Brazilian health regulator Anvisa said it has serious doubts about Sputnik V’s safety and efficacy and defended its decision to block the COVID-19 vaccine for emergency use, saying Russia lacks vaccine experience and was defensive in its responses to the agency, The Wall Street Journal reported.
Gustavo Mendes, Anvisa’s medicines and biological products manager, said Monday that Brazil is concerned the vaccine could contain active adenovirus particles, responsible for the common cold, which could make recipients sick.
Mendes added that the country also had doubts about the methodology used in Sputnik’s clinical trials and whether the batch of doses that Brazil would receive would be identical to the shots tested in trials.
Both Chile and Colombia have sought further information from Brazil on Sputnik’s possible problems after Anvisa’s ruling last week, Mendes said.
Anvisa could still approve the shot if Russia’s Gamaleya Research Institute provides more information to prove its safety and efficacy, or adjusts its manufacturing process, he added.
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