According to the State Register of Medicines (GRLS) (1), the Cegardex vaccine has been included in the list of interchangeable medicinal products with respect to the Gardasil vaccine. The relevant information was published in April 2026.

Interchangeable status means that the products are recognized as comparable in terms of quality, efficacy, and safety. In practice, this allows vaccination with Cegardex to complete a vaccination course that was initiated with Gardasil.

“Inclusion of Cegardex in the list of interchangeable medicinal products is an important confirmation of the high quality of the Russian vaccine. This decision has practical significance for physicians, the healthcare system, and patients alike, as it allows continuation of HPV vaccination without the need to restart the vaccination course when switching between products,” said Elena Stukun, Deputy General Director and Commercial Director of Nanolek.

Cegardex is the first (2) Russian quadrivalent vaccine for the prevention of human papillomavirus (HPV) types 6, 11, 16, and 18. The full production cycle of the vaccine is carried out at Nanolek’s manufacturing site in the Kirov Region. The first commercial batches of the vaccine are expected to enter civilian circulation in the second half of 2026.

Clinical trials of the Cegardex vaccine were conducted in two stages. The first stage included healthy volunteers aged 18–45 years, while the second stage involved children of both sexes aged 9–17 years. According to the results of the clinical studies, the vaccine demonstrated good tolerability, a favorable safety profile, and efficacy comparable to that of a foreign-manufactured quadrivalent vaccine (3).

Interchangeability of medicinal products is determined based on the following criteria: equivalence or comparability of the antigen composition of vaccines, equivalence of the dosage form, equivalence or comparability of excipient composition, identical route and method of administration, and compliance of the manufacturer with Good Manufacturing Practice (GMP) requirements (4).

(1) https://grls.rosminzdrav.ru/ForumTopic.aspx?idTopic=13820

(2) https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=28c34cae-5bcb-4795-9417-1264be63b56f

(3) Multicenter randomized comparative parallel-group study evaluating the immunogenicity, tolerability, and safety of a recombinant quadrivalent (types 6, 11, 16, 18) human papillomavirus vaccine in children aged 9–17 years. The study was conducted from February 2024 to August 2025. Unpublished data. Planned publication date – 2026.

(4) Decree of the Government of the Russian Federation No. 1360 dated September 5, 2020 “On the procedure for determining interchangeability of medicinal products for medical use.”