Enlarge / Russia's President Vladimir Putin. (credit: Getty | Mikhail Klimentyev )

Russian President Vladimir Putin on Wednesday announced the second dubious approval of a COVID-19 vaccine that has not been evaluated in clinical trials.

The vaccine, dubbed EpiVacCorona, is said to be a synthetic peptide-based vaccine, which uses fragments of the pandemic virus, SARS-CoV-2, to spur protective immune responses in those vaccinated. It was developed by Vector State Virology and Biotechnology Center, a former Soviet bioweapons research lab.

Like the first Russian-approved vaccine, whether EpiVacCorona is actually safe and effective is completely unknown. In a televised news conference , Putin said that early trials involving 100 people were successful. But researchers have not published any safety or efficacy data from those trials. Russian health officials have said they are still reviewing the vaccine for “safety and quality” but declined to provide any additional information on the vaccine, data, or approval process.

Enlarge / Russian President Vladimir Putin address the 75th session of the United Nations General Assembly, via teleconference call, in Moscow on September 22, 2020. (credit: Getty | MIKHAIL KLIMENTYEV )

Some United Nations staff are likely brushing up on their Russian—specifically how to say “Thanks, but no thanks” in the nicest way possible.

On Tuesday, Russian President Vladimir Putin offered UN staff free doses of the country’s COVID-19 vaccine, Sputnik V, which has not completed clinical trials for efficacy and has not been thoroughly vetted for safety.

Still, Putin suggested that his offer was prompted by the desire to give the people what they want: “Some colleagues from the UN have asked about this, and we will not remain indifferent to them,” he said during a speech Tuesday at this year’s (virtual) General Assembly.

Enlarge (credit: Aurich Lawson / Getty Images)

After hastily granting approval last week for a COVID-19 vaccine that has yet to enter rigorous clinical trials, Russia has now announced plans to give the vaccine to more than 40,000 volunteers in a trial that starts next week.

The “previously planned post-registration” injections are part of a “randomized, double-blind, placebo-controlled multicenter clinical study” of the vaccine, dubbed Sputnik V, according to an August 20 press release from the Russian Direct Investment Fund , which has financially backed the development of the vaccine. The more than 40,000 people for the trial will be recruited from more than 45 medical centers, the press release added.

On August 11, Russian President Vladimir Putin announced that Sputnik V had won regulatory approval, making it the first COVID-19 vaccine in the world to achieve domestic approval. Putin hailed Sputnik V as a breakthrough and even announced that one of his daughters had already received one dose of the two-dose vaccine.