisoned,” she said, adding that vaccine is supposed to be kept between 2-8 degrees Celicius.

However, she said that NDA is awaiting a comprehensive report from WHO and MHRA that covers a full range of confirmatory tests.  

Background

The falsified Hepatitis B vaccines were discovered by the authority’s pharmacy vigilance team in March. The facilities  found administering Hepatitis B vaccines included; Mbarara Community Hospital, Devine Mercy, Mayanja Memorial, Family Doctors Clinic in Ntungamo, Mbarara City Clinic, UMC Hospital in Bukoto, Malcolm Health Centre Kisaasi, and Kampala Chambers on Buganda Road.