Pfizer Vaccine is FDA Approved – What Now?

Pfizer Vaccine is FDA Approved – What Now?

Pfizer Vaccine is FDA Approved – What Now?

With the Pfizer vaccine now approved by the FDA, some people wonder what that will mean for everyone, vaccinated and unvaccinated. Vaccines typically go through a rigorous process that the FDA monitors. When the pandemic broke out, the world was placed in a state of emergency. The world needed a quick solution to combat covid-19, so vaccines were released ahead of schedule to provide medical help. Since the Pfizer Vaccine is FDA Approved – What Now?

Process of Approving and Developing a Vaccine

When developing a vaccine, six stages in the developmental process are required by the FDA:

  1. Exploratory Stage 
  1. Pre-Clinical Stage 
  1. Clinical Development 
  1. Regulatory Review and Approval 
  1. Manufacturing 
  1. Quality Control

Step three of the developmental process, Clinical Development, contains three phases within itself. In Phase I, small groups of people receive trial vaccines. In Phase II, the clinical study is expanded to include characteristics (such as age, injury risk, and physical health) like those covered by the new vaccine. This is the normal process of a vaccine.

How Was the Pfizer Vaccine Released Early

The Pfizer vaccine was initially introduced in the U.S. under an emergency use authorization issued by the FDA, which permits it to expedite the delivery of medical products in times of public health emergencies. The vaccine was authorized for an emergency release after trials were done, proving the vaccine was over ninety percent effective. However, the FDA could not put their seal of approval on the vaccine at that time because it was released before all stages of the developmental process were complete. Because of the ninety percent approval rate, though, the Pfizer vaccine was granted its emergency authorization.

FDA Approval of the Pfizer Vaccine

Now that the FDA has put its stamp of approval on the vaccine, people can get vaccinated without fear of something going wrong. For those 16 and older, Pfizer’s shot has now been tested and reviewed as rigorously as dozens of other long-established vaccines. In addition to the FDA inspections of the production plants where vaccines are made, it required six months of follow-up data. FDA inspectors also reviewed each step of the production process for extra assurance that the shots are made under sterile conditions.

The Vaccine Does Not Prevent Transmission

Regardless of whether an individual has received the vaccine, they can still be exposed and infected. The vaccine is given to provide our bodies with the tools it needs to fight off the virus. Our bodies struggle to fight foreign infections because we have no antibodies built up to fight them. However, those given the vaccine were proven to have less severe symptoms, and they were sick for a shorter amount of time than those that were unvaccinated.

CDC’s Health and Safety Guidelines for Covid-19

The CDC (Center for Disease Control) released guidelines to help keep everyone safe: 

  • Always wear your mask. Your mask should fit snugly around your face and to your nose. When choosing your mask, choose a breathable fabric. Choosing a mask with a wire that fits over the brim of your nose is also very efficient in preventing any infection from entering the mask. 
  • Keep a distance of 6 feet between you and everyone else. 
  • Sanitize and disinfect. It would be very efficient always to have hand sanitizer and disinfecting wipes on you, as well as in your home. You need to make sure that you are wiping down all surfaces touched throughout the day by people. You should also sanitize smaller areas such as doorknobs, keyboards, and phones.  
  • Always wash your hands and sanitize if you touch your face or mask. 
  • Isolate people who are sick with Covid-19.

The pandemic has changed the world from the very first day it was discovered. It has taken lives and changed so many lives in the U.S. and across the globe. Pfizer has proven to be a large part of the answer to our battle with Covid-19. However, it is not the complete solution to getting the pandemic under control. Every individual should make sure that they receive the vaccination, if not for the people around them, but themselves. Our bodies need to learn how to fight this virus, and the vaccine is the solution to this problem. The vaccine does not prevent sickness, but we can by following the guidelines given to us by the CDC. Sanitizing, disinfecting, social distancing, and wearing our masks help combat Covid-19 alongside the vaccine.




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