The collegiate board of the Health Surveillance Agency (Anvisa) unanimously approved a new presentation for the CoronaVac vaccine, with a 1ml vial containing two doses.
Anvisa reminds that, currently, there are two approved presentations for Coronavac: multidose vial, containing ten doses, and single dose vial, monodose.
The agency explained that this request by the Butantan Institute to include a new presentation is a demand from countries importing the vaccine, as it has a lower cost compared to the single-dose presentation. The approval by the agency took place yesterday (6).
Incorrect usage will be avoided
According to Anvisa, the new presentation and the single-dose presentation are manufactured exclusively by Sinovac Life Sciences, which has a valid Good Manufacturing Practices Certificate, issued by the agency.
The Butantan Institute will have to provide the state health secretariats and the National Immunization Program (PNI) with all information about the new presentation, including the 12-month validity period, package inserts and labeling in Portuguese, in order to avoid incorrect use .
The packaging in English of the new presentation will contain the alert “emergency use” printed on the cartridge, as well as the expiration date of 12 months approved by Anvisa.
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