Petrovax Group was issued MA’s for two influenza A/H1N1 vaccines

On October 16th, Petrovax Group, a Russian innovative vaccine and pharmaceutical developer and manufacturer, was issued marketing authorizations for MonoGrippol Neo and MonoGrippol vaccines. MonoGrippol Neo and MonoGrippol are new-generation preservative-free inactivated subunit adjuvant vaccines targeting highly pathogenic influenza virus A/H1N1 that fully conform to the WHO requirements. These vaccines contain immunoadjuvant Polyoxidonium.

MonoGrippol Neo was developed based on an innovative cell technology for antigen development. MonoGrippol is a monovalent analogue of widely known seasonal influenza vaccine Grippol.

In early October 2009, clinical trials were initiated at the sites of the Research Institute of Children’s Infections and I.P. Pavlov State Medical University (both St. Petersburg) to study the vaccines’ safety and efficacy. The study procedure included a double immunization of each of the two volunteer groups, 60 and 90 subjects, respectively.

On October 16th, the preclinical and clinical files were submitted to the Russian Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor). The clinical trial data in adults is indicative of good tolerability, safety, and absence of reactogenicity of both vaccines. Following Roszdravnadzor’s inspections, MonoGrippol Neo and MonoGrippol were issued marketing authorizations.

MonoGrippol Neo will be manufactured preservative-free in disposable single-dose syringes to international GMP standards at one of Petrovax Group sites in Moscow region.

MonoGrippol will be manufactured by FSUE Research Institute of Vaccines & Sera and Bacteriologicals Enterprise.