CHUMAKOV’S COVIVAC – UPHILL RUN FOR RUSSIA’S THIRD VACCINE



By John Helmer, Moscow
  @bears_with

Nothing is more certain than that wars make fortunes for gunmakers and pandemics make fortunes for vaccine makers.

It’s uncertain whether it’s the market, the politics, or the science which advances some vaccines at the expense of others.  In the 150-year history of medical markets, the Covid-19 vaccines have been fastest from the science to the money – faster and further ahead of the vaccines for measles, hepatitis, cervical cancer, and polio.  At this speed, profit and share price have done most of the talking, followed by the politics of regulator approval. It’s too soon for science to measure and report the long-term benefit versus harm of these Covid-19 vaccines, especially the genetic engineering types known as messenger ribonucleic acid (mRNA).  

After two years of the coronavirus, the World Health Organization (WHO) reports there are 148 vaccines currently under clinical testing.   It’s quite late for most of them to make back their cost, let alone earn super profits.

The US has developed two of the vaccines, Moderna and Johnson & Johnson (Janssen), and with German science, produced and marketed a third, Pfizer-BioNTech. China has developed and marketed three major vaccines – Sinopharm, CoronaVac, Convidecia – and several minor ones.  India has produced more than three, as have Cuba and Iran. Turkey, Kazakhstan, and the UK have produced one each; the last of them, Oxford-Astra-Zeneca is the runner-up to Pfizer in  reach worldwide.  France’s Sanofi has produced one, but it has yet to reach market.  

Russia has produced three Covid-19 vaccines – Sputnik (Sputnik V and Sputnik Lite), EpiVacCorona, and CoviVac.  

Vaccine market entry decided by national and international regulators is a measure of political and corporate power; global dosage totals are the result. Pfizer has dominated the European Union market with roughly three times the number of doses administered than all its competitors combined. In rank order after Pfizer come Moderna, Astra-Zeneca, Johnson & Johnson, Sputnik, Sinovac and Sinopharm.   In the US market, Pfizer dominates with a 59% share; Moderna with 38%; Johnson & Johnson with just 3%. Non-American vaccines have been kept out of the American market entirely. That isn’t the result of science.   

But in the world as a whole, China and India lead in the aggregate of doses; Cuba, the United Arab Emirates, and Chile lead in the number of doses administered per hundred people.  

By contrast with the global and European standards, Russians have been more resistant to vaccination and more skeptical of the science. With a dosage per hundred people of 111, the Russian vaccination rate has been half the European Union average;  a third the US rate; about equal to Honduras or Pakistan.  

In the Russian market this is the short story of CoviVac —  the vaccine which has tried to make its way against oligarch money, Moscow politics, and the paradoxical contest of one of  the most advanced vaccine science establishments in the world with one of the most coronavirus skeptical  of populations.

During 2021 the Russian government announced its target was to vaccinate about 60% of the population, or about 88 million people. According to this year’s data, full vaccination has been achieved for 49%; one dose for 54%.

By May of 2020, Russia’s state-financed medical research centres were reported to be experimenting with prototypes of four dozen vaccines.  By mid-year, however, government officials in Moscow had decided with business leaders that just three vaccines and three companies would be selected for the full cycle of development, testing, mass production, and national distribution.

The first vaccine of the three was Gam-Covid-Vac, trademark Sputnik V; it was registered in August 2020, and was developed by the Gamalei National Research Center for Epidemiology and Microbiology. The second was EpiVacCorona, developed by Vector, the Federal State Scientific Center for Virology and Biotechnology, and launched in October 2020.  The third, CoviVac, was invented by the Chumakov Federal Scientific Center for Research and Development of Immunobiological Drugs, and registered in February 2021. Sputnik is a viral vector type; EpiVacCorona a peptide vector type; CoviVac an inactivated type; for the biochemical differences between the types,  read this.  The Russian vaccines do not use mRNA technology.

At the same time as these vaccines were being rushed to market, public Russian resistance to vaccination was growing, while the readiness to be vaccinated was dropping. Age, education and urban residence – middle-class factors – appear to have increased skepticism towards the vaccines rather than encouraged compliance with the government’s vaccination policy.  Discrimination between the vaccine types also began to appear in public. “Usually, those who want CoviVac are older,” reported this US academic assessment of November 2021. “Some believe that they might experience fewer negative side effects than with Sputnik V, and they also think [CoviVac] was created with better technology because they could spend more time [developing] it.”  

Source for both tables: https://www.levada.ru/ -- published in April 2021.

As the year 2021 wore on and infection rates rose, the resistance to vaccination softened. However, opposition to mandatory vaccination and policing systems like the QR code hardened. The Levada polling group in Moscow reported: “More than half of respondents do not support it (35% are completely against it, 19% are rather unsupportive). 42% of Russians are in favour of the idea: 21% of Russians support universal mandatory vaccination of the population in some way.”  

Source: https://www.levada.ru/

Follow the Russian opinion polls from the beginning of the pandemic to the end of 2021 here.   

By the middle of 2021, Sputnik dominated state procurement and distribution – more than 30 million sets of Sputnik V had been produced; about 1.5 million of EpiVacCorona;  352,000 of CoviVac. The latest available production and supply data indicate that in 2021,  85 million sets of Sputnik had been marketed;   12.9 million doses of EpiVacCorona;  and 4 million doses of CoviVac.

PRODUCTION OF SPUTNIK-V BY COMPANY

The companies producing Sputnik V reported by Forbes, August 31, 2021.  KEY: blue=Binnopharm; red=Pharmstandard; yellow=R-Pharma; orange=Medglamal; grey=Biocad. Medglamal is the production unit of the Gamalei Centre; for investment in its production lines it depended on Yevtushenkov’s Binnopharm.

Commercially, production, distribution and marketing were quickly concentrated into two pairs of hands – Vladimir Yevtushenkov with about one-quarter of the business, and Viktor Kharitonin, three-quarters.

Counting Medglamal of the Gamalei Centre,  the vaccine developer,  seven commercial pharmacological companies were issued government licences for production of Sputnik —  Binnopharm (Zelenograd region), Generium (Vladimir), R-Pharm (Yaroslavl),  Biocad (St Petersburg), LECCO (Vladimir), and Pharmstandard (Bashkiria). Controlling Binnopharm is the Sistema group is owned by Yevtushenkov; follow his assets here.  Generium, LECCO and Pharmstandard belong to Kharitonin, the leading pharmaceutical oligarch in the country; for the backfile on him, click to read.  Kharitonin had consolidated his group by buying 50% of Biocad, as well as assets connected with the family of Tatiana Golikova, the deputy prime minister in charge of the pandemic.

Left to right: Vladimir Yevtushenkov of Binnopharm; Viktor Kharitonin of Pharmstandard; Deputy Prime Minister Tatiana Golikova; Vladimir Khristenko, Golikova’s son and chief executive of Nanolek, the marketer of CoviVac.   

A second string of companies took licences for the second and third vaccines, EpiVacCorona and CoviVac. The Vector Centre, developer of the EpiVacCorona vaccine, licensed its own commercial unit, VectorBi-Algam, as well as an established producer of insulin, Geropharm. Their combination is controlled by Leonid Nikulin and Pyotr Rodionov. It is widely reported in the Russian press that Anna Popova, a professor of medicine and head of Rosptrebnadzor, the chief regulator of the coronavirus vaccines, was personally involved in the Vector Centre’s development of EpiVacCorona.

In 2019, Chumakov, developer of CoviVac, had started a commercial venture it called InVak with Nanolek as the principal investor. When the pandemic began in 2020, it was agreed with Nanolek to concentrate on CoviVac. Nanolek announced a target of 5 million doses by the end of 2020. But hitches in the testing and production technology caused delays.

Left to right: Dmitry Morozov of Biocad; Alexei Repik of R-Pharm; Leonid Nikulin of Vector; Pyotr  Rodionov of Geropharm.

For more on how the concentration of the Russian pharmacological industry operates, click to read.

Source: http://johnhelmer.net/

The export of the Russian vaccines has also proved extremely lucrative. According to Federal Customs Service figures released last month, in 2020 Russian vaccine exports earned $72 million. In 2021 the earnings had jumped to $1.42 billion. Sputnik has dominated these sales but has been held back by US, British and European Union lobbying of their national vaccines; these have gained WHO certification while Sputnik and the other Russian vaccines have been stalled.  

Many countries, however, have unilaterally authorised the use of Sputnik, and during 2021 contracted to buy supplies from Russia — Argentina (imports from Russia amounted to $204 million in 2021), Mexico ($199 million), United Arab Emirates ($197 million), India ($112 million) and Kazakhstan ($110 million). They accounted for 60% of sales. With the exception of the UAE, these importing states have also established their own domestic production facilities for Sputnik.

Before the pandemic and the launch of the Sputnik vaccine, Russia had been exporting vaccines for yellow fever and influenza, according to Nikolai Bespalov, a director of RNC Pharma, a Moscow industry consultancy.  Until the takeoff of Sputnik, the trade in these vaccines had been stable with little growth. Bespalov estimates that of the vaccine export total last year of $1.42 billion, 97% was accounted for by Sputnik.  

This export volume appears to have been just over one-third, 37%,  of the total production in Russia. But the Russian exports comprised only 2% of the global supply – the EU led with 38% of the market; followed by China, 36%, the US, 13%; and India 2.4%. The WHO’s refusal after two years to certify Sputnik has restricted it to fifth place, protecting the European and American grip on more than half the global trade.

At home, popular resistance to vaccination has been an unexpectedly big hitch for government officials like Golikova and Popova.  But an even bigger hitch for vaccine makers like Golikova’s  son, and for Yevtushenkov and Kharitonin, has been whether their vaccines work effectively. To answer this question, in August 2021 medical researchers in St Petersburg reported their detailed study of the results of vaccination in protecting against lung injury for patients admitted to hospital with Covid-19.    Three months later, the group also reported their comparison of the effectiveness of Sputnik, EpiVacCorona,  and CoviVac.   

The outcome of the comparison of the three Russian vaccines was dramatic. In testing with patients with the delta variant of the coronavirus, Sputnik’s efficiency was measured at 58%, CoviVac at 38%. EpiVacCorona was reported to have “negative efficiency”. According to Anton Barchuk, the lead researcher, “Sputnik V is effective against infection caused by the delta variant. It is likely that against the background of a booster dose, a certain effectiveness against the omicron variant will be maintained. The comparable effectiveness of Sputnik Lite in the study is due to the fact that the vaccine was often used as a booster for those who were ill. As for the EpiVacCorona, it did not show effectiveness at all against the delta variant in this study.”

The Vector Centre, producer of EpiVacCorona, has disputed the published results, claiming the sampling of patients with EpiVacCorona was far too small to be representative.  Notwithstanding, promoters of Sputnik continue to dominate the Russian media. Asked to comment on the science,  the spokesmen for EpiVacCorna and CoviVac decline to reply.

The vigour of professional Russian criticism of the individual vaccines has been more than matched by the countrywide debate of the effectiveness of them all.



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