Fake Hepatitis B vaccine not harmful - minister

The phony hepatitis B vaccines that were previously found in various health centers across the country pose no health risks, said the Department of Health.

During the routine monitoring in Mbarara in March of this year, the National Drug Authority (NDA) collected about 48 ampoules of suspected hepatitis B vaccines from different health centers. The discovery led to a series of investigations in at least 18 drug shops in West and Central Uganda.

Yesterday, the Minister of Health published Dr. Jane Ruth Aceng's research findings that the counterfeit hepatitis B vaccines were subjected to tests and did not appear to be harmful to the recipients.

"Chemical tests performed on both samples (authentic and false vaccines) found no harmful active pharmaceutical ingredient that would be harmful to the recipient, and additional field monitoring did not confirm adverse drug reaction," said Aceng.

Aceng said the NDA has endeavored to monitor any side-effects of the counterfeit vaccines, as well as those reported by the media, but so far none have been found.

"The NDA has made efforts to monitor the side effects in those who received the counterfeit vaccines, but none of them have been reported and identified, and other events reported in the media were examined by NDA and were not related to the vaccine. "said Aceng.

Aceng also said that the potency levels in the false hepatitis B vaccine were reduced, which means that it may not have produced effective immunization.

"Given the reduced potency levels observed in the counterfeit samples, the counterfeit vaccine may not have generated the expected immune response that is protective against Hepatitis B infection for those who have received this vaccine," she said.

Aceng said the counterfeit vaccines had agreements with government-issued vaccines manufactured by the Serum Institute of India, which led the government to believe that the vaccines had been stolen and were not manufactured.

"Given the similarities, we believe that the forged Hepatitis B vaccine was government-issued vaccine and was likely to be diverted or stolen for sale to private health facilities," Aceng said.

She said that one of the differences in the vaccines was the labeling details, which had been deliberately altered.

"However, there was some variation in labeling and related details, such as batch numbers, expiration date, color and design schedule." There was also a deliberate attempt to obtain the inscription from "Government of Uganda, not for sale, just for public use". erase, "she said.

Aceng added that the lower potency in the counterfeit vaccines is most likely due to incorrect storage by the perpetrators, because no other comparable vaccines have come to the country.

"Although the active substance 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 management of the cold chain of the suspected samples during forgery. This is because NDA has not identified any single vaccine intake in the country, "said Aceng.

Aceng said, cases of counterfeit vaccines are currently under investigation, with one case already being completed and ending in a Shs 500,000 fine.

"NDA continues to work with the Ugandan police on eight cases that are at different stages of investigation and trial," she said.

The minister said the government should suspend all private vaccine camps with hepatitis B until they have been released.

"The Ministry of Health has suspended vaccination camps for hepatitis B by private caregivers, and all private medical camps that want to offer Hepatitis B vaccination must be released by the Ministry of Health," Aceng said.

She said the NDA, in order to improve vaccine testing, will spend time building their own laboratory and improving their presence at the borders.

"In order to reduce the infiltration of poor quality medicines and healthcare products to the market, NDA is quickly following the establishment of its state-of-the-art laboratory for microbiology, which will significantly increase the range of testing," she said.


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