Doing the best to fight pneumococcus: the experience of organization of Russian production of innovative vaccines for National vaccination schedule
On the eve of the World Pneumonia Day, Petrovax Pharm informed about many years of experience in fighting against pneumococcal infection. The localization of the full production cycle of the high-tech pneumococcal vaccine FDF[1] allows supplying the required doses number for wide use within the National vaccination schedule to protect children from pneumococcal infection and decrease infant mortality rate from pneumonia.
Pneumonia is an acute respiratory infection that causes damage of the lung tissue. It can develop at any age, but the most vulnerable groups are young children (under 5 years of age), patients with chronic diseases, and adults over 65 years of age[2] . According to WHO statistics, pneumonia is the cause of death in 14% of children under the 5 years of age[3]. The most common causative disease agent is the bacterium Streptococcus pneumoniae[4].
Vaccine prevention is the most effective way to fight pneumococcal infection. It is the reason why Petrovax Pharm and Pfizer biopharmaceutical companies have entered into an agreement to start cooperation in the production of a full-cycle finished dosage form (FDF) of a 13-valent pneumococcal conjugated vaccine at the manufacturing unit of Petrovax Pharm in the Moscow region in 2011. The vaccine has been used successfully in 126 states for more than 10 years, and its inclusion in childhood immunization programs allowed to prevent 175.2 million cases and 625,000 deaths worldwide[5]. The project became a pilot in the field of import substitution of vaccines in Russia and showed that the production of one of the most complex immunobiological drugs at a local enterprise can be successful.
Larisa Dukhina, Director of the Petrovax Pharm manufacturing complex: «Implementation of the project is a real-world evidence of the international cooperation in the field of technology transfer and providing patients with socially significant drugs. Within the project, the technology for the full-cycle FDF vaccine production in accordance with GMP standards was transferred and a large-scale production was fully established. For the Russian pharmaceutical industry, this project was the first one in the field of import substitution of high-tech vaccines, that made possible to localize the production of one of the most complex immunobiological drugs. The amount of joint investments in production exceeded RUB 1 billion».
During the project implementation, a unique equipment was installed at the Petrovax Pharm manufacturing site, a quality assurance system and quality control methods were introduced that meet all the standards of the global biopharmaceutical industry. All production stages are carried out at the plant including the preparation of the finished dosage form (formulation), primary packaging (filling into disposable syringes), secondary packaging and batch release (for the full cycle, each batch of vaccine passes more than 3,500 different quality control tests).
Since 2014, the 13-valent pneumococcal conjugated vaccine has been supplied for the National vaccination schedule of the Russian Federation (NVS of RF). The cumulative supply amount for the NVS of RF for 8 years amounted to more than 30 million doses. During this period, significant results were achieved in decreasing of mortality rate from pneumonia among infants: compared with the pre-vaccination period, infant mortality rate decreased by 56%[6], the 55% epidemiological immunization efficiency against pneumococcal infection was shown related to the community-acquired pneumonia of any etiology in infants vaccinated in a time at the first year of life[7].
Larisa Dukhina, Director of the Petrovax Pharm manufacturing complex: «Our vaccine has been successfully used for many years to prevent pneumococcal infection in patients from the age of 2 months. It includes up to 90% of serotypes that cause invasive pneumococcal infections, i.a. resistant to antibiotic treatment, and is successfully used in real clinical practice in infants and in people with chronic pathology and immune disorders »[8].
About Petrovax
Petrovax is a Russian full-cycle biotechnological company with 25 years of successful experience in the pharmaceutical market. The product portfolio includes original pharmaceutical products, contract medicines and food supplements. The company has its own research and development center and an investment program for R&D; it is the patent holder in Russia and abroad for molecules and production techniques. The modern manufacturing unit for the production of substances and finished dosage forms in the Moscow Region operates in accordance with EAEU and EU GMP standards. Petrovax is one of the largest exporters of influenza vaccines and original pharmaceutical products, the drugs are supplied to the EAEU states, Middle East and EU. The company’s supply area includes 12 states. Petrovax partners are leading international pharmaceutical companies, such as: Pfizer, Abbott, Boehringer Ingelheim, ISU ABXIS. The company’s investment strategy is aimed at the development, production advance, and the medicines and vaccines import substitution that are used for the treatment of socially significant diseases, such as oncological, autoimmune, infectious and orphan diseases.
1ГЛФ – готовая лекарственная форма.
2
3Pneumonia.
4
5Horn E.K. et al. Public health impact of pneumococcal conjugate vaccination: a review of measurement challenges // Expert Rev Vaccines. 2021 Oct; 20 (10): 1291–1309. doi: 10.1080/14760584.2021.1971521
6По данным Росстата.
7Сомова А.В., Романенко В.В., Голубкова А.А. Эпидемиология S. pneumoniae-ассоциированных пневмоний и анализ эффективности вакцинации против пневмококковой инфекции у детей до 6 лет // Эпидемиология и Вакцинопрофилактика. 2018. № 1 (98).
8Вакцинация для всех: простые ответы на непростые вопросы [Текст] : руководство для врачей / С.В. Ильина, Л.С. Намазова-Баранова, А.А. Баранов ; Союз педиатров России. — Москва : Педиатръ, 2016. — 203 с. : цв. ил., портр.; 19 см.; ISBN 978-5-906332-46-2 : 40000 экз. — С.158–159.
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