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Russia has released COVID-19 vaccine but safety concerns remain due to Scientists around the world immediately denounced the certification as premature and inappropriate methods

President Vladimir Putin announced Tuesday that Russia has become the first country to approve a vaccine to prevent coronavirus infection, saying one of his daughters has already received a dose of the new prophylaxis even though that it is still under development.

As the nation’s Ministry of Health issued what’s called a registration certificate for a vaccine candidate that has been tested in just 76 people. The certificate allows the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, to be given to “a small number of citizens from vulnerable groups,” including medical staff and the elderly, a Ministry of Health spokesperson tells ScienceInsider. But the certificate stipulates that the vaccine cannot be used widely until 1 January 2021, presumably after larger clinical trials have been completed.

Scientists around the world immediately denounced the certification as premature and inappropriate, as the Gamaleya vaccine has yet to complete a trial that convincingly shows it is safe and effective in a large group of people. Even some within Russia challenged the move. “It’s ridiculous,” says Svetlana Zavidova, a lawyer who heads the Association of Clinical Research Organizations in Russia. “I feel only shame for our country.” Zavidova, who has worked on clinical trials for 20 years and anticipated the approval, yesterday sent an appeal to the Ministry of Health to postpone registering the vaccine until proper efficacy trials are completed. “Accelerated registration will no longer make Russia a leader in this race, it will only expose end users of the vaccine, citizens of the country of the Russian Federation, to unnecessary danger,” she wrote on behalf of the clinical research group.

Speaking in a teleconference from his residence outside Moscow, Putin said the vaccine had been “registered,” referring to a bureaucratic procedure undertaken by the Russian Health Ministry, which amounts to regulatory approval.

“One of my own daughters has tested the vaccine,” Putin said, speaking in a teleconference from his residence outside Moscow. “All she experienced was a slightly elevated temperature and [she] feels just fine.”

He did not say which of his two daughters, both in their mid-30s, received the inoculation.

Russian President Vladimir Putin reportedly endorsed the use of the vaccine, which is dubbed “Sputnik V,” saying it had “passed all necessary steps” and noting that one of his adult daughters had received it. (Putin has not clearly acknowledged his children in public, but he does sometimes refer to them; one is a medical doctor in Moscow.) Putin, who apparently made these comments at a government meeting, added, “I hope we can start a massive release of this vaccine soon.”

We know the technology works and we will publish the data in August and September to demonstrate that,” Dmietriev said.
Developed by the Moscow-based Gamaleya Institute, the vaccine has yet to go through crucial Phase 3 trials in which it would be administered to thousands of people.
“The rollout in Russia will be very gradual. We are not going to give it to 10 million people tomorrow,” Dmietriev said, adding that frontline medical workers and people who are at high risk of contracting the coronavirus will be first in line to voluntarily receive the vaccine.
Following a planned mass rollout among Russians in October, Dmietriev said the vaccine will be made available to other countries around November. He claimed they have already received pre-orders for a billion doses of the vaccine.
Prashant Tambe
Prashant Tambe
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