"The documentation, which we received, is absolutely poor. It lacks, in particular, data concerning the production and quality," Storova said.
According to her, the vaccine's producer provided only a small part of the documentation necessary in such cases. Storova added that the institute has forwarded all studied materials to the government.
The official added that the institute had not received any governmental request for conducting clinical trials of the vaccine, so they have not been conducted.
The Czech regulator made its decision amid the diplomatic tension between Russia and the Czech Republic caused by the alleged involvement of Russian special services in the explosions at an ammunition depot in Vrbetice. On Sunday, President Milos Zeman, having repeatedly considered the possible registration of Sputnik V, said that he would support its use in case of shortages of other vaccines.
The country has so far registered four vaccines — by Pfizer/BioNTech, AstraZeneca, Moderna, Johnson & Johnson.