The National Health Surveillance Agency (Anvisa) approved, this Wednesday (27), the extension, to 12 months, of the period of validity of all batches of vaccine against covid-19 Comirnaty (Pfizer/Wyeth), in the presentations adult and pediatric, already imported and distributed by the Ministry of Health. Part of the imported batches has a validity period of nine months.
According to Anvisa, the approval allows the manufacturer to continue to import batches of Comirnaty vaccine that have a validity period of less than 12 months printed on the package. Once the doses are in Brazil, the company can apply the validity period of 12 months approved by Anvisa.
“This approval aims to speed up the offer of vaccines to the Brazilian population”, highlighted Anvisa in a statement.
“The exceptional approval to extend the validity of the batches already distributed is based on the approval of the petition to extend the shelf life, already approved by the Biological Products Management through Resolution – RE 1.231, of April 14, 2022, published in the Official Diary of the Union (DOU) on the 18th of April. The opinions issued by the Agency’s Registration and Sanitary Inspection areas were also considered,” the statement added.
Since April 2021, the Pfizer immunizer has been made available in the Unified Health System (SUS) through the National Operationalization Program for vaccination against covid-19. According to the pharmaceutical company, the vaccine is the most used in the country in the program to combat covid-19.
