Brazil’s health regulator voted against importing the Russian Sputnik V coronavirus vaccine on Monday.
Anvisa said that due to lack of “consistent and reliable data”, its board had unanimously decided to recommend against the import of Sputnik V.
About 14 states in Brazil had appealed for an urgent import of Sputnik to counter a growing wave of Covid-19 infections.
Anvisa said that it was not flexible in terms of “product safety”.
Gustavo Mendes, the medicines and biological products manager of Anvisa, said that a crucial issue the board noticed was the presence of adenovirus in the vaccine, which could produce a “serious” defect.
The decision follows a previous statement from Anvisa, expressing “critical issues” around the effectiveness of the vaccine.
Russian scientists claim that the vaccine is 97.6% effective against Covid-19, based on data collected from 3.8 million people in a “real world” assessment.
The EU hasn’t yet approved the jab, saying it needs more information on the tests and manufacturing process.
However, it has been approved in several countries, including India, making it the third Covid-19 vaccine to be approved by the DCGI. The first batch is expected to reach India by the end of May, RepublicWorld is reporting.
Dr Reddy’s, a multinational pharmaceutical company in Hyderabad, and the Russian Direct Investment Fund (RDIF) started conducting clinical trials of Sputnik V in September 2020.
The vaccine will be imported in a frozen condition from RDIF.
A Dr Reddy’s official mentioned that domestic manufacturing of the vaccine is expected to get ramped up from Q2.
RDIF CEO Kirill Dmitriev has said it has partnered up with five Indian drug companies and he expects over 50 million doses to be manufactured in India by this summer.
India’s hope to control the current spread of the virus depends heavily on vaccination. However, new cases are currently climbing to record-breaking heights.