The vaccine was vaccinated on Russian soil
Production of 13-valent pneumococcal vaccine according to GMP standards has been established in Russia
Nadezhda Markina, Newspaper.RuCorrespondent of "Gazeta.
Ru" studied an example of the organization of local production, which will allow Russians not to depend on imported pharmaceuticals: this is the production of a 13-valent pneumococcal vaccine, for the development of which in 2011 was awarded the equivalent of the Nobel Prize in biopharmaceutics – the Galen Prize.
Killer number oneThe vaccine against pneumococcal infection is relatively new for our country, but since 2014 it has been included in the National Calendar of Preventive Vaccinations in Russia.
In just five years of its application, more than 50 thousand children in 49 regions have been vaccinated in our country. Of these, 9 thousand children received a new innovative 13-valetny vaccine PKV 13 as part of the first mass immunization project in St. Petersburg, 2.7 thousand children received a second routine vaccination.
The pneumococcal vaccine works not only against pneumonia, as can be understood from its name. It is directed against pneumococcal streptococcus, which is one of the most common pathogens in the world. These are pneumonia, pneumococcal meningitis, sepsis, otitis media. According to WHO, more than 1.6 million people die from these diseases every year. In 2013, WHO named pneumococcal infection the number one killer in the world. The main risk groups are children and the elderly.
In Russia, according to Rospotrebnadzor, 500 thousand people fall ill with pneumonia every year; 34% of sick children under 5 years of age, 60% of adults over 65 years of age will die from pneumococcal meningitis. Experts estimate the burden of pneumococcal infection in children under 5 years of age in Russia at 11.2 billion rubles, which is comparable to the cost of 57 kindergartens. According to their calculations, prevention of pneumococcal vaccine within ten years will lead to savings of 58,468 billion rubles.
"Pneumococcal infection makes a huge contribution to the number one problem in healthcare – antibiotic resistance," emphasizes Ph.D. Fatima Abazova. – And vaccination is the solution to this problem."
Award for 13 valences
In 2000, the first conjugated 7-valent pneumococcal vaccine appeared. A conjugated vaccine is called if an antigen (in the case of pneumococcus, it is a polysaccharide of the bacterial envelope) is combined with a protein to enhance the immune response. Valence is the number of bacterial types, serotypes, against which the vaccine is directed. Pneumococcus is characterized by a huge number of serotypes. The 7-valent vaccine carries antigens of seven serotypes, which means it protects against seven varieties of pneumococcus.
"Thanks to its use in the world, the population effect of vaccination has been proven," says Fatima Abazova. "Morbidity and mortality have decreased even in those people who have not been vaccinated."
As a result, a 13-valent pneumococcal vaccine (PCV 13) was synthesized, which in 2011 was awarded the Galena Prize – the highest world award in the field of medical, pharmaceutical and biotechnological research.
This prize is considered a "medical Nobel". The vaccine carries 13 antigens, which means it can protect against 13 pneumococcal serotypes.
To date, 78 countries have included PCV 13 in the national vaccination calendar. Epidemiological studies in Russia have shown that PCV 13 covers up to 76% of pneumococcal serotypes that cause meningitis in children under 5 years of age, up to 71.4% – severe pneumonia, up to 91.6% – otitis media.
We produce the vaccine ourselvesA local manufacturer of pneumococcal vaccine using the Galen Award-winning technology has appeared on the territory of Russia.
The production is built according to GMP (Good Manufacturing Practice) standards, which is a piece phenomenon for our country. These standards ensure the reliable required quality of the product, including absolutely sterile conditions for the manufacture of the vaccine.
The creators of PCV 13 are Pfizer. On the territory of Russia, the vaccine is produced by Petrovax Pharm (part of the Interros Group).
The manufacturing process begins with the formulation, that is, mixing of the active components – 13 antigens and conjugate. This process is controlled by a special RDM (Rapid Deployment Module) – an automatic system that is being used for the first time in Russia. The work of RDM is the "holy of holies", it is located in the cleanest production area, where journalists, even dressed in sterile overalls, are not allowed to enter.
Correspondent of "Gazeta.Ru" saw with my own eyes how the finished substance is poured into special syringes (this also happened in a sterile room, behind glass). And in the main hall there is an automatic production line, on which all subsequent operations are performed. The filled syringes coming through the conveyor are supplied with pistons, a special system checks their quality, another machine puts syringes and needles into containers, containers are placed in a box, date and other packaging information are stamped on the box, the boxes are assembled into packaging blocks. And in this form, the finished products come off the assembly line. The production capacity of such a line is 80 million doses of vaccine per year.
This is what PKV 13 looks like
The work of the conveyor line is watched by operators in overalls and with "earplugs" – it is very noisy in the production hall. But this is probably the only harm that employees of the enterprise face. Most importantly, working in a "clean" zone obliges you to strictly follow the rules of GMP production.
Technology transfer, experts emphasize, is a very complex process, it is necessary not only to install equipment, but also to provide control methods. It is necessary to have highly qualified personnel to work, which means to train and prepare people.
The presence of a local manufacturer makes an innovative pneumococcal vaccine available to Russians. The production covers 100% of the country's needs for this drug.
Portal "Eternal youth" http://vechnayamolodost.ru17.04.2014