The Ministry of Health of the Russian Federation has approved the use of the first domestically developed human papillomavirus (HPV) vaccine, Cegardex, in children aged 9 to 17 years. The relevant amendments have been внесены into the vaccine’s registration dossier. The updated prescribing information for Cegardex was published on January 23 in the State Register of Medicinal Products (SRMP).

The approval by the Russian Ministry of Health is based on the results of a Phase III clinical trial involving healthy children aged 9–17 years. The study enrolled 402 children of both sexes and was conducted at five clinical centers across the Russian Federation, including Sechenov University and the V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology. Cegardex demonstrated good tolerability, with efficacy and safety profiles comparable to those of the registered comparator vaccine (a quadrivalent vaccine of foreign manufacture).

It should be recalled that in March 2025, the Ministry of Health of Russia granted marketing authorization for the first domestically produced HPV vaccine, Cegardex, for use in adults aged 18 to 45 years. Expanding the age indication to include the pediatric population represents an important step toward the inclusion of HPV vaccination in the National Immunization Schedule.

The possibility of administering the vaccine starting from the age of 9 is consistent with modern international approaches to immunoprophylaxis, which aim to establish protection before potential exposure to infection. This strategy ensures the maximum preventive effect and contributes to a long-term reduction in the risk of HPV-associated diseases, including cervical cancer, vulvar cancer, vaginal cancer, anal cancer, and other oncological conditions.

HPV vaccination protects against precancerous lesions of the anogenital area in both men and women and helps reduce the incidence and mortality of cervical cancer. Cegardex also prevents the development of anogenital warts, which are among the most common sexually transmitted infections. In Russia, cervical cancer ranks second in prevalence among oncological diseases in women aged 15–44 and first as a cause of cancer-related mortality in women under 44. In more than 30% of patients, the disease is diagnosed at stages III–IV, and first-year mortality after diagnosis reaches 11.7%. Mass HPV vaccination will help reduce the prevalence of HPV-associated diseases, preserve reproductive health, and contribute to increased birth rates.

In October 2025, Nanolek, with the participation of the federal Industrial Development Fund (IDF), launched the first domestic production facility for an HPV vaccine in the Kirov Region. Cegardex will be manufactured under a full-cycle process—from antigen production and subsequent filling into vials to the release of the finished product into civil circulation.

“The first batches of Cegardex are already in production. Market supplies will begin in the second half of 2026. The company is gradually scaling up production capacities to ensure vaccine supply within the National Immunization Schedule starting in 2027. Reaching an output of more than 3 million doses annually will enable stable and predictable supply for the Russian healthcare system.

From the manufacturer’s side, all necessary technological and production conditions have been created; further provision of free HPV vaccination under government programs directly depends on the relevant legislative decisions and the allocation of funding,” said Evgeny Barinov, CEO of Nanolek.