3 Things to Know About the Pfizer Approval
On August 23, 2021, the Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech COVID-19 vaccine. The vaccine, now dubbed Comirnaty, is the first vaccine to be completely licensed for people ages 16 and older by the FDA.
Clearly, this is progress. But what, exactly, does it mean? Here are three things you should know about the licensing of Pfizer’s vaccine.
While the vaccines with emergency use approval (EUA) are tested rigorously for safety and effectiveness, Pfizer has had to provide a great deal more data on their results—a full six months’ worth following the administration of the second dose—as well as important details about their manufacturing process and facilities.
The approval bump
Doctors and public officials are hoping that Pfizer’s approval will instill some much-needed confidence in the country’s vaccination efforts. Since Comirnaty now has the same level of approval as the vaccines for chickenpox and tetanus, indications are that many individuals still on the fence may well decide to get vaccinated. According to one study, even a slight change in the public’s attitude could equate to millions of people finally queueing up to join the ranks of the vaccinated.
In addition to individuals having a change of heart, more government agencies and private companies like CareFirst are likely to adopt vaccine mandates for their employees. This, too, is likely to result in a marked increase in vaccinations.
Not (fully) approved for children
Comirnaty’s full approval doesn’t apply to children under the age of 16. While the Pfizer vaccine is still available for emergency use for individuals between 5 and 15, the data required is still a few months away.
Bonus: What’s in a name? You’re no doubt asking yourself what Pfizer’s marketing department has been up to while its scientists have been busy trying to save the world. Well, of course they were working on a name for what CNN described as “the most consequential vaccine in our lifetimes.”
So…Comirnaty? But a good deal of thought went into it, despite its lack of lyricism. Created by a real-live branding agency, the name is a mash-up of sorts, combining the term “COVID-19 immunity” with “mRNA”—a nod to the biotechnology behind the drug—wedged in the middle.
Well, we can’t all be biochemical engineers.