The suspension is for 90 days as an investigation is carried out, said Anvisa, the regulator, which announced the decision in a statement Saturday. The Butantan Institute, a Sao Paulo biomedical center that has partnered with Sinovac to fill the vaccine for local usage, notified Anvisa about the irregularity the prior day, the agency said.
"The manufacturing unit responsible for the filling was not inspected and was not approved by Anvisa," the regulator said in the statement. "Thus it is necessary to adopt a temporary measure to avoid the exposure of the population to a possible imminent risk."
Plans to distribute an additional 9 million doses of the same vaccine will be halted, as they were also filled at a location that was not inspected by health officials, Anvisa said in the statement.
The regulator said the suspensions were precautionary and not punitive. They aim to "avoid 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.
Anvisa and the Butantan Institute didn't immediately reply to requests for comment. Sinovac also did not immediately reply, but the Beijing-based company has previously blamed delays in deliveries to production bottlenecks and bureaucratic reasons such as export licenses.
The suspensions add to the general confusion surrounding Brazil's vaccine rollout, which has relied on Sinovac for many of its immunization shots.
Brazil's elderly have expressed concern about Sinovac's efficacy against the delta variant, pushing health officials to start administering third doses to older citizens in urban centers last week, despite delays in giving out second doses to the larger population, according to the Associated Press.
And though the number of vaccination shots administered to the public has increased in recent weeks, the country has fully vaccinated only 65.6 million people, or about 31 percent of its population, according to official figures. About 53 percent of the population in the United States has been fully vaccinated.
Meanwhile, Brazil has canceled 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.
Repeated remarks from President Jair Bolsonaro casting doubt on vaccines' efficacy have contributed to the lower-than-hoped-for vaccination rates, local health officials have said. But even among his most ardent supporters, public demand for immunization in Brazil appears to be on the rise, The Washington Post reported last month.
Those developments have coincided with drops in new infections and deaths caused by the coronavirus since earlier this year, and jumps in vaccination doses given to the public.
From March to June, about 500,000 Brazilians per week were infected with the deadly virus, while about 21,000 died in the worst week of that period. By contrast, about 171,000 individuals were infected with the coronavirus on the week of Aug. 29, while deaths numbered about 4,800, according to official figures.
In the same period, the weekly doses of vaccine shots administered has risen from under 5 million per week in March to above 10 million in August.
Brazil has been the second-worst-hit country during the pandemic, only after the United States, with more than 20 million infections and 580,000 deaths. The United States has logged nearly 40 million infections and almost 650,000 deaths.
Published : September 07, 2021