The creators of Russia’s Sputnik V Covid-19 vaccine have demanded an apology from the chairperson of the European Medicines Agency after she likened the emergency approval of the pioneering formula to playing “Russian roulette.”
Austria’s Christa Wirthumer-Hoche was responding to moves by Slovakia and Hungary, two EU countries which have imported the Russian formula amid escalating Covid-19 case numbers in Central and Eastern Europe. Other member states, such as the Czech Republic and her own homeland are also considering using the jab.
Last month, the Russian Direct Investment Fund (RDIF) revealed that it had applied for registration in the EU, and on March 4, the EMA began a rolling review of the vaccine. According to the agency, the human medicines committee cited results from laboratory and clinical studies as a reason to start the formal evaluation.
However, unlike the Western-made vaccines from Pfizer-BioNTech, AstraZeneca, and Moderna, the EMA has yet to recommend Sputnik V for emergency authorization. This is despite a study published in British medical journal The Lancet, which showed that the vaccine has a 91.6 percent efficacy rate.
Speaking to Austrian broadcaster ORF, Wirthumer-Hoche urged EU member states to refrain from accepting the Russian-made vaccine, citing a lack of reviewable information on those vaccinated.
“We could have Sputnik V on the market in future, when we’ve examined the necessary data,” she said, according to France24. “I would strongly advise against a national emergency authorization. It’s somewhat comparable to Russian roulette.”
In response, the creators of the vaccine came out fighting, noting that Wirthumer-Hoche’s comments “raise serious questions about possible political interference” in the review process, noting that she didn’t make similar comments about any other Covid-19 jabs.
We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V. Her comments raise serious questions about possible political interference in the ongoing EMA review. Sputnik V is approved by 46 nations.
— Sputnik V (@sputnikvaccine) March 8, 2021
“After postponing the Sputnik V review for months, the EMA does not have the right to undermine the credibility of 46 other regulators that reviewed all of the necessary data,” a tweet on the official Sputnik V account said.
On Monday, RDIF head Kirill Dmitriev revealed that, after discussions with Rome, the fund had agreed a deal with Swiss-based Adienne Pharma & Biotech for making the vaccine in Italy. Production could potentially begin in June.
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