The National Health Surveillance Agency (Anvisa) authorized, on Tuesday (24/8), the extension of the validity period of the Oxford/AstraZeneca vaccines against Covid-19. Upon release, the drug expires in nine months.
The agency’s board responded to the request of the Institute of Technology in Immunobiologicals (Bio-Manguinhos) to extend the period of doses manufactured by the Serum Institute, in India, and imported by the Oswaldo Cruz Foundation (Fiocruz). With the authorization of the Brazilian regulatory agency, the immunizing units, which previously expired in six months, can remain stored for a period of nine months, provided they are kept at a temperature between 2°C and 8°C.
Anvisa’s determination follows the decisions of the World Health Organization (WHO) and the Central Drugs Laboratory (CDL), an Indian laboratory responsible for the national control of immunobiological products.
“The approval by the CDL was based on data from stability studies conducted with experimental/clinical batches up to nine months and commercial batches up to six months, submitted by the Serum Institute of India Pvt Ltd (SII). These data allowed us to conclude on the possibility of extending the validity period to up to nine months”, informed Anvisa, in a note.
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