Since December of 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under an Emergency Use Authorization (EUA) for those who are 16 years and older. That same authorization was expanded in May to include individuals as young as 12. EUAs are granted by the Food and Drug Administration (FDA) for various reasons, such as a public health emergency, and authorize the use of medical products and treatments that may be effective in preventing a particular disease.
After analysis of the vaccine benefits, risks, and clinical trial data, the FDA has granted full approval of the two-dose Pfizer-BioNTech COVID-19 vaccine for those 16 and older. Because the vaccine has gone through a full review by a U.S. regulator, this approval means the Pfizer vaccine can now be marketed with other approved vaccines and drugs, so the vaccine now wears a ‘brand name’: Comirnaty (reads: koe-mir’-na-tee). Why Comirnaty?
According to the Pfizer and BioNTech, it, "represents a combination of the terms COVID-19, mRNA, community, and immunity."
Let's break that down:
co = COVID-19 (which in turn stands for COronaVIrus Disease 2019, the year it was discovered)
mirna = mRNA, the snippets of genetic code that tell cells to build proteins. In this case, the proteins on the COVID-19 spike protein
ty = some combination of community and immunity
This approval comes at a time when COVID cases are surging across the United States, mostly due to the extremely contagious Delta variant. It’s also likely that we will start to see more requirements around the vaccine now that it has the full FDA approval. Companies like Walmart and Disney have already told their employees that they must be fully vaccinated by Fall.
The vaccine is still under EUA for children ages 12 to 15 as Pfizer completes their trials before submitting for full approval. Pfizer and BioNTech also plan to ask the FDA to approve a third dose as a booster shot following full approval. Last week, the Biden administration said it was preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20.
Sources:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
About the Author: Taylor Genter
Taylor is the Marketing Specialist at Extract with experience in data analytics, graphic design, and both digital and social media marketing. She earned her Bachelor of Business Administration degree in Marketing at the University of Wisconsin- Whitewater. Taylor enjoys analyzing people’s behaviors and attitudes to find out what motivates them, and then curating better ways to communicate with them.