“Natsimbio” is the only vaccine provider in the framework of the National Preventive Vaccination Calendar (which includes measles, rubella, tuberculosis, and viral hepatitis B vaccines). The company first buys vaccines from manufacturers, and then resells them through public procurement (at the same time, it was said that they passed the vaccine manufacturer Microgen and the vaccine manufacturer Fort).
Life compiled a rating of vaccine suppliers by analyzing information from the public procurement portal (from September 2015 to September 2016), and Natsimbio was in second place.
As Life Director General of the Russian Association of Pharmaceutical Manufacturers Viktor Dmitriev told Life, vaccine production in Russia is now generally at risk. According to him, the Ministry of Health and other state purchasers hold auctions at too low prices – and manufacturers are forced to agree, because they have no choice, because you can’t sell vaccines at retail.
– Manufacturing companies cannot produce quality products at a loss, not to mention the development of new generation vaccines. Therefore, for all manufacturers, the question arises of the possibility of producing vaccines according to modern quality standards with the current procurement pricing policy of the state, in the case of individual enterprises (where one or two items are made) – this is a matter of survival.
According to Victor Dmitriev, the survival of enterprises depends on who they belong to and what else they produce.
“If we talk about Microgen and Fort (Natsimbio enterprises. – Note. Life), these are state institutions, and the state will find ways to support them,” said Victor Dmitriev. – And if we talk about commercial structures, they must either compensate their losses at the expense of other products, or refuse production.
Now the point of no return has not yet been passed. We are talking about the need to intervene in this situation and make the production of vaccines cost-effective, because vaccines are the country’s biosafety. What results in unprofitable production, we see on the example of drugs of a low price segment, the prices of which are also regulated by the state.
This is also indicated by the financial performance of companies. “Natsimbio” is a huge holding that supplies a lot of drugs and medical supplies under state contracts, it has something to earn, except for vaccines. Petrovax also produces medications for the treatment of tuberculosis and immunomodulators, cosmetics. These companies are in the black.
But NPO Microgen suffers losses.
– Control is certainly necessary. Vaccines are a serious thing, – says Nikolai Kontarov, a leading researcher at the Research Institute of Vaccines and Serums named after I.I. Mechnikov. – Some vaccines, for example, must be thoroughly cleaned of protein, because someone may have an allergic reaction to protein, up to anaphylactic shock. So, there should be a thorough check of cleaning, and in each series.
According to Kontarov, approximately 80% of substances for vaccines are imported in Russia. They are purchased in China and India and can be of poor enough quality, because of this they are cheaper. In his opinion, this is a threat to the national security of the country, which also indicates the need for control.
However, according to Larisa Popovich, tightening control will now be superfluous.
“If the enterprise complies with GMP (Good Manufacturing Practice, Good Manufacturing Practice”) standards, if the manufacturer is ready to bear responsibility, then such measures are quite sufficient, ”she explained. – It is very difficult to physically verify each batch. Additional problems are created. This is another expression of distrust of existing standards. Control, of course, is needed, but do not bring it to the point of absurdity.
The main supplier of vaccines for the calendar is Nacimbio, a member of Rostec. Since 2015, by order of the government, it has been supplying 18 from 22 with the international nonproprietary names of vaccines from 12 included in the vaccination schedule. All vaccines from Natsimbio are made in Russia. And the production subsidiary of Natsimbio, NPO Microgen, became the leader in vaccine production in physical terms with a share of 2017% in 31,6.
Most foreign manufacturers have lost interest in working with Russian departments because of the sharply reduced margin of their products, says Korduban from the Federal Research Center for Research and Development of Immunobiological Preparations. Foreign manufacturers registered prices for many vaccines in the Ministry of Health in 2010–2011. – with the introduction of price controls for vital medicines. Until October 1, 2015, they did not have the opportunity to revise them, and the euro has since risen in price, respectively, the price of vaccines in the currency of the country of production has decreased, Oshalter says. So, according to him, the registered price for a five-component vaccine in Russia was 40% lower than the lowest price in reference countries.
The vaccine market is historically local, the Microgen NPO was created in the Soviet Union precisely for the mass production of vaccines, recalls the Director General of DSM Group Sergey Shulyak. But new vaccines in the country have not been developed for a long time, he continues, so the calendar expanded due to foreign-made products. And then part of them replaced the Russian vaccines.
For foreign companies, the path to the government segment of the vaccine market is localization. So, Nanolek, in partnership with Bilthoven Biologicals, produces an inactivated polio vaccine Polimelix (its state purchases for the calendar) and under the contract with Sanofi Pasteur (Sanofi vaccine production unit) Pentaxim for the prevention of five diseases.
Pentaxim is on the national calendar to protect children at risk, for example, to vaccinate premature or small babies. If the state decides to expand the use of multicomponent vaccines to the entire cohort of vaccinees, partners will be ready to increase vaccine production, says Guillaume Oscalter, general manager of Sanofi Pasteur in Russia and Belarus.
Leaving the market for some foreign vaccines will give impetus to the development of production and the creation of new products, Russian manufacturers are waiting. Thus, Nanolek plans to expand its portfolio, including the development of a full-cycle vaccine against chickenpox, human papilloma virus, rotavirus infection, notes Khristenko from Nanolek. Also, he continues, a recombinant vaccine of its own design is being developed at the registration stage.
The world industry is moving towards the development and production of new generation vaccines – multivalent, recombinant, etc., writes the Ministry of Industry and Trade in the Pharma 2030 project. The use of five- and six-component vaccines is a global trend, this leads to a decrease in the injection load, reduces the burden on medical workers and increases the effectiveness of healthcare, GSK representative Kamil Saytkulov told Vedomosti earlier.
Since 2018, Petrovax Pharm has moved from a trivalent influenza vaccine to the production of tetravalent. In 2017, the World Health Organization (WHO) recommended tetravalent influenza vaccines for use worldwide – such vaccines, in its estimation, are more effective and safer. According to the St. Petersburg Children’s Scientific and Clinical Center for Infectious Diseases, in Russia by replacing the trivalent vaccine with tetravalent for the season, 265 more cases of influenza can be prevented, and the amount of prevented costs can reach 800 billion rubles. Quadrivalent vaccines are already included in national immunization programs in 2,5 countries and are being produced in addition to Russia in six countries of the world.
Run for export
Until now, Russia has mainly supplied its vaccines to the markets of developing countries. So, the Federal Research Center (FSC) of research and development of immunobiological preparations named after M.P. Chumakova RAS delivered abroad in 2017 more than 14 million doses of yellow fever vaccine. Now the center is conducting clinical trials of an inactivated polio vaccine, which WHO has already shown interest in, says its commercial director Ekaterina Korduban. In the world, the demand for inactivated polio vaccine is growing: since 2019, WHO plans a phased full transition to it. & amp;
Petrovax Pharm is already operating in international markets. About 80% of the produced influenza vaccine we deliver to Iran, Belarus, Kazakhstan, Kyrgyzstan and other countries, including as part of state immunization programs – in 2017 alone, 7 million doses. The launch of the tetravalent vaccine on the market opens up new opportunities in the prevention of influenza for both Russian healthcare and the development of exports of Russian products.
In all foreign markets where we are present, the trivalent vaccine will gradually be replaced by a more modern tetravalent vaccine. We intend to expand our presence in Iran. We are also interested in Egypt – an agreement of intent has been signed with a large Egyptian company. Now Petrovax is preparing to submit an application to WHO to obtain prequalification, which should expand the export potential of the company.
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