Anvisa decides to extend the validity period of Janssen’s vaccine

Remotely, the collegiate board of Anvisa (National Health Surveillance Agency) approved the extension of the validity period of the vaccine against Covid-19 developed by Johnson & Johnson. The decision was unanimous and raised the deadline from four and a half months to six months.

The change in the expiration date was requested by the company on September 15th. In Brazil, the immunizing agent is authorized for emergency use since March 31 this year.

According to Anvisa, in a note sent to the press, 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”.

“I emphasize that, according to the technical report, the company already has stability data of 6 months for at least 3 commercial batches in the multidose presentation. All parameters evaluated remained within specification for the times verified so far, without the observation of downward trend indicative of degradation”, says one of the parts of the decision.

Also according to the document that granted the authorization by Anvisa, the immunizing agent, which is manufactured using the so-called adenovirus, was even modified to produce an “immunological response” against Covid-19, without “causing cold symptoms”.

“After a person receives this vaccine, the body can temporarily produce the spike protein, which does not cause disease, but activates the immune system to learn to react defensively, producing an immune response against SARS-CoV-2”, explains the agency .