Nanolec: Phnemotex (Pneumococcal Vaccine)

Main article: Vaccines in Russia

2023: Results of clinical trials of a domestic vaccine for the prevention of pneumococcal disease

On March 21, 2023, Nanolek presented the results of clinical trials of a domestic vaccine for the prevention of pneumococcal infection. Its release in a full cycle is planned at a plant in the Kirov region. Clinical studies have shown that the vaccine has a favorable safety profile and has proven its immunogenicity.

According to the company, pneumococcal infection caused by the bacterium Streptococcus pneumoniae is a significant problem health care for due to the high pathogenicity of the pathogen and the potential for a severe course of the disease with complications leading to disability death and young children. According to information and, WHO Ministry of Health of the Russian federation pneumococcus more often than other infections leads to pneumonia and bacterial otitis in children under 5 years old, and infants most often die from diseases caused by this infection. In addition, pneumococcus is considered one of the causes of sinusitis and bacterial, meningitis and can also lead to. to sepsis

Several years ago, Nanolek, together with a Korean company specializing in the production of vaccines, started developing a vaccine against pneumococcal infection. As of March 2023, the Nanolek plant in the Kirov region launched the production of a domestic pneumococcal polysaccharide conjugated adsorbed thirteen-valent vaccine. Production is carried out according to GMP (Good Manufacturing Practice) and ISO (International Organization for Standardization) standards.

13-valent conjugate vaccine against pneumococcal infection is registered in the Russian Federation under the trade name "PNEMOTEKS" and can be used in adults and children from 2 months of age (marketing authorization LP-007205). Based on the compliance with the rules for determining the interchangeability of medicinal products for human use, approved by the Decree of the Government of the Russian Federation of September 5, 2020 No. 1360, the status of interchangeable reference medicinal products for the PNEMOTEX vaccine and the Prevenar 13 vaccine was obtained. Pfizer Inc. (registration number LP-000798) about which information is entered on the GRLS website in the updated list of interchangeable medicinal products from 7.11.2022, Appendix No. 1.

Phase 3 clinical studies have been completed for the drug, their results were discussed by leading experts in the field of vaccine prophylaxis at a scientific conference organized by Nanolek. The event was moderated by Doctor of Medical Sciences, Professor, Academician of the Russian Academy of Sciences, Chief Freelance Children's Specialist in Preventive Medicine of the Ministry of Health of Russia, President of the Union of Pediatricians of Russia Leila Namazova-Baranova.

Honored Scientist of the Russian Federation, Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Director of the Institute of Public Health named after F.F. Erisman, Head of the Department of Epidemiology and Evidence-Based Medicine of the FSAOU Nikolai Briko spoke about topical issues related to pneumococcal infection. This is, in particular, insufficient detection, the problem of antibiotic resistance, the refusal of parents from vaccine prophylaxis or failure to comply with the recommended immunization regimens. Nikolai Ivanovich noted that in a number of regions there is insufficient vaccination coverage for children to form population immunity and control diseases associated with Streptococcus pneumoniae. It is necessary to comply with the timely start of immunization of children against pneumococcal infection and the recommended vaccination scheme 2 + 1.

The head of the department for the prevention of infectious diseases of the FSBI "Children's Scientific and Clinical Center of Infectious Diseases" of the FMBA of Russia, Doctor of Medical Sciences, Professor Susanna Harit in her speech focused on clinical trials of phase III vaccine in adults and children, which were carried out on the territory. In Koreas adults, no less PKV13 efficacy was proven compared to the PPV23 vaccine, with the incidence of adverse events comparable between groups. As a result of the phase III study in children, the efficacy of PKV13 in comparison with the reference vaccine, with comparable immunogenicity and activity with respect to the formation of functional antibodies was proved to be not less than the safety parameters of the vaccine were also similar.

Irina Feldblum (Doctor of Medical Sciences, Professor, Head of the Department of Epidemiology, Perm State Medical University named after E.A. Wagner, Ministry of Health of Russia) spoke about the results obtained in clinical trials of the 3rd phase with the participation of adults in Russia. For a prospective, comparative, randomized, double-blind trial volunteers aged 18 to 65 years who had not previously received pneumococcal vaccine were selected. In the course of the study, no less immunological efficacy of PKV13 has been proven compared to the reference vaccine according to primary criterion - the proportion of participants with lgG concentration ≥ 0.35 μg/mL for each serotype, as well as by secondary immunogenicity criteria. Safety in both groups was comparable.

Olga Rychkova, Doctor of Medical Sciences, Associate Professor, Head of the Department of Infectious Diseases, Allergology and Immunology of the Federal State Budgetary Educational Institution of Higher Education of the Tyumen State Medical University of the Ministry of Health of the Russian Federation, Chief Allergist-Immunologist DZ TO O.A. Rychkova presented data that the study in children consisted of two stages: primary double vaccination of children aged 2 and 4.5 months and revaccination at 15 months of age. The results of the study demonstrated that immunization of children with pneumococcal vaccines according to the 2 + 1 scheme regulated by the NKPP of the Russian Federation allows you to achieve the necessary immune response. Pneumococcal polysaccharide conjugated adsorbed thirteen-valent vaccine showed no less immunogenicity for all 13 serotypes with respect to the reference vaccine by primary and secondary immunogenicity criteria. According to the results of the phase 3 study in children, PKV13 has a high  safety profile comparable to the comparator. This study proved the immunological efficacy and safety of PKV13 for the prevention of pneumococcal infectious diseases in children from 2 months.

The Nanolek company is ready to provide vaccine supplies to the National Calendar of Preventive Vaccinations, it will be available for citizens RUSSIAN FEDERATION free of charge. The presence of this vaccine will ensure states the stability of supplies and confidence that residents of Russia will be provided with the drug. told Maxim Stetsyuk, First Deputy General Director of Nanolek

In Russia, vaccination against pneumococcal infection has been included in the National Calendar of Preventive Vaccinations (NCPP) since 2014, it is vaccinated children aged 2, 4.5 and 15 months. In addition, vaccination against pneumococcal infection is included in the Calendar of preventive vaccinations for epidemic indications for children aged 2 to 5 years and adults belonging to risk groups. Today, in 168 countries of the world, vaccination against pneumococcal infection is included in national immunization programs. Italian study conducted among 6,680 person, shows that among people of different ages vaccinated against pneumococcal infection and influenza, the percentage of cases COVID-19 is much less.