Petrovax Group receives MA for Grippol Neo, an innovative flu vaccine

On July 23rd, the registration procedure for Grippol Neo at the Federal Service for Surveillance in Healthcare and Social Development was completed. Petrovax Group, a Russian developer and manufacturer of innovative pharmaceuticals and vaccines, received Grippol Neo marketing authorization (No. LSR-006029/09) and manufacturing certificate. The creation of the first in the world subunit adjuvanted influenza vaccine is the result of successful cooperation between Russian Petrovax and Belgian Solvay.

Grippol Neo contains influenza virus antigens produced according to Solvay’s innovative cell technology, and Petrovax’s Polyoxidonium (an immunoadjuvant) due to which the antigen content has been reduced threefold. Polyoxidonium formulated into the vaccine provides for forming a stable immune response over 8–12 days without overstraining the immune system; that is why Grippol Neo vaccination is possible at the beginning of a flu epidemic as well. The new vaccine is preservative-free, and will be manufactured in disposable single-dose syringes at Petrovax Group’s state-of-the-art facility in Moscow region to the international GMP and ISO standards.

The cell antigen production technology is one of the vaccine safety guarantors as a pure lab cell culture is not contaminated with other microorganisms. Besides, given possible flu pandemics, the cell technology, unlike egg technology, provides for working up the required flu virus amount in the shortest time possible for subsequent vaccine formulation.

Previously, egg white allergy was a contraindication for flu vaccination. Grippol Neo removes this problem. This vaccine supplemented the Grippol vaccine family with a new efficacious medication, and preventive medicine received a new influenza management tool. At that, for the first time, influenza vaccination is permitted for those suffering from egg white allergy.

This medicinal product will become available on the Russian pharma market in epidemic season 2009–2010.

Petrovax Group also plans production of MonoGrippol Neo vaccine (a monovalent Grippol Neo analogue) against A/H1N1 virus. In August, Petrovax Group filed a MonoGrippol Neo Master File with the Federal Service for Surveillance in Healthcare and Social Development. Petrovax manufacturing facility in Moscow region (Pokrov village) provides for manufacturing 6 m MonoGrippol Neo doses a month.

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Petrovax Group made first vaccine shipments for National Priority Health Project