As Brazil is caught in the whirlwind of a deadly second wave witnessing over 8.45 million coronavirus infections till date, the country’s health
regulator has declined the request to approve the Russian-developed Sputnik V
vaccine for emergency use in Brazil, ANI reported.
The request does not comply with the minimal criteria for
this task, Russia’s TASS news agency reported.
“The request was returned to Uniao Quimica, because it does
not comply with the minimal criteria in particular, due to lack of permission
for third phase of clinical trials, as well as in regards to issue dealing with
the advanced production methods,” TASS quoted the Brazilian National Health
Surveillance Agency (Anvisa).
Brazil’s health regulator on Sunday granted emergency
authorisation to two COVID-19 vaccines as the country prepped for a mass
inoculation programme.
The health regulator approved vaccines from China’s Sinovac Biotech and Britain’s AstraZeneca
for emergency use in Brazil, which has recorded over two million deaths
since the disease struck the nation.
Also Read | Hard-hit Brazil approves first two COVID-19 vaccines: Regulator
Uniao Quimica, a partner of the Russian Direct Investment
Fund filed a request for emergency use of 10 million doses of the Sputnik V
vaccine in Brazil on Friday.
They came in touch with Anvisa in December, 2020 seeking
permission to conduct third phase of clinical trials for Sputnik V vaccine in
Brazil. After careful reviewing, the agency requested additional information on
the vaccine.