PRAGUE (Reuters) - Russia on Thursday called on Slovakia to return hundreds of thousands of doses of the Sputnik V coronavirus vaccine, citing breaches of contract, in a growing row between the two countries after a Slovak watchdog raised doubts about the shooting.
Earlier Thursday, Slovak pharmaceutical agency SUKL said the Sputnik V vaccine lots it had received differed from those reviewed by international scientists and the European Union regulator.
Slovakia imported 200,000 doses of Sputnik V last month, the second EU country to do so after Hungary, despite the lack of regulatory approval from the EU.
Although approving the vaccine for therapeutic use of the vaccine as an unregistered drug and receiving an initial shipment, he had not started administering the vaccine, and the Slovak Ministry of Health also asked his agency pharmaceutical company to conduct a review.
The agency said it had found that the dosage form of the vaccine - the way the drug is presented, such as in a solution - differed from the product currently being reviewed by the European Medicines Agency as part of an ongoing review. of vaccine, required for EU Approval.
SUKL said the lots sent to Slovakia also exhibited different characteristics from those used in studies published in The Lancet.
The Russian Direct Investment Fund, the Russian sovereign wealth fund responsible for marketing the vaccine abroad, has vigorously denied the allegations, calling them "fake news".
He said the Slovak side had not tested the shooting in a specially certified laboratory, adding that this was in violation of contractual obligations and "an act of sabotage".
The RDIF said it had asked the Slovak government to send certain lots to a laboratory certified by the European Union for further testing, as well as to return the main cargo to Russia.
"The RDIF ... sent a letter on April 6, 2021 asking to return the vaccine due to multiple breaches of contract so that it can be used in other countries," said a statement, shared on the Twitter page official vaccine.
"All batches of Sputnik V are of the same quality and go through rigorous quality control at the Gamaleya Institute," he says.
DATA GAP
The Slovak pharmaceutical agency also concluded that it could not determine the benefits and risks of Sputnik V, due to gaps in the data provided by Moscow on preclinical testing, production and clinical trials.
"A substantial part of the data, around 80%, was not provided even after repeated requests," he said.
RDIF did not respond to questions about data gaps identified by SUKL.
The wealth fund said its chief executive, Kirill Dmitriev, held a meeting with Slovak Finance Minister Igor Matovic earlier today, adding that "RDIF remains committed to helping the Slovak people get vaccinated by Sputnik V. "
Given the significant delays in EU-wide vaccine orders, Matovic planned to make Slovakia the second EU country after Hungary to start using the vaccine, despite the lack of clearance from the European Medicines Agency EMA.
Slovakia, hard hit by an upsurge in COVID-19 infections in recent months, wanted to speed up vaccinations.
But in ordering the firing, Matovic acted behind the backs of his coalition partners and was forced to resign in a coalition crisis that followed.
Matovic had said that Slovakia had ordered 2 million doses, a substantial amount for a country of 5.5 million people. No further shipments since the initial batch of 200,000 have arrived, although Matovic said another 400,000 were expected in March.
Slovakia's health ministry said it plans to announce new measures next week regarding the use of Sputnik V. Matovic is expected to speak about his trip to Moscow on Friday.
https://www.medscape.com/viewarticle/948978?src=rss
