The First Russian Microgen’s Pentavalent Vaccine Approval
The first domestic pentavalent vaccine for the prevention of diphtheria, tetanus, whooping cough, hepatitis B and hemophilic infection on the principle of “5-in-1 shot” was approved by the Ministry of Health of the Russian Federation according to the results of clinical trials. The vaccine was developed by SPA Microgen, Naсimbio holding, Rostec State Corporation, and is intended for children aged 6 months.
In the course of the clinical trials, the safety and efficacy of DTaP–HepB + Hib vaccine in the prevention of five “childhood” infections have been proven. Among these parameters, the new product is not inferior to foreign analogues. Previously, for vaccination from these diseases it was required to make several shots. Now, with the appearance of a new Russian product on the market, only one is required. The acellular pertussis component will allow to vaccinate children with chronic diseases.
The inclusion of a new vaccine in the National Immunization Calendar will reduce the stress for infants and the number of visits. In addition, switching to polyvalent vaccines will create opportunities for optimizing the Immunization Calendar and coverage of a larger number of children, including those with contraindications to the whole-cell vaccine. The pentavalent vaccine will be manufactured in Russia using full cycle technology.