When asked why Russia is requesting that the batch of Sputnik V delivered to Slovakia be returned, Finance Minister Igor Matovič (OĽaNO) said that the vaccine was tested by a lab unregistered in the European network.
He was particularly critical of the State Institute for Drug Control (ŠÚKL), which was assigned to check the vaccine before it can be administered to people. Although Sputnik V has not been registered by the European Medicines Agency yet, it can still be approved by the local authorities based on an exception from the Health Ministry.
“They feel exceptional damage was caused to them when the ŠÚKL assigned the assessment of the vaccine to a non-registered laboratory,” Matovič told journalists on April 9, adding that the results of the assessment “flooded the world” and “harmed the image of the vaccine”.
The request to test the vaccine in the labs of the Biomedical Research Centre of the Slovak Academy of Sciences (SAV) was signed by the former health minister of OĽaNO, Marek Krajčí, on March 5, the Sme daily reported.
The ex-minister asked the Biomedical Research Centre to test the vaccine within its competencies. Subsequently, they signed an agreement with the ŠÚKL on March 10, the centre wrote in a press release.
Krajčí has not said yet whether he sent the request and why he approached the Biomedical Research Centre, which Matovič has criticised, Sme reported.
The biomedical centre responds
Before ŠÚKL started testing the vaccine, it said that it would have to ask external experts for help.
Most of the tests were carried out in biotechnological labs that belong to SAV’s Biomedical Research Centre. These are not part of the Official Medicines Control Laboratories (OMCL) network, but they have a certificate for microbiological, chemical and biological tests of medications, said its head Silvia Pastoreková, as reported by Sme.
Moreover, the labs are registered in the EudraGMP database.
Other tests were carried out in the labs of the Institute of Virology belonging to the SAV’s Biomedical Research Centre, which are not in this database.
“Both the Health Ministry and the ŠÚKL were notified about it and had no fundamental objections,” Pastoreková said, as quoted by Sme.
She did not specify what kind of analyses they carried out, referring to the confidentiality agreement.
“I hope the Biomedical Research Centre has had enough opportunities to show its erudition and professionalism since the pandemic outbreak,” Pastoreková added, as quoted by Sme, adding they have contributed to the testing, the development of tests, their validation and various pilot tests. “I doubt we have made any mistake.”
Still, Matovič said on the evening of April 9 that Sputnik V will be checked by the Hungarian labs.