A senior official of EU’s medical regulator, European Medicines Agency (EMA) warned against the approval of Russia’s Sputnik V vaccine in member countries before the agency has reviewed and cleared its safety, reported Money Control.
Christa Wirthumer-Hoche, head of EMA’s managing board went on to compare the idea to ‘Russian Roulette’ while speaking on an Austrian talk show last week.
“We need documents that we can review. We also don’t at the moment have data...about vaccinated people. It is unknown. That’s why I would urgently advise against giving a national emergency authorisation.”Christa Wirthumer-Hoche, EMA Managing board Head
The EMA also announced that it’s Committee for Medicinal Products for Human Use (CHMP) would be holding a meeting on 11 March to review Johnson & Johnson’s single-dose vaccine for use in the EU.
Sputnik, however, was not very happy with the remark, taking to Twitter to make their discontent with the statement known.
The representatives of Sputnik claim that the EMA has been “postponing Sputnik V review for months,” and that such comments undermine its own credibility.
Sputnik V has so far been greenlighted and rolled out in 46 countries, which also include three EU member countries— Hungary, Slovakia, and the Czech Republic.
Sputnik V’s phase 3 trial results were published in the Lancet back in February, wherein the vaccine was found to have 91.6% efficacy overall & 100% for severe cases, validated by internationally peer reviewed data.
(With inputs from Money Control and Reuters)
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