The Pfizer-BioNTech COVID-19 vaccine was given full approval for use in individuals 16 and older by the United States Food and Drug Administration on Aug. 13.
The vaccine had been available since Dec. 11, 2020, under the FDA’s emergency use authorization. The vaccine was given emergency use authorization for children ages 12 and older on May 10, 2021.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Acting FDA Commissioner Dr. Janet Woodcock said in a press release when the vaccine gained fulled approval.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
As more people weigh getting the fully approved vaccine as the delta variant of the virus surges, a common question often arises.
“How do I know what’s in the vaccine?”
According to information on the Centers for Disease Control’s website, there are 10 total ingredients in the Pfizer-BioNTech vaccine. Nine of those ingredients are inactive, and one is active.
With 10 ingredients, the Pfizer-BioNTech COVID-19 vaccine has fewer ingredients than an Extra Strength Tylenol, which has 15 ingredients, or a generic ibuprofen from a Walgreens drugstore, which has 13.
According to the CDC, the one active ingredient in the vaccine is nucleoside-modified mRNA that encodes the viral spike glycoprotein of SARS-CoV-2.
A glycoprotein is a type of protein that has carbohydrates attached to it, and this type of protein is what is found on the outside of the coronavirus. Since it is on the outside of the virus it is known as a “spike protein.”
The mRNA, or messenger ribonucleic acid, is a molecule that is read by ribosomes in human cells for the purposes of protein synthesis.
According to the CDC, the mRNA in the vaccine is encoded with instructions that, when read by ribosomes, direct cells to produce copies of the glycoprotein found on the outside of the COVID-19 virus. That “spike protein” is then displayed on the cells’ surface after it is produced, allowing the human immune system to recognize that the protein does not belong on the cells and build an immune response to the protein through antibodies. The immune system is then able to recall and neutralize the protein when it enters the body again attached to COVID-19, therefore also neutralizing the virus in the process.
The mRNA in the vaccine does not interact with human DNA in any way as it never enters the nucleus of the cell, which is where human DNA and genetic material is kept.
According to the CDC, the nine other inactive ingredients are used to safely deliver the delicate mRNA into cells, and many of these ingredients can be found in the foods people eat on a daily basis.
The inactive ingredients consist of sucrose, four salts, and four lipids which are fatty acids.
Sucrose, commonly known as table sugar, is a naturally occurring sugar in many fruits and vegetables that most people eat every day. It is also the sugar that is put in sweet tea and cookies.
The sucrose in the vaccine helps protect the vaccine ingredients when it is frozen for transport.
The four salts are sodium chloride, monobasic potassium phosphate, potassium chloride, and dibasic sodium phosphate dihydrate.
These salts help balance the acidity of the vaccine with the natural acidity of the of the human body. If the vaccine did not have the correct matching acidity, it would break down quickly before it was able to deliver its mRNA instructions.
Sodium chloride, also known as table salt, can be found in most every kitchen in America. It is the salt that is most commonly use for seasoning foods, and is also what gives the ocean its saltiness.
Potassium chloride is a common table salt substitute for those with sodium sensitivities, as it contains lower levels of sodium than regular table salt.
Dibasic sodium phosphate dihydrate is a salt often used as a thickening and baking agent in desserts and puddings such as Jell-O Instant Pudding.
Monobasic potassium phosphate can be found in common sports drinks such as Gatorade or Powerade.
The four lipids contained in the vaccine are (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol.
While their names may be long, these are simply nanolipids, which are basically tiny fat molecules. They help shield and stabilize the fragile mRNA in the vaccine. The fat molecules also provide an oily exterior that helps the mRNA slide through the lipid membranes of human cells.
According to the CDC, the vaccine does not contain any metals or any manufactured products such as microelectronics.
The Greene County Health Department at 810 W. Church St. is currently offering free COVID-19 vaccines, either drive-up or walk in. No appointment is necessary. However, those who prefer to make an appointment can go to tn.gov to reserve times for a first or second dose.
Adults aged 18 and older are eligible for all COVID-19 vaccines while children ages 12 and older are eligible for the Pfizer-BioNTech COVID-19 vaccine.
The Health Department is open 8:30 a.m.-4 p.m. Monday through Friday.