EpiVacCorona (COVID-19 vaccine)

2022

Evaluation of the efficacy of the lung lesion vaccine

The effectiveness of EpiVacCorona against lung damage in coronavirus COVID-19 during the spread of delta and omicron strains is only 2%. Such data in the framework of their study received specialists from the European University in St. Petersburg and the Medical Institute. Berezin Sergey (MIBS).

The study was conducted between October 1, 2021 and April 28, 2022. Then scientists analyzed the data of patients with a positive PCR test for coronavirus - the infected were sent for computed tomography (CT) of the lungs. A total of 23,996 people took part in the study.

Patients with COVID-19 were named on CT for the vaccine they were vaccinated with, as well as the number of doses and the dates of their administration. Unvaccinated patients also participated in the study. Fully vaccinated were people who were given a second dose of the vaccine at least 14 days before being referred for a CT scan of the lungs.

Of the 314 people vaccinated with the EpiVacCorona vaccine, only 104 did not receive any lung damage, 210 had them, five more had serious injuries - the proportion of patients with lung damage of any degree was 65%. In individuals who did not receive any vaccinations, 63% were affected by the lungs. Of the more than 6,000 people with two doses of Sputnik V, 54% in principle did not receive lung damage, 45% had any organ damage. In 48% of those who were vaccinated with the CoviVac vaccine, the lungs were affected, in 52% this was not registered.

Of the 12.7 thousand unvaccinated, 8.25 thousand people had lung damage, while 257 participants had it serious. 4.45 thousand people did not have lung damage, researchers said.

Scientists have found that the largest share of cases of severe lung injury occurred during the spread of the delta strain in Russia, that is, from October 2021 to January 2022.^[1]

KoviVac and EpiVacCorona stopped producing due to lack of demand

In May 2022, KoviVak"" and "EpiVacCorona" ceased to be produced due to the lack of demand for these vaccines from. coronavirus COVID-19 Rospotrebnadzor As Alexander Gorelov, deputy director for scientific work of the Central Research Institute of Epidemiology, clarified, manufacturers of these drugs do not receive applications for vaccine supplies in the region.

We are faced with the fact that applications for other vaccine drugs are not received from the regions, except for Sputnik V... As a result, the production of KoviVaka, Epivak was stopped, and I don't know if Convacel appeared, whether it will see its future or not, Gorelov said on May 20, 2022.

According to him, experts still cannot agree on the need for revaccination: there are no population studies to understand how enough post-vaccination and post-infection immunity is, in what time frame and who needs revaccination. Gorelov added that, according to him, a combination of various vaccines is necessary to ensure maximum protection of the body from coronavirus infection.

On May 18, 2022, Maxim Nanolek Stetsyuk, First Deputy General Director of the Biopharmaceutical Company, announced that the production of KoviVaka was suspended due to lack of demand and orders from the Ministry of Health Russian Federation: there have been no applications since December 2021.

In February 2022, the incidence of COVID-19 in Russia began to decline. A month later, the regional authorities began to lift coronavirus restrictions. At the same time, experts do not exclude a new wave: Minister of Health Mikhail Murashko warned of a possible increase in the incidence in June 2022.

By May 13, 2022, collective immunity to COVID-19 in Russia was at the level of 39.2%, follows from the daily summary of the headquarters for the fight against coronavirus.^[2]

Contracts for the export of 50 million doses of EpiVacCorona have been concluded

On February 1, 2022, it became known about the conclusion of contracts for the export of 50 million doses of EpiVacCorona. The agreements with a number of foreign companies were reported at the Vector Scientific Center, which developed this vaccine against the coronavirus COVID-19.

At the same time, it is not specified with whom exactly the contracts were concluded and in which countries the drug will be supplied. Earlier, the general director of "Vector" Rinat Maksyutov said that "EpiVacCorona" is planned to be delivered to Brazil and Venezuela. Subsequently, Venezuela became the first country to export the drug to.

By January 14, 2022, 12.9 million doses of EpiVacCorona "(6.4 million kits) were released.

On January 24, 2022, a group of scientists led by Candidate of Medical Sciences Anton Barchuk published a preprint of a study analyzing the effectiveness of Russian vaccines against COVID-19. EpiVacCorona turned out to be the only vaccine whose effectiveness has not been confirmed. Its protection efficiency turned out to be negative: minus 40%. The center "Vector" replied then that the sample size used by the researchers does not allow assessing the effectiveness of vaccines.

So, for the expected vaccination efficiency of 50%, provided that 20% of the population is vaccinated, WHO recommends a sample of 1,594 people. At the same time, the results of a sample of 17 people were used for calculations for EpiVacCorona, which corresponds to a vaccination coverage of 1.4%... The obtained data on the assessment of the effectiveness of EpiVacCorona may significantly differ from both the true value and the value obtained during clinical trials, the center explained.

They also noted that the method given by the researchers is focused on monitoring the situation and comparison with the data of clinical trials.^[3]

The Ministry of Health stopped purchasing and supplying EpiVacCorona due to low demand

On January 25, 2022, it became known that the Ministry of Health of the Russian Federation stopped purchasing and supplying vaccines against the coronavirus COVID-19 to EpiVacCorona and EpiVacCorona-H. It is assumed that the reason for this is the low demand for drugs in the regions.

At least 28% of doctors reported the absence of EpiVacCorona and EpiVacCorona-H in their hospitals, 48% indicated that they were available, according to a survey of 243 doctors from all over the country, conducted at the request of Vedomosti by the professional community Doctors of the Russian Federation. At the same time, 83% of respondents do not know anything about the timing of future deliveries. Over 70% of respondents said that EpiVacCorona is not in demand among patients.

The Ministry of Health stopped purchasing and supplying EpiVacCorona due to low demand

The fact that since the beginning of 2022 the EpiVacCorona and EpiVacCorona-H vaccines have not been received in the regions was written by Vedomosti on January 25, 2022 with reference to the register of Roszdravnadzor. Sources of the newspaper in the State Duma and the Russian pharmaceutical company claim that the supply of these vaccines has ceased for a long time. One of the interlocutors of the publication said that "there is reason to talk about the suspension of production" of EpiVacCorona.

RNC Pharma Development Director Nikolai Bespalov also did not rule out that the suspension of the purchase of the vaccine may be due to technical difficulties. In his opinion, the Russian authorities are unlikely to refuse to use EpiVacCorona.

The production of EpiVacCorona goes according to the approved plans, and four vaccine series released at the end of 2021 are in the warehouses of manufacturers, a representative of the Vector Scientific Center, which developed the drug, told Vedomosti. But whether the vaccine is produced by January 25, 2022, he did not specify. This vaccine is not, for example, in Moscow, according to the website of the mayor of the capital. EpiVacCorona is also not available in the Nenets Autonomous Okrug, the publication says.^[4]

2021

Start of vaccine supplies abroad

On October 15, 2021, the Deputy Prime Minister Yury Borisov announced the supply of EpiVacCorona abroad. The first foreign country to receive this vaccine against the coronavirus COVID-19 was Venezuela. The supply agreement has already been concluded, he said during an intergovernmental commission of the two countries.

Russia Plans to supply the vaccine created by the Novosibirsk Center Vector"," Venezuela was reported in June 2021. Then it was announced its intention to supply 5 million kits (10 million doses) to the country by the end of the year. Rospotrebnadzor Rinat Maksyutov, Director General of the State Scientific Center for Virology and Biotechnology "Vector" (developer of the drug), reported that batches of the EpiVacCorona vaccine will be delivered Brazil to Venezuela in the fall of 2021.

EpiVacCorona began to be delivered to Venezuela

Venezuela approved EpiVacCorona in July 2021. In addition, another Russian vaccine, Sputnik V, is used in the country. From the end of 2020 to October 2021, 3.86 million doses of the Sputnik V drug were delivered to the country, as well as 600 thousand packages of the Avifavir coronavirus drug.

Earlier, the head of the Ministry of Industry and Trade Denis Manturov said that the export of Russian vaccines against the coronavirus EpiVacCorona and KoviVac could begin by the end of 2021. However, he stressed that the main task is to provide drugs with the country's internal needs.

On October 15, 2021, Iouri Borisov noted that Russia sees significant prospects for further strengthening cooperation in the pharmaceutical industry.

It is especially pleasant to note: we are talking not only about shipments of Russian pharmaceuticals, but also about the transfer of Russian technologies and industries to Venezuelan partners, which will allow Venezuela to be independent from the supply of Western pharmaceutical products, the Deputy Prime Minister said.[5]

Rospotrebnadzor: EpiVacCorona is 90% effective

On September 30, 2021, Deputy Director for Scientific Work of the Central Research Institute of Epidemiology of Rospotrebnadzor, Corresponding Member of the Russian Academy of Sciences Alexander Gorelov said that the effectiveness of the EpiVacCorona vaccine is about 90%. He noted that this indicator is "proven... in various segments of the population. "

By mid-September 2021, about 1 million people were vaccinated by EpiVacCorona. The vaccine is easily tolerated by patients and safe to use, the drug developer claimed at the time. Tatyana Nepomnyashchikh, deputy general director of the Vector center, noted that among the fully vaccinated EpiVacCorona, only 1% of patients are infected with coronavirus.

Rospotrebnadzor: EpiVacCorona's efficiency is 90%

The third/fourth phase of post-registration clinical trials of the EpiVacCorona vaccine is being completed, now we are collecting data from eight clinical bases that conducted the studies. After we receive all the data and process it, the final result will be obtained. I think it will be in the fall. The research results are planned to be published in scientific peer-reviewed journals, Nepomniachtchi said in September 2021.

The developers did not provide official data and publications on the effectiveness of the drug by September 30, 2021. By this time, about 50 million Russians have been vaccinated against the coronavirus COVID-19, said Deputy Head of Rospotrebnadzor Vyacheslav Smolensky.

At the end of April 2021, the Vector Center assured that EpiVacCorona was effective against all known strains of coronavirus. At that time, there were practically no samples of the Indian strain in Russia, which by September 2021 had become dominant in the country.

Ministry of Industry and Trade The head of the Russian Federation Denis Manturov in September 2021 said that in the fourth quarter, the production of EpiVacCorona will quadruple and reach about 10 million sets.^[6]

Among 1 million vaccinated "EpiVacCorona" a little more than 0.5% of vaccinated

At the end of July 2021, the State Scientific Center for Virology and Biotechnology "Vector" of Rospotrebnadzor named the share of people who fell ill with the coronavirus COVID-19 after vaccination with the drug "EpiVacCorona."

Among the 1 million vaccinated by EpiVacCorona, a little more than 0.5% of those vaccinated fell ill. In other words, among 200 people, only one person falls ill. At the same time, we are talking about the Indian strain, - RBC quotes the words of the head of the center Rinat Maksyutov.

Among 1 million vaccinated with the EpiVacCorona vaccine, a little more than 0.5% fell ill

According to him, only weak side effects are noted in a small number of patients vaccinated with EpiVacCorona - short-term soreness at the injection site and an increase in temperature to 37.5.

Maksyutov added that from the beginning of 2021 to the end of July, more than 4 million doses of EpiVacCorona were produced. In the fall, Vector plans to enter production of up to 5 million doses per month thanks to the production of a full-cycle vaccine at the Geropharm site.

Rospotrebnadzor in January 2021 spoke about the 100 percent effectiveness of the vaccine. The head of the Yekaterinburg Research Institute of Viral Infections "Vector" Alexander Semenov in April argued that antibodies after vaccination with "EpiVacCorona" are produced in 94% of cases. At the same time, in May, another representative of "Vector" - Alexander Ryzhikov - called the figure of 90%. Later, the developers argued that the drug is also effective against the British and South African strains of COVID-19.

According to Rinat Maksyutov, by the end of July 2021, the vaccine is delivered to all regions of Russia. At the same time, the drug had not previously arrived in the regions for several weeks. The center "Vector" named as the reason for the break the need to update the state contract for the supply of vaccines. It was noted that the interruption in supplies affected more than 50 regions.^[7]

50% of vaccine-vaccinated volunteers found no antibodies at 9 months after vaccination

In mid-June 2021, it became known about the disappearance of antibodies to the coronavirus COVID-19 in half of the volunteers who were vaccinated with the EpiVacCorona vaccine nine months ago. This was announced by the general director of the FBUN "State Scientific Center of Virology and Biotechnology" Vector "(developer of the drug) Rinat Maksyutov.

As of three and six months [after vaccination], we record the presence of antibodies in all vaccinated volunteers. As of nine months, more than half of the volunteers also observe a detectable level of antibodies to the virus, he said in an interview with the Russia 24 TV channel.

50% of volunteers vaccinated with EpiVacCorona showed no antibodies 9 months after vaccination

According to Maksyutov, out of 100 volunteers, 57 received the EpiVacCorona vaccine, of which 20 people contacted the virus, only two noted a deterioration in health.

Later, Zoya Skorpileva, an immunologist at the European Vaccination Center, said that nine months have not yet passed since the EpiVacCorona vaccination, so the data that those vaccinated with this drug do not have antibodies after this period are incorrect.

Earlier, Vektor claimed that they expect the formation of immunity to COVID-19 for a year after vaccination with EpiVacCorona. Director of the Gamaleya Center Alexander Gintsburg said he hopes for a lifetime effect of the Sputnik V vaccine.

Participants in the clinical study "EpiVacCorona" in March 2021 published an open letter to the Minister of Health Mikhail Murashko with an appeal to organize a vaccine study independent of Rospotrebnadzor. During an independent investigation with the participation of an independent laboratory, the three authors of the letter established in an experiment that in none of the studied cases did the vaccinated develop neutralizing antibodies.^[8]

Start of vaccination in Moscow polyclinics

In mid-May 2021, vaccination against the coronavirus COVID-19 with the drug EpiVacCorona began in Moscow polyclinics, while before it was possible to be vaccinated only with Sputnik V. This was reported to journalists by the vice-mayor of Moscow Anastasia Rakova.

At all vaccination points against coronavirus infection located in city polyclinics, Muscovites have access to vaccination with both Sputnik V and EpiVacCorona vaccines, she said.

According to her, by mid-May 2021, about 100 vaccination points were opened in the capital. The patient can tell the doctor which drug he wants to be vaccinated with.

EpiVacCorona vaccination began in Moscow polyclinics

Anastasia Rakova also said that vaccination takes no more than 40 minutes, of which 30 minutes is observation after vaccination. No special preparation for the medical procedure is required.

By mid-May 2021 Russia , the is vaccinated with a two-time vaccine "EpiVacCorona." According to Deputy Director Central research institute of epidemiology of Rospotrebnadzor Alexander Gorelov, after the first dose, humoral is formed (immunity determined by the presence of antibodies - IgM and IgG immunoglobulins), but it does not fix in the body for a long time. After the second vaccination, a person already forms T-cell immunity ("memory cells" appear), which provides reliable protection against infection.

By mid-May 2021, clinical trials of the EpiVacCorona vaccine are underway, which must be administered with three injections. In early April 2021, the Ministry of Health of the Russian Federation allowed the first and second phases of tests, 300 volunteers aged 18 to 60 take part in them. Experts will assess the safety, tolerability, reactogenicity and immunogenicity of the vaccine for the prevention of COVID-19. Tests of the drug on animals have confirmed the effect of increasing the duration of immunity.^[9]

The Ministry of Health of the Russian Federation explained the difference between the Sputnik V and EpiVacCorona vaccines

At the end of January 2021, the Ministry of Health spoke about the difference between vaccines against the coronavirus COVID-19 Sputnik V and EpiVacCorona. As emphasized in the department, both drugs reliably protect against coronavirus infection, but their mechanism of action is different. Their main differences are that Sputnik V was obtained by biotechnology, which does not use the pathogenic COVID-19 virus for humans. Read more here.

Mishustin allocated 2 billion rubles for the production of the EpiVacCorona vaccine

Prime Minister Mikhail Mishustin signed a government decree on the allocation of 2 billion rubles for the production of the EpiVacCorona vaccine against COVID-19, which is being developed by the Vector Scientific Center. This was announced on January 26, 2021 by the press service of the Cabinet.

It is noted that more than 2 million doses of the drug will be released with the help of federal funding. Part of the money will go to supply the drug to the regions.

According to Mishustin, the Ministry of Health of the Russian Federation received documents for the registration of another vaccine developed at the Chumakov Center.

Mikhail Mishustin allocated 2 billion rubles for the production of the EpiVacCorona coronavirus vaccine

This is the third development of our scientists, and in the coming months it will also enter civilian circulation. All this will allow expanding vaccination, making it more accessible, which means protecting even more people, the Prime Minister emphasized.

By January 27, 2021, mass vaccination against coronavirus with Sputnik V continues in Russia. At a meeting of the Coordination Council under the Government to combat the spread of coronavirus infection, Mikhail Mishustin said that in February it is planned to "large-scale production" of the EpiVacCorona vaccine, which had previously begun to enter civilian circulation.

Earlier Ministry of Health , the Russian Federation issued Vektor permission to conduct post-registration studies of the drug on 150 volunteers over 60 years old and for tests on 3 thousand volunteers from other age groups. Rospotrebnadzor Head Anna Popova said earlier that by the end of 2020, Vector will release 50 thousand doses of its vaccine.

By the end of January 2021, EpiVacCorona had only one production site registered - Vector itself. The pharmaceutical company Geropharm announced its intention to become an industrial partner of Vector for the production of a vaccine against COVID-19. The company intends to produce one of the key components of the vaccine - the carrier protein.^[10]

2020

Efficacy 100% in clinical trials

In January 2020, Rospotrebnadzor reported that the effectiveness of the EpiVacCorona coronavirus vaccine according to the results of clinical trials is 100%.

Start of production of EpiVacCorona vaccine

At the end of October 2020, the production of the second vaccine against the coronavirus COVID-19 began in Russia. We are talking about a drug called EpiVacCorona, which was developed by the Novosibirsk center Vector.

Rospotrebnadzor The head of Anna Popova announced the launch of EpiVacCorona production on October 27, 2020. According to her, by the end of the year "certain volumes" of the drug will be produced.

Production certainly starts at different sites... production of the vaccine by the Gamaleya Institute, production has begun at Vektor, and as soon as, I am sure, the vaccine of the Chumakov Institute will be registered, they will also be ready for production... We have different platform solutions, and all three vaccines, and I think there will also be a fourth, they use different production sites, "Popova said.

Russia began to produce the second vaccine against coronavirus "EpiVacCorona"

She clarified that the fourth means a drug that the Federal Biomedical Agency (FMBA) is developing at the Research Institute of Vaccines and Serums in St. Petersburg.

On October 26, 2020, the Ministry of Health of the Russian Federation added the EpiVacCorona vaccine to the recommendations for the prevention of COVID-19. The Ministry specified that the drug from "Vector" should be injected twice with an interval of at least 14-21 days at a dose of 0.5 ml intramuscularly into the upper third of the shoulder, and, if impossible, into the lateral broad thigh muscle. In addition to EpiVacCorona, the Ministry of Health added Sputnik V to the list of means of preventing coronavirus infection in adults.

By October 27, 2020, the EpiVacCorona vaccine is in the third post-registration phase of clinical trials. As stated in the Ministry of Health, it will be introduced into civilian circulation on January 1, 2021. The first batch of the drug, according to Rospotrebnadzor, should be released at the end of October 2020.^[11]

Registration of the second Russian vaccine against COVID-19 "EpiVac-Corona"

On October 14, 2020, the president Russia Vladimir Putin announced the registration of the country's second coronavirus vaccine. COVID-19 A drug called "EpiVac-Corona" was developed by the Novosibirsk Center "."Vector

Deputy Prime Minister Tatyana Golikova said that clinical trials of the vaccine registered today were carried out on 100 volunteers. Unlike the Sputnik-V vaccine, which is vector, that is, produced on the basis of adenovirus, the new one was created on the basis of one of the promising synthetic platforms.

It is a peptide vaccine, consists of artificially synthesized short fragments of viral peptide proteins, through which the immune system learns and further recognizes and neutralizes the virus, "Golikova explained.

Second EpiVac-Corona coronavirus vaccine registered in Russia

According to her, the first 60 thousand units of the vaccine of the Vector Center are planned to be released in the near future. 40 thousand volunteers will be involved in trials of the new vaccine, including people over 65 years old. Golikova assured that the new vaccine is characterized by "lack of reactogenicity and a fairly high level of safety."

By mid-October 2020, the third Russian vaccine against coronavirus is on the way - from the Chumakov Center of the Russian Academy of Sciences. This is a whole-virion vaccine that contains a whole virus. Golikova said that the second phase of clinical trials of this vaccine will begin on October 19, and will end by December. According to her, "another 285 volunteers will be immunized."

Vladimir Putin called on "to increase the production of both our first vaccine and the second vaccine now."

And, of course, first of all, it is necessary to provide the Russian market with these drugs: they should go to the pharmacy chains of Russia, and as wide as possible, "the head of state emphasized, adding that Russia continues to cooperate with foreign partners and will" promote "the vaccine abroad.[12]

Start of clinical trials of a vaccine against COVID-19 in Russia

On July 27, 2020, Vector clinical trials on volunteers began at the State Research Center for Virology and Biotechnology. coronavirus vaccines COVID-19 This was announced by the head Rospotrebnadzor Anna Popova.

According to her, preclinical tests, which were completed earlier in July, were successful. On July 24, the virology center received permission for clinical trials. Even then, it was said that on July 27, volunteers would be injected.

The vaccine is different from all such, it is peptide, that is, the vaccine does not carry a biological agent in any part, and in this regard is absolutely areactogenic, "said Anna Popova, speaking at the virtual symposium" The impact of the COVID-19 pandemic and HIV on achieving Sustainable Development Goals 3.3. "

Clinical trials of EpiVacCorona began in Russia

According to the Pharmvestnik edition with reference to the public procurement website, research on the COVID-19 coronavirus vaccine at the State Research Center for Virology and Biotechnology Vector will cost the federal budget about 46.2 million rubles. The drug was called EpiVacCorona.

The contract for testing the EpiVacCorona vaccine on volunteers was signed on July 14. As follows from the information on the execution of the contract, "Vector" contributed 9.3 million rubles in advance or 30% of the cost of the study. According to the estimate, the payment for volunteer services and immunological research is almost half of the contract price - 21.8 million rubles. Each volunteer will receive 148 thousand rubles.

Simple-blind, placebo-controlled randomized trials will involve 100 volunteers aged 18 to 60 years. The EpiVacCorona vaccine is a suspension for intramuscular administration, must be stored at reduced temperatures: from + 2 to + 8 °^[13]

Notes