British purchasing agency Crown Agents will purchase COVID-19 vaccines for Ukraine, Health Minister Maksym Stepanov said during a press briefing in Kyiv on Friday.
“At an extraordinary meeting of the government, it was decided that the procurement of vaccines against COVID-19 will be carried out by the international organization Crown Agents. It will have the authority to conclude contracts in accordance with the preliminary negotiations held by the Ministry of Health, the leadership of the state, as well as logistics support of goods,” he said.
Stepanov noted that the company is purchasing vaccines against COVID-19 for different countries, in particular for the UK.
“We have changed the purchasing organization, because at the end of 2020, the work of the State Enterprise Medical Procurement of Ukraine was extremely ineffective. I consider the organization of the process by the leadership of this company ineffective,” the minister added.
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.
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.
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.
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.
Ukraine will receive the vaccine produced by the Sinovac Biotech Chinese company within 30 days after registration, Health Minister of Ukraine Maksym Stepanov said during a press briefing in Kyiv on Thursday.
“Due to the supply of the vaccine from Sinovac Biotech, we will receive 1.913 million doses of vaccine against coronavirus disease. During the first delivery, some 700,000 doses will arrive in Ukraine, we will receive them within 30 days after the vaccine is registered either in the manufacturing country or in other countries (the United States, UK, EU, Brazil, etc.),” he said.
“The company is to release the results of clinical trials in Brazil on January 7. It is stipulated that the vaccine must have an efficiency of at least 70%. Negotiations with the manufacturer have lasted since September 2020. The agreement was signed by the Lekhim Ukrainian pharmaceutical company,” the minister said.
According to Stepanov, the third phase of clinical trials was done in Brazil (13,060 patients), Indonesia (1,600 patients) and Turkey (1,325 patients). The efficiency in Indonesia was 97%, in Turkey it was 91%. The FDA recommends that COVID-19 vaccines should be more than 50% effective.
The minister said that all vaccines purchased for government funds will be free for all citizens of Ukraine.
In addition, the head of the Health Ministry said that the department is at the final stage of signing contracts with other vaccine manufacturing companies, and also intends to increase the number of vaccines that will be supplied to Ukraine as part of the COVAX initiative.
