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Hungary’s approval of the vaccine is independent of the European Union and could cause tensions with Brussels as the jab is yet to be approved by the European Medical Agency (EMA). Russia filed for registration of the vaccine in the bloc on Wednesday. Russia said it could supply Hungary with its Sputnik V coronavirus vaccine from next month after Budapest gave initial approval to the shot, which was also registered for domestic use on Thursday by the United Arab Emirates.
Russia is seeking international endorsement for Sputnik V, named after the satellite that triggered the Cold War space race, and is steadily building up its global customer base. It has signed numerous supply deals and regulators in eleven countries have now granted approval for the shot’s domestic use.
Some countries such as Argentina, have based the decision to use Sputnik V on data provided by Russia from its large-scale Phase III trial. Others, such as the UAE, granted approval following their own domestic trials.
Further registrations of the Russian shot by regulators are expected this month, primarily by countries in Asia and Africa, Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF) which is responsible for marketing the vaccine abroad, said in a briefing on Thursday.
Moscow has said Sputnik V is 91.4 percent effective at protecting people from COVID-19, based on interim results, but it has not yet released the full dataset for the trials.
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Phase III trial data is expected to be published in an international medical journal likely as early as next week, Dmitriev said.
Scientists have raised concerns about the speed at which Moscow has launched its vaccine, giving the regulatory go-ahead for the shot at home and launching mass vaccinations before full trials to test its safety and efficacy had been completed.
German Chancellor Angela Merkel said on Thursday that the German regulator could help guide Russia through the EMA approval process. If approval is granted, Merkel said, Moscow and Berlin could discuss joint production of the vaccine.
Dmitriev also said on Thursday that RDIF’s Brazilian manufacturing partner, pharmaceutical company Union Quimica, had already begun manufacturing the Sputnik V vaccine, though Brazilian regulators have not yet approved the shot.
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Union Quimica is one of several foreign producers on which Russia will rely to fulfil its large-scale vaccine export deals.
The RDIF sovereign wealth fund has pledged to deliver Sputnik V shots to over 500 million people this year, across dozens of countries.
These will primarily be supplied by producers in Kazakhstan, China, India, and South Korea, among others.
Domestic production of the shot will focus on meeting the needs of the Russian population first.
As of Wednesday, 6.5 million doses of the vaccine – each dose including a shot and a booster deployed 21 days later – have been produced, TASS cited the health minister as saying. 5.17 million doses will reach the Russian regions in February.
The move comes ahead of the virtual summit of European Union leaders.
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EU news: Hungary’s decision to approve the Russian vaccine could cause tensions with Brussels
The summit, set to start at 5pm on Thursday seeks to address the coronavirus pandemic’s mounting challenges, from containing more infectious variants to the threat of border closures and the slow roll-out of vaccines across the bloc.
The heads of EU institutions have urged the leaders to maintain unity and step up testing and vaccinations, though no formal conclusions are expected from the online video conference, the ninth since the pandemic began.
The European Commission said on Tuesday that the 27 EU countries should have vaccinated at least 70 percent of adults by summer and needed to be genome sequencing at least five percent of positive tests to identify new coronavirus variants.
Vaccinations have begun slowly, with the bloc lagging the likes of Britain and Israel in terms of per-capita coverage.
EU countries expressed alarm when they found out last week that Pfizer, the manufacturer of one of only two EU-approved vaccines, would temporarily reduce deliveries.
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Italy is considering legal action.
German Chancellor Angela Merkel warned on Tuesday that her locked-down country may need to consider border crossing curbs if other European countries did not act to halt the spread of the new more transmissible virus variants.
European Commission President Ursula von der Leyen told the European Parliament on Wednesday that EU countries should be able to scale up sequencing to 5 percent and then 10 percent of positive tests.
The European Centre for Disease Prevention and Control had the capacity to do so.
All EU members had access to that capacity, but only two had so far used it, she said.
Von der Leyen also insisted that blanket border closures made no sense and were not as effective as targeted measures.
EU Council President Charles Michel will lead the summit on Wednesday
The EU executive also wants member states to agree to a common approach to vaccination certificates by the end of January. So a certificate from Italy would be accepted in Poland, for example.
Greek Prime Minister Kyriakos Mitsotakis floated the idea last week that they could help restore cross-border travel.
EU diplomats said this was premature as it was not yet clear if vaccinated people could still transmit the virus to others.
“As for (non-EU) third countries, then you’d have to look into whether to accept Russian or Chinese vaccines,” one added.
Published at Thu, 21 Jan 2021 17:15:00 +0000