Russia just became the first nation to grant regulatory approval to a coronavirus vaccine. President Vladamir Putin also shared that one of his daughters had received two doses of the vaccine.
Scientists around the world have responded with skepticism since the vaccine was developed in just two months. Moreover, the vaccine was in use before phase three of human trials, which typically involved thousands of volunteers over a few months.
Putin assures that the vaccine is safe and went through proper testing. "I know it has proven efficient and forms a stable immunity, and I would like to repeat that it has passed all the necessary tests," he said. "It is a time to be grateful for the achievement—for Russia and the entire world."
Describing one of his daughters who took part in the trials, she initially had a fever at 100.4 Fahrenheit after the first shot. The next day, her temperature dropped to 98.6 Fahrenheit. She had another fever after the second dosage, then was well soon after.
Currently, she seems to be "feeling well and has a high number of antibodies," shared Putin. The Health Ministry reported that the antibodies should provide immunity until 2022.
The Gamaleya Vaccine
Authorities said that medical frontliners, teachers, and other risk groups would be the first to receive the vaccine, with the first dosages released by the end of the month, said Deputy Prime Minister Tatyana Golikova.
Mass production of the vaccine will start by September and become available by October. Vaccinations will be available as phase three of trials are still ongoing, shared Professor Alexander Ginsburg of the Gamaleya Institute in Moscow whose team developed the vaccine.
Human trials began in mid-June, with 76 volunteers who received either a liquid dose or soluble powder. Most of the volunteers were military servicemen, as phase 2 trials ended in July. Other volunteers from countries such as the U.A.E., Saudi Arabia, and the Philippines also took part in the tests.
The Russian vaccine is one of the hundreds being developed around the world and one of the few in phase three of human trials. The Russian Direct Investment Fund, which is helping develop the Gameleya vaccine, had assured that they will follow all of the required procedures for approval.
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Skepticism from ACTO
The Association of Clinical Trials Organizations openly expressed their concern as Executive Director Svetlana Zavidova said that corporation rules could not be violated. "This is a Pandora's Box, and we don't know what will happen to people injected with an unproven vaccine."
Zavidova was also worried about Russia's lack of publications. "This runs counter to the rest of the world. There is a standard to publish data even from unsuccessful studies."
Other pharmaceutical companies that are also in phase three of human trials include Moderna (United States), Pfizer (United States), AstraZeneca (British-Swedish), and Sinopharm (China). All trials include thousands of volunteers worldwide with trials to be completed around October.
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