Anvisa authorizes extension of the validity of the Comirnaty vaccine

The National Health Surveillance Agency (Anvisa) decided to extend the validity period of the Comirnaty vaccine, a monovalent vaccine against covid-19, produced by Pfizer, to 18 months.

Anvisa reported that the extension of the deadline applies to all presentations of the product produced from January 9, 2023 and authorized for use in children from 6 months of age, adolescents and adults. The previous validity was 12 months.

“The approval was based on new data from stability studies conducted by Pfizer. These studies demonstrated that there is no change in the vaccine quality specifications during the period additional to the previously authorized period”, said Anvisa.

The administration of batches already produced and distributed in the country, which are identified with a 12-month period, Pfizer was instructed by Anvisa to request an exceptional authorization for use.

“In this order, Pfizer must prove the proper traceability of the batches, so that health professionals and individuals who receive the vaccine can promptly verify the correct expiration date, at the time of its application”, determined Anvisa.

The agency also said that for the bivalent versions of the Comirnaty vaccine, vaccines that contain specific strains of the Ômicron variant of the virus that causes covid-19, there was no change in the previously approved deadline.

Translated to english by RJ983

From Brazil, by EBC News