1 INDIA RECORDS WORLD’S HIGHEST ONE-DAY SURGE IN COVID CASES WWW.BLOOMBERG.COM PUBLISHED:2021/04/22      2 AUSTRALIAN GOVERNMENT TEARS UP VICTORIA'S BELT AND ROAD AGREEMENT WITH CHINA, ANGERING BEIJING WWW.CNN.COM PUBLISHED:2021/04/22      3 CLIMATE CHANGE: US SURPRISES SUMMIT WITH ‘BOLD' EMISSIONS TARGET WWW.BBC.COM PUBLISHED:2021/04/22      4 MONGOLIA RECORDS 1,328 NEW COVID-19 CASES, FIVE DEATHS WWW.MONTSAME.MN PUBLISHED:2021/04/22      5 JUWAI IQI EXPANDS GLOBAL FOOTPRINT VIA PARTNERSHIP WITH MONGOLIA’S REAL ESTATE PORTAL OLY.MN AND TOP LOCAL AGENT RE/MAX MONGOLIA WWW.PRWEB.COM PUBLISHED:2021/04/22      6 MONGOLIA OFFERS JOB SUPPORT LOANS FOR COVID-19 PANDEMIC WWW.XINHUANET.COM PUBLISHED:2021/04/22      7 SPECIAL DEPARTURE FLIGHTS FOR FOREIGN CITIZENS IN MONGOLIA AFFECTED BY COVID-19-RELATED TRAVEL RESTRICTIONS WWW.MN.USEMBASSY.GOV  PUBLISHED:2021/04/22      8 GOVERNMENT OF MONGOLIA TO RAISE COUNTERCLAIM REGARDING OYU TOLGOI TAX DISPUTE WWW.MONTSAME.MN PUBLISHED:2021/04/22      9 SEEKING TO UNSEAT AUSTRALIA, MONGOLIA'S GIANT COAL MINE PLANS $700 MLN BOND WWW.REUTERS.COM PUBLISHED:2021/04/21      10 PM ADDRESSES AT BOAO FORUM FOR ASIA ANNUAL CONFERENCE 2021 WWW.MONTSAME.MN PUBLISHED:2021/04/21      SXCOAL: НИЙЛҮҮЛЭЛТ БУУРСНААР КОКСЖИХ НҮҮРСНИЙ ҮНЭ 22 САРЫН ДЭЭД ТҮВШИНД ХҮРЧ ӨСӨВ WWW.BLOOMBERGTV.MN НИЙТЭЛСЭН:2021/04/22     "50,400 ТУН АСТРАЗЕНЕКА ВАКЦИН ХҮЛЭЭН АВЛАА. СИНОФАРМЫН 900,000 ТУН ВАКЦИНЫГ ОЙРЫН ӨДРҮҮДЭД АВЧИРНА" WWW.IKON.MN НИЙТЭЛСЭН:2021/04/22     ЗГ: 8,000 ГАРУЙ ААН, ИРГЭН 560 ТЭРБУМ ТӨГРӨГИЙН ЗЭЭЛ АВААД БАЙНА WWW.GOGO.MN НИЙТЭЛСЭН:2021/04/22     “ОЮУТОЛГОЙ”-Н ЗЭСИЙН БАЯЖМАЛЫН ЭКСПОРТ СЭРГЭВ WWW.NEWS.MN НИЙТЭЛСЭН:2021/04/22     БАНКНЫ САЛБАРЫН ЖЕНДЕРИЙН ТАЛААРХ СТАТИСТИКИЙГ ТАНИЛЦУУЛАВ WWW.MONTSAME.MN НИЙТЭЛСЭН:2021/04/22     ТАТВАРЫН ОРЛОГО 78.1 ХУВИЙН ГҮЙЦЭТГЭЛТЭЙ БАЙНА WWW.MONTSAME.MN НИЙТЭЛСЭН:2021/04/22     ГУРВАН ХУВИЙН ХҮҮТЭЙ ЗЭЭЛИЙГ 8092 ХҮН АВЧЭЭ WWW.EAGLE.MN НИЙТЭЛСЭН:2021/04/22     ШҮЛСНЭЭС КОРОНАВИРУС ИЛРҮҮЛЭХ ОНОШЛУУРЫГ ИРЭХ ДАВАА ГАРАГААС ХЭРЭГЛЭНЭ WWW.EAGLE.MN НИЙТЭЛСЭН:2021/04/22     НӨАТ-ЫН БУЦААН ОЛГОЛТЫГ ИРГЭДИЙН ДАНСАНД ШИЛЖҮҮЛЖ ЭХЭЛЛЭЭ WWW.GOGO.MN НИЙТЭЛСЭН:2021/04/21     ЭКСПОРТ 100 САЯ ГАРУЙ АМ.ДОЛЛАРООР ӨСЖЭЭ WWW.MONTSAME.MN НИЙТЭЛСЭН:2021/04/21    

Europe starts formal review of Russia's Sputnik V COVID-19 vaccine www.reuters.com

MOSCOW (Reuters) - Europe’s medicines regulator said on Thursday it had started a rolling review of Russia’s Sputnik V COVID-19 vaccine, an important display of confidence in the shot that paves the way for its potential approval across the 27-nation bloc.
Hungary became the first EU country to grant the Russian vaccine emergency national approval in January, Slovakia has ordered shipments, and Czech Prime Minister Andrej Babis has said his country could move to use Sputnik V.
The European Medicines Agency (EMA) said in a statement it would review data from ongoing trials of the vaccine until there was enough evidence for a formal marketing authorisation application. (bit.ly/3uQxwfL)
EMA’s ‘rolling reviews’ are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is ready.
“While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” it said.
Kirill Dmitriev, CEO of the RDIF sovereign wealth fund that is promoting Sputnik V internationally, hailed the start of EMA’s rolling review as an important moment for Russia which he said showed its application had been a strong one.
“Sputnik V can act as a bridge between Russia and Europe, but its roll out should not get bogged down in politics,” Dmitriev told Reuters, praising Germany, France, Italy and Austria for what he called their pragmatic approach to Sputnik V.
The shot’s efficacy was initially greeted with scepticism by some Western scientists after Russia approved it in August last year without waiting for the results of full clinical trials.
However, some of those initial concerns appear to have faded after scientists said it was almost 92% effective in fighting COVID-19, based on peer-reviewed late-stage trial results published in The Lancet medical journal last month.
The two-shot vaccine uses two different weakened common cold viruses to deliver immune-building protein to the human body.
Dmitriev said Moscow could provide vaccines for 50 million Europeans starting from June if the shot won EU-wide approval, adding he expected several EU countries to approve the use of Sputnik V this month for their national use.
He did not name the countries.
Europe has so far approved vaccines from Pfizer/BioNTech, Moderna and AstraZeneca/Oxford, while ongoing reviews for CureVac and Novavax’s candidates are underway.
The EMA is expected to give its verdict on J&J’s single-shot vaccine on March 11.
Reporting by Andrew Osborn in Moscow and Pushkala Aripaka in Bengaluru; Editing by Sriraj Kalluvila, Bernard Orr, William Maclean
 
 

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Published Date:2021-03-04