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The quadrivalent (recombinant, adsorbed) vaccine Tsegardex protects against HPV types 6, 11, 16, and 18. Types 16 and 18 are particularly significant, as they cause approximately 50% of high-grade precancerous cervical lesions.
The vaccine received regulatory approval for adult use in March 2025. Before this domestic alternative became available, only Gardasil from the American company MSD was used to prevent these HPV types in Russia. In 2024, the government allocated 1.7 billion rubles (212,500 packages) for Gardasil procurement by public medical facilities.
The manufacturing cycle for Tsegardex takes approximately 8 months, so the first batches are expected to reach the market in the second half of 2026. The facility's initial capacity is a minimum of 600,000 doses annually. By 2027, after the second phase launches, production volume will exceed 3 million doses. The company is confident these volumes will fully meet domestic healthcare needs. Total investment in the project reached 7.5 billion rubles.
HPV causes over 95% of cervical cancer cases that result from persistent infection—a condition in which the virus remains in the body for an extended period without causing noticeable symptoms. The WHO considers immunization the most effective preventive measure and recommends vaccinating children of both sexes between ages 9-14, before they become sexually active. Systematic screening to detect precancerous changes at early stages is equally critical.
Cervical cancer ranks fourth in frequency among female cancer diagnoses worldwide. According to WHO projections, without additional interventions, the number of new cases will increase from 570,000 in 2018 to 700,000 by 2030, while deaths will rise from 311,000 to 400,000.
In Russia, approximately 15,000 new cervical cancer cases are diagnosed annually. Only breast cancer, colorectal cancer, and uterine (endometrial) cancer are detected more frequently among women. Concerningly, about 30% of cervical cancers are discovered at advanced stages 3-4—making it one of the cancers most frequently diagnosed at late stages in Russia.