Nanolek received approval to conduct a randomised controlled clinical trial of a new 23-valent polysaccharide vaccine for the prevention of pneumococcal infections. The vaccine will be available in Russia thanks to co-operation between Nanolek and the international biopharmaceutical company Beijing Zhifei Lvzhu Biopharmaceutical.

The clinical trial will be conducted at research centres in the Russian Federation, including the I.I. Mechnikov Research Institute of Vaccines and Sera. The study will investigate the efficacy (immunogenicity), reactogenicity and safety of the 23-valent pneumococcal vaccine ‘Nanolek’ within 30 days after a single intramuscular injection in comparison with the vaccine ‘Pneumovax 23’ already registered in the Russian Federation by Merck Sharp and Doom B.V., the Netherlands. Pneumococcal infections are of high epidemiological and socio-economic importance in Russia and worldwide. They cause a number of diseases, both life-threatening (meningitis, septicaemia, pneumonia) and milder but widespread (sinusitis, otitis media, etc.). Vaccination is recommended even if a person has had a pneumococcal disease in the past, as it protects against several of the most common and invasive pneumococcal serotypes at once.

Vaccination against pneumococcal infection is included in the National Preventive Vaccination Calendar (NPVC) of the Russian Federation and the calendar of preventive vaccinations for epidemic indications. Vaccination is indicated for children from two years of age, as well as adults with an increased risk of contracting or complicating pneumococcal infections: persons over 50 years of age, conscripts, persons with chronic diseases of the cardiovascular and respiratory system, chronic liver disease, diabetes mellitus, etc.

‘The creation of a domestic vaccine against pneumococcal infection is part of Nanolek's strategy focused on building Russia's drug independence in the fight against highly contagious infectious diseases. The company is developing a whole range of medicines for the prevention of such pathologies, including a vaccine against chickenpox, shingles and others. Production plans for launching such vaccines are formed in accordance with the current needs of the healthcare industry,’ says Evgeny Barinov, Nanolek's General Director.