Sinovac submits additional documents to Brazil's health regulator after shots suspended: company
By Leng Shumei Published: Sep 05, 2021 10:34 PM
Sinovac said it is closely working with Brazilian partner Institute of Butantan to submit additional documents to Anvisa, Brazil's health regulator, after it announced Saturday it was suspending the distribution of millions of Sinovac's COVID-19 vaccines for 90 days, as they were produced at an unauthorized plant.
According to media reports, Anvisa said in a statement on Saturday that it had determined the precautionary interdiction of batches of CoronaVac vaccine, prohibiting the distribution and use of batches in the plant not approved by the Authorization for Emergency Use (AUE).
Anvisa inspected Sinovac's filling lines in their Yongda site in Beijing in December 2020. At that time only one plant at the site was finished, Sinovac spokesperson Liu Peicheng told the Global Times on Sunday.
In order to increase the production capacity for global use, Sinovac built several new filling lines at the site after Anvisa's inspection, and these filling lines had already been inspected and approved by Chinese authorities in March 2021, Liu noted.
Media reports said that Anvisa would seek to inspect the new lines during the 90-day ban.
"So far, we have already submitted some documents including but not limited to product comparability report, process validation report and product stability report to Anvisa for the approval of GMP (Good Manufacturing Practices) on this site, and we are still closely working with our partner, Institute of Butantan, for some additional requirements of certain documents/data as per Anvisa's requirements," Liu said.
According to Liu, Anvisa's ban came after Butantan reported the new lines to Anvisa.
Sinovac's COVID-19 vaccine, CoronaVac, has been approved for emergency use or conditional marketing authorization in more than 50 authorities globally since January, 2021, according to Liu.
As of the end of August, 12.13 million CoronaVac doses had already entered Brazil in 25 batches. Another 17 batches containing a total of 9 million doses are being prepared for shipment. In total, more than 840 million doses of CoronaVac filled and packaged at this site have been distributed globally, according to Liu.
The government of Brazil's Sao Paulo state signed a contract in October, 2020, to receive 46 million doses of CoronaVac from Sinovac.
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