A shipment of doses of the Sputnik V vaccine arrives at Ezeiza International Airport in Buenos Aires, Argentina
Credit: Reuters
Russia’s Sputnik V vaccine looks set to be produced in Europe after a deal was concluded with Italy, as the developers demanded an apology from the European Medicines Agency for warning against hasty approval of the jab.
The head of the EMA said that any move to grant approval for the vaccine would be “comparable to Russian roulette.”
Christa Wirthumer-Hoche, the chair of the agency’s management board, urged EU member states not to approve Sputnik V until the agency had reviewed it properly.
“I would strongly advise against a national emergency authorisation,” she told ORF, an Austrian broadcaster, on Sunday.
The developers of the vaccine said she had overstepped the mark, accusing her of political interference in the drug’s approval process.
“We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V.
“Her comments raise serious questions about possible political interference in the ongoing EMA review,” they wrote on Twitter.
A nurse injects a performer in a bear costume with the Gam-COVID-Vac vaccine (under the brand name of Sputnik V) at a temporary COVID-19 vaccination site in a Moscow shopping centre
Credit: Getty
The development of the jab was funded by the Russian Direct Investment Fund, a Kremlin-backed sovereign wealth fund.
The Russian developers said that the EMA had not made similar comments about other vaccines, calling the remarks “inappropriate”.
They vented their frustration over the EMA dragging its feet on approving the jab for the EU.
“After postponing Sputnik V review for months, the EMA does not have the right to undermine the credibility of 46 other regulators that reviewed all of the necessary data.”
Russia says it is ready to sell 50 million two-dose vaccines to Europe as soon as the EU gives its official approval.
The EMA, which is based in Amsterdam, last week embarked on a review of Sputnik V, a key step towards it being approved as the first non-Western jab to be used in the EU’s 27 member states.
Hungary has already approved Sputnik V and started using it as part of its vaccine programme, while the Czech Republic and Slovakia have also ordered doses ahead of what they hope should be an imminent registration.
The Russian developers say the jab is 91.6% effective against Covid-19, based on peer-reviewed findings published last month in The Lancet, and claim that “Sputnik V is a vaccine for all humankind”.
It has been approved for use by 46 countries, from Argentina and Hungary to Serbia, Belarus, Iran and the UAE.
The production of the vaccine in Europe came a step further on Tuesday when the Russian sovereign wealth fund signed a deal with Adienne Pharma & Biotech, a Swiss pharmaceutical company, for the jab to be manufactured in Italy.
The deal will need to be approved by Italian regulators before production can start. But it could lead to the production of 10 million doses of Sputnik V in Italy by the end of the year.
A year ago this week, Italy became the first Western country to go into lockdown. It is now in the third wave of the pandemic and on Monday reached the grim milestone of registering 100,000 deaths from the virus.
The government has promised that from April 1, around 50 million doses will be delivered, pledging that half the population will be vaccinated by the summer.
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