COVID-19 coronavirus vaccine

2022: CoviVak and EpiVakCorona stopped producing due to lack of demand

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

2021

Start of production at the Nanolek plant in the Kirov region

In mid-December 2021, Nanolek began production of a vaccine for the COVID-19 COViVAK coronavirus, developed by the Chumakov Center. Investments in this project amounted to  40 million rubles. More details here.

In Nicaragua, launch the production of "CoviWaka"

During the VI International Congress of Russia-Nicaragua "World after the Pandemic: Directions for the Development of the Pharmaceutical Industry," held in Managua on October 18-21, 2021, the launch of the production of the CoviVak vaccine in Nicaragua was announced. The corresponding agreement was concluded by the developer of the drug FSBNU "FNCIRIP named after M.P. Chumakova RAS" and the Russian-Nicaraguan joint venture LBP Mechnikov. More details here.

Developer "CoviVaka": Our vaccine protects against COVID-19 by 98.4%

On September 29, 2021 Federal Scientific Center for Research and Development of Immunobiological Drugs named after M.P. Chumakov , they announced the high effectiveness of their coronavirus vaccine. COVID-19 According to Alexandra Sinyugina, director of quality at the center, the KoviVak drug protects 98.4% from infection and 99.1% from a severe form of the disease.

In a conversation with TASS, Sinyugina noted that the level of antibody production is directly related to the type of vaccine. At CoviVac, antibodies are produced containing information about all proteins of the virus, and immune memory is formed on the entire structure of the viral agent, which allows even with a small number of antibodies to have effective protection against this infection, she said.

The production of neutralizing antibodies in the inactivated whole-virion vaccine "KoviVak" is lower than in vector and RNA vaccines, this is directly related to the type of vaccine, but not in any way to the quality of production, "added the representative of the center Chumakova.

According to her, by the end of September 2021, more than 500 thousand Russians passed the full vaccination course of CoviVak.

Sinyugina said that during phase I/II clinical trials of the vaccine, scientists found that CoviVak causes antibody seroconversion in 85% of cases based on the results of the coronavirus neutralization reaction. Also, when undergoing vaccination, it is worth considering factors that affect the production of antibodies and the body's protective reaction, such as chronic somatic diseases, taking autoimmune therapy, drugs for correcting hyperglycemia, thyroid diseases, etc., she emphasized.

According to Alexandra Sinyugina, when passing the control for the presence of antibodies by ELISA methods (test systems), the interpretation of data on the number and quality of antibodies can be difficult.^[1]

The effectiveness of CoviVak was lower than that of other Russian vaccines

In early June 2021, the Federal State Budgetary Scientific Institution "Federal Scientific Center for the Research and Development of Immunobiological Drugs named after M.P. Chumakova RAS" named the indicator of the effectiveness of its vaccine for coronavirus COVID-19 "KoviVak."

The effectiveness of the vaccine is over 80%, the final phase of the trials has not yet been completed, the Center notes.

The Chumakov Center also reported that the production of the drug can be increased from the planned 10 million per year by more than six times.

The effectiveness of the CoviVak vaccine was lower than that of other Russian vaccines for coronavirus

On May 25, 2021, the director of the Chumakova Center, who developed the vaccine, Aidar Ishmukhametov said that the third stage of the KoviVaka tests could begin in a week. The exact date depends on the decision of the Ministry of Health of the Russian Federation. Under the third stage, studies will be conducted on volunteers over 60 years old and patients suffering from chronic diseases.

The performance figures of CoviVak called today [June 2, 2021] are just estimates. According to preliminary results of clinical studies of the second phase, about 80% of volunteers formed antibodies, "he said (quote from TASS).

On June 2, 2021, Aidar Ishmukhametov explained that the final level of efficiency of KoviVak can be talked about only after the completion of all phases of the tests.

In early June 2021, the CoviVak vaccine entered Moscow and the regions. The metropolitan health department specified that 3 thousand doses of the drug are already available in the city. Prior to this, Muscovites could get vaccinated with Sputnik V (the head of the Ministry of Health Mikhail Murashko in early June 2021 announced the effectiveness of this drug at 96%) and EpiVakKorona (94% - assessment of developers).^[2]

Immunity to COVID-19 after the Kovivak vaccine does not last very long

In early May 2021, the Federal Scientific Center for the Research and Development of Immunobiological Drugs named after M.P. Chumakov RAS named the timing of maintaining immunity to the COVID-19 coronavirus after vaccination a drug developed by him.

Our experience is about eight months, "said Aidar Ishmukhametov, director general of the Chumakova Federal Scientific Center, answering a corresponding question on the Russia 1 television channel.

He added that the Kovivak vaccine is "soft," since antibodies after vaccination are produced quite slowly.

Immunity to COVID-19 coronavirus after Kovivak vaccination does not last very long

We received data, up to 85% is the occurrence of antibodies, "he said.

Eight months is very little compared to how long the immunity to coronavirus remains in Sputnik V vaccinated. The head of the Center for the development of this drug named after N.F. Hamalei Alexander Ginzburg in April 2021 said that he hoped for lifelong preservation of immunity after vaccination with Sputnik V.

I have hope that the vaccine will not be valid for a year or two, but for life. I pricked twice, well, live there for 5-10 years, longer. As I say, I will leave my antibodies in the will to my descendants, "said Ginzburg.

At the same time, he emphasized that the Gamalei Center, which created the vaccine, will re-vaccinate those who have fallen antibody levels, as part of a special study.

At the end of April 2021, the Chumakova Center submitted documents to the World Health Organization (WHO) for the prequalification of the KoviVak coronavirus vaccine. The third phase of clinical studies of the vaccine is planned to involve 32,000 volunteers. The trials will involve people over 60 and with comorbidities.

According to the developers, the main advantage of CoviWaka is that the use of the vaccine can develop immunity in humans not only on Spike protein, but also on fragments of the Chinese virus. It is claimed that antibody production begins after the first injection, and the second vaccination strengthens the effect.^[3]

Availability of first vaccine batches for use

The third Russian coronavirus vaccine COVID-19 KoviVak, developed, Federal Scientific Center for Research and Development of Immunobiological Drugs named after M.P. Chumakov RAS comes for use. This was health care Mikhail Murashko announced by the Minister of the Russian Federation in an interview with Naila Asker-zade in the Vesti program on the 1 channel Russia on March 31, 2021.

According to him, the first batches of the drug will be available in early April. The CoviVak vaccine was registered in Russia on February 20, 2021. Then it was reported that in March about 100 thousand doses of the vaccine will enter the civil circulation.

According to Konstantin Chernov, Deputy General Director for Project Activities and Innovations of the Center, about 10 million doses of KoviVak are planned to be produced per year.

The third Russian COVID vaccine "KoviVak" comes for use

Vaccine production began at the end of March 2021. The preparation is in the form of a suspension for intramuscular administration. Its maximum cost, announced on March 25, will be 4330 rubles. We are talking about 10 ampoules of suspension with a volume of 0.5 ml. The price includes logistics costs in the amount of 128.85 rubles.

Unlike Sputnik V and EpiVakKorona, the KoviVak vaccine can help sensitive patients, said Mikhail Kagan, lead scientific editor of the vrachu.ru, in a conversation with Kommersant FM.

According to manufacturers, one of the potential advantages is that antibodies can be produced to different antigens of the virus. Even those that are not susceptible to mutation. Therefore, the drug may be more stable if the epidemic cannot be quickly taken under control and new mutant strains will appear, he said.

At the same time, the Ministry of Health warned that KoviVak should be used carefully, for example, for diseases of the nervous or cardiovascular system, liver and kidneys. Among the main contraindications of this drug are allergies, pregnancies, post-vaccine reactions or complications to any previous vaccination, Kommersant FM reports^{[4] [5]}

2020: Permission to conduct clinical trials

In September 2020 Federal Scientific Center for Research and Development of Immunobiological Drugs named after M.P. Chumakov RAS , he announced that he had received Ministry of Health of the Russian Federation permission from him for clinical trials of his coronavirus vaccine. COVID-19

The development of the center - an all-vinyl inactivated vaccine against COVID-19 - will be tested in Kirov, St. Petersburg and Novosibirsk with the involvement of 3 thousand volunteers in accordance with the requirements of the World Health Organization and international regulators, which will provide research with a reliable amount of scientific data.

The Ministry of Health of the Russian Federation allowed human trials of a whole-virion inactivated vaccine against COVID-19

Clinical trial participants will be provided with all necessary information about the procedure, as well as the benefits and risks associated with participating in this study. After vaccination, the Russians will be isolated in hospital for 16 days, doctors will observe their condition. The studies will be based on the principle of a double-blind placebo - neither the volunteer nor the researcher will know what the patient is taking.

We expect to complete clinical trials in November 2020, "said Aidar Ishmukhametov, Director General of the Center, Corresponding Member of the Russian Academy of Sciences.

In late August, at the Center named after M.P. Chumakova completed the preclinical phase of research and submitted an application to the Ministry of Health for clinical trials of his vaccine. Earlier, Ishmukhametov said that the end of KI and the start of production are planned only in January 2021.

Wholovirione vaccines use either artificially attenuated viruses that are unable to cause the disease, or already killed viruses (inactivated). Details about his drug at the Federal Scientific Center for Research and Development of Immunobiological Drugs named after M.P. Chumakov RAS by September 23, 2020 are not disclosed.^[6]

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