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The European Medicines Agency (EMA) will decide whether to recommend approval for a novel coronavirus infection (Corona 19) vaccine developed by the US pharmaceutical company Johnson & Johnson (J&J) on the 11th (local time).
According to the AFP news agency on the 4th, EMA announced on Twitter that the EMA-affiliated Drug User Advisory Committee (CHMP) will make recommendations on the J&J Janssen Corona 19 vaccine on March 11th.
EMA explained that CHMP plans to hold a meeting that day to finalize the evaluation of the vaccine. Janssen is a European subsidiary of Johnson & Johnson.
When the EMA makes a recommendation to approve the marketing of the vaccine, the final decision is made by the Commission, an EU executive.
If the J&J vaccine is approved, it will be the fourth COVID-19 vaccine available in the EU. Earlier, the EU Commission approved vaccines for Pfizer, Modena and AstraZeneca.
The EU has already secured 400 million doses of J&J vaccine. The US Centers for Disease Control and Prevention (CDC) approved the Johnson & Johnson vaccination on the 28th of last month.
EMA also launched a rolling review of the Russian-developed vaccine’Sputnik V’, the Russian side said on the 4th.
The’Russian Direct Investment Fund’ (RDIF), which is responsible for supporting the development of Sputnik V vaccines and producing and supplying them overseas, said, “EMA has begun the Sputnik V vaccine companion review process,” and “EMA Human Use Medicines Committee (CHMP) “The decision to initiate a concomitant review is based on the results of preclinical and clinical trials in adults (of this vaccine).”
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 first approved by Russia in August last year in the world. However, the phase 3 clinical trial was omitted and approved only with the results of phase 1 and 2, which caused controversy over efficacy and safety.
Since then, the evaluation of the vaccine has been positively changed as a result of the phase 3 that the vaccine’s preventive effect reaches 91.6% was published in the global medical journal’Lancet’ at the beginning of last month.
So far, 42 countries, including Russia, have approved the use of the Sputnik V vaccine. Some EU countries, such as Hungary and Slovakia, also approved emergency use of Sputnik V by independent decision prior to EMA approval.
/ Reporter Maeng Joon-ho [email protected]
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