MOSCOW (AP) – The European Medicines Agency has started a continuous review of the Russian Sputnik V coronavirus vaccine, many months after it was approved for use in Russia and after dozens of countries around the world have authorized it .
In a statement on Thursday, the European regulator said the review is based on results of laboratory studies and research in adults, suggesting that the vaccine may help protect against the coronavirus.
Despite skepticism about the hasty introduction of the vaccine by Russia, which was launched before completing the final stage tests, the vaccine appears to be safe and effective. According to a published study Last month in the Lancet, Sputnik V is 91% effective and appears to prevent inoculated individuals from becoming seriously ill with COVID-19, although it remains unclear whether the vaccine can prevent the disease from spreading.
With the global shortage of COVID-19 vaccines, some experts say that increasing the use of vaccines made by China and Russia – which have not been in as much demand as those made by Western companies – could offer a faster way to increase the global supply . The pandemic has infected more than 115 million people, killing more than 2.5 million people, according to a Johns Hopkins University count.
EMA has so far approved three COVID-19 vaccines for use in the 27 nations of the European Union: injections by Pfizer-BioNtech, Moderna and AstraZeneca. He could license a fourth shot made by Johnson & Johnson at a meeting of experts next Thursday.
The EMA has not set a date for when its group of experts can meet to evaluate Sputnik V data, but the ongoing review aims to speed up the authorization process, which can normally take months.
Dr. Hans Kluge, regional director of the World Health Organization for Europe, called the Sputnik V’s EMA announcement “good news”.
“We desperately need to increase our vaccine portfolio, so I see this as a very welcome development,” said Kluge.
Meanwhile, dozens of countries have already authorized the use of Sputnik V – including EU member Hungary – and many have agreed to buy millions of doses of the vaccine.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund that financed vaccine development, said on Thursday that “vaccine partnerships must be above policy and cooperation with the EMA is a perfect example, demonstrating that joining efforts is the only way to end the pandemic. ”
“After EMA approval, we would be able to supply vaccines to 50 million Europeans starting in June,” added Dmitriev.
The European Commission, the EU’s executive arm, said on Thursday that it does not intend to add the Russian vaccine to its portfolio at this stage.
“There are no ongoing negotiations between the negotiating teams and the producers, institutes, companies or organizations behind the Sputnik vaccine,” said Stefan De Keersmaecker, a spokesman for the Commission’s health policy.
RDIF has been lobbying the EMA to review Sputnik V for months, with Dmitriev first announcing a request to the European regulator in November. In January, the EMA met with developers of the vaccine.
Although there was considerable scientific skepticism when Russia rolled out its vaccine without completing the advanced tests, many doubts were dispelled with the publication of its most recent research. Experts said Russia’s initial immunization campaign was marked by “unseemly haste, reduced corners and a lack of transparency”.
Sputnik V uses a modified version of the adenovirus that causes the common cold to carry genes for the spike protein in the coronavirus to prepare the body to react if COVID-19 appears. It is a technology similar to the vaccine developed by AstraZeneca and the University of Oxford.
But unlike AstraZeneca’s two-dose vaccine, Sputnik V uses a slightly different adenovirus for the second booster injection, a factor that some scientists say may be responsible for its apparently high rate of effectiveness.
The World Health Organization is also considering whether or not to issue an emergency use approval for Sputnik V; employees last month were expecting more details from their Russian developers. Such approval would be essential for any Sputnik V vaccine to be used in the UN-supported COVAX program to try to distribute vaccines fairly to nations around the world, but COVAX has not yet signed an agreement for Sputnik V.
Questions have been raised in the West about Russia’s eagerness to export its vaccine amid the relatively slow release of domestic vaccines – authorities say almost 4 million people, less than 3% of Russia’s 146 million population, received the vaccines until now.
“I have to say that we still wonder why Russia is theoretically offering millions and millions of doses, although it does not go far enough in vaccinating its own people,” said European Commission President Ursula von der Leyen.
Kremlin spokesman Dmitry Peskov replied that Russia’s vaccination campaign is going at “normal” rates, adding that international demand for Sputnik V is “so high that it significantly exceeds (Russia’s) production capacity” .
RDIF claims to have received orders for 2.4 billion doses of the double vaccine, enough to immunize 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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