Russian coronavirus vaccine was 92% effective in phase 3 studies – Telam

The vaccine is in phase 3 with tests on more than 40,000 volunteers in Russia

The Russian vaccine Sputnik V against the coronavirus, the acquisition of which is negotiated with Moscow by the Argentine government, achieved 92% efficiency according to preliminary results of the phase 3 study and did not record “unexpected side effects”The Gamaleya National Research Center and the Russian Direct Investment Fund (RDIF) reported this morning in a statement.

They confirm the high efficiency of the Russian vaccine

“The trials evaluated efficacy among 16,000 volunteers who received the vaccine or placebo 21 days after the first injection. Following a statistical analysis of 20 confirmed coronavirus cases, the distribution of cases between vaccinated individuals and those who received the placebo indicates that the Sputnik V vaccine had a 92% efficacy rate after the second dose “says the official text.

These are the provisional results of the ongoing phase 3, double-blind, randomized, placebo-controlled clinical trials in which 40,000 volunteers are participating in 29 medical centers across Russia, of whom 20,000 have already received the first dose, and 16,000 the first and the second.

The published efficacy data will be published in The Lancet magazine in the coming weeks, as confirmed by Denis Logunov, deputy director of the Gamaleya Center during a virtual conference organized with the Argentinian media last Monday.

Argentine government negotiates possibility of country receiving 25 million doses of Sputnik V“

In today’s statement, Logunov said: “The positive interim phase 3 results give reason to expect a positive outcome from the Sputnik V clinical trials. We will continue to process and analyze all data and consider looking forward with optimism, hoping that the results of our work will help end the pandemic sooner. “

Regarding safety, the developers reported that “some of the vaccinees had minor short-term side effects, such as pain at the injection site, flu-like illness including fever, weakness, fatigue and headache.”

After the completion of the phase 3 clinical trials, the Gamaleya Center announced that it will provide access to the full clinical trial report, while “observation of study participants will continue for six months, after which the final report will be presented “.

During clinical trials, the information is analyzed by the Independent Monitoring Committee, made up of Russian scientists. “The collection, quality control and processing of data is carried out in accordance with ICH GCP standards and with the active participation of the Moscow Department of Health and Crocus Medical, the contract research organization (CRO)”, it was detailed in the statement.

There were no unexpected side effects during the trials

Likewise, it has been argued that “research data will be provided by RDIF to national regulators in countries interested in purchasing the Russian vaccine to speed up the registration process.”

As announced last week, the Argentine government is negotiating the possibility that the country will receive 25 million doses of Sputnik V, 10 of which could arrive next December at an estimated price per regimen (two doses) of 19 $ 95 in total.

Other candidates are vaccines from AstraZeneca, Pfizer, Sinopharm and Janssen, three of which are in clinical trials in the country.

The executive branch enacted the vaccine law last Friday aimed at generating immunity against Covid-19 (27,573), a necessary tool to move forward in contracts with different companies.

A day later, pharmaceutical company AstraZeneca announced that it had signed an agreement with the government to provide more than 22 million doses of its vaccine.

Sputnik V uses a technology called “non-replicating viral vestores”; Vectors are viruses that do not have the ability to reproduce in the body (and are therefore harmless) and are used to transport the genetic material of the virus to be immunized.

Unlike others who use this technology, Sputnik V is the only one to use two human adenoviruses as vectors, one different in each dose administered intramuscularly with a difference of 21 days.

In addition to Russia, Phase 3 clinical trials of Sputnik V are currently underway in Belarus, the United Arab Emirates, Venezuela and other countries, as well as phases 2 and 3 in India.

A separate detailed study of the safety and immunogenicity of the vaccine in the elderly is also underway.

Sputnik V became the world’s first registered vaccine against Covid-19 when the Russian Ministry of Health performed this procedure on August 11.

Beyond clinical trials, the statement reports that “in September, the vaccine was administered for the first time to a group of volunteers from the” red zones “of Russian hospitals.”

“The observation of 10,000 additional vaccinated volunteers representing physicians and other high-risk groups under civilian use of the vaccine outside of clinical trials also confirmed the vaccine’s effectiveness rate of over 90 percent,” said they declared.

“The use of the vaccine and the results of clinical trials show that it is an effective solution to stop the spread of coronavirus infection, a preventive health care tool, and it is the most effective way to overcome it the pandemic, ”he said. today Mikhail Murashko, Minister of Health of the Russian Federation.

According to the statement, more than 50 countries have already requested 1.2 billion doses of vaccine: “Vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and in other countries “. described.