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Russian Federation publishes virus vaccine results, weeks after approval

Russian Federation publishes virus vaccine results, weeks after approval”

The vaccine is named Sputnik-V in homage to the world's first satellite, launched by the Soviet Union.

This raised concerns among Western scientists over a lack of safety data, with some warning that moving too quickly on a vaccine could be risky.

Russia denounced criticism as an attempt to undermine Moscow's research, and a Russian investor claimed vindication when Britain's prestigious The Lancet published research that showed patients in early tests developed antibodies with "no serious adverse events".

In Phase-2, 85 per cent of participants had detectable antibodies at 14 days after the priming dose, rising to 100 per cent by day 21, the results showed.

"With this (publication) we answer all of the questions of the West that were diligently asked over the past three weeks, frankly with the clear goal of tarnishing the Russian vaccine", said Kirill Dmitriev, the head of the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, which has backed the vaccine.

Instead, a spokeswoman said, the state wants to review the data before agreeing to distribute the vaccine.

The trials were open label and not randomised, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomly assigned to different treatment groups.

"Phase 1 and phase 2 trials have been carried out, and there is sufficient reason to scale up into much larger phase 3 trials".

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Worldwide experts remained cautious over the vaccine's effectiveness and safety.

Dr. Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health and colleagues write in the journal that the studies were "encouraging but small".

Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, who is on the FDA vaccine-advisory committee, said in an interview Thursday that it seemed unlikely there would be enough data to demonstrate efficacy of the Covid-19 vaccines in late-stage testing by the end of October.

It is important to note that phase III trials involving tens of thousands of healthy volunteers that test experimental vaccines against a placebo are considered necessary to determine safety and efficacy before they are given to hundreds of millions of people to prevent or lessen the severity of Covid-19.

Lead author Dr Denis Logunov, of the N F Gamaleya National Research Centre for Epidemiology and Microbiology in Russian Federation, said: "When adenovirus vaccines enter people's cells, they deliver the SARS-CoV-2 spike protein genetic code, which causes cells to produce the spike protein". Last week, the Centers for Disease Control and Prevention, which is expected to be involved in distributing vaccines, notified USA states that they should be ready to launch Covid-19 vaccination campaigns by November.

During a video conference with President Vladimir Putin, Sobyanin said he made a decision to get the vaccine to show support for its developers.

Sputnik V was developed by the Gamaleya research institute for epidemiology and microbiology in Moscow in coordination with the Russian defence ministry.

The report's lead author, Denis Logunov of Gamaleya, said the adenovirus vaccine enters people's cells and delivers the SARS-CoV-2 spike protein genetic code, helping the immune system "recognise and attack" the virus.



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