Russian laboratory vaccine development yunhap news
The European Medicines Agency (EMA) has begun evaluating the Corona 19 vaccine developed by Russia.
EMA, the European Union’s drug evaluation and supervision organization, has initiated a rolling review of the Corona 19 vaccine’Sputnik V’, Russia said on the 4th (local time).
The’Russian Direct Investment Fund’ (RDIF), which is responsible for supporting the development of Sputnik V vaccine and producing and supplying it overseas, said in a press release on the day that “EMA has begun the Sputnik V vaccine companion review procedure.” “The decision to initiate a joint review is based on the results of preclinical and clinical trials in adults (of this vaccine).”
He added that EMA will evaluate Sputnik V using common EU standards for vaccine efficacy and safety.
The companion review is a procedure to speed up the evaluation of drugs or vaccines in public health emergencies such as the global pandemic of COVID-19.
The Sputnik V vaccine was approved by Russia for the first time in the world in August last year, but unlike the usual vaccine development procedure, it was approved only with the results of phase 1.2 before the phase 3 clinical trial (Phase 3), causing controversy over efficacy and safety.
Then, early last month, the evaluation of the vaccine is changing positively as the results of the phase 3 of the vaccine’s prevention effect reached 91.6% in the world-class medical journal’Lancet’.
The EU is already vaccinating vaccines developed in Western countries such as Pfizer, Bioentech, Modena, and AstraZeneca in 27 member states.
However, as vaccinations are not speeding up due to insufficient vaccine supplies, voices are rising that some parts of Europe should consider introducing Chinese and Russian vaccines.
German Chancellor Angela Merkel and others said that Russian vaccines could be used with the approval of EU regulatory authorities. Hungary has already approved the Russian vaccine independently of the EU.
Reporter Bae Jae-seong [email protected]
