A senior official with the European Medicines Agency (EMA) has warned European Union members to hold off from giving national authorization for the Russian-developed Sputnik V COVID-19 vaccine until the agency finishes its safety review.
"We need documents that we can review. We also don't at the moment have data...about vaccinated people," EMA managing board chief Christa Wirthumer-Hoche told Austrian broadcaster ORF on March 7.
"It is unknown. That's why I would urgently advise against giving a national emergency authorization," she said.
"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.
"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 authorized in the European Union," she said.
Europe's medicines regulator on March 4 said it had started a "rolling review" of the Sputnik V coronavirus vaccine, a key step toward approval for use across the 27-nation European Union.
The EMA's human medicines committee will review data from ongoing trials of the vaccine until there is enough clinical data for approval, the Amsterdam-based agency said in its statement.
Following some initial uncertainty about the vaccine, peer-reviewed, late-stage trial results published last month in The Lancet medical journal showed the two-dose regimen of Sputnik V was 91.6 percent effective against symptomatic COVID-19, about the same level as the leading Western-developed vaccines.
EMA's "rolling reviews" are intended to speed up the process of approving a successful vaccine by allowing researchers to submit findings in real time, even before final trial data is ready.
The agency has already approved vaccines from Pfizer/BioNTech, Moderna, and AstraZeneca /Oxford, and is expected to give its verdict on Johnson & Johnson's single-shot vaccine next week. Reviews for CureVac and Novavax's candidates are also under way.
Slovakia earlier this month received its first shipment of Sputnik V doses, becoming the second EU member state to obtain the vaccine after Hungary, even though it lacked approval by the EMA.
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The head of the Russian Direct Investment Fund, which has funded the vaccine and is responsible for selling it globally, said on March 4 that the country would be able to provide the vaccine for 50 million Europeans from June if it was approved by the EMA
Kirill Dmitriyev also said that the country expects several European countries to approve the Sputnik V this month.
Macedonian Health Minister Venko Filipce said the small Balkan state had received the first batch of Sputnik V vaccines on March 7 after it began inoculations last month.
The first shipment of 3,000 vaccines out of 200,000 that were ordered was delivered to the country after it approved Sputnik V for emergency use.
North Macedonia began vaccinating its health workers in a COVID-19 center in February after it received a donation of 4,680 doses of the Pfizer/BioNTech shot from Serbia.
