European Medicines Agency Urges EU Member States To Postpone National Rollouts Of Russian Sputnik V Vaccine Medicines & Vaccines 08/03/2021 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Vials of the Sputnik V vaccine that is under rolling review by the EMA. A senior official at the European Medicines Agency (EMA) has cautioned EU member states to wait until the agency has reviewed the safety and efficacy data of Russia’s Sputnik V vaccine before granting the vaccine emergency use authorization at national level, and beginning mass rollouts. Last week, the EMA formally began a rolling review of the Sputnik V vaccine, developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. If approved, the vaccine would be the first jab to be used in the 27 member states that was developed outside of the EU or the United States. The EMA announcement comes after Hungary and Slovakia already approved the Sputnik vaccine for national use and the Czech Republic is currently assessing the vaccine. All three countries are moving ahead without EMA approval. Austria has also expressed an interest in procuring doses of Sputnik V, but officials have indicated that the country won’t bypass the EMA. “I would urgently advise against giving a national emergency authorization,” Christa Wirthumer-Hoche, chair of the EMA managing board, told ORF, an Austrian news broadcast. “We need documents that we can review. We also don’t at the moment have data…about vaccinated people. It is unknown.” The rolling review will continue until enough evidence is gathered for a formal marketing authorization application, said the EMA in a press release. “Data packages are coming from Russian manufacturers and of course they will be reviewed according to European standards for quality, safety and efficacy. When everything is proven then it will also be authorised in the European Union,” Wirthumer-Hoche said. “We can have Sputnik V on the market here in the future when the appropriate data have been reviewed,” she added. Moscow has pointed to the high efficacy results – 91.6% in preventing symptomatic COVID-19 cases and full protection against severe infection – and the 42 countries that have already authorised the use of Sputnik V, pushing the EU to follow their lead. According to Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), the company responsible for marketing the Sputnik vaccine abroad, enough vaccines to inoculate 50 million Europeans will be available to deliver to the EU starting in June 2021. EU Concerned That Russia Is Using The Sputnik V Vaccine As A Geopolitical Tool Doses of the Sputnik V vaccine arriving in North Macedonia on Sunday. While some EU member states have been quick to accept the Sputnik V vaccine, in light of the delays seen in the manufacture and delivery of promised doses from Pfizer and AstraZeneca, with which the EU has created bulk purchase contracts, EU officials remain very wary of Russia’s potential use of the vaccine as a soft-power tool. “Overall I must say we still wonder why Russia is offering theoretically millions and millions of doses while not sufficiently progressing in vaccinating their own people,” said Ursula von der Leyen, President of the European Commission, in mid-February. “This is…a question that I think should be answered.” The Gamaleya Center responded to Von der Leyen’s comments in a Twitter statement, saying that: “Sputnik V considers EU a partner and would like to work together with EU to protect EU citizens and to produce Sputnik V vaccine in EU.” “Sputnik V suggests that vaccines should be above and beyond politics. We hope that EU and EMA will evaluate the vaccine on [a] scientific and not political basis,” the company added. 6. Sputnik V suggests that vaccines should be above and beyond politics. We hope that EU and EMA will evaluate the vaccine on the scientific and not political basis. Sputnik V has already been approved by 29 countries. — Sputnik V (@sputnikvaccine) February 17, 2021 This message was echoed by RDIF CEO Dmitriev: “Vaccine partnerships should be above politics and cooperation with EMA is a perfect example demonstrating that pooling efforts is the only way to end the pandemic,” he said in a press release last week. The slow rollout of vaccines in Europe has pushed several countries to pivot to the Sputnik V vaccine, hoping that it will fill the gap left by the delays in deliveries of the Western vaccines, namely Pfizer/BioNTech, Moderna and AstraZeneca. Some of the region’s most powerful states, such as Germany, have indicated that if the Sputnik V vaccine receives approval from the EMA, it would be keen to procure and even produce the Russian vaccine. “We are open to the idea of bilateral cooperation for the purpose of tapping European production capacities” for the vaccine, said Ulrike Demmer, deputy spokesperson for the German government, at a press conference in early January. The statement was made after German Chancellor Angela Merkel had a phone call with Vladimir Putin, Russia’s President, to discuss cooperation on vaccine production. RDIF Already Received ‘Numerous Requests’ “We have received numerous requests from EU states to provide Sputnik V directly to them based on the reviews of their national agencies. We will continue to do so as well as work with EMA based on the rolling review procedure,” said Dmitriev in a press release. The decision of some countries to unilaterally approve of the Sputnik V vaccine goes against the EU’s unified approach to the pandemic and could cause a rift in the European Commission. Already in November officials from the European Commission warned Hungary against procuring the vaccine ahead of the rest of the bloc. “This is where the authorization process and vaccine confidence meet. If our citizens start questioning the safety of a vaccine, should it not have gone through rigorous scientific assessment to prove its safety and efficacy, it will be much harder to vaccinate a sufficient proportion of the population,” a spokesperson for the Commission told Reuters. Even within Slovakia the decision to purchase two million doses of the Sputnik V vaccine ahead of approval by the EMA has caused some friction among government officials, with the foreign minister opposing the prime minister’s decision. “It is clear that Sputnik V is not just a vaccine, but a tool in hybrid warfare,” said Ivan Korcok, Slovakia’s Foreign Minister. “It divides us at home, it divides us abroad, it aims to create doubt about processes in the European Union.” The EMA, which has been criticised for its slow approval process for COVID-19 vaccines, is already set to make a decision on Johnson & Johnson’s single-dose vaccine on 11 March. Along with Sputnik, jabs by Novavax and CureVac, a German biotech firm, are also currently under a so-called “rolling review” with no timeline yet announced for a decision. Image Credits: Twitter – Sputnik V, RDIF. 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