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| Developers of Sputnik V demand apology from European Medicines Agency chief after she calls approval of vaccine ‘Russian Roulette’ | Developers of Sputnik V demand apology from European Medicines Agency chief after she calls approval of vaccine ‘Russian Roulette’ |
| (about 1 month later) | |
| 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.” | 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. | 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. | 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. | 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. | 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.” | “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. | 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. |
| “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. | “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. | 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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