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 committeewill 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.
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