Light satellite

2022: Confirmation of safety of AstraZeneka vaccine combination

On February 14, 2022, the R-Farm Group of Companies, the Russian Direct Investment Fund (RDIF, Sovereign Fund of the Russian Federation) and AstraZeneka announced the interim results of phase II clinical studies to assess the safety of the combined use of AstraZeneka vaccine and the first component of the coronavirus vaccine Satellite V (Human Satellite) based on adenovirus 26.

In studies involving 100 volunteers in Russia and 100 volunteers in Azerbaijan, the combination of drugs demonstrated an optimal safety and tolerability profile, which relates to the results of previously conducted clinical studies on the safety of AstraZeneka, Sputnik V and Sputnik Light vaccines.

Monitoring of volunteers continued for 57 days after the first vaccination and showed high safety rates of combined drug use. The follow-up revealed no serious adverse events associated with vaccination.

The Russian Direct Investment Fund (RDIF), Gamalei Center, AstraZeneka and R-Pharm launched a clinical research program that assesses the combined use of different adenovirus vaccines to prevent coronavirus infection. In December 2021, the World Health Organization (WHO) recommended a similar approach, also known as heterologous prime bust vaccination, for use in real clinical practice. According to WHO estimates, heterologous vaccination regimens with different drugs will provide more flexibility to vaccination programs, making them more accessible to the population, as well as increase the effectiveness of vaccination.

A joint clinical study to assess the safety and immunogenicity of phase II of the combination of AstraZeneka vaccine and the first component of the Sputnik V vaccine is carried out as part of a four-party memorandum signed in December 2020 by the Russian Direct Investment Fund, Gamalei Center, AstraZeneka Company and R-Farm Company. The study takes place in Azerbaijan, Russia and the United Arab Emirates. Intramuscular injections of the AstraZeneka vaccine and the Ad26-S component of the Sputnik V vaccine are administered to volunteers in different sequences at intervals of 28 days.

Preliminary data on the combined use of Sputnik Light and AstraZeneka vaccines confirm the correctness of the use of various vaccines during revaccination. In the event of the emergence of dangerous strains of coronavirus, it is this approach that can provide safe, effective and long-term protection. said Kirill Dmitriyev, CEO of the Russian Direct Investment Fund.

Data on the safety profile complements the previously announced information about the high immunogenicity of the vaccine combination. We are one step closer to completing research. Work on the interpretation of data continues, noted Vasily Ignatiev, General Director of R-Farm.

"The results from the study suggest the safety of combined vaccine use. The use of "vaccine cocktails" can be a way out in the context of the continuing needs of health systems around the world associated with population revaccination, added Irina Panarina, CEO of AstraZeneka, Russia and Eurasia.

2021

About 85 million sets of vaccines for the Sputnik V and Sputnik Light coronavirus were produced

As of November 25, 2021, about 85 million sets of vaccines for the Sputnik V and Sputnik Light coronavirus have been produced. This was announced by the director of the National Research Center for Epidemiology and Microbiology named after Hamalei (developer of these drugs) Alexander Ginzburg. More details here.

Putin revaccinated from coronavirus "Satellite Light"

On November 21, 2021, the president Russia Vladimir Putin announced that he had undergone revaccination from coronavirus. COVID-19

Today, on your recommendation, on the recommendation of your colleagues, I gave myself another vaccination "Sputnik Light," this is already called revaccination, "the head of state said at a meeting with the deputy director of the Gamalei Center Denis Logunov.

Putin revaccinated from coronavirus "Satellite Light"

According to Putin, two hours after the vaccination, he has no unpleasant feelings, he feels normal.

The president was vaccinated against COVID-19 coronavirus in the spring of 2021, but then he did not name the drug that was introduced to him. He received the first component of the drug on March 23, the second on April 14. Putin later said that he was vaccinated by Satellite V.

Putin also announced on November 21, 2021 that he was ready to participate in the test of the COVID-19 vaccine in the form of a nose spray - such an experiment is conducted by the Gamalei Center. Logunov answered positively: Putin will be able to become a volunteer.

According to Kremlin spokesman Dmitry Peskov, Vladimir Putin feels normal after re-vaccination with Sputnik Light. A presidential spokesman on November 22, 2021 emphasized that after vaccination, the president follows the working schedule.

Answering the question about when Vladimir Putin will test the nasal vaccine for coronavirus, Peskov explained:

Timely, as doctors will come to the conclusion that this can be done.

Denis Logunov at a meeting with Putin noted that the effectiveness of revaccination from coronavirus is almost twice as high as primary vaccination, which can be judged based on their incidence index.

According to him, the principle of revaccination has already been repeatedly used earlier in the fight against other infections, and in the case of coronavirus, the "correct option" is to receive repeated vaccination after six months.^[1]

Ginzburg: With a sick coronavirus, it is better to be vaccinated by Satellite Light

November 17, 2021 N.F. Gamalei National Research Center for Epidemiology and Microbiology (FSBI "NITSEM named after N.F. Gamalei") Ministry of Health Russia gave people with coronavirus COVID-19 recommendations for vaccination.

The Ministry of Health made the right decision: those who are under 60 years old - "Light," and those who are over 60 - "Satellite V," Alexander Ginzburg, director of the Hamalei Center, told RIA Novosti.

Thus, people under the age of 60 who have a coronavirus should be vaccinated by Sputnik Light, and over 60 years old - by Sputnik V.

Alexander Ginzburg: With a sick coronavirus, it is better to be vaccinated by Sputnik Light

The Ministry of Health explained that, according to the instruction, the Sputnik Light drug is used:

• for the prevention of a new coronavirus infection in citizens aged 18 to 60 years;
• for repeated vaccination or previously ill persons over 60 years of age.

It is specified that for 60 + citizens who were not vaccinated against COVID-19 earlier and did not suffer from a new coronavirus infection, the use of the Sputnik Light drug was not recommended for the formation of immunity due to a decrease in the function of the immune system. For immunization of this population, it is recommended to use the available two-component drugs (Sputnik V and EpiVaCorona).

Earlier, Ginzburg said that the need to revaccinate is "very critical," and the methodological recommendations of the Ministry of Health "say that once every six months in the conditions of a complex epidemic, it is necessary to revaccinate Satellite Light."

And there will be some other strain - then we'll see if there are any new properties of this strain, "he said, noting that in six months the level of antibodies decreases if we constantly do not encounter a foreign antigen, so we need to overwrite.

On November 15, 2021, Alexander Ginzburg said that in Russia there are cases of multiple revaccination from coronavirus. According to him, the vaccinated had "absolutely no" negative consequences.^[2]

The effectiveness of the vaccine in Muscovites was 70%, with age it decreases

The effectiveness of the Sputnik Light vaccine in Muscovites was 70%. With age, it decreases. This was reported to the Russian Direct Investment Fund (RDIF) in mid-October 2021.

As specified in the fund, Sputnik Light protects 70% from the delta strain of SARS-CoV-2 within three months after vaccination. The study was conducted on the basis of data for July 2021 obtained in Moscow. Experts analyzed the data of 28 thousand people vaccinated by Satellite Light and compared them with a control group of 5.6 million unvaccinated Russians. In the vaccinated group, 126 people fell ill (0.44%), and in the group of people without immunity to COVID-19, 82,196 people (1.45%).

Among people over 60 years old, the effectiveness of the Russian vaccine against the Indian strain COVID-19 exceeded 75%. In addition, according to the RDIF, the effectiveness of Sputnik Light against the delta strain when used as a booster for other vaccines "will be close to that of the delta version of the Sputnik V vaccine - more than 83% against infection and more than 94% against hospitalization."

The effectiveness of the Sputnik Light vaccine in Muscovites was 70%, with age it decreases

At the same time, the effectiveness of immunization with the Sputnik Light drug decreases with age: from 88.61% in the youth group (18-29 years old) to 53.63% in the group of people over 70 years old, according to a study, a copy of which is published on the medRxiv.org portal.

Denis Logunov, deputy director of the N.F. Gamalei National Research Center for Epidemiology and Microbiology, noted at the end of June 2021 that in relation to the delta strain, Sputnik V showed a decrease in serum activity by 2.6 times, but the efficiency remains high - 90%. The assessment of virus-neutralizing activity is not identical to the effectiveness of the vaccine, emphasized in the RDIF: with a decrease in the activity of neutralizing antibodies in serum by 2.6 times, the effectiveness of the vaccine decreases slightly - these are separate indicators.^[3][4]

Vaccine entry into civil circulation

The Sputnik Light vaccine entered civil circulation at the end of June 2021. The minister reported about it zdravookhraneniyamikhait Murashko. According to him, by the end of the month 2.5 million doses of the drug will be available.

The head of the Ministry of Health of the Russian Federation said that Sputnik Light is intended for those who have already suffered from COVID-19 coronavirus, as well as for previously provoked citizens. He also added that the vaccine is allowed for use by citizens under 60 years old.

COVID-19 Sputnik Light vaccine entered civil circulation

The head of Rospotrebnadzor, Anna Popova, previously said that after vaccination with this vaccine, antibody production occurs after 21 days, while from the rest of the drugs after 42 days.

Earlier, the director of the center named after Hamalei Alexander Ginzburg said that Sputnik Light is planned to be delivered abroad, and Russians will be vaccinated with two components of Sputnik V. In addition, the Moscow City Hall reported that Sputnik Light plans to vaccinate labor migrants.

Part of the Sputnik Light series, according to numerous appeals from employers, is likely to enter commercial circulation. Thus, vaccination will be available for foreigners, including labor migrants, the Ministry of Health said.

In early June 2021, Oleg Gridnev, deputy head of the Ministry of Health, said that Sputnik Light would be used mainly to vaccinate young people, primarily students.

On June 22, 2021 the CEO of the Russian fund of straight lines investitsiykirill Dmitriyev emphasized that the revaccination "Light Satellite" promotes fast increase in level of active antibodies and, as a result, immune protection of an organism against COVID-19.

Light Satellite is the first injection of Sputnik V. The effectiveness of Sputnik Light, according to the developers, is 79.4% from 28 days after receiving immunization. It is claimed that the cellular immune response to the S-protein is SARS-CoV-2 formed in 100% of those vaccinated on the 10th day.^[5]

Start of clinical trials

January 11, 2021 it became known about the issued Ministry of Health of the Russian Federation permission to conduct clinical research " coronavirus vaccines COVID-19 Sputnik Light." It was developed, National Research Center for Epidemiology and Microbiology named after N.F. Gamalei which previously created and launched the vaccine "" into mass circulation.Satellite V

As follows from the entry in the register of the Ministry of Health, the tests began on January 8, their completion is scheduled for December 2021. 150 volunteers will take part in the tests. The preparation is a solution for intramuscular administration, one dose is 0.5 ml. The tests will be carried out on the basis of Sechenov University in Moscow and two organizations in St. Petersburg - the Eco-Security Research Center and the A.A. Smorodintsev Influenza Research Institute.

Clinical trials of Sputnik Light coronavirus vaccine have begun

In mid-December 2020, the president announced the creation of a light version of the Sputnik V vaccine. Russia Vladimir Putin He noted that the drug involves only one vaccination and helps to work out faster. antibodies to coronavirus

As the director of the Hamalei Center Alexander Ginzburg later explained, immunity from the use of the "light vaccine" is formed for three weeks and will remain for about 3-4 months. The main task of using such a drug is to reduce the number of deaths from coronavirus infection in those countries where mortality is very high, he said.

According to Ginzburg, "clinical studies of light vaccines on certain age groups will naturally be required."

The Sputnik Light coronavirus vaccine will be used in other countries, in Russia they will still be vaccinated by Sputnik V (introduced in two doses), the Director General of the Russian Direct Investment Fund (RDIF) Kirill Dmitriyev said on January 11, 2021 .^[6]

Notes