The new drug will be fully made by a plant in Perm

Photo: Rostec State Corporation

Nacimbio holding has created Russia’s first combined diphtheria, tetanus and pertussis vaccine for adults. Clinical studies confirmed high safety and efficacy profile of the vaccine. Drug master file was submitted to the Ministry of Health of the Russian Federation for marketing authorization in accordance with the EAEU regulations. 

The aAKDS-M vaccine contains reduced amounts of diphtheria and tetanus toxoids, and an acellular pertussis component. Due to this, the drug may be used as a booster shot for adults over the age of eighteen.

Clinical studies of the new vaccine were conducted at ten Russian research centers with participation of 436 volunteers 18 years of age to 60 years of age. Most participants developed a protective antibody titer to diphtheria, tetanus and pertussis. All volunteers showed only good and very good vaccine tolerance.

WHO currently recommends both acellular and whole cell vaccines as the main means of pertussis prevention. Whole cell vaccines are produced in Russia at Nacimbio’s Microgen facilities and has been used for many years for vaccination of children in accordance with the National Immunization Schedule.

The new vaccine will extend the company’s range of TDaP-containing drugs and will be used for vaccination not only of children, but also of adults. Such extended vaccination coverage will significantly reduce morbidity of pertussis in all age groups.