MOSCOW (AP) – The European Medicines Agency has launched an ongoing review of Russia’s Sputnik V coronavirus vaccine, many months after its first approval was approved in Russia and after dozens of countries around the world the world has authorized it.
In a statement Thursday, the European regulator said the review is based on the results of laboratory studies and research in adults, which suggest the vaccine may help protect against the coronavirus.
Despite skepticism about the rapid introduction of the vaccine by Russia, which was rolled out before completing the final phase trials, the vaccine appears to be safe and effective. According to a published study last month in Lancet magazine, Sputnik V is 91% effective and appears to prevent inoculated individuals from developing serious COVID-19 disease, although it is not yet clear whether the vaccine can prevent the spread of the disease.
With the global shortage of COVID-19 vaccines, some experts say that increasing the use of vaccines manufactured by China and Russia (which have not been as in demand as those of Western companies) could offer a faster way to increase the world supply. The pandemic has already infected more than 115 million people, killing more than 2.5 million, according to a Johns Hopkins University account.
To date, the EMA has approved three COVID-19 vaccines for use throughout the European Union in 27 countries: shots fired by Pfizer-BioNtech, Moderna and AstraZeneca. He could license a fourth shot made by Johnson & Johnson at an expert meeting next Thursday.
The EMA has not set a date by which its expert group could meet to evaluate Sputnik V data, but the ongoing review aims to streamline the authorization process, which can normally take months.
Dr Hans Kluge, regional director for Europe at the World Health Organization, called the EMA’s announcement at Sputnik V “good news”.
“We desperately need to expand our vaccine portfolio, so I see this as a very welcome development,” Kluge said.
Meanwhile, dozens of countries have already authorized the use of Sputnik V, including Hungary, a member of the EU, 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 associations should be above policy and that cooperation with EMA is a perfect example.” which demonstrates that pooling efforts is the only way to end the pandemic. ”
“Following the approval of the EMA, we could provide vaccines for 50 million Europeans from June,” Dmitriev added.
The European Commission, the EU’s executive arm, said on Thursday it did not want to add the Russian vaccine to its portfolio at this stage.
“There are no ongoing talks between the negotiating teams and the producers, or institutes, or companies or organizations behind the Sputnik vaccine,” said Stefan De Keersmaecker, the Commission’s health policy spokesman.
RDIF has been pushing for EMA to review Sputnik V for months, and Dmitriev first announced an application to the European regulator in November. In January, the EMA met with vaccine developers.
Although there was considerable scientific skepticism when Russia developed the vaccine without completing advanced trials, doubts have since been reduced with the publication of the latest research. Experts said Russia’s initial vaccination campaign was affected by “undue haste, cuts and lack of transparency.”
Sputnik V uses a modified version of the common adenovirus that causes colds to carry spike protein genes to the coronavirus to prepare the body to react if COVID-19 appears. This is a vaccine-like technology developed by AstraZeneca and Oxford University.
But unlike AstraZeneca’s two-dose vaccine, Sputnik V uses a slightly different adenovirus for the second booster shot, a factor some scientists say may explain its high rate of effectiveness.
The World Health Organization is also considering whether or not to issue an emergency approval for Sputnik V; officials last month expected more details from their Russian developers. This approval would be essential for any vaccine against Sputnik V used in the UN-supported COVAX program to try to distribute vaccines fairly to nations around the world, but COVAX has not yet signed any agreement for Sputnik V.
Questions have been raised in the West about Russia’s eagerness to export its vaccine amid its comparatively slow deployment of domestic vaccines: officials say nearly 4 million people, less than 3% of Russia’s 146 million population , have received the shots so far.
“I must say that we still wonder why Russia theoretically offers millions and millions of doses without making enough progress in vaccinating its own people,” said European Commission President Ursula von der Leyen.
Kremlin spokesman Dmitry Peskov retorted that Russia’s vaccination campaign is going at “normal” pace, adding that international demand for Sputnik V is “so high that it significantly exceeds (Russia’s) production capacity.” .
The RDIF says it has received requests for 2.4 billion doses of two-shot vaccine, enough to vaccinate 1.2 billion people in 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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