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Fake Hepatitis B vaccine not harmful – minister

During its routine surveillance in Mbarara in March this year, the National Drug Authority (NDA) picked up about 48 vials of suspected falsified Hepatitis B vaccines from several health centres. The discovery triggered off a series of investigations in at least 18 drug outlets in western and central Uganda.

 

Releasing the investigation findings yesterday, minister of Health Dr Jane Ruth Aceng said the falsified Hepatitis B vaccines were subjected to tests and found not to be harmful to the recipients.  

“Chemical tests done on both samples (authentic and false vaccines), did not find any harmful active pharmaceutical ingredient that would be injurious to the recipient. Additional field monitoring confirmed no adverse drug reaction,” Aceng said.

Aceng said NDA has made efforts to monitor any side effects of the falsified vaccines, as well as the ones reported by the media, but so far none have been found.

“NDA has made efforts to monitor side effects amongst those who received the falsified vaccines, but none have been reported and identified. Other events reported in the media were investigated by NDA and found not to be related to the vaccine,” Aceng said.

 

Aceng also said that the potency levels in the false Hepatitis B vaccine had been reduced, meaning it might not have given effective immunisation.

“Given the reduced potency levels observed in the falsified samples, the falsified vaccine may not have elicited the expected immune response that is protective against Hepatitis B infection for the individuals who received this vaccine,” she said.

Aceng said the falsified vaccines had similarities with the government issued vaccines manufactured by the Serum Institute of India, prompting government to believe the vaccines were stolen and not manufactured.

“Given the similarities we believe that the falsified Hepatitis B vaccine was government-issued vaccine and was most likely diverted or stolen for sales to private health facilities,” Aceng said.

She said, among the differences in the vaccines was the labelling details, which had been deliberately altered.

“There was however some variation in labelling and related details, such as batch numbers, expiry date, colour, and design schemes. There was also a deliberate attempt to erase the inscription of “Government of Uganda, not for sale, for public use only”,” she said.

Aceng added that the lower potency in the falsified vaccines is most likely due to improper storage by the perpetrators, since no other similar vaccines had been coming in to the country.

“Although the active ingredient and in-vitro potency test showed some differences between the two samples, with the suspect samples returning lower specifications, the difference could have been in poor cold-chain-management of the suspect samples during falsification. This is because NDA did not identify any inlet of that vaccine into the country,” Aceng said.

Aceng said, cases of falsified vaccines are currently undergoing investigation, with one case already finished, which ended in a Shs 500,000 fine.

“NDA continues to work with the Uganda Police, on eight cases which are at various stages of investigation and court hearing,” she said.

The minister said that government is to suspend all private Hepatitis B vaccine camps, until they have been cleared.

“The ministry of Health suspended vaccination camps for Hepatitis B by private health providers. All private medical camps seeking to offer Hepatitis B vaccination must be cleared by the ministry of Health,” Aceng said.

She said, in order to improve the testing of vaccines, the NDA will advance the time on the construction of their own lab, as well as improve their presence on the borders.

“To reduce the infiltration of poor-quality medicines and health care products on the market, NDA is fast-tracking the establishment of its state-of-the-art microbiology laboratory that will significantly increase the scope of testing,” she said.

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