Moscow, March 21, 2023. The Russian biopharmaceutical company Nanolek has presented the results of clinical trials for a domestic vaccine to prevent pneumococcal infections. Full-cycle production of it is planned at a plant in the Kirov Region. Clinical studies have shown that the vaccine possesses a favorable safety profile and have proven its immunogenicity.
Pneumococcal infections caused by Streptococcus pneumoniae bacteria are a significant problem for healthcare because of the pathogen's high pathogenicity and the potential for a severe course of the disease with complications leading to disability and death in young children. According to the World Health Organization and the Russian Ministry of Health, pneumococcus more often than other infections leads to pneumonia and bacterial otitis media in children under the age of 5, and infants most often die from diseases caused by this infection. Pneumococcus is additionally considered one of the causes of sinusitis and bacterial meningitis, and can also lead to sepsis.
Several years ago Nanolek took up the development of a vaccine against pneumococcal infections alongside a Korean company specializing in the production of vaccines. The production of a new domestic pneumococcal polysaccharide conjugate vaccine (thirteen-valent, adsorbed) has been launched at a Nanolek plant in the Kirov Region. Production is carried out according to GMP (Good Manufacturing Practice) and ISO (International Organization for Standardization) standards.
The new 13-valent pneumococcal conjugate vaccine has been registered in the Russian Federation under the commercial name PNEMOTEX® and can be used in adults and children from 2 months of age and older (registration certificate number LP-007205). Based upon compliance with the rules determining the interchangeability of medicinal products for medical use, approved by decree N 1360 of the Government of the Russian Federation dated September 5, 2020, the status of interchangeable reference medicinal products for the vaccine PNEMOTEX® and the vaccine Prevenar® 13, Pfizer Inc., (registration number LP-000798) was obtained. Information concerning the former was entered on the website of the State Register of Medicines (GRLS) in the updated list of interchangeable drugs dated November 7, 2022, Appendix No. 1.
Phase 3 clinical trials have been completed on the drug, with their results discussed by leading experts in the field of vaccines at a scientific conference organized by Nanolek. The event was moderated by Leyla Namazova-Baranova, MD, professor, member of the Russian Academy of Sciences, chief freelance children's specialist in preventive medicine at the Russian Ministry of Health, and president of the Union of Pediatricians of Russia.
Nikolai Briko, honored scientist of the Russian Federation, member of the Russian Academy of Sciences, MD, professor, director of the F.F. Erisman Institute of Public Health, and head of the Department of Epidemiology and Evidence-Based Medicine, spoke about topical issues regarding pneumococcal infections. Particularly about insufficient detection, the issue of antibiotic resistance, parents' refusal to vaccinate or failure to comply with recommended immunization regimens. Nikolai Ivanovich noted that in a number of regions there is insufficient vaccination coverage of children to form population immunity and control over diseases associated with Streptococcus pneumoniae. It is necessary to adhere to the start of immunization of children against pneumococcal infections and the recommended 2 + 1 vaccination schedule in a timely manner.
**Susanna Harit **(head of the Department for the Prevention of Infectious Diseases, FSBI "Children's Scientific and Clinical Center for Infectious Diseases" at the Federal Medical-Biological Agency of Russia, MD, and professor) in her speech focused on Phase 3 clinical trials of a new vaccine for adults and children conducted in Korea. PCV13 has been shown to be no less effective than PPV23 in adults, with comparable rates of adverse events between groups. PCV13 proved to be no less effective than the reference vaccine in terms of results in a Phase 3 study in children, with comparable immunogenicity and activity concerning the formation of functional antibodies. The safety parameters of the vaccines were also similar.
Irina Feldblum (MD, professor, head of the Department of Epidemiology at Academician E.A. Wagner Perm State Medical University of the Russian Ministry of Health) spoke about the results obtained in Phase 3 clinical studies involving adults in Russia. Volunteers aged 18 to 65 who had not previously received a pneumococcal vaccine were selected for a prospective comparative randomized double-blind study. The study proved no less immunological efficacy for PCV13 when compared to the reference vaccine in terms of the primary criterion - the proportion of participants with a concentration of lgG ≥ 0.35 μg/ml for each serotype, as well as the secondary criteria, immunogenicity. Safety in both groups was comparable.
Olga Rychkova (MD, professor, head of the Department of Infectious Diseases, Allergology, and Immunology at Tyumen State Medical University of the Russian Ministry of Health, chief allergist-immunologist at the Tyumen Region Health Department) spoke about the results of a Phase 3 clinical study among children. Olga Rychkova reported that the study in children consisted of two stages: primary double vaccination of children ages 2 and 4.5 months and revaccination at 15 months of age. The results of the study showed that the immunization of children with pneumococcal vaccines per the 2 + 1 schedule regulated by the Russian National Immunization Calendar allows the necessary immune response to be achieved. The pneumococcal polysaccharide conjugate vaccine (thirteen-valent, adsorbed) demonstrated no less immunogenicity for all 13 serotypes when compared to the reference vaccine according to both the primary and secondary criteria for assessing immunogenicity. As per the results of the Phase 3 study in children, the new PCV13 has a high safety profile versus the comparison drug. This study proved the immunological efficacy and safety of the new PCV13 for the prevention of pneumococcal diseases in children ages 2 months and older.
_"Nanolek is ready to supply the vaccine to the National Immunization Calendar, it will be available to citizens of the Russian Federation free of charge. The vaccine's availability will ensure the stability of supplies and the state's confidence that the people of Russia will be provided with the drug," said Nanolek First Deputy General Director** Maxim Stetsyuk**. _
Vaccination against pneumococcal infections has been part of the National Immunization Calendar (NIC) in Russia since 2014. Children ages 2, 4.5, and 15 months are vaccinated with it. Vaccination against pneumococcal infections is also included in the Calendar of Preventive Immunization according to epidemic indications for children 2 to 5 years of age and at-risk adults. Today, vaccination against pneumococcal infections is part of the national immunization programs of 168 countries around the world. An Italian study conducted among 6,680 people shows the percentage of cases of COVID-19 is significantly lower among individuals of different ages vaccinated against pneumococcal infections and influenza.
Nanolek is a modern biopharmaceutical company founded in 2011. It specializes in the production of import-substituting and innovative medicines. The firm is one of the leading producers of pediatric vaccines in Russia. In addition to vaccines, its portfolio includes medications to treat HIV, oncological and orphan (rare) diseases.
Because of the localization of the vaccines PENTAXIM® and MENACTRA®, Nanolek is the only Russian company that possesses vaccines in its portfolio of medications to prevent bacterial meningitis, most often caused by three main infections: Haemophilus influenzae type b (as part of the vaccine PENTAXIM®), meningococcal infection (as part of the tetravalent conjugate vaccine for serogroups A, C, Y, and W MENACTRA®), and pneumococcal infections (as part of a 13-valent vaccine for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14 , 18C, 19A, 19F, and 23F PNEMOTEX®).