Russia, China vaccines must ‘show data’ for EU approval

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Brussels

European Commission chief Ursula von der Leyen said Tuesday that coronavirus vaccines from Russia and China could be approved for use in the bloc if they “show all the data”, lawmakers told AFP.

Her remarks came as the EU faces criticism over a slow vaccination roll-out across the 27 nation bloc as supply shortfalls have hampered deliveries.
Some European leaders have now expressed willingness to consider using Russia’s Sputnik V virus after trial results showed it was 91.6 percent effective.
“If the Russian producers, the Chinese producers open their books, show transparency, show all the data… then they could get… a conditional market authorisation like the other ones,” von der Leyen told EU lawmakers at a meeting, according to those in attendance.
Brussels has said previously the Russian manufacturer has been in contact with the bloc’s medicines regulator but no formal application for market authorisation has been submitted.
A commission spokesman said Tuesday that one of the criteria for the EU contracts for vaccines was that producers had the capacity to make them inside the bloc.
So far the EU has signed agreements with six vaccine suppliers, but only the three jabs from Pfizer/BioNtech, Moderna and AstraZeneca have been approved for use.
Germany’s Federal Health Minister Jens Spahn has hinted that coronavirus vaccines from China and Russia could be used in Europe to overcome the current deficit of doses.
“Regardless of the country in which a vaccine is manufactured, if they are safe and effective, they can help cope with the pandemic,” Spahn told the Frankfurter Allgemeine Zeitung newspaper on Sunday, adding that they must be approved by the European Medicines Agency (EMA).
The minister said he sees no fundamental obstacle to the use of Chinese and Russian COVID vaccines.

Russia announced Friday it would be able to supply 100 million doses of its Sputnik V vaccine to the EU in the second quarter of the year, which would allow some 50 million people to be vaccinated. The application for approval of the vaccine has already been submitted to the EMA.

Spahn also expressed hope that the pandemic will be brought under control in the course of the year, and that there will be no “second virus anniversary in this form.—APP