MOSCOW (AP) – The European Medicines Agency has begun an ongoing 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 approved it.
In a statement, the European regulator said on Thursday that the review is based on results from laboratory studies and research in adults, suggesting the vaccine may help protect against the coronavirus.
Despite skepticism about Russia’s hasty introduction of the vaccine, which was rolled out before it completed the final stages of trials, the vaccine appears to be safe and effective. According to a published study Last month in the journal Lancet, Sputnik V is 91% effective and appears to prevent inoculated individuals 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 boosting the use of vaccines from China and Russia – which are not as much in demand as Western companies – could provide a faster way to increase global supply. to increase. The pandemic has already infected more than 115 million people, of which more than 2.5 million have died, according to a Johns Hopkins University count.
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 take a fourth shot of Johnson & Johnson at an expert meeting next Thursday.
The EMA has not set a date for its expert group to meet to review Sputnik V data, but the ongoing review is designed to speed up 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 urgently need to expand our vaccine portfolio, so I see this as a very welcome development,” said Kluge.
In the meantime, dozens of countries have already approved the 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 that funded the development of the vaccine, said on Thursday that “vaccine partnerships should be above politics and that collaboration with EMA is a perfect example, showing that pooling efforts is the only way. is to end the pandemic. ”
“Following EMA approval, we could deliver vaccines to 50 million Europeans from June,” Dmitriev added.
The European Commission, the EU’s executive arm, said on Thursday that it has no plans to add the Russian vaccine to its portfolio at this stage.
“There are no discussions going on between negotiating teams and the producers, or institutions, or companies or organizations behind the Sputnik vaccine,” said Stefan De Keersmaecker, the Commission’s health policy spokesman.
The RDIF has been pushing for months for the EMA to review Sputnik V, with Dmitriev first announcing an application to the European regulator in November. In January, the EMA met with the developers of the vaccine.
While there was considerable scientific skepticism when Russia rolled out its vaccine without completing advanced trials, many doubts have since been allayed with the publication of its latest research. Experts said Russia’s initial vaccination campaign was marred by “inappropriate haste, cutting corners and a lack of transparency.”
Sputnik V uses a modified version of the cold-causing adenovirus to insert genes for the spike protein into the coronavirus to excite the body to respond when COVID-19 comes along. This is a technology similar to the vaccine developed by AstraZeneca and Oxford University.
But unlike the AstraZeneca two-dose vaccine, Sputnik V uses a slightly different adenovirus for the second booster shot, a factor that some scientists say may explain its apparently high efficacy.
The World Health Organization is also considering whether or not to issue an emergency use approval for Sputnik V; officials awaited further details from the Russian developers last month. That approval would be essential for all Sputnik V vaccines used in the UN-backed COVAX program to attempt to distribute vaccines fairly to countries around the world, but COVAX has not yet signed any agreements for Sputnik V.
In the West, questions have arisen about Russia’s eagerness to export its vaccine amid the relatively slow introduction of domestic vaccines – officials say that so far nearly 4 million people, less than 3% of Russia’s 146 million population, have received shots.
“I have to say that we still wonder why Russia is theoretically offering millions and millions of doses when it is not making enough progress in vaccinating their own people,” said Ursula von der Leyen, President of the European Commission.
Kremlin spokesman Dmitry Peskov replied that the Russian vaccination campaign is running at “normal” rates, adding that international demand for Sputnik V “is so high that it significantly exceeds (Russian) production capacity.”
The RDIF says it has received requests for 2.4 billion doses of the two-stage vaccine, enough to immunize 1.2 billion people, from more than 50 countries. According to Prime Minister Mikhail Mishustin, Russia has produced just over 10 million doses so far.
Jamey Keaten in Geneva and Samuel Petrequin in Brussels contributed to this report.
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