A month after arriving in Slovakia, the first 200,000 doses of the vaccine remain in a warehouse and without authorization for administration. The Russian Direct Investment Fund has accused the European country of having breached the bilateral contract by analyzing Sputnik V doses in non-EU certified drug control laboratories.
This Thursday, the Russian Direct Investment Fund (FIDR) accused Slovakia of contractual failures and demanded the return of vaccines to the Central European country, which it revealed has not been able to determine the safety of a batch of the Russian vaccine.
“The FIDR (…) sent a letter on April 6 with the request to return the vaccine due to the numerous violations of the contract, so that it can be used in other countries”, reads the note published in the Twitter.
According to the official publication, Slovakia violated the bilateral contract analyzing the doses of Sputnik V in drug control laboratories not certified by the European Union (EU), reports the agency EFE.
The Russian body described this behavior as “an act of sabotage” and asked the country to repeat the analyzes in laboratories approved by Brussels.
The FIDR also rejected the Slovak regulator’s accusations that the vaccines supplied to Bratislava are different from those that have been subjected to clinical tests.
“All Sputnik V trials have identical quality and they are subjected to strict quality control at the Gamaleya Institute ”, he stressed. And he accused Slovaks of launching a “disinformation” campaign against the Russian vaccine.
Slovakia’s drug regulator said it was unable to determine the safety of a batch of the Russian Sputnik V vaccine, delivered in March, and expressed doubts about its composition.
“The vaccine batches [Sputnik V] used in preclinical tests and clinical studies published in the Lancet magazine do not have the same characteristics and properties as those imported into Slovakia, ”said the National Institute for Drug Control (SUKL), in statements to the AFP agency.
“Based on laboratory tests only, it is not possible to conclude about the effectiveness and safety for humans ”from the batch sent to Slovakia, added the institute.
The European regulator has already started a “continuous review” of Sputnik V to determine whether it meets the requirements of the EU-European Union in terms of effectiveness, safety and quality.
The country’s Ministry of Health will await the completion of the national regulator’s evaluation process before proceeding with the administration of the first doses of the Russian vaccine.
On the official account of Sputnik V no Twitter, there is a denial that the doses sent to the country are different. The news “based on anonymous sources” that the doses of the vaccine sent to Slovakia are different from the Sputnik V of clinical trials “are false“, It reads in the publication.