MOSCOW (AP) – The European Medicines Agency has begun a continuous 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 have authorized it.
In a statement on Thursday, the European regulator said the review is based on the results of laboratory studies and research in adults, suggesting the vaccine may help protect against coronavirus.
Despite skepticism about Russia’s hasty introduction of the vaccine, which was launched before the end of studies at a late stage, 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 people from becoming seriously ill with COVID-19, although it is not yet clear whether the vaccine can prevent the spread of the disease.
With a global shortage of COVID-19 vaccines, some experts say increasing the use of vaccines produced by China and Russia – which have not been as popular as those made by Western companies – could provide a faster way to increase supply. global. The pandemic has already infected more than 115 million people, killing more than 2.5 million of them, according to a Johns Hopkins University report.
EMA has so far approved three COVID-19 vaccines for use in the European Union from 27 nations: photos taken by Pfizer-BioNtech, Moderna and AstraZeneca. He could license a fourth hit by Johnson & Johnson to an expert meeting on Thursday.
The EMA has not set a date for which its panel could meet to evaluate Sputnik V data, but the ongoing review 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, called the EMA announcement on Sputnik V “good news.”
“We desperately need to expand our vaccine portfolio, so I see this as a very welcome development,” Kluge said.
In the meantime, 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 shots.
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 policy and cooperation with the EMA is a perfect example, proving that pooling efforts are the only way.” to end the pandemic. ”
“With the approval of the EMA, we will be able to provide vaccines to 50 million Europeans from June,” Dmitriev added.
The European Commission, the EU’s executive arm, said on Thursday it was not trying to add the Russian vaccine to its portfolio at this stage.
“There is no discussion between the negotiating teams and the manufacturers, or the institutes or companies or organizations behind the Sputnik vaccine,” said Stefan De Keersmaecker, the Commission’s spokesman for health.
RDIF has been pushing for the EMA to review Sputnik V for months, with Dmitriev announcing a request to the European regulator for the first time in November. In January, the EMA met with vaccine developers.
Although there was considerable scientific skepticism when Russia developed its vaccine without completing advanced studies, many doubts have since been allayed by the publication of its latest research. Experts said Russia’s initial immunization campaign was affected by “inappropriate haste, cutting corners and lack of transparency”.
Sputnik V uses a modified version of the common cold-causing adenovirus to carry spike protein genes into the coronavirus to direct the body to react if COVID-19 occurs. This is a technology similar to the vaccine developed by AstraZeneca and Oxford University.
But unlike the two-dose AstraZeneca vaccine, Sputnik V uses a slightly different adenovirus for the second booster vaccine, a factor some scientists say could explain the seemingly high rate of effectiveness.
The World Health Organization is also considering whether or not to issue an emergency use approval for Sputnik V; officials last month were waiting for more details from its Russian developers. This approval would be essential for any Sputnik V vaccines to be used in the UN-supported COVAX program to try to distribute the vaccines fairly to nations around the world, but COVAX has not yet signed any agreement for Sputnik V.
In the West, questions have been raised about Russia’s willingness to export its vaccine amid its relatively slow launch of vaccines – officials say nearly 4 million people, less than 3 percent of Russia’s 146 million people, have received the fires so far.
“I must say that we still wonder why Russia theoretically offers millions and millions of doses, while not making enough progress in vaccinating its own people,” said European Commission President Ursula von der Leyen.
Kremlin spokesman Dmitry Peskov said Russia’s vaccination campaign was running at “normal” rates, adding that international demand for Sputnik V was “so high that it significantly exceeded (Russia’s) production capacity.”
RDIF says it has received requests for 2.4 billion doses of two-shot 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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