FDA fully approves Pfizer COVID-19 vaccine

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Joseph Zuloaga ’23, National and World Editor

The FDA fully approved the Pfizer COVID-19 vaccine on August 23, eight months after being authorized for emergency use. This is the first vaccine approved for full use in the United States and comes in the midst of the rise of cases in all 50 states as the Delta variant continues to ravage the country.

Because of the official complete approval, the brand name Comirnaty was given to the vaccine. Pfizer is now able to market and advertise the vaccine, something not authorized while it was under emergency approval. “Since some people who have been vaccine-hesitant claimed they were waiting for full FDA approval, hopefully it will mean they will now feel more confident getting the shot” asserted Biology teacher Colleen O’Rourke. “However, it is also clear that many people who have been avoiding the vaccine are casting around for excuses to support their previous beliefs, rather than basing decisions based on objective, scientific information. For these people, renaming the vaccine probably won’t be enough, as they will likely find some new excuse to avoid getting it.” 

She concluded, “In the end, total vaccination numbers are the only thing that matters in reaching community-wide herd immunity and we will just have to watch them to gauge how people are responding.”

Comirnaty is a mashup of the words “COVID-19,” “mRNA,” and “immunity,” meaning to evoke the word “community.” This puzzling name has been the recent tongue-twister for news reporters and has been poked fun at by late-night show hosts. 

Jimmy Fallon said that the name “sounds like a drunk person saying ‘community.” “I guess we ran out of pharmaceutical names. What is up with Comirnaty?” added Seth Meyers. “God, it’s like a riddle Tom Hanks would have to solve in ‘The Da Vinci Code’ to find the location of the Holy Grail.”

Regardless of roasts from comedians, this approval is extremely significant. This now gives validity to the claims of the Biden administration that the vaccines are “safe and effective” and shows that the vaccine has gone under additional review and further trials. 

Of these trials, Chemistry teacher Lauren Upadhyaya explained, “Two months of data on a vaccine are required for a vaccine to receive an emergency use authorization, while six months of data are needed for full approval.  The Pfizer vaccine, along with the other COVID-19 shots, underwent three phases of study before it received its emergency use authorization last December.” 

She continued, “The first and second phases of study investigated the kind of immune response the vaccines triggered and any harmful effects of the shots. The third phase of study looked into the efficacy of the vaccines by administering real and placebo doses to study participants. The review for full FDA approval looked at a larger sample of vaccine and placebo recipients over a longer period of time than the emergency approval review included.” 

The big question that looms over the vaccination effort is if the approval will change the minds of anti-vaxxers who had been repeatedly stating that they would not get vaccinated until the vaccine was FDA approved. 

Things are looking up. New data reports that more Americans are getting vaccinated following the full FDA approval to protect themselves from the Delta variant. 

Mason McKee ’23 stated, “Just like other vaccines, its design is to protect our community and that’s what it should be about.” 

He added, “Get the vaccine to protect your mom and dad, your grandma and grandpa, your neighbors, and your friends. We have the opportunity to help others, especially those who physically can’t take the vaccine, and during this pandemic, we are all in it together, and now isn’t a time to be selfish.” 

Only time will tell when the United States will finally return to the normality everyone desires.