Brazil’s health regulator has temporarily suspended the use of over 12.1 million doses of China’s Sinovac Covid vaccine over fears of the vials being contaminated, media reports said.
Anvisa, the regulator, suspended Sinovac for a period of three months after learning that vials containing the shots were filled at an unauthorised production base, the Washington Post reported. The matter is being investigated.
The Butantan Institute, a Sao Paulo based biomedical centre that has partnered with Sinovac to fill the vaccine for local usage, notified Anvisa about the irregularity, the agency said.
“The manufacturing unit responsible for the filling was not inspected and was not approved by Anvisa,” the report quoted Anvisa as saying in a statement, adding: “Thus it is necessary to adopt a temporary measure to avoid the exposure of the population to a possible imminent risk.”
Anvisa added that it has halted plans to distribute an additional 9 million doses of Sinovac, as they were also filled at a location that was not inspected by the health officials, the report said.
The regulator noted that the suspension is precautionary, and not punitive.
They aim to aceavoid use of irregular or suspect products,” Anvisa said. The lack of information about the environment at the production bases, combined with the need for vaccine shots to be made in strictly aseptic settings, persuaded officials to take the measure, Anvisa said.
Meanwhile, Brazil has cancelled deals from vaccine providers in recent weeks including 10 million doses of Russia’s Sputnik V and 20 million doses from India’s Bharat Biotech, adding to public worries about timely deliveries of second shots for the broader public, the Post reported.
Brazil has been the second worst-hit country by the pandemic after the US, with more than 20 million infections and 580,000 deaths.
According to official figures, Brazil has fully vaccinated 65.6 million people. Some cities in the country are also providing booster shots of the Covid vaccine, even though most people are yet to receive their second jabs, media reports said.