Russia Reports Having First Licensed Novel Coronavirus Vaccine

According to The Washington Post, Russian authorities are reporting that they have developed and licensed the first vaccine against the novel coronavirus that is causing the COVID-19 pandemic:

Officials have pledged to vaccinate millions of people, including teachers and front-line health-care workers this month — before even finishing clinical trials — with the formula developed by the Gamaleya Institute in Moscow.

But Russia’s hard charge toward a potential vaccine has raised alarm among global health experts that the country is jumping dangerously ahead of critical, large-scale testing that is essential to determine if a possible covid-19 protection is safe and effective. Few details of the Gamaleya research have been made public or underwent peer review.

Russia’s Health Ministry did not respond to requests for comment, and the Gamaleya Institute referred an interview request to the ministry.

The vaccine is named Sputnik V, a reference to the first orbital satellite, which was launched by the Soviet Union in 1957 and set off the global space race. The name also evoked how Putin’s government has seen the vaccine race as a point of national pride and competition on a global scale, with labs in the United States, Europe, China and elsewhere are also in the hunt for a potential vaccine.

“Of course, what counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished,” Putin said at a meeting with government members Tuesday, adding that one of his two daughters had received the potential Gamaleya vaccine. He didn’t identify which daughter.

The Washington Post, August 11, 2020: https://www.washingtonpost.com/world/russia-unveils-coronavirus-vaccine-claiming-victory-in-global-race-before-final-testing-is-complete/2020/08/11/792f8a54-d813-11ea-a788-2ce86ce81129_story.html

There are a few instances in which vaccines and medicines still in trials may be offered to the general public. First, if the vaccine is showing exceptional efficacy and safety, and the disease it targets is causing significant levels of disease. Second, if the vaccine is showing not to be worse than the disease it targets, and that disease is causing significant numbers of deaths and injuries. Third, if the vaccine is showing acceptable safety levels and — while it may not be efficacious against the targeted disease — it shows some sort of protection or benefit against another disease or condition.

Notice that in those three scenarios, the paramount variable is safety. If a vaccine is not safe, it simply doesn’t make it out of Phase I or Phase II trials. Until there is more information about Sputnik V, other countries around the world may be hesitant to use the vaccine. In the meantime, you can track the progress of other vaccine development projects using the University of Notre Dame Vaccine Mapper application: https://vaccinemapper.nd.edu/.

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Author: René F. Najera, DrPH

I am the editor of the History of Vaccines site, an online project by the College of Physicians of Philadelphia. All opinions expressed on these blog posts are not necessarily those of the College or any of my employers. Check out my professional profile on LinkedIn: https://www.linkedin.com/in/renenajera Feel free to follow me on Twitter: @EpiRen

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