The sanitary regulator ofBrazil suspended the use of just over 12.1 million dosesof the coronavirus vaccine manufactured by the Chinese companySinovacafter knowing thatthe vials containing the vaccines were filled on an unauthorized production base.
Suspension is for 90 dayswhile an investigation is underway, claims Brazilianregulator, which announced the decision in a statement on Saturday. TheButantan Institute, a Sao Paulo biomedical center that has partnered with Sinovac to fill the vaccine for local use, notified Anvisa of the irregularity the day before, the agency said.
"The manufacturing unit responsible for the filling was not inspected and was not approved" the regulator said in the statement. "Therefore, it is necessary to adopt a temporary measure to avoid exposing the population to a possible imminent risk.".
Plans to distribute another 9 million doses of the same vaccine will also be halted., since they were also filled in a place that was not inspected by the health authorities, Anvisa said in the statement.
The regulator said the suspensions were preventive and not punitive. Its objective is "avoid using irregular or suspicious products", saidAnvisa. The lack of information on the environment of the production bases, combined with the need for vaccines to be manufactured in strictly aseptic environments, convinced authorities to take the measure, Anvisa said.
Brazilian authorities did not immediately respond to requests for comment. Sinovac also did not respond immediately, but the Beijing-based company has blamed delivery delays on production bottlenecks and bureaucratic reasons such as export licenses.
The suspensions add to the general confusion surrounding the rollout of the vaccine in Brazil, who has relied on Sinovac for many of his immunizations.
Older adults in Brazil have expressed concern about the efficacy of Sinovac against the delta variant, which has led the health authorities to start administeringthird dosesolder citizens in urban centers last week, despite delays in administering second doses to the general population, according toAssociated Press./AP
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