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The European Union’s drug regulator has finally started reviewing Russia’s Sputnik V COVID-19 vaccine, ending an extraordinary standoff over the drug’s deployment in the EU.
The Russian Direct Investment Fund (RDIF), which is bankrolling the apparently highly effective vaccine, says Sputnik V’s approval by the European Medicines Agency (EMA) should enable the vaccination of 50 million Europeans, starting in June.
The RDIF has been insisting for more than a month that it applied for authorization from the EMA in late January. But the agency has consistently pushed back, telling Fortune as recently as Tuesday that the situation described in a Feb. 10 statement, in which it denied having received an application for a Sputnik V rolling review or formal marketing authorization, “still stands.”
On Thursday morning, though, the regulator said its rolling review of Sputnik V had in fact begun.
As the phrase suggests, these are ongoing reviews of incoming trial data, which make it possible to authorize drugs without waiting for the finalized data that must normally accompany an application for authorization. Sputnik V’s efficacy has been reported to be over 91%, but that’s based on only interim trial data. And, as it happens, a perception that Sputnik V hasn’t been sufficiently tested is a major reason why many Russians are loath to get the jab.
“EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety, and quality,” the agency said in a statement. “While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.”
The EU applicant for Sputnik V is listed as R-Pharm Germany, a manufacturer and packager of medicines and nutritional supplements. German Chancellor Angela Merkel said a month ago that “every vaccine is welcome in the European Union” once it has EMA approval and offered help with the application process.
RDIF CEO Kirill Dmitriev welcomed the EMA’s rolling-review announcement, saying Sputnik V “can make an important contribution to saving millions of lives in Europe.”
Indeed, three EU countries—Hungary, Slovakia, and the Czech Republic—have already decided to take Russia’s vaccine despite its lack of EMA approval, which is supposed to be the starting point for any COVID vaccine’s rollout in the bloc. This has caused intense political tension within the EU, with a French diplomat telling Politico Playbook this week it is “unacceptable that those who benefit the most from European solidarity spit in [the EU’s] face.”
Now, the EU’s solidarity-based approval process is finally underway for the Russian vaccine.
The EMA said in its Thursday statement that it would only provide further updates when the official authorization application has been submitted. That will probably take a while, so the next big EMA announcement to look out for is the one due in a week’s time, when the regulator may authorize the rollout of Johnson & Johnson’s eagerly awaited single-dose vaccine.
More health care and Big Pharma coverage from Fortune:
- Russia’s Sputnik V vaccine is winning over Eastern Europe—but most Russians don’t want it
- China sets a goal of vaccinating half a billion people in 5 months. Can it meet the target?
- With a new vaccine and fast-spreading variants, U.S. COVID fight becomes a head-to-head race
- Biden officials warn Johnson & Johnson vaccine rollout may be slow
- Will America’s vaccine hesitancy stymie the COVID shot rollout?
