Brazil’s health authority, Anvisa, said late on Monday that
it would not recommend importing
Sputnik V, the
COVID-19 vaccine developed by
Russia.
اضافة اعلان
Brazil’s need for vaccines is urgent: It has been battered
by one of the world’s worst outbreaks, driven by the highly contagious P.1
virus variant.
But Anvisa said that important safety tests had not been
performed on Sputnik V, and that questions remained about the vaccine’s
development, safety, and manufacturing.
Data about the vaccine’s efficacy were “uncertain”, Gustavo
Mendes Lima Santos, Anvisa’s manager of medicine and biological products, said
in a lengthy presentation explaining the health authority’s decision. The
presentation said that there were “crucial questions” that had gone unanswered,
including concerns about potential adverse events, such as clotting.
Russia is using Sputnik V in its mass vaccination campaign,
and the vaccine has been approved for emergency use in dozens of other
countries. Its rollout has been entangled in politics and propaganda, with
President Vladimir Putin announcing its approval for use even before late-stage
trials began. For months, it was pilloried by Western scientists.
The Gamaleya Research Institute, part of Russia’s Ministry
of Health, developed the vaccine, also known as Gam-COVID-Vac. A peer-reviewed
study published in The Lancet in February said the vaccine had an efficacy rate
of 91.6 percent.
Skepticism from Western experts has focused mostly on its
early approval, not the vaccine’s design, which grew out of decades of research
on adenovirus-based vaccines. Other COVID-19 vaccines are also based on
adenoviruses, such as one from Johnson & Johnson using Ad26, and one by the
University of Oxford and AstraZeneca using a chimpanzee adenovirus.
While Sputnik V’s developers have yet to release detailed
data on adverse events observed during the trials, the Russian government has
been using the vaccine to inoculate its own citizens for months. Russia has
also exported Sputnik V to Belarus, Argentina, and other countries, suggesting
that any harmful side effects overlooked during trials would by now have come
to light.
As vaccine supply woes in Europe worsened, the European
Union’s drug regulator announced last month that it was reviewing the Sputnik V
vaccine after member nations began announcing they would acquire the shot on
their own.
Read more
region & world
.jpg)
.jpg)
