One vaccine down, two more to go.
Under Emergency Use Authorization (EUA), the Pfizer-BioNTech vaccine has been available since Dec. 2020. Now, it now has the Food and Drug Administration's (FDA) approval for people over 16 years of age. However for those who are 12-15 years old the vaccine is under EUA.
The recent approval is not the only thing changing, the vaccine will now be marketed as Comirnaty.
While this is only one of three COVID-19 vaccines to be FDA approved, many people received the shot before having the backing of the FDA.
The University Health Services (UHS) is reporting 8,301 fully vaccinated individuals who received the vaccine from UHS and 176 active cases.
In a statement the FDA reports vaccines meeting the its standards for safety, effectiveness and quality are reviewed by the agency using data and information in the manufacturer’s submission of a biologics license application (BLA) according to the FDA.
This contains information supporting the vaccine’s EUA. Information includes the details of the manufacturing process, vaccine testing results, inspections where the vaccine is made, and preclinical and clinical data.
According to the FDA, the vaccine contains messenger RNA (mRNA). This mimics one of the proteins that causes COVID-19. The mRNA in the vaccine is in the body for a short amount of time and will not change a person’s genetic material.
While the vaccine is under a different name, the FDA said it is made out of the same genetic material and will continue to be given in two doses three weeks apart.