Anvisa authorizes extension of the validity period of the Pfizer vaccine to 18 months

The National Health Surveillance Agency (Anvisa) authorized the extension of the period of validity of Pfizer monovalent vaccines against Covid-19, for 18 months.

According to Anvisa, the expansion applies to all presentations of the product produced as of today and authorized for use in children from 6 months of age, adolescents and adults.

The approval, according to Anvisa, was based on new data from stability studies carried out by Pfizer. The results demonstrated that there was no change in the vaccine quality specifications in the period additional to the previously authorized period.

For the management of batches already produced and distributed in the country, but which are identified with the old expiration date, the company was instructed to request an exceptional authorization for use from Anvisa.

In this order, Pfizer must demonstrate adequate batch traceability, so that healthcare professionals and individuals receiving the vaccine can readily verify the correct expiration date at the time of application.

For the bivalent versions of the immunizer, which contain specific strains of the Ômicron variant of the virus that causes Covid-19, there was no change in the previously approved deadline.

Source: CNN Brasil

You may also like