Disputed batches of BCG (BSŽ) vaccines from the Institute of Virology, Torlak vaccines and serums have been withdrawn from the Montenegrin market, "Vijesti" has learned unofficially.
It is a vaccine against tuberculosis, which newborns receive when they are discharged from the maternity hospital.
The Montenegrin Institute for Medicines and Medical Devices (CINMED) replied to "Vijesta" that the vaccine was not registered in Montenegro, however, their import was approved in accordance with the Law on Medicines in order to ensure adequate vaccination.
"In the specific case, the Institute approved the mentioned series of BCG vaccine based on the assessment of the submitted documentation, which proved that the vaccine meets the prescribed standards in terms of quality, safety and efficiency. The mentioned documentation, among other things, includes two certificates on the quality control of the medicine - Certificate of analysis of the manufacturer of the drug and the Certificate of Analysis issued by the National Control Laboratory of the Agency for Medicines and Medical Devices of Serbia, which is a member of the European network of official control laboratories for the testing of drugs," reads CINMED's response.
This institution explained that subsequent routine tests carried out by the manufacturer determined that there is a possibility of a potential deviation of the number of live, attenuated bacteria Bacillus Calmette-Guerin (Mycobacterium bovis BCG) compared to the declared number.
"Accordingly, the expected immune response may be incomplete in an extremely small number of patients (newborns, children and adults at high risk for developing tuberculosis). For this reason, the said batches of the vaccine have been withdrawn, bearing in mind that the manufacturer is obliged to carry out the recall procedure drug from circulation, even though it is a question of suspected malfunction that cannot cause serious consequences for human health," reads CINMED's response.
According to unofficial information, the controversial series of vaccines was withdrawn at the end of last week by "Montefarm" - in charge of supplying public health institutions with medicines and medical devices.
This was confirmed today by Montefarma.
"On the same day, March 15.03.2023, 15.03.2023, the official importer of the vaccine BCG-Glosarij doo, after receiving from Torlak an urgent recall of the disputed batch that was imported into Montenegro, forwarded the same to Montefarm as the distributor of the said vaccine. Acting on the said notification, MONTEFARM on the same day, therefore, on March XNUMX, XNUMX, first verbally, and then by e-mail, he notified all PHCs where immunization is carried out to immediately withdraw the disputed batch from use and return it to our warehouse, which was done," the Montefarma press release states.
Torlak: Babies receive safe vaccines
The Institute for Virology, Vaccines and Serums "Torlak" announced that due to a minimal deviation from the drug's specification, one batch of BSŽ vaccine was withdrawn and replaced by another, Radio Television of Serbia announced.
The vaccines were withdrawn on March 16, 834 vials. The series was withdrawn and replaced by another within 24 hours, stated Torlak and pointed out that babies in maternity hospitals receive proven and safe vaccines. transmissions H1.
"Caring for the safety and health of the population of Serbia, the Torlak institute, as a national, responsible manufacturer and license holder for the drug 'BCG vaccine, lyophilized', due to minimal deviation from the strict requirements of the drug specification, made the decision to voluntarily withdraw batch number 2710822 from circulation from the territory of the whole country", the announcement states.
The Ministry of Health previously announced that "Torlak", as soon as there was the slightest suspicion of a deviation from the specification requirements of that vaccine, reacted preventively and withdrew batch number 2710822 from circulation.
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