The new term approved by the regulatory agency changes from four and a half months to six months, under specific storage conditions, from 2°C to 8°C.
By Agency Brazil – Brasilia
The collegiate board of the National Health Surveillance Agency (Anvisa) unanimously approved the extension of the validity period of the Janssen (Johnson & Johnson) vaccine against covid-19. The term is extended from four and a half months to six months, under storage conditions of 2°C to 8°C.
Janssen-Cilag Farmacêutica requested, on September 15, a change in the validity period for the temporary authorization of emergency use, on an experimental basis, of the immunizing agent.
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According to Anvisa, the approval was based on a careful evaluation of the quality data of the studies that showed that the vaccine remained stable for a period of six months.
In Brazil, Janssen’s vaccine is authorized for emergency use since March 31 this year. The vaccine is the only one approved by Anvisa in a single dose and, when stored between temperatures of -25°C and -15°C, it has a shelf life of 24 months from the date of manufacture.