The Health Surveillance Agency (Anvisa) collective board has unanimously approved a new presentation for the CoronaVac vaccine, with 1 mL vials containing two doses.
Anvisa states that there are currently two approved presentations for Coronavac: a multi-dose vial, containing ten doses, and a single-dose, single-dose vial.
The agency explained that this request by the Butantan Institute to include a new presentation is a request from countries importing the vaccine, as the cost of the vaccine is lower compared to a single dose. Approved by the agency yesterday (6).
Incorrect use will be avoided
According to Anvisa, the new presentation and single-dose presentation are manufactured exclusively by Sinovac Life Sciences, which has a valid Good Manufacturing Practices certificate, issued by the agency.
The Putantan Institute will have to provide the state health departments and the National Immunization Program (PNI) with all information about the new presentation, including the 12-month validity period, package and label entries in Portuguese, to avoid incorrect use.
The packaging in English for new presentation will have an “emergency use” alert printed on the cartridge, as well as an Anvisa-approved 12-month expiration date.
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