Pfizer Has Received FDA Approval: What Does This Mean For Colorado?
The first COVID-19 vaccine has officially been FDA approved as of Monday morning. The FDA announced they have approved the Pfizer-BioNTech COVID-19 Vaccine for individuals who are 16 years and older.
Now that the vaccine has been granted approval, it will now be marketed as Comirnaty, according to the FDA. Although the vaccine has been FDA approved for anyone of and over the age of 16, it will still be available under the emergency use authorization for anyone ages 12 to 15 and for the additional third dose for immunocompromised individuals.
In order for the vaccine to gain FDA approval, it had to be evaluated on its data and information present in the submission of a biologics license application (BLA). According to the FDA, in the case of Comirnaty, "the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality and inspections of the sites where the vaccine is made".
What does this mean for Colorado?
Although no official changes or statements have been released, we're staying on top of any announcements coming from state, university, or school systems regarding the FDA approval.
Colorado State University previously stated in an email to incoming and returning students and staff that their COVID protocols would not include vaccination requirements. They were initially waiting on FDA approval to require a vaccine.
However, after staff submitted a formal request to have vaccine and mask mandates revisited with the swell of the Delta variant, CSU opted to require vaccines.
As far as the state of Colorado goes, while several businesses have individually started to require proof of vaccination, a statewide mandate has not gone into effect. Governor Jared Polis has spoken several times about how not one approach to COVID is enough to eliminate it, but he has said that vaccination is the best chance at protection for the people.
We will continue to monitor any announcements from government and city officials and continue to update as further information comes forward.