Uganda embroiled in fake hepatitis B vaccine scandal

An investigation into the circulation of fake hepatitis B vaccines in Uganda is spiralling out of control as concerns about the government’s oversight of drug importation and supply are raised.

The developing scandal first originated in Mbarara several weeks ago following a tip-off that fake labels were being used on vials of hepatitis B vaccines. This led to the seizure of counterfeit drugs from immunisation camps in Mbale and Entebbe, while at least eight private hospitals and clinics, including in the Uganda capital Kampala, have been found with stocks of fake 10ml multi-dose vials of the vaccine.

The initial investigation in Mbarara had not been made public until the National Drug Authority (NDA) realised the counterfeits, which are not believed to be harmful, were more widespread than first thought.

“Some of the fake vaccines were found with no manufacturing dates while others had four-year expiry dates [when it should be three years]. In other cases, the shelf life showed two years and below, instead of three years,” Hellen Ndagije, NDA director of product safety, said in a press conference.

The agency alleges that the fake vaccines have been manufactured by the Serum Institute of India, according to Uganda-based The Observer, but Serum denies supplying the vaccines.

Although reports also claim that the facilities found with the fake vaccine, which is available in 1ml ampoules and 10ml multi-dose vials, appeared to have bought the drugs from unlicensed dealers with fake addresses in invoices/receipts.

The Serum Institute of India is an approved manufacturer of the hepatitis B vaccine in Uganda.

But according to another report by The Observer, investigators believe some of the suspected counterfeit vaccines may have been stolen from the government supply.

“The 10ml vaccines are then distributed in a clandestine style to only known clients or their agents,” an unnamed source told the publication. “NDA found evidence of re-labelling of expired laboratory consumables in the outlet [Mackie laboratory] with cut labels fixed with new expiry dates. There is need for a thorough investigation in the supply of government hepatitis B vaccines in the last one year to know where the vaccines are siphoned from the system.”

Government supplier and registered importer of the vaccine manufactured by Serum Institute of India, Norvik Enterprises, is assisting with the investigation and has handed over import documentation to the authorities. The company asserts it has never sold 10ml vials to private facilities or individuals.

In response to the incident, the NDA has asked all private health facilities stocking the Serum Institute of India-manufactured 10ml vials to cease using them and hand them in to the NDA for testing as part of the ongoing investigation.

The NDA has also asked for the public to remain calm while the investigation continues, although it says immunisations may need to be repeated based on the investigation’s findings.

In a move aimed to show the government is taking action, the Ministry of Health has ordered that all private health care providers must be assessed and accredited by the government before administering the vaccines, The Observer reported. 

The clampdown, however, has sparked a backlash. One pharmacist is suing the NDA for declaring her vaccine stock fake when it had already been verified as genuine by NDA officials on importation. Other pharmacists have accused the NDA of double standards and claim the agency is too incompetent to conduct an investigation and test the fake vaccines.

Meanwhile, the Anti-Counterfeit Network (ACN) Africa has called on the Ugandan government to provide answers on how the fake vaccines were able to enter the country, how many people may have been vaccinated with the fake product, how the situation is being monitored and what measures will be taken against the individuals involved in the distribution of the fake vaccines.

“The fake hepatitis B vaccines scandal places the government in the middle of promotion and fight of counterfeits,” said Fred Muwema, the ACN legal and corporate affairs director. “If government and its agencies don’t come out to inform us on the matters concerning procurement of the fake vaccines, we shall seek legal redress not only but also on international level.” 

The NDA has been unable to explain the existence of the fake vaccines so far.

Hepatitis B is the most prevalent hepatitis virus in Uganda, affecting more than 3.5 million people.