Doubts Mount About Efficacy of Russia's Sputnik Vaccine
https://www.voanews.com/europe/doubts-mount-about-efficacy-russias-sputnik-vaccine
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.”