MOSCOW (Reuters) – President Vladimir Putin said Tuesday that Russia was the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a Moscow resolution compared to its good fortune in the Space Cold War. Career.
However, the vaccine, which will be called “Sputnik V” in homage to the first global satellite introduced through the Soviet Union, has yet completed its last tests.
Moscow’s decision to grant approval before that date has raised considerations among some experts. Only about 10% of clinical trials are a success and some scientists fear that Moscow will put national prestige first to safety.
Putin and other officials said it was absolutely safe. The president stated that one of his daughters accepted him as a volunteer and felt intelligent afterwards.
“I know it works effectively, the bureaucracy has strong immunity and, I repeat, has passed all the mandatory controls,” Putin said at a government meeting.
The Russian conglomerate System said it plans to put the vaccine, developed through the Gamaleya Institute in Moscow, into mass production until the end of the year.
Government officials said it would be administered to doctors and then teachers on a voluntary basis on the expiration of this month or early September. The massive deployment in Russia is expected to begin in October.
The vaccine is given in two doses and is composed of two serotypes of a human adenovirus, which carries an S antigen of the new coronavirus, which enters human cells and produces an immune response.
The platform used for the vaccine has been developed through Russian scientists for more than two decades and has served as the basis for several vaccines in the past, adding those that oppose Ebola.
The government hopes that this will allow the Russian economy, which has been hit by the consequences of the virus, to regain its full capacity.
Kirill Dmitriev, director of Russia’s sovereign wealth fund, said Russia had already won billion-dose foreign applications. He added that the vaccine will also be produced in Brazil.
Dmitriev said clinical trials will soon begin in the United Arab Emirates and the Philippines. Philippine President Rodrigo Duterte said he was in a position to participate personally.
PHASE III TEST
Approval from the Ministry of Health comes before the start of a larger trial involving thousands of participants, known as a phase III trial.
These trials, which require a certain proportion of participants to contract the virus to practice the effect of the vaccine, are considered essential precursors for a vaccine to obtain regulatory approval.
The Moscow-based Association of Clinical Trial Organizations (OTCA), an industry framework representing the world’s leading drug brands in Russia, suggested this week that the ministry postpone approval until the final trial is effectively completed.
In a letter to the department, he claimed that there were the main dangers associated with registering a drug before that happened.
“It is at this stage that the greatest evidence of the efficacy of a vaccine is collected, as well as data on the adverse effects that would possibly occur in certain patient teams: other people with impaired immunity, others with concomitant diseases, etc.
Some foreign experts also know how fast Russia has approved its vaccine.
“Normally, you want a large number of people to check before passing a vaccine,” said Peter Kremsner of Tuebingen University Hospital, Germany, who is lately testing CureVac’s COVID-19 vaccine in clinical trials.
“In this sense, I think it is unwise to do so (approve) if many other people have not yet been tested.”
U.S. Health Secretary Alex Azar when asked about Russia’s announcement, said protection is paramount and complex testing is essential. He said the United States is on its way to an effective vaccine until the end of the year, with six applicants in development.
“The purpose is not to be the first to receive a vaccine. The purpose is to have an effective vaccine,” Azar said on ABC News’ “Good Morning America” program.
“We hope this is true, but as is the case with Russia: accept as true by check,” said the acting president of the White House Council of Economic Advisers, Tyler Goodspeed, on Fox Business Network, referring to a Russian proverb quoted. through former U.S. President Ronald Reagan during negotiations. with the Kremlin.
More than one hundred COVID-19 vaccines are being developed imaginable worldwide. At least 4 are in the final phase of phase III human trials, according to WHO data.
(Additional reports through Maxim Rodionov, Polina Ivanova and Alexander Marrow in Moscow and Caroline Copley in Berlin, Josephine Mason and Kate Kelland in London, Susan Heavey in Washington; written through Gabrielle Tétrault-Farber / Andrew Osborn; edited through Giles Elgood)
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