State Institute for Drug Control says materials for Sputnik V assessment insufficient
The State Institute for Drug Control (SÚKL) says it has studied the materials received for the Russian Sputnik V coronavirus vaccine and concluded that they are insufficient for it to properly evaluate the risks and benefits.
Health Minister Petr Arenberger asked the institute for an evaluation in view of launching a clinical study. According to the SÚKL head Irena Storová no such request has been made to date.
The European Medicines Agency (EMA) has warned European Union members to refrain from granting national approval for Sputnik V until the agency reviews its safety and efficacy. The EMA also has complained about a lack of sufficient data.