The Russian Ministry of Health issued an authorization for NPO Petrovax Pharm LLC for a
full-cycle
manufacturing of
13-valent
conjugated pneumococcal vaccine Prevenar® 13, including preparation of a finished dosage form (formulation), primary packaging (filling into disposable syringes), secondary packaging, and release quality control. On August 11, 2015, relevant changes were made to Prevenar® 13 MA No.
LP-000798
of
03.10.2011
. This officially marked the completion of a
full-cycle
manufacturing technology transfer fr om Pfizer.
Elena Arkhangelskyaya, Petrovax Pharm President: «For the Russian pharma industry, this is the first
full-cycle
manufacturing localization project for an immunobiological agent, including transfer of all control methods. An official confirmation by the Russian Ministry of Health is a
well-deserved
recognition of Petrovax Pharm’s high manufacturing standards and professional level. The Russian manufacturer status in respect of this vaccine opens for us new
long-term
prospects of project development and cooperation with international partners. Importantly, along with more than 100 countries wh ere Prevenar® 13 is used, the Russian population also has access to this innovative pneumococcal vaccine manufactured at a local facility."
Danil Blinov, General Manager Pfizer Russia: «We sincerely believe that transfer to the Russian manufacturer of a
full-cycle
manufacturing technology for an innovative pneumococcal vaccine within the framework of the MORE THAN strategy will help provide the Russians with
high-quality
, state-
of-the-art
, and affordable drugs for immunization against dangerous diseases, and will promote the development of advanced technologies used by Russian manufacturers to produce innovative drugs."
About the project
In March 2011, Petrovax Pharm and Pfizer, the PCV13 developer, signed an agreement on the start of cooperation for manufacturing a
13-valent
conjugated pneumococcal vaccine in Russia. The project implementation in 4 years required substantial investment, and marked the companies’ contribution into execution of the tasks outlined in the
Pharma-2020
Strategy as well as the state public health and pharmaceutical programs.
During the project execution, unique equipment was installed at Petrovax Pharm manufacturing site as well as a Quality Assurance System, and quality control methods were implemented that were in line with the best standards of the world biopharmaceutical industry. For the first time in Russia, a
high-efficacy
automated formulation monitoring system RDM (Rapid Deployment Module) was used; the manufacture complies with the national and international GMP standards. In the technology transfer process, more than 55 Petrovax Pharm employees were trained; 25 additional jobs for highly skilled personnel were created. Petrovax Pharm production capacities provide for covering 100% of the state demand for pneumococcal vaccine within the framework of the existing immunization programs, and responding quickly to any extra demand, including on a quarterly basis. Presently, Prevenar® 13 is used in more than 100 countries, and only four countries manufacture finished dosage forms using a
full-cycle
technology, namely, USA and Ireland (Pfizer’s own facilities), Turkey and Russia (localized projects).
Aboutpneumococcalinfection
Pneumococcal infection is the cause of most severe pneumonia, sepsis, meningitis, and otitis cases. It is especially dangerous for subjects with compromised immunity. According to the WHO, pneumonia is one of the
top-ranking
death causes on the world scale: in 2012, it claimed 3.1 million people1. In Russia, pneumonias rank first among infectious disease fatal cases, and sixth among the total lethality causes2, thus significantly affecting
all-cause
mortality.
The WHO recommends vaccination as the most efficacious way of preventing infectious diseases, including pneumococcal infections3. More than 100 countries included pneumococcal vaccination into their national immunization schedules; at that, more than 85% of such countries use a
13-valent
pneumococcal vaccine. In Russia, pneumococcal vaccination has been on the National Immunization Schedule since 2014.
AboutPCV13
To immunize the population within the framework of the National Immunization Schedule, the Ministry of Health of the Russian Federation purchased
13-valent
pneumococcal vaccine Prevenar® 13 that covered maximum of the serotypes relevant for this country among conjugated vaccines4,5.
Pharmacoeconomic studies suggest that avoided costs associated with treatment of pneumococcal infections over 10 years after the initiation of mass immunization of children aged 1 to 3 years using the
13-valent
pneumococcal vaccine in Russia will amount to 58.5 bn rubles6.
In late 2014, in Russia, the
13-valent
conjugated pneumococcal vaccine was awarded Prix Galien Russia as the best biotechnological product7.
This vaccine is manufactured by Petrovax Pharm in Moscow region at a state-
of-the-art
facility to the GMP standards using the technology transferred by Pfizer.
Petrovax Pharm: background information
NPO Petrovax Pharm LLCis a Russian developer and manufacturer of innovative pharmaceuticals and vaccines. The company was founded in 1996 by a team of Russian scientists to develop, manufacture, and implement original pharmaceuticals into health practice.
The company’s key focus areas are manufacturing of influenza and pneumococcal vaccines for the National Immunization Schedule as well as the development and production of immunobiological products.
Petrovax Pharm’s production and warehousing complex located in Podolsk district of Moscow region is one of the most advanced and
high-tech
full-cycle
biopharmaceutical facilities in Russia. It has GMP EU and ISO:9001 certificates of conformity.
Petrovax Pharm has more than 600 employees. The facility’s controlling interest is owned by Vladimir Potanin’s company. Mr. Potanin is Interros Group founder and owner.
For more details, please go to www.petrovax.ru
For detailed information on Pfizer, please go to www.pfizer.com and www.pfizer.ru.
1World Health Organization (WHO). Media centre: The top 10 causes of death. Fact sheet N°310. Updated May 2014. http://who.int/mediacentre/factsheets/fs310/en/
2Хамитов Р.Ф., Визель А.А., Амиров Н.Б. и др. Клинические рекомендации по диагностике и лечению внебольничных пневмоний у взрослых. Казань 2011.
3World Health Organization (WHO). 10 facts on immunization. April 2012. http://www.who.int/features/factfiles/immunization/en/index.html
4Резолюция заседания общественного Координационного совета по пневмококковой инфекции и вакцинации в России. Педиатрическая фармакология 2013/ 6/с.90–100
5Брико
Н. И. Бремя
пневмококковых инфекций и направления совершенствования эпидемического надзора в России. Эпидемиология и инфекционные болезни. Актуальные вопросы 6/2013/c.55–59
6
А. В. Рудакова
,
А. А. Баранов
,
Ю. В. Лобзин
. Фармакоэкономические аспекты вакцинации детей
13-валентной
пневмококковой конъюгированной вакциной в Российской Федерации. Вопросы современной педиатрии 2014/ 1/с.34–41
7
http://prixgalienrussia.com/otborochnyiy-komitet-premii-prix-galien-russia-2014-nagradil-pyat-laureatov-vo-
vremya-torzhestvennoy-tseremonii
