Phase 2 Trials Have Begun, Intent to Distribute Nationally by September
The Russian Gamaleya Institute in Moscow has reportedly already completed a phase 1 trial of an experimental COVID-19 vaccine. Military personnel made up the test subjects, but now top executives and politicians have been given the opportunity to receive the 2 shots that are purported to create an immune response lasting for 2 years.
Russia has the fourth-highest number of COVID-19 cases in the world, reporting over 750,000.
The Gamaleya vaccine was funded by the Russian Direct Investment Fund (RDIF) and has been in trials since April, although the information is not public for fear of being overwhelmed by potential participants.
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The phase 1 trial included roughly 40 participants. Although the results have not been published, Gamaleya is moving into a much larger phase 2 trial. According to RDIF chief Kirill Dmitriev, Phase 3 is scheduled to begin on August 3 and include participants from Russia, Saudi Arabia, and the United Arab Emirates. The vaccine could be available nationally in Russia as early as September.
Western researchers will typically run a phase 3 trial over several months to better understand efficacy and safety.
What Is Known About the Vaccine
Russian Defence ministry n Gamaleya Institute in Moscow complete successful phase 1 n Phase 2 trials of anti Covid vaccine likely to come out in September https://t.co/wdmoSRVjeB
— Etrending News (@EtrendingN) July 21, 2020
The “viral vector vaccine” fuses a common cold virus with the SARS CoV-2 protein to create an immune response. It mirrors a vaccine being developed in China that has also moved to phase 2 trials.
Last week, the U.S., Canada, and the U.K. all accused Russian government hackers of attempting to steal COVID-19 vaccine secrets. Russia denied the allegations.
According to a Gamaleya researcher, hundreds of people have already received the vaccine, including high-ranking government officials and wealthy professionals, as well as their families. RDIF chief Kirill Dmitriev and his family are among those that have received the shots, as well as many Gamaleya employees. It is unknown if President Vladimir Putin or others in his administration have had the shots.
Some participants have reported having no side effects to the shots, while others have had fevers and muscle aches.
Participants are Volunteers
The Russian elite who are currently receiving the shots are not part of the trials, but are monitored by Gamaleya, with their results recorded. It is unclear how the volunteers are selected, but there is no cost to them. They do sign a waiver that they understand the risks associated with the shots.
Offers were put out to large, influential companies, for their top executives to receive the shots. While some have accepted and others are still deliberating, others have declined, citing that the vaccine has not been proven to be safe yet.
Some doctors are advising against their patients receiving the vaccine, explaining that it can take a year or more to understand all of the potential risks associated with it.
RDIF’s Dmitriev confirmed that two types of vectors are being tested.
While there is a worldwide race to develop an effective COVID-19 vaccine, sufficient and responsible clinical testing is necessary before releasing one on a large scale.
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