EMA Chair: "Chance of Approving Russian Vaccine is Like Russian Roulette"... Russia Calls It "Inappropriate Remark"

Chairman: "Insufficient Safety Data on Sputnik V Vaccine"
Russia: "Chairman Must Publicly Apologize for Negative Remarks"

[Image source=Yonhap News]

[Asia Economy Reporter Ki Ha-young] Russia has demanded a public apology after a senior official of the European Medicines Agency (EMA), the European Union's (EU) pharmaceutical evaluation and supervision body, gave a negative assessment of the Russian-made COVID-19 vaccine 'Sputnik V'.

According to RIA Novosti and AFP on the 9th (local time), Krista Wirthumer-Hoche, Chair of the EMA Management Board and Head of the Austrian Health Authority's Pharmaceutical Market Supervision, stated in an interview with Austria's ORF broadcast the previous day, "The possibility of Austria independently approving the Sputnik V vaccine is very low."

Wirthumer-Hoche said, "Hungary has independently approved emergency use, but in our (Austria's) case, it will not be easy," adding, "The government must authorize it, but that would be comparable to Russian roulette."

She pointed out that there is still insufficient data on the safety of vaccinated individuals and advised, "I strongly recommend that (Austria) not approve emergency use."

In response to Wirthumer-Hoche's remarks, the Russian vaccine developers demanded a public apology on Twitter, stating, "We demand a public apology from Wirthumer-Hoche for her negative comments about the EU countries that approved Sputnik V," and criticized, "Her comments raise serious concerns about possible political interference in the ongoing EMA review process of Sputnik V."

They continued, "EMA has never made similar comments about other vaccines," and accused, "EMA has no right to undermine the trust of the 46 national regulatory authorities that have approved Sputnik V."

Dmitry Peskov, spokesperson for the Kremlin, also told reporters on the same day, "This regrettable statement (by Chair Wirthumer-Hoche) is inappropriate," and argued, "The demand for the Sputnik V vaccine in many countries worldwide shows the necessity and popularity of this vaccine."

In response, Wirthumer-Hoche reiterated her negative view regarding the EMA's prospects for approving the Sputnik V vaccine at a press conference on the 9th, stating that communication with the Russian side is proceeding with difficulty and it is hard to predict when the vaccine will enter the EU market. She emphasized, "A few days ago, the first data verification of Sputnik V submitted by Russia to EMA began," and "Like all other vaccines, this vaccine must meet EU standards related to product quality, safety, and efficacy."

The dispute between Chair Wirthumer-Hoche and the Russian side arose amid reports that Austria, an EU member state, is considering approving the domestic use of Sputnik V independently of EMA approval. Russian President Vladimir Putin held a phone call with Austrian Chancellor Sebastian Kurz on the 26th of last month to discuss the supply of Sputnik V to Austria and local production issues. Chancellor Kurz reportedly met last week with a senior Russian official responsible for marketing Sputnik V.

Earlier, Kurz pointed out, "The vaccine issue should not be caught up in the geopolitical struggle between Russia and the West," but also stated, "Austria will follow EMA's recommendations regarding COVID-19 vaccine approval."

The EU is concerned that Russia might use the Sputnik V vaccine as soft power to pressure the West. So far, the EU has approved the emergency use of the US Pfizer and Moderna vaccines and the UK AstraZeneca vaccine, and this week is expected to decide on the approval of the single-dose US Johnson & Johnson (J&J) vaccine. EMA began reviewing the Russian-made Sputnik V vaccine for approval on the 4th.

According to Russian authorities, 46 countries, including Russia, have approved the use of the Sputnik V vaccine. Some EU countries, such as Hungary and Slovakia, have also independently approved the emergency use of Sputnik V ahead of EMA approval.

This content was produced with the assistance of AI translation services.