Determination on Pfizer COVID-19 vaccine

11 February 2021

An EPA decision-making committee has determined that the Pfizer COVID-19 vaccine is not a new organism.

The pharmaceutical company, Pfizer, applied to the EPA for a statutory determination of whether its COVID-19 vaccine is considered a new organism under the Hazardous Substances and New Organisms Act 1996.

An EPA decision-making committee has assessed the application, and determined that the vaccine is not a new organism and therefore is not regulated under HSNO.

There are no other applications relating to COVID-19 vaccines currently before the EPA.

Read the decision on the COVID-19 vaccine (PDF, 250 KB)