Biopharmaceutical company “Nanolek” was granted a permission by the Ministry of Health of the Russian Federation for clinical trials of the first phase of HPV vaccine. This vaccine is expected to become the first domestic HPV vaccine to hit the market in late 2024. The company is planning to invest appr. 2 billion rubles in its development and full production cycle.

Nanolek is about to release the quadrivalent HPV [types 6, 11, 16, 18] recombinant vaccine in partnership with Kombiotech and purchase full rights to the product, vaccine has not received a commercial name yet. The vaccine will be tested on healthy adult volunteers, with the first phase of the clinical trial to begin in June 2021. During the trial, scientists will evaluate the safety, tolerability, and immunogenicity of the vaccine — the ability of an antigen to elicit an immune response regardless of its immune specificity.

The German scientist Harald zur Hausen, who demonstrated that cervical cancer in females is caused by HPV, was awarded the Nobel Prize in Medicine in 2008. This spurred the development of vaccine programs: Currently, HPV vaccination is included in national vaccination schedules in 91 countries worldwide. It is used in the prevention of cervical cancer, rectum cancer, oral cavity and laryngeal cancer, genital cancer. Vaccination decreases the risk of certain cancer types by 90%. According to standard healthcare recommendations which are in place in European countries, the United States and Israel, children 9 years and older and adults up to 26 years of age get a vaccine.

The vaccine developed by Nanolek is believed to become the first domestic HPV vaccine to substitute commercially available HPV analogues produced by Merck & Co and GlaxoSmithKline. Development of a cutting-edge HPV vaccine is consistent with the strategy for strengthening the preventive vaccination approach in the Russian Federation until 2035, which aims at adding more vaccines for children and adults to the National Preventive Immunization Schedule. HPV vaccination is expected to be included in the schedule in 2024.

“According to analysts, the economic burden of HPV-associated diseases exceeds 60 billion rubles, these data originate from Russia,” says Vladimir Khristenko, President of Nanolek.”A full-scale vaccination of children of both sexes reduces the losses related to a decline in the birth rate due to HPV, decreases the risk of cancer in whole and, as a consequence, cuts the treatment expenses incurred by the healthcare facilities.”

After rolling out the HPV vaccine, Nanolek will be able to supply all vaccination needs of the Russian Federation, depending on the adopted vaccination schedule. The company plans to invest about 2 billion rubles in its development and full-cycle production.

In 2025, Nanolek intends to submit the vaccine to the WHO for re-qualification in order to produce and supply the vaccine to foreign countries. During this procedure, the World Health Organization evaluates additional clinical data obtained from testing and regular use of the vaccine, and verifies its safety and effectiveness.