Pfizer Vaccine: FDA Approved

Grace+Swift+%2812%29+getting+her+first+dosage+of+the+vaccine.++Photo+Credit%3A+Jeff+Swift

Grace Swift (12) getting her first dosage of the vaccine. Photo Credit: Jeff Swift

Alexandra Wiggins

After an extensive wait, the Food and Drug Administration (FDA) approved the Pfizer vaccine. On Aug. 23, they made their decision final for ages 16 and above. This approval has been a major leap for the United States regarding the Corona Virus pandemic. The vaccine was originally called Pfizer-BioNTech COVID-19 Vaccine, but now it will be known as the Comirnaty. This is a term formed from multiple words, “community, immunity, and mRNA, the technology used in the vaccine,” mentions Smithsonian Magazine.  

 

Since December of 2020, three COVID-19 vaccines have been granted the use of Emergency Use Authorization (EUA), where the FDA allows unmedically approved medicines to be used in the case of a health disaster, like a pandemic. These vaccines consist of Johnson & Johnson, Pfizer, and Moderna. Within this process though, some recipients of the Johnson & Johnson vaccine received a rare form of blood clot in the brain. This caused a halt in the distribution of this vaccine. Moderna has begun releasing qualification requests and submissions to the FDA for further development, but approval could take multiple weeks or even up to a year. Pfizer has officially been the first one to be approved out of the three through a Biological License Application.  

 

The process to approve a vaccine is tremendously extensive. The FDA must take multiple scientific steps regarding the vaccine itself and how it will affect the population. Without scientific study and research to begin with, the vaccine could go a variety of ways, both good and bad. Peter Marks, director of the FDA’s center for Biologics and Research Evaluation states, “We have evaluated scientific data and information included in hundreds of thousands of pages conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.” Since 1906, the FDA has been known as an organization that can be trusted when it comes to approval of drugs and vaccines because of the amount of research and work put into these experiments.  

 

The vaccine’s main ingredient is mRNA which causes cells to fight off the protein that the Corona Virus evokes when diagnosed. It essentially strengthens the recipient’s immune system in the case of receiving the virus. If a recipient receives the virus vaccinated, there is still a chance that they can spread it to other people. When vaccinated though, if one contracts the virus, the vaccine will help reduce the symptoms.

 

In a random survey of all grade levels, students had the choice to answer if they were fully vaccinated or not. The results showed that about 79.5% of students who responded are, whereas about 20.5% of students who responded are not. With the approval of the vaccine, the main goal was to get more people to get vaccinated. This approval should provoke not only people in the United States but also Roswell students to get vaccinated now that it has been scientifically approved.  

 

For further information on the reasons why it is safe to get the vaccine, click here