Russia demanded an apology from the EU drug regulator after its top official compared getting the Sputnik V vaccine to playing 'Russian roulette'

• A European Medicines Agency official compared taking Russia's COVID-19 vaccine to Russian roulette.
• She made the remark while urging countries to wait for the EMA's approval before authorizing it.
• Sputnik V's official Twitter account called the comments "inappropriate" and demanded an apology.

Russia has demanded an apology from a top European Medicines Agency official after she said that approving the country's prized Sputnik V vaccine was like playing "Russian roulette."

The EMA began rolling trials of Sputnik V on March 4, but EU member states like Hungary have already approved the shot or, like Czechia and Slovakia, ordered batches from Moscow.

Last month, Austria also expressed interest in approving Sputnik V, prompting Christa Wirthumer-Hoche, the chief of the EMA management board, to urge caution.

"I would strongly advise against a national emergency authorization," Wirthumer-Hoche told Austria's ORF broadcaster Sunday, according to Agence France-Presse. "It's somewhat comparable to Russian roulette."

On Monday, the verified Twitter account of the Sputnik V vaccine rollout scheme hit back at Wirthumer-Hoche's comments, calling them "inappropriate" and asking for an apology.

"We demand a public apology from EMA's Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V," it said.

"Her comments raise serious questions about possible political interference in the ongoing EMA review. Sputnik V is approved by 46 nations."

"Such comments are inappropriate and undermine credibility of EMA and its review process," it added. "Vaccines and EMA should be above and beyond politics.

-Sputnik V (@sputnikvaccine) March 8, 2021

In a Tuesday statement to the state-run TASS news agency, the Kremlin spokesman Dmitry Peskov called Wirthumer-Hoche's remarks "regrettable" and "incorrect to say the least."

"The demand for the vaccine and the vaccination campaigns in many countries indicate its relevance and popularity," Peskov said.

In recent months, much doubt has been cast on the safety of the Sputnik V vaccine, which was given emergency-use approval by Moscow in August.

Reports at the time said scientists developing the vaccine at the state-run Gamaleya Institute rushed through trials to please the Kremlin.

The nationwide vaccination drive started in December, but Russians reportedly reluctant to take it up.

"Once a country has blatantly violated all of the scientific and ethical rules about deploying a vaccine, it's hard to regain trust," Lawrence Gostin, a professor of medicine at Georgetown University, previously told Insider.

Despite the worries, the results of a late-stage trial published in The Lancet in February found Sputnik V was 92% effective against COVID-19.

The Russian Foreign Ministry has also offered foreign diplomats working in Russia shots of the vaccine, but those representing European nations have chosen to wait for EMA approval.

While the EMA and US Food and Drug Administration have yet to approve Sputnik V, Russia has signed deals to sell batches to countries around the world. So far, 46 countries have approved Sputnik V, according to the Gamaleya Institute.

European doubts

The deals have drawn skepticism from European officials.

Last month, European Commission President Ursula Von Der Leyen questioned why Russia was selling its vaccine stores instead of vaccinating its people.

"We still wonder why Russia is offering theoretically millions and millions of doses while not sufficiently progressing in vaccinating their own people," she said.

While the EMA has not been in a rush to approve Sputnik V, it was announced on Tuesday that Russia had signed a deal to produce Sputnik V in Italy, the first manufacturing site outside the country.

While President Vladimir Putin and Russian state media championed Sputnik V, the US has also accused Russian intelligence services of working to smear the vaccine made by Pfizer, an American company.

A State Department official said Russian operatives were planting news articles online that cast doubt on the efficacy of the shot, The Wall Street Journal reported.

"We can say these outlets are directly linked to Russian intelligence services," the official said. "They vary a lot in their reach, their tone, their audience, but they're all part of the Russian propaganda and disinformation ecosystem."