Russia’s HPV vaccine landscape: New developments and future outlook

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Experts refer to the human papillomavirus as a “silent” virus. It can remain undetected for a long time while affecting healthy cells. Specialists predict that without preventive measures, the number of women diagnosed with cervical cancer will continue to rise, potentially reaching 30 cases per 100,000 by 2030. Experts discussed the current preventive options available during the XXVII Congress of Pediatricians of Russia.

In 1976, German scientist Harald zur Hausen hypothesized that the human papillomavirus contributes to the development of cervical cancer. In 1983, he identified HPV types 16 and 18 as the primary cause of cervical cancer. In 2008, he was awarded the Nobel Prize in Physiology or Medicine for his work. This discovery proved the link between HPV and oncological diseases and was the first step toward creating HPV vaccines.

Even decades after the discovery, this virus remains under intense scientific focus. WHO experts state that “almost all sexually active people will be infected at some point in their lives.” According to various sources, the prevalence of HPV in Russian regions ranges from 14% to 84.5%.

The risk of developing malignant neoplasms directly depends on a person’s immunity and the virus type. Types 16 and 18 are high oncogenic risk viruses, causing more than 70% of cervical cancer cases and 90% of anal canal cancers. They are also responsible for the majority of cancers of the oral cavity, pharynx, vulva, vagina, and penis. Certain HPV types (notably 6 and 11) can cause a range of benign changes: for example, skin papillomas, condylomas, and laryngeal papillomatosis.

Cervical cancer can progress over 5–7 years, from the moment the virus penetrates the epithelium to the formation of a malignant tumor.

According to Elena Uvarova, the chief freelance specialist for pediatric and adolescent gynecology at the Russian Ministry of Health, cervical cancer is a serious socially significant problem. “It ranks first in the structure of mortality from malignant neoplasms, is the second most frequent cancer in women aged 15 to 44, the fourth most frequent cancer in the female population, and occupies the sixth place in the number of years of life lost among women in Russia,” says Uvarova.

Despite the high infection rate, many people are unaware of their carrier status because dangerous symptoms do not appear. However, unlike most other sexually transmitted viruses (herpes simplex virus, human immunodeficiency virus, hepatitis viruses), HPV can clear on its own within a few years. The body can fight off the infection itself because the virus resides in the upper layers of the skin, which are constantly renewed. But this does not happen in all cases, and one should not rely on it.

It has now been proven that HPV infection affects the reproductive function of both women and men. “In recent years, evidence has accumulated that HPV infection affects the course of pregnancy and the health of the newborn. There is an increased frequency of spontaneous miscarriages in the first trimester and the rate of premature births. Inflammatory changes with thromboses develop. And the saddest part is intrauterine growth restriction and developmental delays,” explained Elena Uvarova.

In Russia, starting in 2026, an HPV DNA test has become available as part of the reproductive health check-up covered by compulsory medical insurance. These diagnostic tests are included in the first stage of the check-up for women aged 21 to 49, aiming to detect the virus before any cellular changes appear.

Vaccination as a way to defeat cancer

Today, vaccination is the only effective means of protection against HPV infection, preferably during adolescence, before sexual exposure, or later, up to the age of 45.

In 2006, the first HPV vaccine, Gardasil, was approved in the USA, and many countries have since included it in their national immunization schedules. It is worth noting that Australia is close to defeating cervical cancer thanks to its national vaccination program and regular screening: the incidence rate has dropped to 7 cases per 100,000 population. In Russia, the vaccine is included in regional calendars or programs in only 43 regions.

In March 2025, the pharmaceutical company Nanolek registered the first Russian HPV vaccine, Cegardex, which, like Gardasil, protects against four virus types: 6, 11, 16, and 18. In January 2026, the manufacturer received approval to use the vaccine in children aged 9–17.

Discussing the results of multicenter randomized trials evaluating the immunogenicity, tolerability, and safety of the recombinant quadrivalent vaccine, Irina Felblyum, Head of the Department of Epidemiology and Hygiene at Academician E.A. Wagner Perm State Medical University, emphasized that they confirmed its efficacy compared to the reference drug. Cegardex also demonstrated comparable safety to the comparator drug.

“The conducted studies confirm the good tolerability, favorable safety profile, and potentially high efficacy of the Russian vaccine,” said Irina Felblyum.

The first batches of the vaccine will be released for civilian use in the second half of 2026. Production is organized in the Kirov region as a full-cycle process, from antigen development to the final dosage form.

Thus, all the necessary scientific, clinical, and industrial prerequisites have been established in Russia for including HPV vaccination in the National Immunization Schedule, making it accessible not just to individual regions but to the entire country.

Federal-level support and the adoption of a unified program, as is done in many countries around the world, will help achieve systemic results much faster. According to Leila Namazova-Baranova, Academician of the Russian Academy of Sciences and Chair of the Union of Pediatricians of Russia, the responsibility falls on pediatricians to inform parents about modern immunoprophylaxis methods in a concise, clear, and reasoned manner.

“The opportunities that have opened up today for the prevention of oncological diseases thanks to HPV vaccination cannot be overstated. Parents must understand that vaccination is not just protection against infectious diseases; it is changing the trajectory of an entire life,” concluded Leila Namazova-Baranova.

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