FDA fully approves Pfizer Vaccine: here’s what you need to know

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Pfizer Inc.

The Pfizer-BioNTech COVID-19 Vaccine was approved by the FDA on August 23, 2021.

Lily Ha, Staff Writer

On Aug. 23, 2021 the U.S. Food and Drug Administration (FDA) officially approved the COVID-19 vaccine created by Pfizer, a bio-pharmaceutical company. This was the FDA’s first approval for a COVID-19 vaccine, which President Joe Biden called “another milestone, a key milestone, in our fight against COVID.” The Pfizer-BioNTech COVID-19 Vaccine will now be marketed under the name Comirnaty for the prevention of COVID-19 disease for individuals to those 16 years old and above. The vaccine is also available for the administration of a third dose for those immunocompromised and under emergency use authorization, specifically for individuals 12 through 15 years old.

 

The Pfizer-BioNTech Vaccine has been available under emergency use authorization in individuals 16 and above since Dec. 11, 2020, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2020. Emergency use authorizations have historically been used  by the Food and Drug Administration during public health emergencies to determine that the benefits of a product, when used against a disease, exceed any possible risk or harm. 

 

The FDA’s final approval to the Pfizer-BioNTech Vaccine could help to increase the number of people vaccinated. According to Our World in Data, 54.5 percent of individuals in the United States are fully vaccinated. This is also crucial, as the Coronavirus’ recent Delta variant is again increasing the case count for those infected. 

 

Pfizer plans to request the Food and Drug Administration for a booster shot by the end of September. The Centers for Disease Control and Prevention (CDC) are required to approve the booster shot after a discussion with the department committee. Both the Food and Drug Administration and the Centers for Disease Control and Prevention are trying to ensure that safety measures are put in place, in order to be evaluated by the planned deadline.

 

In Will County, there are several vaccination options available; however, there is some exclusive Pfizer information about getting the vaccine. The Will County Health Department has easy vaccine registration, specifically addressed to minors ages 12 to 17. It also states that the CDC recommends people whose immune systems are moderately to severely compromised should receive an additional dose of mRNA COVID-19 vaccine. This shot should be registered at least 4 weeks (minimum of 28 days) after their second dose, for a total of three doses. 

 

As the number of people vaccinated increases every day, many are expecting for the Pfizer vaccine approval to help turn things around, and hopefully, one day, have everything go back to normal.