MOSCOW (AP) – The European Medicines Agency has launched an ongoing review of the Russian Sputnik V coronavirus vaccine, many months after it was first approved for use in Russia, and after dozens of countries around the world approved it has.
In a statement Thursday, the European regulator said the review was based on the results of laboratory studies and research among adults, suggesting that the vaccine could help protect the coronavirus.
Despite skepticism about Russia’s hasty launch of the vaccine, which was rolled out before completing late-stage trials, the vaccine appears to be safe and effective. According to a study published last month in Lancet magazine, Sputnik V is 91% effective and prevents vaccines from becoming seriously ill with COVID-19, although it is still unclear whether the vaccine can prevent the spread of the disease.
With a global shortage of COVID-19 vaccines, some experts say that the use of vaccines made by China and Russia – which were not yet as popular as by Western companies – could provide a faster way to increase the global supply to increase. The pandemic has already infected more than 115 million people and killed more than 2.5 million people, according to a version by Johns Hopkins University.
The EMA has so far approved three COVID-19 vaccines for use in the European Union with 27 countries: shots made by Pfizer-BioNtech, Moderna and AstraZeneca. It could license a fourth shot from Johnson & Johnson at an expert meeting next Thursday.
The EMA has not set a date on which its expert group can meet to review the Sputnik V data, but the ongoing investigation aims to speed up the authorization process, which can usually take months.
Dr. Hans Kluge, the regional director of the World Health Organization for Europe, calls the EMA announcement on Sputnik V ‘good news’.
“We urgently need to expand our portfolio of vaccinations, so I consider this a very welcome development,” Kluge said.
Meanwhile, dozens of countries have already approved Sputnik V for use – including EU member Hungary – and many have agreed to buy millions of doses of the shot.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund in charge of vaccine development, said on Thursday that “vaccine partnerships should be above politics and co-operation with the EMA is a perfect example, showing that pooling efforts is the only way is to end the pandemic. ”
“After the EMA’s approval, we will be able to provide 50 million Europeans with vaccinations from June,” Dmitriev added.
The European Commission, the EU’s executive, said on Thursday it did not want to add the Russian vaccine to its portfolio at this stage.
“There are no discussions going on between negotiating teams and the producers, or institutes, or companies or organizations behind the Sputnik vaccine,” said Stefan De Keersmaecker, spokesman for the Health Policy Commission.
The RDIF has been insisting for months that the EMA should review Sputnik V, and Dmitriev first announced an application to the European regulator in November. In January, the EMA met with the developers of the vaccine.
Although there was great scientific skepticism when Russia rolled out its vaccine without completing advanced trials, there has since been much doubt about the publication of the latest research. Experts said Russia’s initial vaccination campaign was tainted by “insignificant haste”, “cutting corners” and a lack of transparency. ”
Sputnik V uses a modified version of the cold adenovirus to carry genes for the protein in the coronavirus to make the body react when COVID-19 comes together. It is a similar technology to the vaccine developed by AstraZeneca and the University of Oxford.
But unlike the AstraZeneca two-dose vaccine, Sputnik V uses a slightly different adenovirus for the second shot, a factor that scientists say could explain the seemingly high efficiency rate.
The World Health Organization is also considering issuing emergency use approvals for Sputnik V; officials waited for further details from its Russian developers last month. The approval is essential for any Sputnik V vaccines used in the UN-backed COVAX program to try to distribute vaccines fairly to countries around the world, but COVAX has not yet signed any transactions for Sputnik V.
Questions have been raised in the West about Russia’s eagerness to export the vaccine amid relatively slow deployment of domestic vaccines – officials say nearly 4 million people, less than 3% of Russia’s 146 million people, have been shot. obtained so far.
“I have to say that we still wonder why Russia theoretically offers millions and millions of doses while not making enough progress to vaccinate their own people,” said European Commission President Ursula von der Leyen.
Kremlin spokesman Dmitry Peskov responded that the Russian vaccination campaign was going on at “normal” rates, adding that international demand for Sputnik V was so high that it significantly exceeded (Russian) production capacity. ‘
The RDIF says it has received requests for 2.4 billion doses of the shotgun vaccine, enough to immunize 1.2 billion people from more than 50 countries. According to Prime Minister Mikhail Mishustin, Russia has so far produced just over 10 million doses.
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Jamey Keaten in Geneva and Samuel Petrequin in Brussels contributed to this report.
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