EU regulator urges caution on Sputnik V, Russia's coronavirus vaccine

A senior official of the European Medicine Agency (EMA) on Sunday urged European Union members to refrain from granting approval for Sputnik V, Russia's COVID-19 vaccine.

Currently, the agency is reviewing the safety and efficacy of the vaccine and has asked national approvals to not be handed out.

"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," EMA managing board head Christa Wirthumer-Hoche said on an Austrian talk show.

"We can have Sputnik V on the market here in future when the appropriate data have been reviewed. The rolling review has begun now at EMA," she added. The agency launched a review last week.

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"Data packages are coming from Russian manufacturers and of course they will be reviewed according to European standards for quality, safety and efficacy. When everything is proven then it will also be authorised in the European Union," she further said.

Currently, Sputnik V has received approval or is being assessed for approval in three member states of the EU - Hungary, Slovakia, and the Czech Republic. In addition, EU officials say that the bloc would begin negotiations with the makers of Sputnik V if at least four member states request the same.

Also read: Russia's Sputnik V vaccine gets all-clear in Hungary

Wirthumer-Hoche additionally said that EMA's Committee for Medicinal Products for Human Use (CHMP) would conduct a meeting on March 11 to review Johnson & Johnson's coronavirus vaccine and whether it can be used in the EU.

"We expect a positive assessment and that the (European) Commission will quickly grant authorisation," she added.

(With inputs from Reuters)