Business news from Ukraine

UKRAINE CAN BUY INDIAN VACCINE AGAINST COVID-19

The state-owned enterprise Medical Procurement of Ukraine negotiated the purchase of a vaccine against COVID-19 with India’s Serum Institute, MP from the Holos faction Oleksandra Ustinova has said with reference to SOE Medical Procurement of Ukraine. According to the response of the SOE to her request, the Ministry of Health has suspended negotiations with the manufacturer.
“Negotiations with manufacturers or potential suppliers of vaccines have been suspended due to the failure to authorize SOE Medical Procurement of Ukraine to act as the recipient of budgetary funds, the lack of appropriations in 2021 for the purchase of vaccines for SOE Medical Procurement of Ukraine and the lack of an approved additional amount of vaccine for the purchase,” MP said.
Ustinova said that the vaccine from Serum Institute was procured for the COVAX global initiative.
In addition, according to her, the cost of a dose of the vaccine from the manufacturer Sinovac, the supply agreement for which was signed by Ukraine, is six times higher than the cost of the Indian vaccine.
Serum Institute of India Pvt. Ltd. specializes in the production of immunobiological preparations, among which, in particular, vaccines against poliomyelitis, measles, hepatitis B, BCG vaccine against tuberculosis, as well as DPT vaccine against whooping cough, diphtheria and tetanus.
Earlier, preparations for immunoprophylaxis produced by Serum II were supplied to Ukraine, in particular, the DPT vaccine, and Hib vaccine to prevent Haemophilus influenzae type b. In 2018, the State Service of Ukraine for Medicines and Drug Control imposed a temporary ban on the DTP Serum II series vaccines due to reports of a fatal case following the use of these series. However, later the ban was lifted on the basis of a conclusion of the regional rapid response group (in Ternopil region) regarding the absence of a causal relationship between the death and immunization.

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UKRAINIAN LEKHIM PLANS TO REGISTER CHINESE VACCINE AGAINST COVID-19

The Lekhim group of pharmaceutical companies (Kyiv) plans to register in Ukraine a vaccine against coronavirus (COVID-19) disease produced by the Chinese company Sinovac Biotech until February 5, after the vaccine is registered in Brazil, Chairman of the Supervisory Board of the Lekhim group of pharmaceutical companies Valeriy Pechayev said at a press conference held at Interfax-Ukraine on Wednesday.
“The company received confirmation from the Health Ministry that when registering a vaccine in Brazil, Ukraine will register the vaccine as well. From January 25, Brazil will start immunization with the Sinovac vaccine, they should register the vaccine by January 25. As soon as registration in Brazil is completed, we will submit documents to the State Expert Center. I think we will register the vaccine before February 1-5,” he said.
Pechayev said that Lekhim received from Sinovac a quota of 5 million doses of vaccines for sale in Ukraine in the first half of 2021, of which 1.913 million doses are planned to be purchased by the Health Ministry.
“Until February 15, Lekhim is receiving applications from enterprises for the supply of vaccines. Lekhim will check customers for compliance with the cool chain. The price for customers will be UAH 504 per one dose of vaccine. The profitability of the deal for Lekhim is 4-5%,” he said.
In turn, Director of the Department for Development of the Lekhim group of pharmaceutical companies Mykhailo Rensky said that it is difficult to talk about the timing of vaccine supply, since they are prescribed only for a contract with the Health Ministry.
According to Head of the National Technical Group of Experts on Immunoprophylaxis, pediatric immunologist Fedir Lapiy, as clinical studies in Brazil have shown, the effectiveness of the vaccine to prevent mortality was 100%.
Lapiy said that there is no generalized report on clinical trials for any of the COVID-19 vaccines. “After clinical studies, manufacturers take data from different countries and combine them. There is no such data from any manufacturer yet,” he said.
At the same time, Lapiy said that it is impossible to assess the effectiveness of the Russian vaccine against COVID-19, since it failed the third phase of clinical trials.
Sinovac Biotech is a Chinese vaccine producing company founded in Beijing in 2001 with a capacity of 300 to 500 million doses of six types of vaccines for humans and animals per year. Sinovac’s main products are vaccines against hepatitis A (prequalified by the WHO) and B, influenza, mumps, chickenpox, which are registered and approved for vaccination in 34 countries around the world.
The Lekhim group of pharmaceutical companies was founded in 1992. It includes three enterprises: PJSC Technolog (Uman) (at the final stage of obtaining WHO prequalification), JSC Lekhim-Kharkiv (Kharkiv) and the management company JSC Lekhim (Kyiv).
CoronaVac is an inactivated vaccine. It uses a traditional vaccine mechanism in which a non-living virus that cannot replicate in human cells is used to activate the immune system. Phase 3 trials of the Chinese vaccine have already taken place in Brazil and Indonesia. Tests are ongoing in Turkey and Chile.

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UKRAINIAN LEKHIM TO SUPPLY 5 MLN DOSES OF COVID-19 VACCINE FROM CHINAC TO UKRAINE

The Lekhim group of pharmaceutical companies has signed an agreement to supply 5 million doses of CoronaVac vaccine against COVID-19 produced by the Chinese company Sinovac Biotech in the first half of 2021, the company said in a press release on its website.
“Lekhim Group and Sinovac Biotech, which are partners, have reached an agreement in negotiations that lasted for 10 months on cooperation in the distribution and localization of production in Ukraine of the vaccine against the SARS-CoV-2 virus for a period of five years,” the press release reads.
According to the report, Lekhim is the official and exclusive supplier of CoronaVac vaccine in Ukraine.
The release recalls that in addition to the sale of the CoronaVac vaccine, cooperation involves the organization of production of finished dosage forms of vaccines (including CoronaVac) from 2022 in Ukraine (Lekhim-Kharkiv), and from 2025 it is planned to organize a full production cycle of the main list of vaccines.
Sinovac Biotech is a Chinese vaccine producing company founded in Beijing in 2001 with a capacity of 300 to 500 million doses of six types of vaccines for humans and animals per year. Sinovac’s main products are vaccines against hepatitis A (prequalified by the WHO) and B, influenza, mumps, chickenpox, which are registered and approved for vaccination in 34 countries around the world.
CoronaVac is an inactivated vaccine. It uses a traditional vaccine mechanism in which a non-living virus that cannot replicate in human cells is used to activate the immune system. Phase 3 trials of the Chinese vaccine have already taken place in Brazil and Indonesia. Tests are ongoing in Turkey and Chile.

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KHARKIV COMPANY BIOLIK CONFIRMS APPLICATION FOR REGISTRATION OF RUSSIAN VACCINE AGAINST COVID-19

The pharmaceutical company JSC Biolik (Kharkiv) confirmed that on December 31, 2020, it submitted an application to the Ministry of Health of Ukraine for registration of the Sputnik V vaccine against COVID-19 developed in Russia.
“In connection with numerous inquiries, the administration of JSC Biolik informs that on December 31, 2020 we did send to the Ministry of Health of Ukraine an application for state registration of a medicinal product – vaccine Gam-COVID-Vac, combined vector vaccine for the prevention of coronavirus infection caused by SARS-CoV-2 virus, produced by the Gamaleya Research Institute of Epidemiology and Microbiology of the Russian Federation,” the company’s press service said.
The text of the statement was also made public.
As reported, earlier, head of the political council of the Opposition Platform – For Life party Viktor Medvedchuk said that on December 30, the Biolik pharmaceutical company applied to the Ministry of Health of Ukraine and the State Expert Center of the Ministry of Health with an application for state registration of the Sputnik V coronavirus vaccine.
On January 4, the State Expert Center, with reference to its head Mykhailo Babenko, told Interfax-Ukraine that “as of 11:00 of January 4, 2021, the State Expert Center didn’t receive applications for registration of any vaccines against COVID-19 from the company Biolik.
The Sputnik V vaccine has not passed the third phase of clinical trials.
In turn, Deputy Minister of Health, Chief Sanitary Doctor of Ukraine Viktor Liashko assured that only those vaccines against coronavirus infection that have successfully completed clinical trials will be used in Ukraine, “therefore, all rumors and political statements about the state registration of the Russian vaccine candidate in Ukraine do not correspond to reality.” Liashko said that according to available data, the completion of the third phase of clinical trials of the Sputnik V vaccine is scheduled for December 2021.
In early December, the Russian Direct Investment Fund announced readiness of JSC Biolik (Kharkiv) to produce the Russian Sputnik V vaccine against COVID-19 in Ukraine. At the same time, Biolik company denied that statement then.

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Additional strengthened quarantine restrictions starts in Ukraine

Additional strengthened quarantine restrictions began to operate to prevent the spread of COVID-19 in Ukraine from 00:00 on Friday, January 8.

As reported, according to resolution of the Cabinet of Ministers of Ukraine No. 1236 of December 9, 2020, the lockdown will last until 00:00 on January 25, 2021.

During this period, the operation of cafes, restaurants and bars (except for delivery and takeaway), non-food stores, non-food markets, cinemas, fitness clubs, gyms, swimming pools, theaters and shopping centers is prohibited. Also, all educational institutions are placed on vacation, except for kindergartens and special educational institutions. In addition, all public events are prohibited.

During a lockdown, retail chains are allowed to sell food products, provided that at least 60% of their area is intended for food sales.

It is also allowed to trade in medicines, medical goods, hygiene products, communication equipment, veterinary drugs, feed, seeds, plant protection products, household chemicals and the printed press, trade in fuel.

According to decree No. 1236, trade in other groups of goods can only be carried out on condition of targeted delivery of orders.

It is also allowed “to carry out activities for the provision of financial services, activities of financial institutions and activities for the collection and transportation of currency values, the activities of postal operators, as well as medical practice, veterinary practice, the activities of gas stations (without food zones), activities for maintenance and repair vehicles, hairdressers and beauty salons by appointment.”

It is prohibited to conduct all mass (entertainment, sports, social, advertising and other) events (except for the organization of skiing leisure, but without the work of catering establishments and the sale of alcoholic beverages). At the same time, the ban also does not apply to the New Year and Christmas holidays (without concerts and fairs, including food fairs), official sports events included in the Unified Schedule of Physical Culture and Health and Sports Events of Ukraine and matches of team playing sports of professional sports clubs without spectators, provided that the participants of such events comply with the relevant sanitary and anti-epidemic measures and the implementation of mandatory daily monitoring of the health of the participants.

Also, the work of catering establishments and places for food in hotels is prohibited from 11:00 to 6:00 the next day, except for the provision of catering services in a hotel room at the request of customers.

Central and local executive authorities, other state bodies, from January 11 to January 22, 2021 inclusively, were instructed to establish a remote (home) work mode for employees, except for employees for whom it is impossible to establish a remote (home) work mode due to the nature of the performed tasks, and workers providing administrative services.

It is also recommended “to local government bodies, enterprises, institutions, organizations regardless of the form of ownership, except for institutions, regardless of the form of ownership, providing financial, banking and housing services, health protection, food supply, energy supply, water supply, communications, those that provide the functioning of the infrastructure of transport support, the sphere of defense, law and order and protection, critical infrastructure facilities, to establish a remote (home) work mode for workers in the period from January 11 to January 22, 2021, inclusively.”

Resolution No. 1236 also extended the quarantine regime in Ukraine until February 28, 2021. At the same time, planned hospitalizations in communal and state medical institutions are prohibited, the work of private clinics is not limited. Private medical institutions can carry out planned hospitalizations and operations in compliance with the necessary sanitary and epidemiological standards.

As mayor of Kyiv Vitali Klitschko said earlier, during the lockdown, public transport of the capital, including the metro, will work, but urged to use public transport only when it is necessary.

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Illegal import of vaccine against COVID-19 in significant volumes is hardly possible – expert

Illegal import of vaccine against COVID-19 in significant volumes is hardly possible due to strict control over its circulation, senior partner of ABSC Krzysztof Siedlecki believes.

“The demand for the vaccine is huge, the requirements for its logistics are very high. I have very great doubts about the possibility of smuggling the vaccine into Ukraine, although it cannot be ruled out,” he told Interfax-Ukraine, commenting on the statement of businessman Mykhailo Brodsky that a number of Ukrainian government officials, in particular some people’s deputies and top officials, were secretly vaccinated against COVID-19 with the Pfizer vaccine illegally imported to Ukraine from Israel.

He noted that the COVID-19 vaccine is not currently in free circulation.

“This is not a product that you can just call and order from Pfizer. It doesn’t work that way. It’s hard to even imagine that some distributor can illegally import the vaccine, because this vaccine requires special transportation conditions, a very low temperature – 70 degrees below zero, because at higher temperatures the vaccine is stored for only a few days. The possibility of smuggling this vaccine under such conditions is very small,” he said.

The expert stressed that due to the high demand for the COVID-19 vaccine, the distribution of these vaccines around the world is carried out under the strict control of state authorities. At the same time, he admitted that “the doctor can take several doses of the vaccine uncontrollably, but their validity is limited: if they are in the refrigerator, then the shelf life is several days.”

“I’m not saying it’s impossible, but it’s not easy. If we were talking about several hundred doses, then there would be a resonance. I don’t believe that Pfizer would have allowed such a leak,” he said.

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