Burning stage?
Earlier this week, President Vladimir Putin announced Russia officially became the first country to approve the Covid-19 vaccine called Sputnik-V.
Vaccine Sputnik-V researched and developed by the Gamaleya Research Institute in Moscow in collaboration with the Russian Ministry of Defense. Russian scientists have been testing this vaccine on humans for months but it seems that only Stage 1 and Phase 2 are implemented, while information about Stage 3 is still questionable.
Stage 1 and Stage 2 usually test only a few hundred people to determine if the vaccine triggers the body’s immune response without causing dangerous side effects. Meanwhile, phase 3 aims to determine if a vaccine will prevent the risk of Covid-19 infection before it is approved, and the process requires testing on tens of thousands of people.
According to Russian media, the number of people who tested the Sputnik-V vaccine in both phases 1 and 2 was only 76 people. Russian Deputy Defense Minister Ruslan Tsalikov said in a recent interview that the Russian army completed phase 2 testing by the end of July.
In April, Russia passed a law allowing a third testing phase to be skipped before the approval of the Covid-19 vaccine. Now, after Sputnik-V has been approved, Russia can distribute tens of thousands of doses of this vaccine in parallel with phase 3 testing.
According to the AP, on August 11, Mr. Kirill Dmitriev, managing director of the Russian Direct Investment Fund - the Sputnik-V development sponsor, said phase 3 has been started and has been tested with more than 2,000 people. in Russia and some Middle East countries, Latin America. However, Russia will start vaccinating the vaccine within the next 2 weeks and the vaccine will begin massively from around October.
"The vaccine is not actually growing faster than other vaccines," said Neal, who said Moderna and Oxford’s vaccines have already begun to be tested in phase 3.
Doubting the effectiveness of the Sputnik-V
There are still many doubts about the effectiveness of the Sputnik-V. (Image: Reuters)
So far, no one seems to be able to give a definitive answer whether Russia’s Sputnik-V vaccine is really effective and safe when the available scientific data are relatively limited. "We do not have any information to confirm whether it is safe or not," commented Keith Neal, professor of infectious diseases at the University of Nottingham, commented.
Russian officials said that the volunteers participating in the phase 1 and 2 trials felt healthy after vaccination and did not have any unwanted side effects. Speaking of which, however, Professor Neal said: "You won’t know side effects without extensive testing, especially if those are rare side effects. That’s the crux of the trial. stage 3 ".
Talking about the effectiveness of Sputnik-V, Neal said: "I think it can at least produce antibodies. What we don’t know is whether it helps prevent the risk of infection."
Sputnik-V is developed based on virus vector technology, the technology used to develop vaccines for Ebola, MERS in the past. Accordingly, scientists will choose a harmless virus, in this case Adenovirus, the virus that causes the common cold. They then remove the infectious gene so that it cannot cause disease. Adenovirus continues to be implanted with a sequence of the SARS-CoV-2 virus, which produces the spiny protein of SARS-CoV-2, to attack cells. When that protein is injected into the human body, the body may have an immune response, but this approach still carries risks.
Scientists who developed Sputnik-v say that the vaccine induces a strong cellular immune response and antibody in the volunteers to test it. Information on the Russian Sputnik-V website says: "No volunteer gets Covid-19 after vaccination".
"It is not clear how effective the Russian vaccine is and whether the volunteers have previously been immune to Adenovirus," said Scott Gottlieb, a former member of the US Food and Drug Administration (FDA).
Who gets the shot first?
More than 20 countries have ordered Sputnik-V. (Artwork: Getty)
The Russian Ministry of Health said that the frontline medical team and teachers will be the first to receive the Sputnik-V injection. At the end of July, the country’s officials denied the news that politicians and elites would be vaccinated first.
Mr. Kirill Dmitriev said that Russia will start mass production of Sputnik-V vaccines from October with production of about 5 million doses per month. "We will start mass production in Russia in October. The vaccine will be distributed to other countries around November," said Dmitriev.
Immediately after announcing the approval of Sputnik-V, Russia said more than 20 countries had ordered more than 1 billion doses of the vaccine. "Countries in Latin America, the Middle East and Asia want to buy this vaccine, we expect to complete many contracts," said Mr. Dmitriev.
However, the Sputnik-V is difficult to get ratified in the European Union and the US. “The problem is not that it is the first vaccine. The problem is whether the vaccine is safe and effective for the American people and for the people of the world or not ”, US Secretary of Health and Human Services Alex Azar commented on 11/8.
