Sputnik Vaccine as ‘Reliable as a Kalashnikov,’ Putin Says, But Doubts Persist 

Doubts are mounting about the efficacy of Russia’s Sputnik vaccine. Drug regulators in the Czech Republic and Brazil have withheld approval and counterparts in Slovakia have also expressed doubts.   

European Union regulators are still assessing Sputnik for its effectiveness and safety but a former executive director of the European Medicines Agency, EMA, told the Politico.eu news site that objections raised about Sputnik by Brazil’s regulatory authority, Anvisa, would likely be taken seriously by their counterparts in Brussels.  “It's a very mature authority,” said Rasi, who added that its flagging of quality and safety issues are worrisome. Anvisa announced on April 28 that it was withholding approval because of “flaws in product development” which deviate from the quality standards recommended by the World Health Organization (WHO).   The authority also noted “an absence or insufficiency of quality control, safety and efficacy data.” It raised concerns also with the vaccine’s efficacy for people “with low immunity and respiratory problems, among other health problems.” The Slovak medicines authority has also expressed worries about quality control and insufficient data. Irena Storová, head of SÚKL, told Slovakia’s Radiožurnál recently that the regulator received “only a fraction of the documentation that is submitted by default for the registration or assessment of a drug or medicine.”