Nacimbio presents its new products at the international conference

Nacimbio (part of Rostec Corporation) presented to the scientific community the results of the study of epidemiological efficacy of the flu vaccines manufactured by the enterprises of the holding company.

NPO Microgen, a part of Nacimbio Holding Company, has successfully completed Phase 1 clinical trials of Microsplit, a new preventive medication which is an inactivated split vaccine containing both the virus surface and internal antigens.

“In Phase 1 trials, Microsplit demonstrated good results, the vaccine has low reactogenicity and good tolerability. There was also preliminary data on immunogenicity of the vaccine, which meets the requirements of the Russian Federation and EU for the efficacy of inactivated flu vaccines,” said Denis Trofimov, the Deputy Head of Registration and Medical Research Department at NPO Microgen, a Federal State Unitary Enterprise of the Russian Ministry of Health.

Ultrix, a flu vaccine manufactured in Russia by Fort, a part of Nacimbio Holding Company, is produced in compliance with GMP requirements and standards. This is the only vaccine supplied under the National Immunization Calendar and containing 45 μg of hemagglutinin per dose. It does not contain any preservatives and adjuvants. The medicine went through all phases of preclinical and clinical trials, which revealed its high immunogenicity, safety, good tolerability, and low reactogenicity when it is used for immunization.

Sovigripp, a flu prevention vaccine manufactured by NPO Microgen, is used for annual preventive immunization against seasonal flu. Both vaccines are approved for immunization of children aged six months and older, pregnant women during the first or second trimesters of pregnancy, adolescents and adults without age restriction.

SOURCE: gmpnews.ru
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