Information on quality non-compliance for “Specific Safety” of DTP vaccine, U34 batch by FSUI NPO Microgen, Russian Ministry of Health, withdrawn from circulation, which was published this September, is found to be wrong. Random control data for samples taken from the State Budgetary Healthcare Institution of Kaliningrad Region “Municipal Children Polyclinic No 2”, Kaliningrad, received by the expert organization Federal State Budgetary Institution Information-Methodological Center for Expertise, Accounting and Analysis of Circulation of Medicinal Drugs, Roszdravnadzor (Krasnoyarsk Affiliate) did not confirm the information.
NPO Microgen performed analysis of Dossier for the batch of product and in-house quality control of archive samples of the vaccine of the batch for “specific safety” at a laboratory of the institution in Ufa, as provisioned by Clause 38 of the Federal Law of 27.12.2002 N 1 84-FZ “On Technical Regulation”. Currently an independent expert evaluation of the quality of archive samples of DTP vaccine, batch U34 is being performed. Its results will be submitted to Roszdravnadzor in November.
Currently the condition of infants immunized with the above-mentioned vaccine of U34 batch is followed-bup by Roszdravnadzor and “National Immunobiological Company”. No cases of adverse events were reported, as confirmed by Igor Nikitin, Doctor of Medicine, Nacimbio Adviser to general director on science.
To avoid such problems in the near future, a national center of standardization and metrology of pharmacopoeia analysis is expected to open. It will become a scientific and laboratory base for cetification and manufacture of samples for drug quality control, and a laboratory benchmark center for quality control of all drugs, manufactured or supplied by Nacimbio. Additionally, the holding will establish a large logistics center, which will supply vaccines and other immunobiological products within the cold chain to the remotest regions of Russia.