17 June 2021

Instead of Gardasil

Nanolek starts the first phase of clinical trials of a vaccine against human papillomavirus (HPV)

Nanolek biopharmaceutical Company has received permission from the Ministry of Health of the Russian Federation for clinical trials of the first phase of the HPV vaccine. This will be the first domestic HPV vaccine to enter the market at the end of 2024. The company invests about 2 billion rubles in its development and full production cycle.

A quadrivalent recombinant (types 6, 11, 16, 18) HPV vaccine will be sold by Nanolek in partnership with Kombiotech with the purchase of full rights to the product, it does not have a commercial name yet. The vaccine will be tested on healthy adult volunteers, the first phase of the clinical trial begins in June 2021. During the trial, scientists will evaluate the safety, tolerability and immunogenicity of the vaccine – the ability of the antigen to cause an immune response regardless of its immune specificity.

German scientist Harald zur Hausen, who proved that the human papillomavirus is the cause of cervical cancer, received the Nobel Prize in Medicine in 2008. This gave impetus to the development of vaccine programs: HPV vaccination is now included in national vaccination calendars in 91 countries around the world. It is used to prevent cancer of the cervix, rectum, oral cavity and larynx, genitals. The risk of certain types of cancer after vaccination is reduced by 90%. According to standard medical recommendations in European countries, the USA and Israel, children aged 9 years and adults up to 26 years are vaccinated.

The HPV vaccine manufactured by Nanolek will be the first domestic analogue of existing HPV vaccines produced by Merck & Co and GlaxoSmithKline. The creation of a modern HPV vaccine corresponds to the development strategy of immunoprophylaxis in the Russian Federation until 2035, according to which more vaccines for children and adults will appear in the National Calendar of Preventive Vaccinations. HPV vaccination is planned to be included in the calendar in 2024.

"According to analysts, the economic burden of HPV–associated diseases is more than 60 billion rubles, this is data for Russia," says Vladimir Khristenko, president of Nanolek. "Full vaccination of children of both sexes reduces the losses associated with a drop in the birth rate due to HPV, generally reduces the risk of cancer and, as a result, the health budget costs for treatment against them."

By bringing the HPV vaccine to the market, Nanolek will be able to cover 100% of the needs of the Russian Federation, depending on the adopted vaccination scheme. The company plans to invest about 2 billion rubles in its development and full production cycle.

In 2025, Nanolek plans to submit the vaccine for retraining to the WHO in order to be able to produce and supply the vaccine to foreign countries. During this procedure, the World Health Organization evaluates additional clinical data obtained as a result of testing and use of the vaccine on a regular basis, checks its safety and effectiveness.

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