Nanolek and Sanofi produced the first batch of meningitis vaccine at a plant in the Kirov region

2022: Release of 53,000 doses of Menaktra vaccine

On March 10, 2022, the Nanolek company announced that the first series of the Menaktra vaccine was released at its plant in the Kirov Region - 53,000 doses. As part of the localization of the Sanofi vaccine, it is planned to produce up to 3.5 million doses annually.

An agreement on the localization of a vaccine for the prevention of meningococcal infection between Nanolek and Sanofi was signed in 2021. At the beginning of 2022, the first stage of technology transfer was completed and Nanolek was registered as a secondary packer with producing control. The next stage will be the transition to aseptic bottling and other steps to move to the production of a ready-made dosage form.

It is planned to produce 2.2-3.5 million doses per year - this volume is enough to fully ensure the need of Russian health care for a vaccine for children of the first years of life for the prevention of meningococcal infection caused by pathogens of four of the most common serogroups (A, C, W, Y).

This is in line with the Global Road Map to the Meningitis Goals launched by the World Health Organization on 28 September 2021. The authors of the project estimated that the creation of new vaccines and support for vaccine prevention worldwide will eliminate epidemics of bacterial meningitis by 2030. Vaccination against meningitis will protect adults and children from an infection that affects 5 million people and claims about 290,000 lives worldwide annually. At the same time, a third of those who recovered remain with severe complications, such as hearing loss, memory problems, and impaired mental development.

{{quote 'author = said Frederick Jumel, general manager of the business unit of "Vaccines" Sanofi in the Eurasian region. |

I am glad that we are actively developing local vaccine production together with our partner, Nanolek. I hope that this will provide all Russian children with protection from meningococcal infection. The danger of meningococcal infection in high mortality and disability after the disease. We have taken an important step towards our goal of saving lives and protecting children from infectious diseases,}}

Шаблон:Quote 'author = noted Vladimir Khristenko, President of Nanolek.

2021: Menaktra Vaccine Production Localization Agreement

As it became known on October 4, 2021, Sanofi and Nanolek agreed to localize the production of meningococcal Menaktra vaccine. The drug will be produced at the plant of a Russian company in the Kirov region. The company has already received a registration certificate for the manufacture of the drug.

The next stage is the transfer of quality control techniques and vaccine packaging processes, as well as the signing of an additional agreement on aseptic bottling conditions and other steps to localize vaccine production, including the production of a ready-made dosage form.

It is planned to produce 2.2-3.5 million doses per year. This volume, according to companies, is enough to fully meet the need of Russian healthcare for this vaccine.

"Menactra" is used to vaccinate children of the first years of life against meningococcal infection caused by pathogens of four of the most common meningococcal serogroups at once: A, C, W, Y. The vaccine has been supplied as part of the National Preventive Vaccination Calendar since 2017.

According to Kommersant, the meningococcal vaccine is included only in the vaccination calendar according to epidemiological indications and is purchased by the regions on its own. According to the plan approved by the Government of the Strategy for the Development of Immunoprophylaxis of Infectious Diseases until 2035, the inclusion of this vaccine in the national calendar of preventive vaccinations (NCPP) is planned for 2025. After that, the drug will begin to be purchased centrally by the Ministry of Health.

According to the source of the publication on the market, in Russia the total market for pediatric vaccinations, which includes Menaktra, can reach 15-20 million doses per year. Sanofi told the newspaper that they supply the drug in the amount of 1.5 million doses per year.^[1]

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