The Ministry of Health of the Russian Federation has approved the use of the first Russian human papillomavirus (HPV) vaccine “Cegardex” in children aged 9 to 17 years. Relevant changes have been made to the vaccine’s registration dossier documents. The updated instruction for medical use was published on January 23 in the State Register of Medicines (GRLS).
Clinical Trial Results
The approval from the Russian Ministry of Health was obtained based on the results of a Phase 3 clinical trial involving healthy children aged 9–17. The study of the vaccine, involving 402 children of both sexes, took place in five clinical centers across the Russian Federation, including Sechenov University and the V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology.
The “Cegardex” vaccine is characterized by good tolerability and efficacy and safety profiles comparable to the registered comparator vaccine (a quadrivalent vaccine of foreign manufacture). As a reminder, in March 2025, the Russian Ministry of Health issued a registration certificate for the first Russian HPV vaccine “Cegardex” for use in adults aged 18 to 45.
Immunoprophylaxis Strategy and Statistics
Expanding the age indications to the pediatric age group is an important milestone on the path to including HPV vaccination in the National Calendar of Preventive Inoculations (NCPI). The possibility of using the vaccine starting from age 9 corresponds to modern international approaches to immunoprophylaxis, implying the formation of protection before potential contact with the infection.
This approach ensures maximum preventive effect and contributes to the long-term reduction of risks of developing HPV-associated diseases, including cervical cancer (CC), vulvar cancer, vaginal cancer, anal cancer, and other oncological nosologies. HPV vaccination protects against precancerous lesions of the anogenital region in men and women and contributes to reducing morbidity and mortality from cervical cancer. The “Cegardex” vaccine also prevents the development of anogenital warts, which are among the leaders in sexually transmitted infections.
In Russia, cervical cancer ranks second in prevalence among oncological diseases in women aged 15 to 44 and first among causes of cancer mortality in the age group under 44. In more than 30% of patients, the disease is detected at stages III–IV, and lethality in the first year after diagnosis reaches 11.7%. Mass vaccination against HPV will allow reducing the prevalence of HPV-associated diseases, preserving the population’s reproductive health, and contributing to increasing the birth rate.
Full-Cycle Production
In October 2025, Nanolek, with the participation of the federal Industrial Development Fund (IDF), opened the first Russian production facility for the human papillomavirus vaccine in the Kirov region. The “Cegardex” vaccine will be produced in a full cycle – from antigen production and subsequent filling into vials to the release of the finished product into civil circulation.
“The first batches of the ‘Cegardex’ vaccine are already in production. Market deliveries will begin in the second half of 2026. The company is gradually increasing production capacity to implement the task of ensuring HPV vaccine supplies within the framework of the National Calendar of Preventive Inoculations, starting from 2027. Reaching a volume of over 3 million doses annually will ensure a stable and predictable supply for the Russian healthcare system. From the manufacturer’s side, the necessary technological and production conditions have been created; further provision of free HPV vaccination within state programs directly depends on relevant legislative decisions and funding allocation.”
— Eugene Barinov, General Director of Nanolek
