EU regulator starts a review of Russia’s vaccine

MOSCOW — The European Medicines Agency has started a rolling review of Russia’s Sputnik V coronavirus vaccine, many months after it was first approved for use in Russia and after dozens of countries around the world have authorized it.

In a statement Thursday, the European regulator said the review is based on results from lab studies and research in adults, which suggests the vaccine may help protect against the coronavirus.

Despite skepticism about Russia’s hasty introduction of the vaccine, which was rolled out before it had completed late-stage trials, the vaccine appears to be safe and effective. According to a study published last month in the journal Lancet, Sputnik V is 91% effective and appears to prevent inoculated individuals from becoming severely ill with COVID-19, although it’s still unclear if the vaccine can prevent the spread of the disease.

With a global shortage of COVID-19 vaccines, some experts say boosting the use of vaccines made by China and Russia — which have not been as in demand as those made by Western companies — could offer a quicker way to increase the global supply. The pandemic has already infected over 115 million people, killing over 2.5 million of them, according to a tally by Johns Hopkins University.

The EMA has so far approved three COVID-19 vaccines for use across the 27-nation European Union: shots made by PfizerBioNtech, Moderna and AstraZeneca. It could license a fourth shot made by Johnson & Johnson at an expert meeting next Thursday.

The EMA has not set a date for when its expert group might meet to assess Sputnik V data but the rolling review aims to expedite the authorization process, which can typically take months.

Dr. Hans Kluge, the World Health Organization’s regional director for Europe, called the EMA announcement on Sputnik V “good news.”

“We desperately need to enlarge our portfolio of vaccines, so I see this as a very welcome development,” Kluge said.

In the meantime, dozens of countries have already authorized Sputnik V for use — including EU member Hungary — and many have agreed to purchase millions of doses of the shot.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund that bankrolled the development of the vaccine, said Thursday “vaccine partnerships should be above politics and cooperation with EMA is a perfect example, demonstrating that pooling efforts is the only way to end the pandemic.”